VITROS CV2G Reagent Pack Instruction Manual

VITROS CV2G Reagent Pack

Product Information

Specifications

• Product Name: VITROS Immunodiagnostic Products Anti-SARS-CoV-2  IgG Reagent Pack
• Product Code: CV2G
• Item Numbers: 619 9951, 619 9952
• Intended Use: In vitro qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma
• Compatibility: VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems
• Incubation Time: 37 minutes
• Reaction Sample Volume: 20 L
• Time to First Result: 48 minutes

Product Usage Instructions

Warnings and Precautions

WARNING: Potentially Infectious Material
Treat as if capable of transmitting infection. Use caution when handling material of human origin. Consider all samples potentiallyinfectious. No test method can offer complete assurance that hepatitis B virus, hepatitis C virus (HCV), human immunodeficiency virus (HIV 1+2) or other infectious agents are absent. Handle, use, store and dispose of solid and liquid waste from samples and test components, in accordance with procedures defined by appropriate national biohazard safety guideline or regulation (e.g. CLSI document M29).

WARNING: VITROS Immunodiagnostic Products AntiSARS-CoV-2 IgG Calibrator contains:

• SARS-CoV-2 antibody negative plasma obtained from donors who were tested individually and who were found to be negative for hepatitis B surface antigen, and for antibodies to hepatitis C virus (HCV) and HIV, using approved methods (enzyme immunoassays).

WARNING: VITROS Immunodiagnostic Products AntiSARS-CoV-2 IgG Calibrator in addition contains:

• SARS-CoV-2 IgG antibody. Handle as if capable of transmitting infection.
• Contains Mixture, 3(2H)-isothiazolone, 5-chloro-2-methyl-with 2-methyl-3(2H)isothiazolone (CAS 55965-84-9)
• Contains 2-methyl-3-isothiazolone (CAS 2682-20-4)

Reagents

Reagent Pack Contents: 1 reagent pack containing:

• Specific contents not provided in the manual

Reagent Pack Handling: Follow the instructions provided with the reagent pack for proper handling.

Reagent Pack Storage and Preparation:

• Unopened: Store the reagent pack refrigerated until use.
• Opened: Place the reagent pack on the system and ensure the  system is turned on.

Specimen Collection, Preparation and Storage

• Calibrator Contents: Specific contents not provided in the manual.
• Calibrator Handling: Follow the instructions provided with the calibrator for proper handling.

FAQ

Where can I find the Safety Data Sheets and contact information for Ortho Clinical Diagnostics?
You can find the Safety Data Sheets and contact information for Ortho Clinical Diagnostics on their website at www.orthoclinicaldiagnostics.com.

How should I dispose of this product?
Follow local disposal regulations based on your location along with recommendations and content in the Safety Data Sheet to determine the safe disposal of this product.

Intended Use
For in vitro diagnostic and laboratory professional use.

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma (K2-EDTA and, K3-EDTA) samples collected on or after 15 days post-symptom onset using the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
For use in the calibration of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems for the in vitro qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma.

Summary and Explanation of the Test

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is a novel beta coronavirus that caused an outbreak of Coronavirus Disease 2019 (COVID-19), resulting in a world-wide pandemic. SARS-CoV-2 is mainly transmitted through droplets and contact routes. 1- 2 People who are infected with SARS-CoV-2 may show symptoms of acute respiratory illness, such as fever, cough, shortness of breath, but can also be asymptomatic. Symptomatic, pre-symptomatic (infected but still symptom-free) and asymptomatic SARS-CoV-2 carriers all can be potential sources for viral transmission. 3

Real-time reverse transcription polymerase chain reaction (rRT-PCR) detecting the genetic material of SARS-CoV-2 genes is considered the gold standard for the diagnosis of COVID-19, and SARS-CoV-2 antigen assays have also been used to detect acute infection. 4 Individuals infected with SARS-CoV-2 start to produce antibodies to the virus 1–2 weeks post symptom onset, and most individuals achieve seroconversion in week 3–4 after symptom onset. 5- 6 Patients with SARS-CoV-2 infection produce antibodies to multiple viral antigens including the spike protein and the nucleocapsid protein. 7 However, the level of antibodies that confers protection from re-infection is not known yet.

Principles of the Procedure

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is performed using the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack and the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator on the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. An immunometric technique is used; this involves a two stage reaction. In the first stage antibodies to SARS-CoV-2 present in the sample bind with SARS-CoV-2 spike protein coated on the wells. Unbound sample is removed by washing. In the second stage horseradish peroxidase (HRP)-labeled murine monoclonal anti-human IgG antibodies are added to the conjugate reagent. The conjugate binds specifically to the antibody portion of the antigen-antibody complex. If complexes are not present, the unbound conjugate is removed by the subsequent wash step.

