P10.Ek37-Rev.01/25.09.2023 PIS.

115
For in vitro diagnostic use only.
For professional use only.

Cat No: BS-SY-MX24L-25/BS-SY-MX24L-100

Respiratory Tract RT-qPCR MX-24L Panel

Package Insert
Table 1. Kit Content
Component Intended Use Component Intended Use 12 Reactions 30 Reactions
Specific nucleic acid amplification and
SY-1 Rxn detection: PC-SY 1 FAM: SARS-CoV-2 + Template
FAM: SARS-CoV-2 HEX: Human (IC-Internal Control) + Template
1: 1:
HEX: Human (IC-Internal Control) ROX: Influenza B + Template
ROX: Influenza B CY5: Influenza A + Template
CY5: Influenza A
FAM: Human Coronavirus 229E FAM: Human Coronavirus 229E + Template
12 SY-1 Rxn 30 SY-1 Rxn
HEX: Human Coronavirus OC43 HEX: Human Coronavirus OC43 + Template
2: 2: strips strips
ROX: Human Coronavirus NL63 ROX: Human Coronavirus NL63 + Template
+ +
CY5: Human Coronavirus HKU1 CY5: Human Coronavirus HKU1 + Template
6 SY-1 PC strips 15 SY-1 PC strips
FAM: Human Parainfluenza 1 FAM: Human Parainfluenza 1 + Template
HEX: Human Parainfluenza 2 HEX: Human Parainfluenza 2 + Template
3: 3:
ROX: Human Parainfluenza 3 ROX: Human Parainfluenza 3 + Template
CY5: Human Parainfluenza 4 CY5: Human Parainfluenza 4 + Template
FAM: Human Metapneumovirus FAM: Human Metapneumovirus + Template
4: HEX: Human Enterovirus 4: HEX: Human Enterovirus + Template
CY5: Human Adenovirus CY5: Human Adenovirus + Template
PC-SY 2
SY-2 Rxn
FAM: Human Bocavirus FAM: Human Bocavirus + Template
5: 5:
CY5: Human Rhinovirus CY5: Human Rhinovirus + Template

FAM: Legionella pneumophila FAM: Legionella pneumophila + Template

6: HEX: Streptococcus pyogenes 6: HEX: Streptococcus pyogenes + Template
ROX: Mycoplasma pneumoniae ROX: Mycoplasma pneumoniae + Template 12 SY-2 Rxn 30 SY-2 Rxn
strips strips
FAM: Haemophilus influenzae FAM: Haemophilus influenzae + Template + +
7: ROX: Bordetella pertussis 7: ROX: Bordetella pertussis + Template 6 SY-2 PC strips 15 SY-2 PC strips
CY5: Streptococcus pneumoniae CY5: Streptococcus pneumoniae + Template

FAM: Respiratory Syncytial Virus A/B +

FAM: Respiratory Syncytial Virus A/B
Template
HEX: Influenza A H1
8: 8: HEX: Influenza A H1 + Template
ROX: Influenza A H3
ROX: Influenza A H3 + Template
CY5: Influenza H1N1-2009
CY5: Influenza H1N1-2009 + Template
Control Template Nuclease-free Water (CT) 1 x 1250 µL 2 x 1250 µL

Table 2. Storage Condition and Shelf Life of The Components

Component Transport Condition Storage Condition* Shelf Life
SY-1 Rxn/SY-2 Rxn Strips (-22) °C – (-18) °C
PC-SY 1/ PC-SY 2 Strips (-22) °C – (-18) °C (-22) °C – (-18) °C 12 Months
Control Template (-22) °C – (-18) °C before opening, (+2) °C – (+8) °C after first thaw
*Each reagent stored at storage temperature can be used until the expiration date indicated on the tube following the first opening. The kit’s expiration date is determined by the
expiration date of the reagents.
Table 3. Components Required but Not Included with The Test
Components Required but Not Included with The Test
1. Magnetic Induction Cycler (Mic) (Bio Molecular System – BMS) Real-Time PCR systems
2. Micropipettes and filtered pipette tips (nuclease-free) suitable for transferring 1-10 µL of liquid
3. Mic Cold Rack
Table 4. Intended Use, Test Principle and Analytical Specifications
Function Aid to diagnosis Sample Type(s) Table 5
Analyte(s) Table 1 Nucleic Acid Preparation Method(s) Table 5
Qualitative/Quantitative Qualitative Validated PCR Instrument(s) Table 3
Reverse transcription and Real-Time PCR
Test Principle Validated on the reference strains and the field
(RT-qPCR) Inclusivity and Exclusivity
isolates.
Automated/Manual Manual
Intended Users Professional use Limit of Detection (LoD) Table 5
Target Population Individuals with the suspected infection Sensitivity and Specificity 99.93% and 99.14%

