ARCHITECT U.S.

Assay Menu
157 Assays Available 13 Assays in Development
See subsequent pages for intended use and important safety information
Cancer Infectious Disease Therapeutic Drug Monitoring
AFP Anti-HAV IgG Carbamazepine
CA 125 Anti-HAV IgM Digoxin
CA 15-3 Anti-HBc Gentamicin
CA 19-9 XR Anti-HBc IgM Phenobarbital
CEA Anti-HBs Phenytoin
Free PSA Anti-HCV Theophylline
Assays in HE-4 / ROMA HBsAg Valproic Acid
Development* Total PSA HBsAg Confirmatory Vancomycin
IMMUNOASSAY

HIV Ag/Ab Combo

• High Sensitive Cardiac Syphilis
Troponin I BNP Thyroid
• Tg CK-MB Anti-Tg
• Rubella IgG Galectin-3 Metabolic Anti-TPO
• Rubella IgM Myoglobin Active-B12 (HoloTC) Free T3
• Toxo IgG Troponin-I Anti-CCP Free T4
• Toxo IgM B12 T-Uptake
• CMV IgG Fertility / Pregnancy C-Peptide Total T3
• CMV IgM DHEA-S Cortisol Total T4
• HSV -1 Estradiol Ferritin TSH
• HSV -2 FSH Folate
hCG (Total ß-hCG) Hemoglobin A1c
* - Not available in US LH Homocysteine Transplant
Progesterone Insulin Cyclosporine
Prolactin Intact PTH Sirolimus
SHBG Procalcitonin Tacrolimus
Testosterone Vitamin D

Drugs of Abuse /Toxicology General Chemistry (cont) Proteins (cont)

6-Acetylmorphine Creatine Kinase (CK) Apolipoprotein B
Acetaminophen Creatinine (Enzymatic/JAFFE) ASO
Amphetamine/Methamphetamine Direct Bilirubin Beta2 Microglobulin
Barbiturates Direct LDL (D-LDL) C-Reactive Protein
Benzodiazepines (Urine/Serum) Gamma-Glutamyl Transferase (GGT) C-Reactive Protein (HS)
Buprenorphine Glucose Ceruloplasmin
Oxycodone HDL, Ultra Complement C3
Cannabinoids ICT Cl Complement C4
Cocaine ICT K Free Light Chain: Kappa
CLINICAL CHEMISTRY

Ecstasy ICT Na Free Light Chain: Lambda

Ethanol Iron (S, P) Haptoglobin
Methadone Lactate Dehydrogenase (LD) Immunoglobulin A (IgA)
Opiates Lactic Acid Immunoglobulin E (IgE)
Assays in Phencyclidine (PCP) Lipase Immunoglobulin G (IgG)
Development* Propoxyphene Magnesium (Arsenazo) Immunoglobulin M (IgM)
Salicylate Phosphorus Lp(a)
• Fentanyl Tramadol Total Bilirubin Microalbumin (u)
• Magnesium Tricyclic Antidepressants Total Protein Prealbumin
(Enzymatic) Triglycerides Rheumatoid Factor (RF)
• Methadone General Chemistry UIBC Transferrin
(EDDP) Acid Phosphatase Urea Nitrogen
Alanine Aminotransferase (ALT) Uric Acid, Next Generation Therapeutic Drug Monitoring
* - Not available in US Activated ALT Urine/CSF Protein Amikacin
Albumin BCG Carbamazepine
Albumin BCP Metabolic Digoxin
Alkaline Phosphatase Ferritin Gentamicin
Ammonia Hemoglobin A1c Lithium
Amylase Hemoglobin A1c (Whole Blood) Phenobarbital
Aspartate Aminotransferase (AST) Phenytoin
Activated AST Proteins Quinidine
Calcium Alpha-1 Antitrypsin Theophylline
Carbon Dioxide (CO2) Alpha-1 Glycoprotein Tobramycin
Cholesterol Apolipoprotein A1 Valproic Acid
Vancomycin

