Assay Summary Tables

Assay Summary Tables

For use with the Access Family of Immunoassay Systems
This document is only appropriate for use outside the U.S.
February 2019
Revisions have been made to the Assay Summary Tables document based on the improved menu of assays
available for use on the Access Family of Immunoassay Systems.
The summary tables contain frequently referenced information for assays run on the Access systems, grouped
by assay type (Adrenal/Pituitary, Anemia, Blood Virus, Bone Metabolism, Cardiac, Diabetes, Infectious
Disease, Inflammation, Reproductive, Sepsis, Thyroid, Tumor Markers, and RUO assays). The summary
information is taken from the assay Instructions For Use (IFU) documents and other Access system
documentation. For a more thorough description of an assay and its performance characteristics, refer to its IFU.

NOTE
An assay may not be available for use on all systems. In addition, the assays that are available in your
country are dependent on the status of regulatory submissions. Contact your Beckman Coulter
representative if you have questions about the availability of particular assays.
Keep the Assay Summary Tables document where it is most convenient for your laboratory.

Table of Description of Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Contents Updating Your Document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Contact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Adrenal/Pituitary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Anemia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Blood Virus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Bone Metabolism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Cardiac. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Diabetes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Infectious Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Inflammation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Reproductive. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Sepsis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Thyroid. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Tumor Markers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Research Use Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

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Description of The Assay Summary Tables document has been updated to include new Access PCT
Changes information.
Information for all assays included in the Assay Summary Tables document has been
reviewed and updated to correspond to the current versions of the assay Instructions
for Use.

Updating Your Discard all previous versions of the Assay Summary Tables document
Document (P/N 387968A-K, B63375A-B, 2016-2155, 2017-3014, 2017-3765, 2017-4083 and
2018-4720), and replace with this version, 2019-5711.

Contact If you have any questions about this information, or for technical assistance regarding
the Access Family of Immunoassay Systems, contact Beckman Coulter.
• In Canada, contact Beckman Coulter Technical Support by phone at
1-800-854-3633, or online at www.beckmancoulter.com. Before using online
support the first time, you will need to register online.
• Outside Canada, contact your local Beckman Coulter representative.

NOTE
Be prepared to provide your system ID.

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Access Immunoassay Systems Assay Summary Tables

Adrenal/Pituitary

Cortisol

Adrenal/Pituitary
Test Name / LIS Code: Cortisol / Cort
Access & DxI/DxC
Test Number 119
Remisol Code A10
Catalog #s
Reagent 33600
Calibrator 33605
QC NA
Diluent* 33606 (S0)
Assay Type 1-Step Competitive
Minutes to 1st Result ~20
Reportable Range ~0.4–60 g/dL (11-1655 nmol/L)
SI Units Conversion Factor g/dL x 27.59
Sample Dilution if OVR 1/2
Analytical Sensitivity 0.4 g/dL (11 nmol/L)
Expected Values** See IFU
Days Stable: Curve 28
Days Stable: Open Pack 14
Expected Total Imprecision < 12% at ~ 5 g/dL (138nmol/L)
< 10% at > 5 g/dL
Sample Pickup 25 L
Sample Type Serum, Urine, Plasma (H, E)
Sample Avoid Turbidity, particulate matter,
multiple freeze/thaws
Sample Max. Time at:
RT 8 hours
2–8C 48 hours
-20C Undetermined
Sample Max. Thaws 1
Calibrator:
Levels, Form 6 @ 1 x 4 mL liquid
Storage, Stability 2–10C until exp.
Primary Standard USP
QC NA

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Anemia

EPO Ferritin,
EPO–Diluted*** Diluted Ferritin,
Ferritin–Diluted***
Anemia
EPO EPO–Diluted Ferritin/Dil. Fer Ferritin–Diluted
Test Name/LIS Code: EPO / EPO dEPO / dEPO Ferritin / Ferr d-Fer / d-Fer
Access & DxI/DxC Dil-Fer / dFer
Test Number 209 11209 125 11125
218 (Dil-Fer)
Remisol Code A81 A160 A19 A146
A83 (Dil-Fer)
Catalog #s
Reagent A16364 33020
Calibrator A16365 33025
QC NA NA
Diluent* S0, Samp. Dil. A (81908) S0, Samp. Dil. A (81908), or Wash Buffer II
Diluent Pack (Dilutions/Pack) A79783 (90) A79784 (102)
Assay Type 2-Site Sandwich 2-Site Sandwich
Minutes to 1st Result ~45 ~30
Reportable Range • ~0.6–750 mIU/mL (EPO) • ~0.2–1500 ng/mL (g/L) (Ferritin)
• ~637–4500 mIU/mL (dEPO) • 1300 – ~15,000 ng/mL (g/L) (Dil-Fer)
• ~1275–7500 ng/mL (g/L)(d-Fer)
SI Units Conversion Factor 1 1
Sample Dilution if OVR 1/6 or 1/11 1/6 Onboard 1/5 1/5 Onboard
Analytical Sensitivity  0.6 mIU/mL 0.2 ng/mL (g/L)
Expected Values** 2.59–18.50 mIU/mL F: 11.0–306.8 ng/mL (g/L)
M: 23.9–336.2 ng/mL (g/L)
Days Stable: Curve 28 28
Days Stable: Open Pack 28 28
Expected Total Imprecision 10%at > 3 mIU/mL < 10%
< 20% (Dil-Fer)
Sample Pickup 85 L 61 L 10 L 66 L
Sample Type Serum, Plasma (H) Serum, Plasma (H)
Sample Avoid Glass tube storage Gross hemolysis
Sample Max. Time at:
RT 8 hours 8 hours
2–8×C 24 hours 48 hours
-20×C Undetermined Undetermined
Sample Max. Thaws 3 1
Calibrator:
Levels, Form S0 1 x 10 mL liquid 6 @ 1 x 4.0 mL, liquid
S1–S5 1 x 2.5 mL liquid
Storage, Stability 2–10C until exp. or 90 days 2–10C until exp.
after initial use
Primary Standard WHO 2nd IRP 67/343 WHO 3rd IS 94/572
QC NA NA

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Folate
RBC Folate
Folate–Diluted***
Anemia
Traceable to WHO International Standard 03/178
Folate Folate–Diluted RBC Folate
Test Name/LIS Code: FOLW/ FOLW dFOLW/dFOLW RBCW/ RBCW
Access & DxI/DxC
Test Number 156 11156 157
Remisol Code A170 A172 A171
Catalog #s
Reagent A98032
Calibrator A98033
QC N/A
Diluent* S0 (A99250) Folate, or Wash Buffer II;
Lysing Reagent - RBC Folate (A14206)
Diluent Pack (Dilutions/Pack) A79784 (174)
Assay Type 2 -Step Competitive
(Online serum pretreatment; offline RBC pretreatment)
Minutes to 1st Result ~35
Reportable Range • ~1.0–24.8 ng/mL (2.27 – 56.2 nmol/L) (FOLW)
• ~21–50 ng/mL (~47.6 – 112.4 nmol/L) (dFOLW)
SI Units Conversion Factor ng/mL x 2.266
Sample Dilution if OVR 1/2 1/2 Onboard 1/2
Analytical Sensitivity < 0.80 ng/mL (< 1.81 nmol/L)
Expected Values** See IFU
Days Stable: Curve 28 days
Days Stable: Open Pack 14 days
Expected Total Imprecision  15% at > 2.0 ng/mL
 0.3 ng/mL SD at  2.0 ng/mL
Sample Pickup 55 L 155 L Manual 1/21 predil.
Sample Type Fasting Serum, Plasma (H) Whole Blood (E, H)
Sample Avoid Exposure to light, hemolysis
Sample Max. Time at:
RT Refrig. ASAP 1.5 hrs. (hemolysate)
2–8C 48 hours 4 hrs. (whole blood)
-20C 6 months See IFU (hemolysate)
Sample Max. Thaws 1
Calibrator:
Levels, Form 6 @ 1 x 4 mL, liquid
Storage, Stability -20C or colder until exp. / 2–10C for 90 days
Max. Thaw 1x
Primary Standard WHO IS 03/178
QC NA
Levels, Form:
Storage, Stability:

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Intrinsic Factor Ab sTfR

sTfR–Diluted***
Anemia
sTfR sTfR–Diluted
Test Name / LIS Code: IFAb / IFAb sTfR / sTfR dsTfR / dsTfR
Access & DxI/DxC
Test Number 194 245 11245
Remisol Code A72 A95 A155
Catalog #s
Reagent 387992 A32493
Calibrator 387993 A32494
QC 387999 B11056 (QC1) & B11057 (QC2 & QC3)
Diluent* NA S0 or Wash Buffer II
Diluent Pack (Dilutions/Pack) NA A79784 (70)
Assay Type 2 -Step Competitive 2 -Step Sandwich
Minutes to 1st Result ~35 ~35
Reportable Range NA See IFU ~128-1200
nmol/L (9.4-88.6
mg/L)
SI Units Conversion Factor NA nmol/L x 0.0738
Sample Dilution if OVR NA 1/8 or 1/15 1/8 Onboard
Analytical Sensitivity NA 0.05 nmol/L
Expected Values** See IFU See IFU
Days Stable: Curve 14 28
Days Stable: Open Pack 56 28
Expected Total Imprecision <10%  8% CVs at > 9nmol/L
 0.72 nmol/L SD at  9nmol/L
Sample Pickup 55 L 25 L 55 L
Sample Type Serum, Plasma (H) Serum, Plasma (H)
Sample Avoid Hemolysis, Plasma (E), None
Patients receiving B12
injections in the past week
Sample Max. Time at:
RT 8 hours 8 hours
2–8C 48 hours 7 days
-20C Undetermined Undetermined
Sample Max. Thaws 2 3
Calibrator:
Levels, Form 1 @ 2 x 4.0 mL, liquid S0 @ 1 x 4mL
S1-S5 @ 1 x 2.5 mL
Storage, Stability 2–10C until exp. or 56 days Unopened: 2–10C until exp.
after initial use Opened: 90 days @ 2-10C
Primary Standard Internal Internal
QC
Levels, Form: 2 @ 3 x 4.0 mL liquid QC1 @ 2 x 2.5 mL
QC2 and QC3 @ 2 x 2.5 mL / Level
Storage, Stability: Unopened: 2–10C until exp. Unopened: -20C until exp.
Opened: 2–10C for 56 days (thaw only 1x)
Opened: 90 days @ 2–10C

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Vitamin B12
Vitamin B12–Diluted***
Anemia
Vitamin B12 Vitamin B12–Diluted
Test Name / LIS Code: VitB12 / B12 dB12 / dB12
Access & DxI/DxC
Test Number 190 11190
Remisol Code A60 A161
Catalog #s
Reagent 33000
Calibrator 33005
QC NA
Diluent* S0 (33006) or Samp. Dil. A (81908)
Diluent Pack (Dilutions/Pack) A79783 (102)
Assay Type 2 -Step Competitive
(Online sample pretreatment)
Minutes to 1st Result ~40
Reportable Range • ~50–1500 pg/mL (37–1107 pmol/L) (VitB12)
• ~1275–7500 pg/mL (941–5533 pmol/L) (dB12)
SI Units Conversion Factor pg/mL x 0.7378
Sample Dilution if OVR 1/5 1/5 Onboard
Analytical Sensitivity 50 pg/mL (37 pmol/L)
Expected Values** 180–914 pg/mL
(133–675 pmol/L)
Days Stable: Curve 21
Days Stable: Open Pack 14
Expected Total Imprecision See IFU
Sample Pickup 45 L 66 L
Sample Type Serum, Plasma (H)
Sample Avoid Hemolysis
Sample Max. Time at:
RT 8 hours
2–8C 24 hours
-20C Undetermined
Sample Max. Thaws 1
Calibrator:
Levels, Form 6 @ 1 x 4.0 mL, liquid
Storage, Stability 2–10C until exp.
Primary Standard Internal
QC NA
Levels, Form:
Storage, Stability:

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Blood Virus

HAV Ab

Blood Virus
Test Name / LIS Code: HAVAb / HAVAb
Access & DxI/DxC
Test Number 140
Remisol Code A26
Catalog #s
Reagent 34200
Calibrator 34205
QC 34209
Diluent* Wash Buffer II
Assay Type 2-Step Competitive
Minutes to 1st Result ~50
Reportable Range • 0.0–80 mIU/mL
See IFU
SI Units Conversion Factor NA
Sample Dilution if OVR 1/11, 1/101, or 1/1001
Analytical Sensitivity NA
Expected Values** See IFU
Days Stable: Curve 28
Days Stable: Open Pack 28
Expected Total Imprecision < 10%
Sample Pickup 75 L
Sample Type Serum, Plasma (H, E, oxalate, citrate)
Sample Avoid NA
Sample Max. Time at:
RT 8 hours
2–8C 48 hours
-20C Undetermined
Sample Max. Thaws 3
Calibrator:
Levels, Form 5 @ 1 x 2.0 mL liquid
Storage, Stability 2–10C until exp.
Primary Standard WHO Ref. Preparation
QC
Levels, Form: 2 @ 3 x 3.5 mL liquid
Storage, Stability: 2–10C until exp.

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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HAV IgM HBc Ab

Blood Virus
Test Name / LIS Code: HAV-IgM / HAV-M HBc-Ab / HBcAb
Access & DxI/DxC
Test Number 141 143
Remisol Code A25 A27
Catalog #s
Reagent 34210 34240
Calibrator 34215 34245
QC 34219 34249
Diluent* NA NA
Assay Type 2-Step Sandwich 1-Step Sandwich
Minutes to 1st Result ~35 ~36
Reportable Range Reactive / Non reactive Reactive / Non reactive
See IFU
SI Units Conversion Factor NA NA
Sample Dilution if OVR NA NA
Analytical Sensitivity NA NA
Expected Values** See IFU See IFU
Days Stable: Curve 28 28
Days Stable: Open Pack 28 28
Expected Total Imprecision See IFU < 10% with Reactive Samples
Sample Pickup 10 L 5 L
Sample Type Serum, Plasma (H, E, citrate) Serum, Plasma (H, E, citrate)
Sample Avoid NA Hemolysis, turbidity,
heat-inactivated
Sample Max. Time at:
RT 8 hours 8 hours
2–8C 48 hours 48 hours
-20C Undetermined Undetermined
Sample Max. Thaws 1 1
Calibrator:
Levels, Form 2 @ 1 x 1.0 mL liquid 2 @ 1 x 1.0 mL liquid
Storage, Stability 2–10C until exp. 2–10C until exp.
Primary Standard Internal Internal
QC
Levels, Form: 2 @ 3 x 2.5 mL liquid 2 @ 3 x 2.0 mL liquid
Storage, Stability: Unopened: 2–10C until exp. Unopened: 2–10C until exp.
Opened: 30 days Opened: 30 days

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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HBc IgM HBs Ab

Blood Virus
Test Name / LIS Code: HBc-IgM / HBc-M HBAb3 / HBAb3
Access & DxI/DxC
Test Number 142 247
Remisol Code A28 A107
Catalog #s
Reagent 34250 A24296
Calibrator 34255 A24297
QC 34259 A24298
Diluent* NA Negative human serum
Assay Type 2-Step Sandwich 1-Step Sandwich
Minutes to 1st Result ~35 ~55
Reportable Range Reactive / Non reactive 0– ~750 mIU/mL
See IFU
SI Units Conversion Factor NA NA
Sample Dilution if OVR NA See IFU
Analytical Sensitivity NA • 1.87 mIU/mL with
WHO 1st IRP (W1042;
17-2-77)
• 0.81 mIU/mL with
SFTS Panel (02/08.02.22C)
Expected Values** See IFU See IFU
Days Stable: Curve 28 56
Days Stable: Open Pack 28 56
Expected Total Imprecision < 10% with Reactive Samples 10% with Reactive Samples
Sample Pickup 10 L 110 L
Sample Type Serum, Plasma (H, E, citrate) Serum, Plasma (Na or Li H)
Sample Avoid Hemolysis, turbidity, Microbial contamination;
heat-inactivated Turbid samples - See IFU
Sample Max. Time at:
RT 8 hours 8 hours
2–8C 48 hours 4 days
-20C Undetermined Undetermined
Thawed samples, or those
stored > 8 hours -See IFU for
processing information
Sample Max. Thaws 1 5
Calibrator:
Levels, Form 2 @ 1 x 1.0 mL liquid 6 @ 1 x 2.5 mL liquid
Storage, Stability 2–10C until exp. Unopened: 2–10C until exp.
Opened: 90 days @ 2-10C
Primary Standard Internal WHO 1st IRP (W1042,
Lot no. 17-2-77)
QC
Levels, Form: 2 @ 3 x 2.5 mL liquid 2 @ 3 x 3.5 mL liquid
Storage, Stability: Unopened: 2–10C until exp. Unopened: 2–10C until exp.
Opened: 30 days Opened: 90 days

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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HBs Ag
HBs Ag Confirmatory
Blood Virus
Test Name / LIS Code: HBsAgV3 / HBsAg HBsBkV3 / HBsBk &
Access & DxI/DxC HBsCtV3 / HBsCt
Test Number 223 239 & 238
Remisol Code A98 A99 & A100
Catalog #s
Reagent A24291 A24295
Calibrator A24292 A24292
QC A24294 A24294
Diluent* NA Wash Buffer II
Assay Type 1-Step Sandwich 1-Step Sequential
Minutes to 1st Result ~55 ~55
Reportable Range Reactive / Confirmed /
Non reactive Non confirmed
See IFU See IFU
SI Units Conversion Factor NA
Sample Dilution if OVR See IFU See IFU
Analytical Sensitivity 0.1 ng/mL NA
(with French SFTS
2005 panel)
Expected Values** See IFU
Days Stable: Curve 56
Days Stable: Open Pack 56
Expected Total Imprecision 10% with 10% with
Reactive Samples Reactive Samples
Sample Pickup 110 L 2 x 110 L
Sample Type Serum, Plasma (E, citrate, H, ACD)
Sample Avoid Turbidity, particulate matter, fibrin
Sample Max. Time at:
RT 8 hours
2–8C 4 days
-20C Undetermined
Sample Max. Thaws 5
Calibrator:
Levels, Form 2 @ 1 x 2.7 mL/vial
Storage, Stability 2–10C until exp. or 90 days after
initial use
Primary Standard Internal
QC
Levels, Form: 2 @ 3 x 4.0 mL liquid
Storage, Stability: Unopened: 2–10C or -20C until exp.
Opened: 2–10C 56 days

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Access HCV Ab Plus* Access HCV Ab V3* Access HIV combo*

Blood Virus
Test Name / LIS Code: HCVPLUS / HCVAb HCV-V3/HCV-3 HIVco / HIVco
Access & DxI/DxC
Test Number 148 276 262
Remisol Code A34 A185 A167
Catalog #s
Reagent 34330 B33458 A59428
Calibrator 34335 B33459 A59429
QC 34339 B33460 A59430 (Neg, HIV-1 Ab, HIV-1 Ag)
Diluent NA NA NA
Assay Type Indirect 2-Step Indirect 2-Step 2-Step Sandwich
Minutes to 1st Result ~55 ~57 ~60
Reportable Range Reactive / Non reactive Reactive / Non reactive Reactive / Non reactive
See IFU See IFU See IFU
SI Units Conversion Factor NA NA NA
Sample Dilution if OVR NA NA NA
Analytical Sensitivity See IFU See IFU <2 IU/mL to HIV-1 p24 Ag
Expected Values See IFU See IFU See IFU
Days Stable: Curve 28 56 56
Days Stable: Open Pack 28 28 56
Expected Total Imprecision <10% <10% <10%
Sample Pickup 25 L 10 L 110 L
Sample Type Serum, Plasma (EDTA, citrate, H) Serum, Plasma (See IFU) Serum, Plasma (Li H)
Sample Avoid Fibrin and cellular material Fibrin and cellular material Fibrin and cellular material
Sample Max. Time at:
RT 8 hours 4 days 24 hours
2–8C 48 hours 7 days 8 days
-20C Undetermined Undetermined Undetermined
Thawed Samples - See IFU for Thawed Samples - See IFU for Thawed Samples - See IFU for
processing information processing information processing information
Sample Max. Thaws 1 5 3
Calibrator:
Levels, Form 2 @ 1 x 1 mL liquid 2 @ 1 x 1 mL liquid 2 @ 1 x 1.7 mL liquid
Storage, Stability 2–10C until exp. Unopened: 2–10C until exp. Unopened: 2–10C until exp.
Opened: 2–10C 120 days Opened: 2–10C 120 days
Primary Standard Internal Internal Internal
QC:
Levels, Form: 2 @ 3 x 2.5 mL liquid 2 @ 2 x 3.5 mL liquid 3 @ 2 x 4.4 mL, liquid
Storage, Stability: Unopened: 2–10C until exp. Unopened: 2–10C until exp. Unopened: 2–10C until exp.
Opened: 2–10C 30 days Opened: 2–10C 120 days Opened: 2–10C 120 days
*Available through partnership with Bio-Rad. Bio-Rad and the Bio-Rad logo are registered
trademarks of Bio-Rad Laboratories, Inc.
NOTES:
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.
• The contents of this page are under the control of Bio-Rad.