Revision Date: 2024-03-01/Rev.01 1

Published Date: 2023-10-04
P10.Ek37-Rev.01/25.09.2023
For in vitro diagnostic use only.
For professional use only.
Table 1. Collection, Storage and Transfer of Clinical Specimens / Nucleic Acid Preparation Methods and the Respected LoD Values
Sample Type** Sample Transfer Sample Storage Nucleic Acid Preparation Method LoD (cp/mL)
vNAT® Transfer Tube 3 months at (+2) °C – (+8) °C Nucleic acid preparation is not needed, samples can be
250
Combined nasopharyngeal and (Cat. No: BS-NA-513m) One year at -20 °C used directly in RT-qPCR
oropharyngeal swab samples Transport Medium 3 days at (+2) °C – (+8) °C
RINA™ M14 Nucleic Acid Extraction Device 125
(without antibiotics) 1 year at -20 °C
(Robot Catalog No: RINA-M14-01, Kit Cat. No: RN-NA-101)
Bronchoalveolar lavage (BAL),
Preservative-free sterile 3 days at (+2) °C – (+8) °C Zybio EXM3000 Nucleic Acid Isolation System
sputum, and nasopharyngeal 500
containers/tubes 1 year at -20 °C (Robot Catalog No: EXM3000, Kit Cat. No: ZFNAE01)
aspirate (NAP) samples
** Clinical specimens should be collected by a healthcare provider in accordance with national/international clinical specimen collection regulations.

1. RT-qPCR Application Protocol

1. Program the qPCR instrument using the QR code/link given in Table 6.
2. Take the “Mic Cold Rack” out of (-22) °C – (-18) °C. Place the “SY-1 Rxn” and “SY-2 Rxn” strips quickly onto the rack afterward.
3. Add 10 µL of "Template Nucleic Acid (Sample)" to the SY-1 Rxn and SY-2 Rxn strips and close the strips.
4. Positive Control Test: In each run, add 10 µL of "Control Template" to the each well of a PC-SY-1 and PC-SY-2 strips and close the strips.
5. Negative Control Test: In each run, add 10 µL of "Control Template" to the each well of new SY-1 Rxn and SY-2 Rxn strips and close the strips.
6. Place the strips in the qPCR instrument and start the run.

Table 6. qPCR Program Details

Step Cycle No. Temperature Duration
Reverse Transcription 1 Cycle 52 °C 3 min
Pre-Incubation 1 Cycle 95 °C 10 sec
Denaturation 12 Touchdown Cycles: 95 °C 1 sec
Annealing and Extension 1 °C decrement in annealing temperature per cycle 67 °C – 56 °C 15 sec
Denaturation 95 °C 1 sec
Annealing and Extension 30 Cycles 55 °C 15 sec
Detection (Reading) (FAM-Green)/(HEX-Yellow)/(ROX-OranSY)/(CY5-Red)

W AR N IN G : The RT-qPCR program file should be downloaded from the QR code on the left or
from the link below.
https://www.bioeksen.com.tr/files/L_TD_43P/

2. Interpretation of the Assay Results

All default analysis options (e.g., auto-calculated threshold) in the PCR instrument software should not be changed to calculate Cq values.
The shape of the amplification curves should be examined for all reaction wells returning with Cq values. All the sigmoidal curves above the threshold should be recorded as
“positive” and their Cq values should be recorded. Non-sigmoidal curves should be recorded as “negative”.

Table 7. Expected Performance of Kit Controls

Expected Results and Cq Values
Control Type Purpose
IC (HEX) Target
Negative Control Contamination control during RT-qPCR Not detected (No Cq) Not detected (No Cq)
Positive Control Reagent integrity Detected (Cq≤30) Detected (Cq≤30)
To monitor the integrity of nucleic acid Detected (Cq≤30) If the target is “Detected” according to the result
Internal/Extraction Control
extraction and RT-qPCR from each sample If the IC is “Not detected”, check the target Cq. interpretation criteria, IC is valid.