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Company Confidential – For internal use only
ADD‐00060754 • Assay menu subject to platform ©2018 Abbott Laboratories
©2014 Abbott
 ARCHITECT U.S. Assay Menu
INTENDED USE AND IMPORTANT SAFETY INFORMATION
•For In Vitro Diagnostic Use Only
•CAUTION: United States Federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory.
•For complete assay information, see the assay specific package insert.
ARCHITECT AFP
Intended Use: The ARCHITECT AFP assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of
alpha-fetoprotein (AFP) in:
1. Human serum or plasma to aid in monitoring disease progression during the course of disease and treatment of patients with
nonseminomatous testicular cancer.
2. Human serum, plasma and amniotic fluid at 15 to 21 weeks gestation to aid in the detection of fetal open neural tube defects (NTD). Test
results when used in conjunction with ultrasonography or amniography are a safe and effective aid in the detection of fetal open NTD.
Important Safety Information: The concentration of alpha-fetoprotein (AFP) in a given specimen, determined with assays from different
manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician
must include the identity of the AFP assay used. Values obtained with different assay methods cannot be used interchangeably. If, in the
course of monitoring a patient, the assay method used for determining AFP levels serially is changed, additional sequential testing should be
carried out. Prior to changing assays, the laboratory MUST:
1. For Cancer Management - Confirm baseline values for patients being serially monitored.
2. For Prenatal Testing - Establish a range of expected values for the new assay based on serum or plasma and amniotic fluid from pregnant
women with confirmed gestational age.
United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is
restricted to, by, or on the order of a physician. Package insert instructions must be carefully followed. Reliability of assay results cannot be
guaranteed if there are any deviations from the instructions in this package insert. This product contains sodium azide. Contact with acids
liberates very toxic gas. This material and its container must be disposed of in a safe way.
ARCHITECT Free PSA
Intended Use: The ARCHITECT Free PSA assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative
determination of free prostate specific antigen (PSA) in human serum. The ARCHITECT Free PSA assay is intended to be used in
conjunction with the ARCHITECT Total PSA assay in men aged 50 years or older with total PSA values between 4 and 10 ng/mL and DRE
non-suspicious for cancer to determine the % free PSA value. The ARCHITECT % free PSA value can be used as an aid in discriminating
between prostate cancer and benign disease.
Important Safety Information: The concentration of free PSA in a given specimen, determined with assays from different manufacturers,
can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the
identity of the free PSA assay used. Values obtained with different assay methods cannot be used interchangeably. United States Federal
Law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to by or on
the order of a physician. Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are
any deviations from the instructions in this package insert.
ARCHITECT Total PSA
Intended Use: The ARCHITECT Total PSA assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative
determination of total PSA (both free PSA and PSA complexed to alpha-1-antichymotrypsin) in human serum:
• 1. As an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (DRE) in men 50 years or older.
Prostatic biopsy is required for diagnosis of cancer.
• 2. As an adjunctive test to aid in the management of prostate cancer patients.
Important Safety Information: The concentration of total PSA in a given specimen, determined with assays from different manufacturers,
can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the
identity of the total PSA assay used. Values obtained with different assay methods, including Abbott PSA assays, cannot be used
interchangeably. If, in the course of monitoring a patient, the assay method used for determining total PSA levels serially is changed,
additional sequential testing should be carried out. Prior to changing assays, the laboratory MUST confirm baseline values for patients being
serially monitored. United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to a clinical
laboratory; and use is restricted to, by, or on the order of a physician. Package insert instructions must be carefully followed. Reliability of
assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.
ARCHITECT Anti-HBc
Intended Use: The ARCHITECT CORE assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgG
and IgM antibodies to hepatitis B core antigen (anti HBc) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium
heparin, sodium heparin) and neonatal serum. It is intended as an aid in the diagnosis of acute, chronic, or resolved hepatitis B virus (HBV)
infection in conjunction with other laboratory results and clinical information.

WARNING: Not intended for use in screening blood, plasma, or tissue donors. The effectiveness of ARCHITECT CORE for use in screening
blood, plasma, or tissue donors has not been established. Assay performance characteristics have not been established when the
ARCHITECT CORE assay is used in conjunction with other manufacturers’ assays for specific hepatitis markers. Users are responsible for
establishing their own performance characteristics. Assay performance characteristics have not been established for immunocompromised or
immunosuppressed patients. Users are responsible for establishing their own assay performance characteristics in these populations.