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Bone Metabolism

Ultrasensitive hGH Ostase

Ultrasensitive hGH–Diluted*** Ostase–Diluted***
Bone Metabolism
Ultrasensitive hGH Ultrasensitive hGH–Diluted Ostase Ostase–Diluted
Test Name / LIS Code: hGH2 / hGH2 dhGH2 / dhGH2 Ostase / Ostas dOst / dOst
Access & DxI/DxC
Test Number 232 11232 153 11153
Remisol Code A92 A123 A12 A129
Catalog #s
Reagent 33580 37300
Calibrator 33585 37305
QC NA 37309
Diluent* S0 or Samp. Dil. A (81908) Sample Dil. A (81908)
Diluent Pack (Dilutions/Pack) A79783 (174) A79783 (123)
Assay Type 1-Step Sandwich 1-Step Sandwich
Minutes to 1st Result ~42 ~30
Reportable Range • ~0.002–35 ng/mL (g/L) (hGH2) • 0.1 – ~120 g/L (Ostase)
• ~34–70 ng/mL (g/L) (dhGH2) • ~102–360 g/L (dOst)
SI Units Conversion Factor 1 NA
Sample Dilution if OVR 1/2 1/2 Onboard 1/3, 1/5, or 1/10 1/3 Onboard
Analytical Sensitivity 0.002 ng/mL 0.1 g/L
Expected Values** F: 0.010–3.607 ng/mL Males: 20.1 g/L
M: 0.003–0.971 ng/mL Females:
Premen.:  14.3 g/L
Post men.:  22.4 g/L
Days Stable: Curve 56 42
Days Stable: Open Pack 28 42
Expected Total Imprecision < 20% at ~0.007 ng/mL See IFU
< 10% at 0.007–0.07 ng/mL
< 8% at > 0.07 ng/mL
Sample Pickup 25 L 155 L 25 L 110 L
Sample Type Serum, Plasma (H) Serum, Plasma (Na or Li H)
Sample Avoid NA Turbidity
Sample Max. Time at:
RT 8 hours 24 hours
2–8C 48 hours 48 hours
-20C Undetermined NA
2 months @ -70C
Sample Max. Thaws 2 Undetermined
Calibrator:
Levels, Form 6 @ 1 x 2.0 mL lyophilized 6 @ 1 x 2.5 mL liquid
Storage, Stability 2–10C until exp. Unopened: 2–10C until exp.
(Reconst. 2 mos. at 2–10C) Opened: 2–10C for 58 days
Primary Standard WHO 2nd IS 98/574 Internal
QC NA
Levels, Form: 2 @ 1 x 4 mL liquid
Storage, Stability: Unopened: 2–10C until exp.
Opened: 2–10C for 58 days

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Intact PTH
Intact PTH–Diluted***
Bone Metabolism
Intact PTH Intact PTH–Diluted
Test Name / LIS Code: PTH / PTH (routine) dPTH / dPTH(routine)
Access & DxI/DxC PTHIO / PTHIO (intraoperative) dPTHi / dPTHi (intraoperative)
Test Number 214 (PTH) 11214 (dPTH)
215 (PTHIO) 11215 (dPTHi)
Remisol Code A85 (PTH) A134 (dPTH)
A86 (PTHIO) A135 (dPTHi)
Catalog #s
Reagent A16972
Calibrator A16953
QC NA
Diluent* Sample Dil. A (81908)
Diluent Pack (Dilutions/Pack) A79783 (60)
Assay Type 1-Step Sandwich
Minutes to 1st Result ~30 (PTH)
~15 (PTHIO)
Reportable Range • 1 – ~3500 pg/mL (0.1 – 371 pmol/L) (PTH)
• 6 – ~3500 pg/mL (0.6 – 371 pmol/L) (PTHIO)
• ~2975 – 35,000 pg/mL (316 – 3714 pmol/L) (dPTH & dPTHi)
SI Units Conversion Factor pg/mL x 0.106
Sample Dilution if OVR 1/10 1/10 Onboard
Analytical Sensitivity • PTH: 1 pg/mL (0.1 pmol/L)
(<4 pg/mL functional) (< 0.4 pmol/L)
• PTHIO: 6 pg/mL (0.6 pmol/L)
(<8 pg/mL functional) (< 0.8 pmol/L)
Expected Values** 12 – 88 pg/mL (1.3 – 9.3 pmol/L)
Days Stable: Curve 28
Days Stable: Open Pack 28
Expected Total Imprecision  8% above 12 pg/mL (1.3 pmol/L)(PTH/dPTH)
 12% above 12 pg/mL (1.3 pmol/L)(PTHIO/dPTHi)
Sample Pickup 55 L 50 L
Sample Type Serum, Plasma (H, E)
Sample Avoid Lipemic, hemolysis
Sample Max. Time at: Serum Plasma (H,E)
RT 4 hours 8 hours
2–8C 8 hours 48 hours
-20C 6 months 6 months

Sample Max. Thaws 3

Calibrator:
Levels, Form 6 @ 1 x 1 mL lyophilized
2 x 4 mL reconstitution buffer
Storage, Stability Lyophilized Calibrators and reconstitution buffer: 2–10C until
exp. Reconstituted: 2 hours @ 18 – 25C; 10 hours @ 2 – 10C
Primary Standard WHO 79/500
QC NA
Levels, Form:
Storage, Stability:

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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25(OH) Vitamin D Total 25(OH) Vitamin D Total

For use on Access 2 and For use on UniCel DxI 600 and 800, and
UniCel DxC 600i UniCel DxC 880i, 860i, 680i, and 660i
Bone Metabolism Integrated Workstations

Test Name / LIS Code: VitdA / VitdA VitdD / VitdD

Access & DxI/DxC
Test Number 272 271
Remisol Code A182 A181
Catalog #s
Reagent B24838 A98856
Calibrator B24839 A98857
QC NA NA
Diluent* Do not dilute Do not dilute
Assay Type Two-step competitive
Minutes to 1st Result 39
Reportable Range 2.0 - 167 ng/mL (5.0 - 418 nmol/L) 2.00 - 210 ng/mL (5.0 - 525 nmol/L)
SI Units Conversion Factor 2.5
Sample Dilution if OVR NA
Analytical Sensitivity • LoB 1.50 ng/mL (3.75 nmol/L) • LoB 1.50 ng/mL (3.75 nmol/L)
• LoD 2.0 ng/mL (5.0 nmol/L) • LoD 2.00 ng/mL (5.0 nmol/L)
• LoQ 7.0 ng/mL (17.5 nmol/L) (20% CV) • LoQ 7.0 ng/mL (17.5 nmol/L) (20% CV)
Expected Values** See IFU
Days Stable: Curve 28
Days Stable: Open Pack 28
Expected Total Imprecision 10.0% CV for samples > 15.0 ng/mL (37.5 nmol/L) and
Total SD  1.5 ng/mL (3.8 nmol/L) at concentrations  15.0 ng/mL
Sample Pickup 30 L
Sample Type Serum, Plasma (LiH)
Sample Avoid lipemic or hemolyzed
Sample Max. Time at:
RT 72 hours
2–10C 7 days
-20C 1 year
Sample Max. Thaws 3
Calibrator:
Levels, Form 6 @ 1 x 1.4 mL

Storage, Stability -15 to -30C until exp. or

56 days at 2–10C (do not refreeze)
Primary Standard NIST-Ghent ID-LC-MS/MS RMP
QC NA
Levels, Form:
Storage, Stability:

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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AccuTnI
This product is being replaced world wide with hsTnI as
registrations are obtained. AccuTnI and AccuTnI+3 will be
discontinued, please check with your local
Beckman Coulter Representative for product availability.
Cardiac
Test Name / LIS Code: TropI / TropI
Access & DxI/DxC
Test Number 275
Remisol Code A115
Catalog #s
Reagent A78803
Calibrator 33345
QC NA
Diluent* NA
Assay Type 2-Site Sandwich
Minutes to 1st Result ~13
Reportable Range ~0.01–100 ng/mL (g/L)
SI Units Conversion Factor 1
Sample Dilution if OVR NA
Sensitivity 0.01 ng/mL
Expected Values** URL: 0.04 ng/mL (99 ptl.)
AMI cutoff: 0.50 ng/mL (Serum, Plasma-LiH)
Days Stable: Curve 56
Days Stable: Open Pack 56
Expected Total See IFU
Imprecision
Sample Pickup 55 L
Sample Type Recommended: Plasma (LiHep)
Acceptable: Serum, Plasma (LiHep, EDTA)
(Plasma-EDTA outside US only)
Sample types not interchangeable - See IFU
Sample Avoid Turbidity, particulate matter, fibrin
Sample Max. Time at:
RT 2 hours
2–8C 24 hours
-20C 6 months
Sample Max. Thaws 1 (avoid water bath)
Calibrator:
Levels, Form 6 @ 1 x 1.0 mL liquid

Storage, Stability Unopened: -20°C until exp.

Opened: 2-10C for 60 days
Primary Standard Internal
QC N/A
Levels, Form:
Storage, Stability:

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information

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hsTnI AccuTnI+3 AccuTnI+3

hsTnI–Diluted***
For use on Access 2 and For use on
UniCel DxI 600 and 800, and
UniCel DxC 600i
Cardiac UniCel DxC 880i, 860i, 680i, and
hsTnI hsTnI–Diluted 660i Integrated Workstations
Test Name / LIS Code: hsTnI dhsTn TnIA2/TnIA2 TnIDx/TnIDx
Access & DxI/DxC
Test Number 299 11299 154 288
Remisol Code A195 A196 A175 A176
Catalog #s
Reagent B52699 B52699 A98143 A98264
Calibrator B52700 B52700 A98144 A98265
QC NA NA NA NA
Diluent* 81908 A79783 Do not dilute Do not dilute
Assay Type 2-Site Sandwich 2-Site Sandwich
Minutes to 1st Result ~17 ~13
Reportable Range 2.3 - ~27,027 pg/mL See IFU
SI Units Conversion 1 1
Factor
Sample Dilution if OVR 1/10 1/10 Onboard NA
Sensitivity LoB: 1.7 pg/mL See IFU
LoD: 2.3 pg/mL
LoQ: 10% CV: 5.6 pg/mL; 20% CV: 2.3 pg/mL
Expected Values** 99th percentile URL (95% CI) See IFU
Females: 11.6 pg/mL (8.4 - 18.3)
Males: 19.8 pg/mL (14.0 - 42.9)
Overall: 17.5 pg/mL (12.6 - 20.7)
Days Stable: Curve 63 56
Days Stable: Open Pack 64 56
Expected Total 10% for concentrations 11.5 pg/mL 8% for samples > 0.075 ng/mL and
Imprecision 1.15 pg/mL for concentrations < 11.5 pg/mL Total SD  0.006 ng/mL (g/L)
at concentrations  0.075 ng/mL (g/L)
Sample Pickup 55 L 50 L 55 L
Sample Type Recommended: Serum, Plasma (LiHep) Recommended: Serum, Plasma (LiHep)
Acceptable: Serum, Plasma (LiHep, EDTA) Acceptable: Serum, Plasma (LiHep, EDTA)
(Plasma-EDTA outside US only) (Plasma-EDTA outside US only)
Sample types not interchangeable - See IFU Sample types not interchangeable - See IFU
Sample Avoid Particulate matter, fibrin, short samples Turbidity, particulate matter, fibrin
Sample Max. Time at:
RT 8 hours 2 hours
2–8C 48 hours 24 hours
-20C 180 days (do not freeze EDTA plasma) 6 months
Sample Max. Thaws 1 (avoid water bath) 1 (avoid water bath)
Calibrator:
Levels, Form 3 @ 1 x 1.5 mL liquid (S0-S2) S0 - S1 @ 1 x 1.5 mL liquid
4 @ 1 x 1.0 mL liquid (S3-S6) S2 - S5 @ 1 x 1.0 mL liquid
Storage, Stability Unopened: -15 to -30°C until exp. Unopened: -20°C until exp.
Opened: 2-10C for 64 days Opened: 2-10C for 60 days
Primary Standard Internal Internal
QC N/A N/A
Levels, Form:
Storage, Stability:

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.

• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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CK-MB
CK-MB–Diluted***

Cardiac
CK-MB CK-MB–Diluted
Test Name / LIS Code: CK-MB / CK-MB dCKMB / dCKMB
Access & DxI/DxC
Test Number 163 11163
Remisol Code A49 A117
Catalog #s
Reagent 386371
Calibrator 386372
QC NA
Diluent* Samp. Dil. A (81908)
Diluent Pack (Dilutions/Pack) A79783 (174)
Assay Type 1-Step Sandwich
Minutes to 1st Result ~15
Reportable Range • ~0.1–300 ng/mL (g/L) (CK-MB)
• ~255–600 ng/mL (g/L) (dCKMB)
SI Units Conversion Factor 1
Sample Dilution if OVR 1/2 1/2 Onboard
Analytical Sensitivity < 0.1 ng/mL
Expected Values** 0.6–6.3 ng/mL (Serum, Plasma-LiH)
0.5-5.0 ng/mL (Plasma-E)
Days Stable: Curve 56
Days Stable: Open Pack 56
Expected Total Imprecision 8% across range
Sample Pickup 55 L 155 L
Sample Type Recommended: Plasma-LiH
Acceptable: Serum, Plasma-E
Sample types not interchangeable - See
IFU
Sample Avoid Lipemic, hemolysis, icterus, turbidity,
fibrin, or particulate matter
Sample Max. Time at:
RT 8 hours
2–8C 48 hours
-20C Undetermined
Sample Max. Thaws 1 (avoid water bath)
Calibrator:
Levels, Form 6 @ 1 x 2.0 mL liquid
Storage, Stability Unopened: 2–10C until exp.
Opened: 2-10°C for 60 days
Primary Standard AACC/IFCC Intl. Ref. Mtl.
QC NA
Levels, Form:
Storage, Stability:

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Digoxin Myoglobin
Digoxin–Diluted*** Myoglobin–Diluted***
Cardiac
Digoxin Digoxin–Diluted Myoglobin Myoglobin–Diluted
Test Name / LIS Code: Dig / Dig- dDig / dDig MYO / MYO dMYO / dMYO
Access & DxI/DxC
Test Number 117 11117 162 11162
Remisol Code A11 A150 A30 A128
Catalog #s
Reagent 33710 973243
Calibrator 33715 973244
QC NA NA
Diluent* S0 (33716), Samp. Dil. A (81908) Samp. Dil. A (81908)
Diluent Pack (Dilutions/Pack) A79783 (174) A79783 (60)
Assay Type 1-Step Competitive 1-Step Sandwich
Minutes to 1st Result ~20 ~15
Reportable Range • ~0.20–6.0 ng/mL (0.3–7.7 nmol/L) (Dig) • ~1-4000 ng/mL (g/L) (MYO)
• ~5.1–12 ng/mL (6.5–15.4 nmol/L) (dDig) • ~3400–40,000 ng/mL (g/L) (dMYO)
SI Units Conversion Factor ng/mL x 1.281 1
Sample Dilution if OVR 1/2 1/2 Onboard 1/10 1/10 Onboard
Analytical Sensitivity 0.2 ng/mL (0.3 nmol/L) < 1 ng/mL
Expected Values** See IFU See IFU
Days Stable: Curve 28 56
Days Stable: Open Pack 14 56
Expected Total Imprecision  10%  10%
Sample Pickup 55 L 155 L 20 µL 50 µL
Sample Type Serum Recommended: Plasma (LiH)
Acceptable: Serum, Plasma (H, E)
Sample types not interchangeable -
See IFU
Sample Avoid See IFU Lipemia, hemolysis
Sample Max. Time at:
RT 8 hours 8 hours
2–8C 48 hours 24 hours
-20C Undetermined Undetermined
Sample Max. Thaws 1 1
Calibrator:
Levels, Form 6 @ 1 x 4.0 mL liquid 6 @ 1 x 1.0 mL liquid
Storage, Stability 2–10C until exp. Unopened: -20C until exp.
Opened: 2-10C for 60 days
Primary Standard USP Internal
QC NA NA

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Diabetes

Ultrasensitive Insulin
Ultrasensitive Insulin–Diluted***
Diabetes
Ultrasensitive Ultrasensitive
Insulin Insulin–Diluted
Test Name / LIS Code: Insulin / Insul dIns / dIns
Access & DxI/DxC
Test Number 182 11182
Remisol Code A40 A127
Catalog #s
Reagent 33410
Calibrator 33415
QC NA
Diluent* S0 or Samp. Dil. A (81908)
Diluent Pack (Dilutions/Pack) A79783 (60)
Assay Type 1-Step Sandwich
Minutes to 1st Result ~40
Reportable Range • ~0.03–300 IU/mL (0.21–2100 pmol/L) (Insulin)
• ~255–3000 IU/mL (1785–21,000 pmol/L)(dIns)
SI Units Conversion Factor IU/mL x 7.0
Sample Dilution if OVR 1/10 1/10 Onboard
Analytical Sensitivity 0.03 IU/mL (0.21 pmol/L)
Expected Values** 1.9–23 IU/mL (13.0 – 161 pmol/L)
Days Stable: Curve 28
Days Stable: Open Pack 28
Expected Total Imprecision < 10%
Sample Pickup 20 L 50 L
Sample Type Serum, Plasma (E)
Sample types not interchangeable -see IFU
Sample Avoid Hemolysis
Sample Max. Time at:
RT 8 hours
2–8C 24 hours
-20C Undetermined
Sample Max. Thaws 1
Calibrator:
Levels, Form 6 @ 1 x 2 mL lyophilized
Storage, Stability Lyophilized: 2–10C until exp.
Reconst: -20C until exp.; Max. Thaws: 3x
Primary Standard WHO 1st IRP (66/304)
QC NA

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Infectious Disease

CMV IgG CMV IgM

Infectious Disease
Test Name / LIS Code CMV-G / CMV-G CMV-M / CMV-M
Test Number 242 254
Remisol Code A110 A112
Catalog #s
Reagent A40702 A40705
Calibrator A40703 A40706
QC A40704 A40707
Diluent* Wash buffer II N/A
Assay Type 2-Step Sandwich 2-Step Sandwich
Minutes to 1st Result ~35 ~55
Reportable Range 0– ~400 AU/mL Reactive / Equivocal /
See IFU Non-reactive
See IFU
SI Units Conversion Factor NA N/A
Sample Dilution if OVR See IFU N/A
Analytical Sensitivity See IFU N/A
Expected Values** See IFU See IFU
Days Stable: Curve 28 28
Days Stable: Open Pack 28 28
Expected Total Imprecision < 20% (For samples > 7 AU/mL) See IFU
Sample Pickup 20 L 10 L
Sample Type Serum, Plasma (E, H) Serum, Plasma (E, H)
Sample Avoid Lipemic, icteric, hemolyzed Lipemic, icteric, hemolyzed
Sample Max. Time at:
RT 8 hours 8 hours
2–8C 5 days 5 days
-20C Undetermined Undetermined
Sample Max. Thaws 5 5
Calibrator:
Levels, Form 6 @ 1 x 1.0 mL liquid 2 @ 1 x 1.0 mL liquid
Storage, Stability Unopened: 2–10C until exp. Unopened: 2–10C until exp.
Opened: 2–10C 90 days Opened: 2–10C 90 days
Primary Standard Internal Internal
QC
Levels, Form: 2 @ 3 x 2.5 mL liquid 2 @ 3 x 2.5 mL liquid
Storage, Stability: Unopened: 2–10C until exp. Unopened: 2–10C until exp.
Opened: 90 days Opened: 90 days

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Rubella IgG Rubella IgM

Infectious Disease
Test Name / LIS Code: Rub-IgG / Rub-G MRub / MRub
Access & DxI/DxC
Test Number 102 233
Remisol Code A46 A102
Catalog #s
Reagent 34430 A32937
Calibrator 34435 34445
QC 34439 34449
Diluent* S0 NA
Assay Type 2-Step Sandwich 2-Step Sandwich
Minutes to 1st Result ~35 ~75
Reportable Range ~10–500 IU/mL 0– ~60 AU/mL
See IFU See IFU
SI Units Conversion Factor NA NA
Sample Dilution if OVR 1/10 NA
Analytical Sensitivity NA NA
Expected Values** See IFU See IFU
Days Stable: Curve 28 28
Days Stable: Open Pack 28 28
Expected Total Imprecision See IFU < 15% (reactive samples)
Sample Pickup 20 L 20 L
Sample Type Serum Serum
Sample Avoid NA Hemolysis, turbidity,
heat treated, fibrin
Sample Max. Time at:
RT 8 hours 8 hours
2–8C 48 hours 48 hours
-20C Undetermined Undetermined
Sample Max. Thaws 3 4
Calibrator:
Levels, Form 6 @ 1 x 1.0 mL liquid 4 @ 1 x 1.0 mL liquid
Storage, Stability 2–10C until exp. 2–10C until exp.
Primary Standard WHO 2nd ISP for Anti-Rubella Serum Internal
QC
Levels, Form 2 @ 3 x 2.5 mL liquid 2 @ 3 x 2.5 mL liquid
Storage, Stability Unopened: 2–10C until exp. Unopened: 2–10C until exp.
Opened: See IFU Opened: 2–10C for 30 days

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Toxo IgG Toxo IgM II

Infectious Disease
Test Name / LIS Code: GToxo / GToxo IgM-Toxo / Tox-M
Access & DxI/DxC
Test Number 228 112
Remisol Code A103 A13
Catalog #s
Reagent A31588 34470
Calibrator A31589 34475
QC A31590 34479
Diluent* S0 Do not dilute
Assay Type 2-Step Sandwich 2-Step Sandwich
Minutes to 1st Result ~35 ~35
Reportable Range 0– ~450 IU/mL Reactive / Equivocal / Non-reactive
See IFU See IFU
SI Units Conversion Factor NA NA
Sample Dilution if OVR See IFU NA
Analytical Sensitivity See IFU NA
Expected Values** See IFU See IFU
Days Stable: Curve 28 28
Days Stable: Open Pack 28 28
Expected Total Imprecision < 20% (for samples > 3.2 IU/mL) < 20% (positive samples, within run)
Sample Pickup 10 L 10 L
Sample Type Serum Serum, Plasma (E, C, H)
Sample Avoid Heat treated NA
Sample Max. Time at:
RT 8 hours 8 hours
2–8C 4 days 48 hours
-20C Undetermined Undetermined
Sample Max. Thaws 4 3
Calibrator:
Levels, Form 6 @ 1 x 1.0 mL liquid 2 @ 1 x 1.5 mL liquid
Storage, Stability Unopened: 2–10C until exp. 2–10C until exp.
Opened: 2-10C for 90 days
Primary Standard WHO 3rd IS (TOXM) Internal
QC
Levels, Form 2 @ 3 x 2.5 mL liquid 2 @ 3 x 3.5 mL liquid
Storage, Stability Unopened: 2–10C until exp. Unopened: 2–10C until exp.
Opened: 2-10C for 90 days Opened: 30 days

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Inflammation

IL-6
IL-6–Diluted***
Inflammation
IL-6 IL-6–Diluted
Test Name / LIS Code: IL-6 / IL-6 dIL-6 / dIL-6
Access & DxI/DxC
Test Number 210 11210
Remisol Code A87 A125
Catalog #s
Reagent A16369
Calibrator A16370
QC A16371
Diluent* S0 or Samp. Dil. A (81908)
Diluent Pack (Dilutions/Pack) A79783 (123)
Assay Type 1-Step Sandwich
Minutes to 1st Result ~35
Reportable Range • ~0.5 – 1500 pg/mL (0.054 – 160 IU/mL)(IL-6)
• ~1275–4500 pg/mL
(136.43 – 481.50 IU/mL) (dIL-6)
SI Units Conversion Factor pg/mL x 0.107
Sample Dilution if OVR 1/3 1/3 Onboard
Analytical Sensitivity 0.5 pg/mL (0.054 IU/mL)
Expected Values** 22 – 73 years: <6.4 pg/mL
Days Stable: Curve 28
Days Stable: Open Pack 28
Expected Total Imprecision <12% at > 2.0 pg/mL
Sample Pickup 110 L 110 L
Sample Type Serum, Plasma (H)
Sample Avoid lipemic, hemolyzed
Sample Max. Time at:
RT 8 hours
2–8C 48 hours
-20C Undetermined
Sample Max. Thaws 1
Calibrator:
Levels, Form S0 @ 1 x 4mL
S1-S5 @ 1 x 2.5 mL
Storage, Stability Unopened: 2–10C until exp.
Opened: 90 days @ 2-10C
Primary Standard Internal
QC
Levels, Form 3 @ 2 x 2.5 mL liquid
Storage, Stability -20C until exp.
14 days @ 2-10C