If any control does not work as described above, the run is reported as follows:
1. Contamination: If Cq≤30 in any NTC test channel.
Recommended action: Repeat the analysis paying attention to the “Warnings and Limitations” section.
2. Reagent Problem: In case a sigmoidal curve with a Cq≤30 cannot be obtained for any of all the samples tested in the run, including the controls.
Recommended action: If all the tested samples show negative results for the target pathogens and controls, the run is considered invalid. In this scenario, it is
essential to conduct testing on the "Positive Control(s)" included in the kit. A negative Positive Control test result suggests a potential "Reagent Problem." If
encountered, please reach out to the manufacturer for further assistance.
3. Invalid: If the IC (Internal Control) and all other targets are “Not detected”.
Recommended action: Sampling isn’t successfully done, or there is a problem during the sample transportation. A new sample from the same patient should be
collected and tested again.

If all the controls are valid, the results are interpreted as follows:
Table 8. Interpretation of Patient Results
Target Internal Control (IC) Result Interpretation
If 26<Cq ≤30 “Low Positive”
Results are valid
Positive (+) Positive (+) or Negative (-) If 16<Cq≤26 “Positive”
Target is detected
If Cq≤16 “High Positive”
Results are valid
Negative (-) Positive (+)
Target is not detected

The results generated by the PCR instruments can be reported manually, as explained earlier, or automatically using the "Sigmoida" software. To obtain the "Sigmoida" software
installer, please send an email to [email protected].

Revision Date: 2024-03-01/Rev.01 2

Published Date: 2023-10-04
P10.Ek37-Rev.01/25.09.2023
For in vitro diagnostic use only.
For professional use only.
3. Warnings and Limitations
1. False-negative results may occur if inadequate numbers (lower than the LoD) of organisms are present in the specimen.
2. Mutations within the tarSYt regions could affect primer and/or probe binding resulting in failure to detect the presence of aSYnts.
3. The “Mic Cold Rack” should be stored at (-22) °C - (-18) °C. Reaction tubes should be immediately placed onto the cold rack after being taken out. Adding the
sample to the reaction tubes should be performed on the cold rack and then placed into the device.
4. The use of cotton or calcium alginate swabs or swabs with wooden sticks can lead to false negative results since they may contain substances that inactivate some
viruses and inhibit PCR.
5. A false-negative result may occur if a specimen is improperly collected, transported, or handled.
6. The clinical specimens shall be collected by a healthcare provider in accordance with the specimen collection guidelines.
7. Test procedures should be performed by personnel trained in the use of the kit.
8. Except for liquid transfers, sample tubes should always be kept closed.
9. Filtered and nuclease-free pipette tips should be used for sample transfer.
10. The components in the kit should not be used toSYther with different lot numbers or chemicals of the same name but from different manufacturers.
11. The caps of the reaction tubes must not be opened after the PCR run. The PCR tubes should be placed in a bag and thrown away after the bag is tightly closed.
12. The surfaces of the workbenches should be wiped with freshly diluted 10% bleach (0.5% NaClO) at the beginning and end of each day.
13. Disposal of waste must be carried out in accordance with local, state, and federal regulations.

4. Explanation of Symbols
Symbol Title of Symbol Symbol Title of Symbol Symbol Title of Symbol

European Conformity CE Mark Batch code Keep away from sunlight

Protect from heat and

In vitro diagnostic medical device Catalogue number
radioactive sources

Do not use if packaSY is damaSYd

Manufacturer Non-sterile
and consult instructions for use
Consult instructions for use or
Use-by date consult electronic instructions for Keep dry
use

Negative control Caution Keep upright

Positive control Temperature limit Contains sufficient for <n> tests

Control

5. Manufacturer and Technical Support

Bioeksen AR SY Teknolojileri A.Ş
Address: Huzur Mah. Metin Oktay Cad. Nurol Life Sitesi D Blok No:3/31, 34396 Sarıyer/İstanbul-TÜRKİYE
Phone: +90 (212) 285 10 17, Fax: +90 (212) 285 10 18
Web: www.bioeksen.com.tr, e-mail: [email protected],
Technical Support: [email protected]
Notice to User: Please inform us about product-related incidents at “[email protected]” within 24 hours.

ALL RIGHTS RESERVED

Revision Date: 2024-03-01/Rev.01 3

Published Date: 2023-10-04