Important Safety Information: Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if
there are any deviations from the instructions in this package insert. This product contains sodium azide. Contact with acids liberates very
toxic gas. This material and its container must be disposed of in a safe way.

TM

Company Confidential – For internal use only

ADD‐00060754 ©2015 Abbott Laboratories
©2014 Abbott
 ARCHITECT U.S. Assay Menu
INTENDED USE AND IMPORTANT SAFETY INFORMATION (continued)

ARCHITECT Anti-HBc
Intended Use: The ARCHITECT CORE assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgG
and IgM antibodies to hepatitis B core antigen (anti HBc) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium
heparin, sodium heparin) and neonatal serum. It is intended as an aid in the diagnosis of acute, chronic, or resolved hepatitis B virus (HBV)
infection in conjunction with other laboratory results and clinical information.

WARNING: Not intended for use in screening blood, plasma, or tissue donors. The effectiveness of ARCHITECT CORE for use in screening
blood, plasma, or tissue donors has not been established. Assay performance characteristics have not been established when the
ARCHITECT CORE assay is used in conjunction with other manufacturers’ assays for specific hepatitis markers. Users are responsible for
establishing their own performance characteristics. Assay performance characteristics have not been established for immunocompromised or
immunosuppressed patients. Users are responsible for establishing their own assay performance characteristics in these populations.

Important Safety Information: Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if
there are any deviations from the instructions in this package insert. This product contains sodium azide. Contact with acids liberates very
toxic gas. This material and its container must be disposed of in a safe way.

ARCHITECT HBsAg Qualitative

Intended Use: The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative
detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum. The assay may also be
used to screen for HBV infection in pregnant women to identify neonates who are at risk for acquiring hepatitis B during the perinatal period.
Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection
with the hepatitis B virus (HBV) (state of infection or associated disease not determined) in persons with signs and symptoms of hepatitis and
in persons at risk for hepatitis B infection. Not intended for use in screening blood, plasma, or tissue donors.

Important Safety Information: United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to
a clinical laboratory; and use is restricted to, by, or on the order of a physician. Package insert instructions must be carefully followed.
Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.

ARCHITECT HBsAg Qualitative Confirmatory

Intended Use: The ARCHITECT HBsAg Qualitative Confirmatory assay is a chemiluminescent microparticle immunoassay (CMIA) for the
qualitative confirmation of the presence of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate
serum by means of specific antibody neutralization. Assay results, in conjunction with other laboratory results and clinical information, may be
used to provide presumptive evidence of infection with the hepatitis B virus (HBV) (state of infection or associated disease not determined) in
persons with signs and symptoms of hepatitis and in persons at risk for hepatitis B infection. Not intended for use in screening blood, plasma,
or tissue donors.

Important Safety Information: United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to
a clinical laboratory; and use is restricted to, by, or on the order of a physician. Package insert instructions must be carefully followed.
Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.

ARCHTECT Anti-HBs (AUSAB)

Intended Use: The ARCHITECT AUSAB assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination
of antibody to hepatitis B surface antigen (anti-HBs) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and
sodium heparin) and neonatal serum. It is intended for quantitative measurement of antibody response following hepatitis B virus (HBV)
vaccination, determination of HBV immune status, and for the laboratory diagnosis of HBV disease associated with HBV infection when used
in conjunction with other laboratory results and clinical information.

WARNING: Not intended for use in screening blood, plasma, or tissue donors. The effectiveness of ARCHITECT AUSAB for use in screening
blood, plasma, or tissue donors has not been established. Assay performance characteristics have not been established for
immunocompromised or immunosuppressed patients. The user is responsible for establishing their own assay performance characteristics in
these populations.

Important Safety Information: United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to
a clinical laboratory; and use is restricted to by or on the order of a physician. Package insert instructions must be carefully followed.
Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. This product contains
sodium azide. Contact with acids liberates very toxic gas. This material and its container must be disposed of in a safe way.