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Reproductive

Alpha-fetoprotein,
Diluted Alpha-fetoprotein,
Alpha-fetoprotein–Diluted***
Reproductive
AFP Dil-AFP AFP–Diluted
Test Name / LIS Code: AFP / AFP Dil-AFP / dAFP d-AFP / d-AFP
Access & DxI/DxC
Test Number 180 208 11180
Remisol Code A02 A77 A143
Catalog #s 100 test kit: 300 test kit:
Reagent (OUS only) (Worldwide)
Calibrator 33210 33211
QC 33215 Included in 33211
Diluent* NA NA
Diluent Pack (Dilutions/Pack) 33216 or Wash Buffer II 33216 or Wash Buffer II
A79784 (132) A79784 (132)
Assay Type 1-Step Sandwich
Minutes to 1st Result ~15
Reportable Range • ~0.5–3000 ng/mL (~0.41–2478 IU/mL) (AFP)
• 2700– ~51,000 ng/mL
(2230–~42,126 IU/mL)(Dil-AFP)
• 2550–303,000 ng/mL
(2107–250,413 IU/mL)(d-AFP)
SI Units Conversion Factor ng/mL x 0.826
Sample Dilution if OVR 1/101: Serum 1/11 1/101
1/11: Amniotic Onboard
Fluid
See IFU for more information.
Analytical Sensitivity 0.50 ng/mL
Expected Values** See IFU
Days Stable: Curve 28
Days Stable: Open Pack 28
Expected Total Imprecision See IFU
Sample Pickup 10 L 10 L 35 L
Sample Type 100 test kit: Serum
300 test kit: Serum, Amniotic Fluid
Sample Avoid Repeated freezing and thawing
Sample Max. Time at:
RT 8 hours
2–8C 48 hours
-20C Undetermined
Sample Max. Thaws 1
Calibrator:
Levels, Form 7 @ 1 x 2.5 mL liquid
Storage, Stability 2–10C until exp.

Primary Standard WHO 1st IS (72/225)

QC NA
Levels, Form
Storage, Stability

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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AMH Total hCG (5th IS),

Diluted Total hCG (5th IS)
Total hCG–Diluted (5th IS)***
Reproductive
Total hCG Dil-Total Total hCG–
AMH AMH-Diluted
(5th IS) hCG (5th IS) Diluted (5th IS)
Test Name / LIS Code: AMH / AMH dAMH / dAMH HCG5 / HCG5d / d-CG5 /
Access & DxI/DxC HCG5 HCG5d d-CG5
Test Number 293 11293 273 274 11273
Remisol Code A183 A184 A178 A179 A180
Catalog #s
Reagent B13127 A85264
Calibrator B13128 B11754
QC B13129 NA
Diluent* Samp. Dil. A (81908) Wash Buffer II
Diluent Pack (Dilutions/Pack) A79783 (60) A79784 (135)
Assay Type One-Step Sandwich 2-Step Sequential Sandwich
Minutes to 1st Result ~40 ~18
Reportable Range • ~0.02 - 24 ng/mL [0.14 - 171 • See IFU (HCG5)
pmol/L] (AMH) • 1,050 – ~270,000 mIU/mL (HCG5d)
• ~20 - 240 ng/mL [146 - 1714 • 1,050 – ~270,000 mIU/mL (d-CG5)
pmol/L] (dAMH)
SI Units Conversion Factor 7.14 1
Sample Dilution if OVR 1/16 or 1/10 1/10 Onboard 1/200 1/200
Onboard
Analytical Sensitivity LoB: 0.01 ng/mL (0.07 pmol/L) LoB and LoD: 0.5 mIU/mL
LoD: 0.02 ng/mL (0.14 pmol/L) 20% LoQ: 0.6 mIU/mL
LoQ: 0.08 ng/mL (0.57 pmol/L)
Expected Values** See IFU See IFU
Days Stable: Curve 31 28
Days Stable: Open Pack 31 28
Expected Total Imprecision 10.0% CV @ 0.16 ng/mL 10.0% CV @ > 3.9 mIU/mL
SD  0.032 ng/mL@ < 0.16 ng/mL  0.39 mIU/mL (1 SD) @  3.9 mIU/mL
Sample Pickup 25 L 50 L 25 L 6 L 20 L
Sample Type Serum, Plasma (LiH) Serum, Plasma (LiH)
Sample Avoid Lipemic or Hemolyzed NA
Sample Max. Time at:
RT 24 hours 8 hours
2–8C 6 days 48 hours
-20C 60 days 6 months
Sample Max. Thaws 2 1
Calibrator:
Levels, Form 6 @ 1 x 2.0 mL lyophilized 6 @ 1 x 4.0 mL liquid

Storage, Stability 2-10C until exp. -20C or colder until exp.

Reconst: 90 days @ 2–10C Re-freeze between uses. Thaw at RT.
Stable 120 days @ -20C or colder after 1st use
Primary Standard Internal WHO 5th IS (07/364)
QC NA
Levels, Form 3 @ 2 x 2.0 mL, lyophilized
Storage, Stability 2-10C until exp.
Reconst: 2 days @ 2-10C or
60 days @ -15 to -30C (thaw 3x)

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Total hCG, DHEA-S

Diluted Total hCG DHEA-S–Diluted***
Total hCG–Diluted***
Reproductive
Dil-Total Total hCG–
Total hCG DHEA-S DHEA-S–Diluted
hCG Diluted
Test Name / LIS Code: TBhCG2 / Dil-hCG2 / d-ThCG / DHE-S / DHE-S dDHES / dDHES
Access & DxI/DxC TBhCG DlhCG d-hCG
Test Number 151 152 11151 235 11235
Remisol Code A17 A18 A145 A94 A144
Catalog #s
Reagent 33500 A10826
Calibrator 33505 A10827
QC NA NA
Diluent* Wash Buffer II Normal Saline or Wash Buffer II
Diluent Pack (Dilutions/Pack) A79784 (135) A79784 (60)
Assay Type 1-Step Sandwich 1-Step Competitive
Minutes to 1st Result ~15 ~30
Reportable Range • ~0.5 – 1000 mIU/mL (TBhCG2) • ~2-1000 g/dL (0.05 - 27.14 mol/L) (DHE-S)
• 1,000 – 200,000 mIU/mL (Dil-hCG2) • ~850–10,000 g/dL
• ~800–200,000 mIU/mL (d-ThCG) (~23.07 - 271.4 mol/L)(dDHES)
SI Units Conversion Factor 1 g/dL x 0.02714
Sample Dilution if OVR 1/200 1/200 1/10 1/10 Onboard
Onboard
Analytical Sensitivity 0.5 mIU/mL < 2 g/dL (< 0.05 mol/L)
Expected Values** M: < 0.5 – 2.67 mIU/mL, See IFU
Non-pregnant F: < 0.5 – 2.90 mIU/mL
Days Stable: Curve 28 28
Days Stable: Open Pack 28 28
Expected Total Imprecision < 10%  10% (for samples  20 g/dL)
Sample Pickup 25 L 10 L 20 L 10 L 50 L
Sample Type Serum, Plasma (H) Serum, Plasma (Li. H, Na H, E)
Sample Avoid NA NA
Sample Max. Time at:
RT 8 hours 8 hours
2–8C 48 hours 48 hours
-20C 6 months Undetermined
Sample Max. Thaws 1 1
Calibrator:
Levels, Form 6 @ 1 x 4 mL liquid 6 @ 1 x 2.0 mL liquid
Storage, Stability -20C or colder until exp. 2–10C until exp. or
Re-freeze between uses. Thaw at RT. 28 days after initial use
Primary Standard WHO 3rd IS (75/537) Internal
QC NA NA

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Estradiol Sensitive Estradiol Unconjugated

Sensitive Estradiol-Diluted*** Estriol
Reproductive SNSE2 SNE2-Diluted
Test Name / LIS Code: E2 / E2 SNSE2 / SNSE2 dSNE2 / dSNE2 uE3 / uE3
Access & DxI/DxC
Test Number 243 292 11292 126
Remisol Code A101 A200 A201 A15
Catalog #s
Reagent 33540 B84493 B84493 33570
Calibrator 33545 B84494 B84494 33575
QC NA NA NA NA
Diluent* S0 (33546) S0 (B97145) A79783 S0
Assay Type 2-Step Competitive 2-Step Competitive 1-Step Competitive
Minutes to 1st Result ~35 ~55 ~30
Reportable Range ~20–4800 pg/mL SNSE2: ~15.0–5200 pg/mL ~0.017–6.9 ng/mL
(73–17,621 pmol/L) (55.1–19,089 pmol/L) (0.059–24.0 nmol/L)

dSNE2: ~3400–10,400 pg/mL

(12,481–38,178 pmol/L)
SI Units Conversion Factor pg/mL x 3.671 pg/mL x 3.671 ng/mL x 3.467
Sample Dilution if OVR 1/2 1/2 1/2 Onboard 1/2 or 1/3
Analytical Sensitivity 20 pg/mL (73 pmol/L) LoB: 10.0 pg/mL (36.7 pmol/L) 0.017 ng/mL
LoD: 15.0 pg/mL (55.1 pmol/L)
LoQ: 19.0 pg/mL (69.7 pmol/L)
Expected Values** See IFU See IFU TBD by laboratory
Days Stable: Curve 14 28 28
Days Stable: Open Pack 14 28 28
Expected Total Imprecision • 12% at 10% at > 30 pg/mL (110.1 pmol/L), See IFU
concentrations SD 5.00 pg/mL (18.36 pmol/L)
 120 pg/mL 30.0 pg/mL (110.1 pmol/L)
• For Imprecision
< 120 pg/mL, see IFU
Sample Pickup 35 L 30 L 155 L 25 L
Sample Type Serum, Plasma (H) Serum, Plasma Serum
(Sodium, Lithium Heparin, EDTA)
Sample Avoid NA NA NA
Sample Max. Time at:
RT 8 hours 8 hours 8 hours
2–8C 48 hours 7 days 14 days
-20C Undetermined  5 days at -20C Undetermined
Sample Max. Thaws 1 3 2
Calibrator:
Levels, Form S0 @ 1 x 4.0 mL liquid S0 @ 1 x 4.0 mL liquid S0 @ 1 x 4.0 mL liquid
S1–S5 @ 1 x 2.5 mL liquid S1–S5 @ 1 x 2.0 mL liquid S1–S6 @ 1 x 2.5 mL liquid
Storage, Stability 2–10C until exp. 2–10C until exp. 2–10C until exp.
Primary Standard ID/GC-MS ID/GC-MS GC-MS
QC NA NA NA