TM

Company Confidential – For internal use only

ADD‐00060754 ©2015 Abbott Laboratories
©2014 Abbott
 ARCHITECT U.S. Assay Menu
INTENDED USE AND IMPORTANT SAFETY INFORMATION (continued)

ARCHITECT Anti-HCV
Intended Use: The ARCHITECT Anti-HCV assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of
immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to hepatitis C virus (anti-HCV) in human adult serum and plasma (potassium
EDTA, lithium heparin, and sodium heparin). Assay results, in conjunction with other laboratory results and clinical information, may be used
to provide presumptive evidence of infection with HCV (state of infection or associated disease not determined) in persons with signs and
symptoms of hepatitis and in persons at risk for hepatitis C infection.

WARNING: Not intended for use in screening blood, plasma, or tissue donors. The effectiveness of ARCHITECT Anti-HCV for use in
screening blood, plasma, or tissue donors has not been established. Assay performance characteristics have not been established for
newborns, infants, children, or populations of immunocompromised or immunosuppressed patients. The user is responsible for establishing
their own assay performance characteristics in these populations.

Important Safety Information: United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to
a clinical laboratory; and use is restricted to by or on the order of a physician. Package insert instructions must be carefully followed.
Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.

ARCHITECT Anti-HBc IgM

Intended Use: The ARCHITECT CORE-M assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of
IgM antibody to hepatitis B core antigen (IgM anti-HBc) in human adult and pediatric serum or plasma (dipotassium EDTA, lithium heparin,
and sodium heparin) and neonatal serum. A test for IgM anti-HBc is indicated as an aid in the diagnosis of acute or recent hepatitis B virus
(HBV) infection in conjunction with other laboratory results and clinical information.

WARNING: Not intended for use in screening blood, plasma, or tissue donors. The effectiveness of ARCHITECT CORE-M for use in
screening blood, plasma, or tissue donors has not been established. Assay performance characteristics have not been established when the
ARCHITECT CORE-M assay is used in conjunction with other manufacturers’ assays for specific hepatitis markers. Users are responsible for
establishing their own performance characteristics. Assay performance characteristics have not been established for immunocompromised or
immunosuppressed patients. The user is responsible for establishing their own assay performance characteristics in these populations.

Important Safety Information: United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to
a clinical laboratory; and use is restricted to by or on the order of a physician. Package insert instructions must be carefully followed.
Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. This product contains
sodium azide. Contact with acids liberates very toxic gas. This material and its container must be disposed of in a safe way.

ARCITECT HIV Ag/Ab Combo

Intended Use: The ARCHITECT HIV Ag/Ab Combo assay is a chemiluminescent microparticle immunoassay (CMIA) for the simultaneous
qualitative detection of human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV type 1 (HIV 1 group M and group O) and/or
type 2 (HIV-2) in human serum and plasma (EDTA and heparin). The ARCHITECT HIV Ag/Ab Combo assay is intended to be used as an aid
in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis
of HIV-1/HIV-2 infection in pediatric subjects (i.e., children as young as two years of age) and in pregnant women.

An ARCHITECT HIV Ag/Ab Combo reactive result does not distinguish between the detection of HIV-1 p24 antigen, HIV-1 antibody, or HIV-2
antibody.

The ARCHITECT HIV Ag/Ab Combo assay is not intended for use in screening blood or plasma donors. The effectiveness of ARCHITECT
HIV Ag/Ab Combo for use in screening blood or plasma donors has not been established. However, this assay can be used as a blood donor
screening assay in urgent situations where traditional licensed blood donor screening tests are unavailable or their use is impractical.

Important Safety Information: United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to
a clinical laboratory; and use is restricted to by or on the order of a physician. Package insert instructions must be carefully followed.
Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. This product contains
sodium azide. Contact with acids liberates very toxic gas. This material and its container must be disposed of in a safe way.

• ARCHITECT and CHOOSE TRANSFORMATION are trademarks of Abbott Laboratories in various jurisdictions
• CA 125, CA 15-3 and CA 19-9 XR are trademarks of Fujirebio Diagnostics, Inc.

TM

Company Confidential – For internal use only

www.abbottdiagnostics.com 1‐877‐4ABBOTT ADD‐00060754 ©2015 Abbott Laboratories
©2014 Abbott