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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hFSH hLH
hFSH–Diluted*** hLH–Diluted***
Reproductive
hFSH hFSH–Diluted hLH hLH–Diluted
Test Name / LIS Code: hFSH / hFSH dhFSH / dhFSH hLH / hLH dhLH / dhLH
Access & DxI/DxC
Test Number 115 11115 116 11116
Remisol Code A36 A122 A39 A124
Catalog #s
Reagent 33520 33510
Calibrator 33525 33515
QC NA NA
Diluent* S0 or Samp. Dil. A (81908) S0 or Samp. Dil. A (81908)
Diluent Pack (Dilutions/Pack) A79783 (174) A79783 (174)
Assay Type 2-Step Sandwich 2-Step Sandwich
Minutes to 1st Result ~55 ~55
Reportable Range • ~0.2–200 mIU/mL (IU/L) (hFSH) • ~0.2–250 mIU/mL (IU/L) (hLH)
• ~170–400 mIU/mL (IU/L) (dhFSH) • ~213–500 mIU/mL (IU/L) (dhLH)
SI Units Conversion Factor 1 1
Sample Dilution if OVR 1/2 1/2 Onboard 1/2 1/2 Onboard
Analytical Sensitivity 0.2 mIU/mL 0.2 mIU/mL
Expected Values** See IFU See IFU
Days Stable: Curve 28 28
Days Stable: Open Pack 28 28
Expected Total Imprecision < 10% < 10%
Sample Pickup 25 L 155 L 55 L 155 L
Sample Type Serum, Plasma (H) Serum, Plasma (H)
Sample Avoid NA NA
Sample Max. Time at:
RT 8 hours 8 hours
2–8C 48 hours 48 hours
-20C 3 months 6 months
Sample Max. Thaws 1 1
Calibrator:
Levels, Form 6 @ 1 x 4 mL liquid 6 @ 1 x 4 mL liquid
Storage, Stability 2–10C until exp. -15 to -30C until exp.
Stable 90 days @ 2-10C after opening
Primary Standard WHO 2nd IRP (78/549) WHO 2nd IRP (80/552)
QC NA NA

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Inhibin A PAPP-A
Inhibin A–Diluted*** PAPP-A–Diluted***
Reproductive
Inhibin A Inhibin A–Diluted PAPP-A PAPP-A Diluted
Test Name / LIS Code: InhibinA / InhbA dInhA / dInhA PAPPA / PAPPA dPAPA / dPAPA
Access & DxI/DxC
Test Number 237 11237 270 11270
Remisol Code A96 A126 A108 A152
Catalog #s
Reagent A36097 A48571
Calibrator A36098 A48572
QC A36100 A48573
Diluent* Samp. Dil. A 81908 Wash Buffer II
Diluent Pack (Dilutions/Pack) A79783 (123) A79784 (174)
Assay Type 2-Step Sandwich 2-Step Sandwich
Minutes to 1st Result ~50 ~68
Reportable Range • ~1 – 1500 pg/mL (InhibinA) • ~1 – 5000 ng/mL (PAPPA)
• ~1275 – 4500 pg/mL • ~4250–10,000 ng/mL (dPAPA)
(~50.8 - 179.3 IU/mL)(dInhA)
SI Units Conversion Factor pg/mL ÷ 25.1 NA
Sample Dilution if OVR 1/3 or 1/11 1/3 Onboard 1/2 or 1/10 1/2 Onboard
Analytical Sensitivity < 1 pg/mL < 1 ng/mL
Expected Values** See IFU See IFU
Days Stable: Curve 28 28
Days Stable: Open Pack 28 28
Expected Total Imprecision 8% at > 30 pg/mL 8% at > 10 ng/mL
Sample Pickup 70 L 110 L 50 L 155 L
Sample Type Serum, Plasma (H, E) Serum
Sample Avoid Lipemic, hemolyzed Lipemic, hemolyzed
Sample Max. Time at:
RT 8 hours 8 hours
2–8C 48 hours 24 hours
-20C Undetermined Undetermined
Sample Max. Thaws 1 1
Calibrator:
Levels, Form 7 @ 1 x 2.5 mL liquid 6 @ 1 x 1.0 mL liquid
Storage, Stability 2–8C until exp. -20C or colder until exp.
Open: 28 days @ 2–8C Opened: -20C or colder (thaw up to 3x)
or 28 days @ 2–10C
Primary Standard Internal Internal
QC:
Levels, Form 3 @ 2 x 2.5 mL, liquid 3 @ 2 x 2.5 mL, liquid
Storage, Stability 2–8C until exp. -20C or colder until exp.
Open: 28 days @ 2–8C Opened: -20C or colder (thaw up to 3x)
or 28 days @ 2–10C

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Progesterone Prolactin
Prolactin–Diluted***
Reproductive
Prolactin Prolactin–Diluted
Test Name / LIS Code: Prog / Prog PRL / PRL dPRL / dPRL
Access & DxI/DxC
Test Number 114 128 11128
Remisol Code A43 A42 A131
Catalog #s
Reagent 33550 33530
Calibrator 33555 33535
QC NA NA
Diluent* S0 (33556) S0 or Samp. Dil. A (81908)
Diluent Pack (Dilutions/Pack) NA A79783 (60)
Assay Type 1-Step Competitive 1-Step Sandwich
Minutes to 1st Result ~30 ~30
Reportable Range ~0.10 – 40 ng/mL • ~0.25 – 200 ng/mL (g/L) (PRL)
(0.32–127.2 nmol/L) • ~170 – 2000 ng/mL (g/L) (dPRL)
SI Units Conversion Factor ng/mL x 3.18 1 ng/mL = 1 g/L
1 g/L x 21.2 = mIU/L
Sample Dilution if OVR 1/3 1/10 1/10 Onboard
Analytical Sensitivity 0.10 ng/mL 0.25 ng/mL
(0.32 nmol/L)
Expected Values** See IFU See IFU
Days Stable: Curve 28 28
Days Stable: Open Pack 28 28
Expected Total Imprecision See IFU < 10%
Sample Pickup 20 L 25 L 50 L
Sample Type Serum Serum, Plasma (H)
Sample Avoid Gross lipemia, gel tube storage NA
Sample Max. Time at:
RT 8 hours 8 hours
2–8C 48 hours 48 hours
-20C Undetermined Undetermined
Sample Max. Thaws 1 1
Calibrator:
Levels, Form S0 @ 1 x 4.0 mL liquid S0 @ 1 x 4.0 mL liquid
S1 – S5 @ 1 x 2.5 mL liquid S1 – S5 @ 1 x 2.5 mL liquid
Storage, Stability -20C until exp. -20C until exp.
2–10C for 3 months Return to -20 after each use.
Thaw at RT  5x
Primary Standard USP WHO 3rd IS (84/500)
QC:
Levels, Form NA NA
Storage, Stability

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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SHBG Testosterone
SHBG–Diluted***
Reproductive
SHBG SHBG–Diluted
Test Name / LIS Code: SHBG / SHBG dSHBG / dSHBG Testo / Testo
Access & DxI/DxC
Test Number 255 11255 195
Remisol Code A106 A154 A16
Catalog #s
Reagent A48617 33560
Calibrator A48618 33565
QC A48619 NA
Diluent* Wash Buffer II S0
Diluent Pack (Dilutions/Pack) A79784 (60) NA
Assay Type 2-Step Sandwich 1-Step Competitive
Minutes to 1st Result ~25 ~16
Reportable Range • 0.33 – ~200 nmol/L (SHBG) ~0.1 – 16 ng/mL
• ~170 – 2000 nmol/L (dSHBG) (0.35 – 55.5 nmol/L)
SI Units Conversion Factor 1 ng/mL x 3.47
Sample Dilution if OVR 1/10 1/10 Onboard 1/2
Analytical Sensitivity Limit of Blank (Analytical Sensitivity): 0.1 ng/mL
0.017 nmol/L
Limit of Detection: 0.33 nmol/L
Expected Values** See IFU M-S: 1.75 – 7.81 ng/mL
M-P: 1.68 – 7.58 ng/mL
F-S: < 0.1 – 0.75 ng/mL
F-P: < 0.1 – 0.9 ng/mL
Days Stable: Curve 28 14
Days Stable: Open Pack 28 28
Expected Total Imprecision < 7% at > 2nmol/L  20% at 0.5 ng/mL
< 10% from 2-10 ng/mL
Sample Pickup 20 L 50 L 20 L
Sample Type Serum, Plasma (H) Serum, Plasma (H)
Sample Avoid Lipemic or hemolyzed samples, E Plasma
Plasma (E)
Sample Max. Time at:
RT 8 hours 8 hours
2–8C 7 days (serum), 5 days (plasma (H)) 48 hours
-20C 2 months Undetermined
Sample Max. Thaws 3 (serum), 2 (plasma (H)) 2
Calibrator:
Levels, Form 6 @ 1x 1.0 mL lyoph. 6 @ 1 x 2.5 mL liquid
Storage, Stability 2-8C until exp. 2–10C until exp.
Reconst: 28 days at 2-8C
Primary Standard WHO 95/560 USP
QC:
Levels, Form 2 @ 3 x 2mL, lyoph. NA
2-8C until exp.
Storage, Stability Reconst: 28 days at 2-8C

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information

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Thyroid

Sepsis Procalcitonin (PCT)

PCT–Diluted

PCT PCT-Diluted
Test Name / LIS Code: PCT PCTd
Access & DxI/DxC
Test Number 280 282
Remisol Code A206 A207
Catalog #s
Reagent C22593
Calibrator C22594
QC NA
Diluent Wash Buffer II
Assay Type Two-step sequential sandwich
Minutes to 1st Result ~20
Reportable Range 0.01 - 100 ng/mL 75.0 - 1000 ng/mL
Unit Conversion Factor 1 ng/mL = 1 g/L
Sample Dilution if OVR 1/10 1/10 Onboard
Limit of Blank (LoB) 0.005 ng/mL
Limit of Detection (LoD) 0.01 ng/mL
Limit of Quantitation (LoQ)
(20% Within Laboratory CV) 0.02 ng/mL
Expected Values* URL (95% CI): 0.065 ng/mL
Days Stable: Curve 42
Days Stable: Open Pack 42
Expected Total Imprecision SD 0.012 ng/mL for values <0.150 ng/mL
CV 8.0% for values 0.150 ng/mL
Sample Pickup 35 L 30 L
Sample Type Serum, Plasma (Li H)
Sample Avoid Lipemic, hemolyzed
Sample Max. Time at:
RT 16 hours
2–10C 48 hours
-30– -15C 60 days
Sample Max. Thaws 3
Calibrator:
Levels, Form 7 @ 1 x 2.0 mL lyophilized
Storage, Stability 2–10C until exp.
After reconstitution:
4 hours at 20C to 25C
90 days at -30C to -15C
Max. thaws: 3x
Primary Internal
QC NA

NOTES:
* Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information

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Thyroid

Free T3 Free T4

Thyroid
Test Name / LIS Code: FT3 / FT3 FRT4 / FRT4
Access & DxI/DxC
Test Number 212 226
Remisol Code A80 A91
Catalog #s
Reagent A13422 33880
Calibrator A13430 33885
QC NA NA
Diluent* Do not dilute Do not dilute
Assay Type 2-Step Competitive 2-Step Competitive
Minutes to 1st Result ~30 ~29
Reportable Range ~0.88–30 pg/mL ~0.25–6.0 ng/dL
(1.4–46 pmol/L) (3.2–77.2 pmol/L)
SI Units Conversion Factor pg/mL x 1.536 ng/dL x 12.87
Sample Dilution if OVR Do not dilute Do not dilute
Analytical Sensitivity 0.88 pg/mL 0.25 ng/dL
(1.4 pmol/L) (3.2 pmol/L)
Expected Values** 2.5–3.9 pg/mL 0.61–1.12 ng/dL
(3.8–6.0 pmol/L) (7.9–14.4 pmol/L)
Days Stable: Curve 28 28
Days Stable: Open Pack 28 28
Expected Total Imprecision See IFU See IFU
Sample Pickup 55 L 30 L
Sample Type Serum, Plasma (H) Serum, Plasma (H)
Sample Avoid NA NA
Sample Max. Time at:
RT 8 hours 8 hours
2–8C 48 hours 48 hours
-20C Undetermined Undetermined
Sample Max. Thaws 3 1
Calibrator:
Levels, Form 6 @ 1 x 2.5 mL liquid 6 @ 1 x 2.5 mL liquid
Storage, Stability 2–10C until exp. -20C or colder until exp.
Opened: 2–10C 4 months Refreeze within 2 hours;
Max. thaws: 5x
Primary Standard Internal Internal
QC NA NA

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Total T3 Total T4

Thyroid
Test Name / LIS Code: TotT3 / TotT3 TotT4 / TotT4
Access & DxI/DxC
Test Number 166 134
Remisol Code A50 A52
Catalog #s
Reagent 33830 33800
Calibrator 33835 33805
QC NA NA
Diluent* S0 NA
Assay Type 1-Step Competitive 1-Step Competitive
Minutes to 1st Result ~35 ~20
Reportable Range ~0.1–8.0 ng/mL ~0.5–30.0 g/dL
(0.2–12.3 nmol/L) (6.4–386 nmol/L)
SI Units Conversion Factor ng/mL x 1.536 g/dL x 12.87
Sample Dilution if OVR 1/2 NA
Analytical Sensitivity 0.1 ng/mL 0.50 g/dL
(0.2 nmol/L) (6.4 nmol/L)
Expected Values** 0.87–1.78 ng/mL 6.09–12.23 g/dL
(1.34–2.73 nmol/L) (78.38–157.4 nmol/L)
Days Stable: Curve 14 21
Days Stable: Open Pack 28 14
Expected Total Imprecision <10% < 10%
Sample Pickup 55 L 30 L
Sample Type Serum, Plasma (H) Serum, Plasma (H)
Sample Avoid NA Pregnant women
Sample Max. Time at:
RT 8 hours 8 hours
2–8C 48 hours 24 hours
-20C Undetermined Undetermined
Sample Max. Thaws 1 1
Calibrator:
Levels, Form 6 @ 1 x 4.0 mL liquid 6 @ 1 x 4.0 mL liquid
Storage, Stability 2–10C until exp. -15C or colder until exp.,
Max. thaws: 5x
2–10C for 6 hours
Primary Standard USP USP
QC NA NA

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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HYPERsensitive hTSH Fast hTSH

HYPERsensitive hTSH–Diluted*** Fast hTSH–Diluted***
Thyroid
HYPERsensitive hTSH–
HYPERsensitive hTSH Fast hTSH Fast hTSH–Diluted
Diluted
Test Name / LIS Code: TSH / TSH dTSH / dTSH fTSH2 / fTSH2 dfTSH / dfTSH
Access & DxI/DxC
Test Number 183 11183 246 11246
Remisol Code A57 A137 A105 A120
Catalog #s
Reagent 33820 33820
Calibrator 33825 33825
QC NA NA
Diluent* S0 or Samp. Dil. A (81908) S0 or Samp. Dil. A (81908)
Diluent Pack (Dilutions/Pack) A79783 (102) A79783 (102)
Assay Type 1-Step Sandwich 1-Step Sandwich
Minutes to 1st Result ~45 ~20
Reportable Range • 0.015– ~100 IU/mL (mIU/L) (TSH) • 0.03 – ~100 IU/mL (mIU/L) (fTSH2)
(incorporates functional sensitivity for lower (incorporates functional sensitivity for
limit of detection) lower limit of detection)
• ~85 – 500 IU/mL (mIU/L) (dTSH) • ~85 – 500 IU/mL (mIU/L) (dfTSH)
SI Units Conversion Factor 1 1
Sample Dilution if OVR 1/5 1/5 Onboard 1/5 1/5 Onboard
Analytical Sensitivity 0.003 IU/mL 0.01 IU/mL
0.015 IU/mL functional 0.03 IU/mL functional
Expected Values** 0.34–5.60 IU/mL 0.34–5.60 IU/mL
Days Stable: Curve 28 28
Days Stable: Open Pack 28 28
Expected Total Imprecision See IFU See IFU
Sample Pickup 110 L 66 L 55 L 66 L
Sample Type Serum, Plasma (H) Serum, Plasma (H)
Sample Avoid Severe hemolysis Severe hemolysis
Sample Max. Time at:
RT 8 hours 8 hours
2–8C 48 hours 48 hours
-20C Undetermined Undetermined
Sample Max. Thaws 1 1
Calibrator:
Levels, Form 6 @ 1 x 4.0 mL liquid 6 @ 1 x 4.0 mL liquid
Storage, Stability 2–10C until exp. 2–10C until exp.
Primary Standard WHO 2nd IRP (80/558) WHO 2nd IRP (80/558)
QC NA NA

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Thyroglobulin Thyroglobulin Antibody II

Thyroid
Version 2
Test Name / LIS Code: Tg / TgAg Tg2 / Tg2 Tg-Ab / Tg-Ab
Access & DxI/DxC
Test Number 197 279 264
Remisol Code A23 A190 A174
Catalog #s
Reagent 33860 A32898
Calibrator 33865 A36920
QC NA NA
Diluent* 33866 NA
Assay Type 1-Step Sandwich 2-Step Sandwich
Minutes to 1st Result ~42 ~48
Reportable Range ~0.1–500 ng/mL ~0.9–2500 IU/mL
SI Units Conversion Factor NA NA
Sample Dilution if OVR 1/5 or 1/10 NA
Analytical Sensitivity 0.1 ng/mL Limit of Blank (Analytical Sensitivity):
0.9 IU/mL
Limit of Detection: 0.9 IU/mL
Expected Values** 1.59–50.03 ng/mL < 4.0 IU/mL
Days Stable: Curve 56 56
Days Stable: Open Pack 28 56
Expected Total Imprecision < 10% @ > 1 ng/mL < 10% @  15 IU/mL
<1.5 IU/mL SD @ <15 IU/mL
Sample Pickup 40 L 10 L
Sample Type Serum, Plasma (H) Serum, Plasma (H,E)
Sample Avoid NA NA
Sample Max. Time at:
RT 8 hours 8 hours
2–8C 48 hours 48 hours
-20C Undetermined Undetermined
Sample Max. Thaws 1 2
Calibrator:
Levels, Form 6 @ 1 x 2.0 mL lyoph. 1 x 4.0 mL liquid (S0)
5 @ 1 x 2.5 mL liquid (S1-S5)
Storage, Stability 2–10C until exp. 2–10C until exp.
Reconst: 4 mos. at 2–10C
Primary Standard BCR CRM 457 Tg Std. WHO 65/93
QC NA NA

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Thyroid Uptake TPO Antibody

TPO Antibody–Diluted***
Thyroid
TPO Antibody TPO Antibody–Diluted
Test Name / LIS Code: TU / TU- TPOAb / TPOAb dTPO / dTPO
Access & DxI/DxC
Test Number 120 165 11165
Remisol Code A59 A79 A136
Catalog #s
Reagent 33810 A12985
Calibrator 33815 A18227
QC NA NA
Diluent* Do not dilute Samp. Dil. A 81908
Diluent Pack (Dilutions/Pack) NA A79783 (60)
Assay Type 1-Step Competitive 2-Step Sandwich
Minutes to 1st Result ~20 ~31
Reportable Range NA • ~0.25 – 1000 IU/mL (TPOAb)
• ~850 – 10,000 IU/mL (dTPO)
SI Units Conversion Factor % x 0.01 NA
Sample Dilution if OVR NA 1/10 or 1/100 1/10 Onboard
Analytical Sensitivity NA 0.25 IU/mL
Expected Values** 32.0–48.4% < 9 IU/mL
Days Stable: Curve 28 56
Days Stable: Open Pack 28 56
Expected Total Imprecision See IFU < 12% @  0.6 IU/mL
Sample Pickup 15 L 10 L 50 L
Sample Type Serum, Plasma (H) Serum, Plasma (Li-H, E)
Sample Avoid NA Lipemic, Hemolyzed
Sample Max. Time at:
RT 8 hours 8 hours
2–8C 48 hours 48 hours
-20C Undetermined Undetermined
Sample Max. Thaws 1 3
Calibrator:
Levels, Form 1 @ 6 x 1.0 mL lyoph. 6 @ 1 x 2.0 mL liquid
Storage, Stability 2–10C until exp. Unopened: 2–10C until exp.
Reconst: 1 mo. at -20C Opened: 120 days at 2–10C
or 2 wks at 2–10C
Primary Standard Internal WHO 66/387
QC NA NA

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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TSH (3rd IS)

Diluted TSH (3rd IS)
Thyroid
TSH (3rd IS) Diluted TSH (3rd IS)
Test Name / LIS Code: TSH3 / TSH3 TSH3d / TSH3d
Access & DxI/DxC
Test Number 277 278
Remisol Code A188 A189
Catalog #s
Reagent B63284
Calibrator B63285
QC NA
Diluent* Wash Buffer II
Diluent Pack (Dilutions/Pack) N/A
Assay Type 2-Site Sandwich
Minutes to 1st Result ~ 26
Reportable Range • 0.005 - ~ 50.0 IU/mL (TSH3)
• 37.5 - ~ 500 IU/mL (TSH3d)
SI Units Conversion Factor 1
Sample Dilution if OVR 1/10 1/10 Dilution Assay
Analytical Sensitivity • LoB: 0.005 IU/mL
• LoD: 0.005 IU/mL
• LoQ: 0.01 IU/mL (10% between run CV)
Expected Values** See IFU
Days Stable: Curve 28
Days Stable: Open Pack 28
Expected Total Imprecision CV ≤ 10% @ > 0.02 µIU/mL
SD ≤ 0.0029 µIU/mL @ ≤ 0.02 µIU/mL
Sample Pickup 55 µL 50 µL
Sample Type Serum, Plasma (Li-H)
Sample Avoid lipemic or hemolyzed
Sample Max. Time at:
RT 18 hours
2–8C 7 days
-20C or colder 90 days
Sample Max. Thaws 2
Calibrator:
Levels, Form 6 @ 1 x 2.5 mL liquid
Storage, Stability 2–10C until exp.
Stable 90 days @ 2-10C after opening
Primary Standard WHO 3rd IS (81/565)
QC N/A

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Tumor Markers

Alpha-fetoprotein, BR Monitor
Diluted Alpha-fetoprotein, BR Monitor–Diluted***
Alpha-fetoprotein–Diluted*** (CA 15-3 Antigen)
Tumor Markers
AFP Dil-AFP AFP–Diluted BR Monitor BR Monitor–Diluted
Test Name / LIS Code: AFP / AFP Dil-AFP / dAFP d-AFP / d-AFP BR15-3Ag / BR153 dBRAg / dBRAg
Access & DxI/DxC
Test Number 180 208 11180 193 11193
Remisol Code A02 A77 A143 A04 A35
Catalog #s 100 test kit: 300 test kit:
(OUS only) (Worldwide)
Reagent 33210 33211 387620
Calibrator 33215 Included in 33211 387647
QC NA NA NA
Diluent* 33216 or Wash Buffer II 33216 or Wash Buffer II Samp. Dil. A 81908
Diluent Pack (Dilutions/Pack) A79784 (132) A79784 (132) A79783 (60)
Assay Type 1-Step Sandwich 2-Step Sandwich
Minutes to 1st Result ~15 ~41
Reportable Range • ~0.5–3000 ng/mL (~0.41–2478 IU/mL) (AFP) • ~0.5–1000 U/mL (BR15-3Ag)
• 2700– ~51,000 ng/mL • ~850–10,000 U/mL (dBRAg)
(2230–~42,126 IU/mL)(Dil-AFP)
• 2550–303,000 ng/mL
(2107–250,413 IU/mL)(d-AFP)
SI Units Conversion Factor ng/mL x 0.826 NA
Sample Dilution if OVR 1/101: Serum 1/11 1/101 1/10 1/10 Onboard
1/11: Amniotic Onboard
Fluid
See IFU for more information.
Analytical Sensitivity 0.50 ng/mL < 0.5 U/mL
Expected Values** See IFU See IFU
Days Stable: Curve 28 56
Days Stable: Open Pack 28 56
Expected Total Imprecision See IFU 10% (15–500 U/mL)
12% (> 500 U/mL)
Sample Pickup 10 L 10 L 35 L 10 L 50 L
Sample Type 100 test kit: Serum Serum, Plasma (H)
300 test kit: Serum, Amniotic Fluid
Sample Avoid Repeated freezing and thawing Hemolysis or lipemic
Sample Max. Time at:
RT 8 hours 8 hours
2–8C 48 hours 48 hours
-20C Undetermined Undetermined
Sample Max. Thaws 1 1
Calibrator:
Levels, Form 7 @ 1 x 2.5 mL liquid 6 @ 1 x 1.5 mL liquid
Storage, Stability 2–10C until exp. 2–10C until exp. or
90 days after initial use
Primary Standard WHO 1st IS (72/225) Internal
QC NA Not Available
Levels, Form
Storage, Stability

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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CEA GI Monitor
GI Monitor–Diluted***
(CA 19-9 Antigen)
Tumor Markers
GI Monitor GI Monitor–Diluted
Test Name / LIS Code: CEA2 / CEA2 GI19-9Ag / GI199 dGIAg / dGIAg
Access & DxI/DxC
Test Number 240 159 11159
Remisol Code A104 A05 A121
Catalog #s
Reagent 33200 387687
Calibrator 33205 387688
QC 33209 NA
Diluent* 33206 Samp. Dil. A 81908
Diluent Pack (Dilutions/Pack) NA A79783 (60)
Assay Type 2-Step Sandwich 2-Step Sandwich
Minutes to 1st Result ~25 ~24
Reportable Range ~0.1–1000 ng/mL • ~0.8–2000 U/mL (GI19-9Ag)
• ~1700–20,000 U/mL (dGIAg)
SI Units Conversion Factor NA NA
Sample Dilution if OVR 1/10 1/10 1/10 Onboard
Analytical Sensitivity 0.1 ng/mL 0.8 U/mL
Expected Values** See IFU See IFU
Days Stable: Curve 28 56
Days Stable: Open Pack 28 56
Expected Total Imprecision See IFU <10%
Sample Pickup 35 L 10 L 50 L
Sample Type Serum Serum, Plasma (H)
Sample Avoid NA hemolysis, lipemic
Sample Max. Time at:
RT 8 hours 8 hours
2–8C 48 hours 48 hours
-20C Undetermined Undetermined
Sample Max. Thaws Undetermined 1
Calibrator:
Levels, Form 6 @ 1 x 2.5 mL liquid 6 @ 1x2.5 mL
Storage, Stability 2–10C until exp. -20C until exp.
2–10C See IFU
Primary Standard Internal Internal
QC NA
Levels, Form 2 @ 3 x 2.5 mL liquid
Storage, Stability 2–10C until exp.

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Hybritech PSA
Hybritech PSA–Diluted***
Hybritech WHO
Tumor Markers Calibration Calibration
PSA PSA–Diluted PSA PSA–Diluted
Test Name / LIS Code: PSA-Hyb / PSA dPSA / dPSA PSA-WHO / PSA-W dPSAW / dPSAW
Access & DxI/DxC
Test Number 170 11170 231 11231
Remisol Code A62 A132 A90 A133
Catalog #s
Reagent 37200
Calibrator 37205
QC 37209
Diluent* 37206 or Wash Buffer II
Diluent Pack (Dilutions/Pack) A79784 (60)
Assay Type 1-Step Sandwich
Minutes to 1st Result ~22
Reportable Range • ~0.008–150 ng/mL (PSA-Hyb) • ~0.008–121 ng/mL (PSA-WHO)
• ~127.5–1500 ng/mL (dPSA) • ~110.5–1210 ng/mL (dPSAW)
SI Units Conversion Factor NA
Sample Dilution if OVR 1/5 or 1/10 1/10 Onboard 1/5 or 1/10 1/10 Onboard
Analytical Sensitivity <0.008 ng/mL
Expected Values** 0–4 ng/mL 0–3.1 ng/mL
Days Stable: Curve 28
Days Stable: Open Pack 28
Expected Total Imprecision See IFU
Sample Pickup 25 L 50 L 25 L 50 L
Sample Type Serum
Sample Avoid Collection after prostatic manipulation; hemolysis, turbidity
Sample Max. Time at:
RT 3 hours
2–8C 24 hours
-20C 5 months
Sample Max. Thaws See IFU
Calibrator:
Levels, Form 6 @ 1 x 2.5 mL liquid
Storage, Stability 2–10C until exp.
Primary Standard Internal WHO 96/670
QC
Levels, Form 3 @ 1 x 5 mL liquid
Storage, Stability 2–10C until exp.

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Hybritech free PSA

Tumor Markers
Hybritech Calibration WHO Calibration
Test Name / LIS Code: freePSA / fPSA fPSA-WHO / fPSAW
Access & DxI/DxC
Test Number 169 230
Remisol Code A63 A89
Catalog #s
Reagent 37210
Calibrator 37215
QC 37219
Diluent* S0
Assay Type 1-Step Sandwich
Minutes to 1st Result ~20
Reportable Range ~0.005–20 ng/mL ~0.005–16 ng/mL
SI Units Conversion Factor NA
Sample Dilution if OVR 1/5 or 1/10
Analytical Sensitivity <0.005 ng/mL
Expected Values** See IFU
Days Stable: Curve 28
Days Stable: Open Pack 28
Expected Total Imprecision <7%
Sample Pickup 25 L
Sample Type Serum
Sample Avoid Collection after prostatic manipulation; hemolysis,
turbidity
Sample Max. Time at:
RT 3 hours
2–8C 24 hours
-20C 5 months
Sample Max. Thaws See IFU
Calibrator:
Levels, Form S0 @ 1x 5 mL, S1-S5 @ 1x 2.5 mL; liquid
Storage, Stability 2–10C until exp.
Primary Standard Internal WHO 96/668
QC
Levels, Form 2 @ 1 x 5 mL liquid
Storage, Stability 2–10C until exp.

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Hybritech p2PSA
&
phi
Tumor Markers
p2PSA phi-HYB phi-WHO
Test Name / LIS Code: p2PSA / p2PSA phi-HYB / NA phi-WHO / NA
Access & DxI/DxC
Test Number 146 NA NA
Remisol Code A111 A164 A163
Catalog #s
Reagent A49752
Calibrator A49753
QC A56934
Diluent* NA
Assay Type 1-Step Sandwich
Minutes to 1st Result ~22
Reportable Range ~ 0.50–5,000 pg/mL
SI Units Conversion Factor NA
Sample Dilution if OVR NA
Analytical Sensitivity LoB 0.50 pg/mL (analytical)
LoQ 3.23 pg/mL (functional)
Expected Values** See IFU
Days Stable: Curve 28
Days Stable: Open Pack 28
Expected Total Imprecision <20% at 3.23-10 pg/mL
10% at 10 pg/mL.
Sample Pickup 50 µL
Sample Type Serum
Sample Avoid Collection after prostatic manipulation;
hemolysis, turbidity
Sample Max. Time at:
RT 3 hours (from time of blood draw)
2–8C 24 hours
-20C 5 months
(store at -70C if >5 months)
Sample Max. Thaws 2
Calibrator:
Levels, Form 7 @ 1 x 2.1 mL
Storage, Stability -20°C until exp.
2–10C See IFU
Primary Standard Internal
QC
Levels, Form 3 @ 1 x 5.0 mL liquid
Storage, Stability -20°C until exp.
2–10C See IFU

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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OV Monitor
OV Monitor–Diluted***
Tumor Markers
OV Monitor OV Monitor–Diluted
Test Name / LIS Code: OV125Ag / OV125 dOVAg / dOVAg
Access & DxI/DxC
Test Number 175 11175
Remisol Code A03 A130
Catalog #s
Reagent 386357
Calibrator 386358
QC NA
Diluent* Samp. Dil. A (81908)
Diluent Pack (Dilutions/Pack) A79783 (63)
Assay Type 1-Step Sandwich
Minutes to 1st Result ~20
Reportable Range • ~ 0.5–5,000 U/mL (OV125Ag)
• ~4250–100,000 U/mL (dOVAg)
SI Units Conversion Factor NA
Sample Dilution if OVR 1/10 or 1/20 1/20 Onboard
Analytical Sensitivity 0.5 U/mL
Expected Values** See IFU
Days Stable: Curve 28
Days Stable: Open Pack 28
Expected Total Imprecision <10% across range
Sample Pickup 25 µL
Sample Type Serum, Plasma-H
Sample Avoid NA
Sample Max. Time at:
RT 8 hours
2–8C 48 hours
-20C Undetermined
Sample Max. Thaws 1
Calibrator:
Levels, Form 6 @ 1 x 2.5 mL
Storage, Stability 2-10°C until exp.
Primary Standard Internal
QC NA
Levels, Form
Storage, Stability

NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

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Research Use Only

Research IL-6 RUO

Use IL-6 RUO–Diluted**
Only

IL-6 RUO IL-6 RUO–Diluted

Test Name / LIS Code: IL-6RUO / IL6RU dILRU / dILRU
Access & DxI/DxC
Test Number 290 11290
Remisol Code A88 A140
Catalog #s
Reagent A30945
Calibrator A30944
QC A30946
Diluent* S0 or Sample Dil. A (81908)
Diluent Pack (Dilutions/Pack) A79783 (123)
Assay Type 1-Step Sandwich
Minutes to 1st Result ~35
Reportable Range • NA
SI Units Conversion Factor pg/mL x 0.107
Sample Dilution if OVR 1/3 1/3 Onboard
Analytical Sensitivity NA
Days Stable: Curve 28
Days Stable: Open Pack 28
Expected Total Imprecision NA
Sample Pickup 110 L 110 L
Sample Type Serum, Plasma (H)
Sample Avoid lipemic, hemolyzed
Sample Max. Time at:
RT 8 hours
2–8C 48 hours
-20C Undetermined
Sample Max. Thaws 1
Calibrator:
Levels, Form S0 @ 1 x 4mL
S1-S5 @ 1 x 2.5 mL
Storage, Stability Unopened: 2–10C until exp.
Opened: 90 days @ 2-10C

Primary Standard NA
QC
Levels, Form 3 @ 2 x 2.5 mL liquid
Storage, Stability -20C until exp.
14 days @ 2-10C

NOTE:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein
are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries.
Hybritech is a trademark of Hybritech Incorporated, a subsidiary of Beckman Coulter, Inc.

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2019-5711