The bound HRP conjugate is measured by a luminescent reaction 8. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system.

Test Type

| ****

System *

| ****

Incubation Time

| ****

Time to first result

| ****

Test Temperature

| Reaction Sample Volume
---|---|---|---|---|---
Immunometric|  ECi/ECiQ, 3600,

5600/XT 7600

| 37 minutes| 48 minutes| 37 °C| 20 μL

• Not all products and systems are available in all countries.

Reaction Scheme

Warnings and Precautions

WARNING:

Potentially Infectious Material
Treat as if capable of transmitting infection. Use caution when handling material of human origin. Consider all samples potentially infectious. No test method can offer complete assurance that hepatitis B virus, hepatitis C virus (HCV), human immunodeficiency virus (HIV 1+2) or other infectious agents are absent. Handle, use, store and dispose of solid and liquid waste from samples and test components, in accordance with procedures defined by appropriate national biohazard safety guideline or regulation (e.g. CLSI
document M29). 9

VITROS Immunodiagnostic Products Anti‑SARS-CoV-2 IgG Calibrator contains: SARS-CoV-2 antibody negative plasma obtained from donors who were tested individually and who were found to be negative for hepatitis B surface antigen, and for antibodies to hepatitis C virus (HCV) and HIV, using approved methods (enzyme immunoassays).

VITROS Immunodiagnostic Products Anti‑SARS-CoV-2 IgG Calibrator in addition contains: SARS-CoV-2 IgG antibody. Handle as if capable of transmitting infection.

WARNING:

Contains Mixture, 3(2H)-isothiazolone, 5-chloro-2-methyl-with 2-methyl-3(2H)-isothiazolone (CAS 55965-84-9) 10 The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack contains 0.03% Mixture, 3(2H)-isothiazolone, 5-chloro-2-methyl-with 2- methyl-3(2H)-isothiazolone.

• H317: May cause an allergic skin reaction.
• P261: Avoid breathing dust/fume/gas/mist/vapors/spray.
• P272: Contaminated work clothing must not be allowed out of the workplace.
• P280: Wear protective gloves.
• P302 + P352: IF ON SKIN: Wash with plenty of soap and water.
• P333 + P313: If skin irritation or rash occurs: Get medical advice/attention.
• P363: Wash contaminated clothing before reuse.
• P501: Dispose of contents/container to an approved waste disposal plant.

WARNING: Contains 2-methyl-3-isothiazolinone (CAS 2682-20-4) 10 The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrators contain 0.0475% 2-methyl-3-isothiazolone.

H317: May cause an allergic skin reaction.

P261: Avoid breathing dust/fume/gas/mist/vapors/spray.

• P272: Contaminated work clothing must not be allowed out of the workplace.
• P280: Wear protective gloves.
• P302 + P352: IF ON SKIN: Wash with plenty of soap and water.
• P333 + P313: If skin irritation or rash occurs: Get medical advice/attention.
• P363: Wash contaminated clothing before reuse. P501: Dispose of contents/container to an approved waste disposal plant.

Refer to www.orthoclinicaldiagnostics.com for the Safety Data Sheets and for Ortho Clinical Diagnostics contact information.

Safe Disposal
Follow local disposal regulations based on your location along with recommendations and content in the Safety Data Sheet to determine the safe disposal of this product.

Reagents

Reagent Pack Contents

1 reagent pack containing:

• 100 coated wells (recombinant SARS-CoV-2 antigen derived from human cells, coated at 110 ng/well)
• 18.0 mL assay reagent (buffer with bovine protein stabilizers and antimicrobial agent)
• 20.4 mL conjugate reagent [anti-human IgG (murine monoclonal) conjugated to horseradish peroxidase, 5 ng/mL] in buffer with bovine protein stabilizers and antimicrobial agent

Reagent Pack Handling

• The reagent pack is supplied ready for use.
• The reagent pack contains homogeneous liquid reagents that do not require shaking or mixing prior to loading onto the system.
• Handle the reagent pack with care. Avoid the following:
  • allowing condensation to form on the pack
  • causing reagents to foam
  • agitation of the pack

Reagent Pack Storage and Preparation

• The VITROS Immunodiagnostic Products Anti‑SARS-CoV-2 IgG Reagent Pack is suitable for use until the expiration date on the carton when stored and handled as specified. Do not use beyond the expiration date.

• Do not freeze reagent packs.

• Load reagent packs directly from refrigerated storage to minimize condensation.

• Opened reagent packs are moisture/humidity sensitive. Store opened refrigerated reagent packs in a sealed VITROS Immunodiagnostic Products Reagent Pack Storage Box with desiccant.
  Calibrator Contents

• 2 vials of VITROS Immunodiagnostic Products Anti‑SARS-CoV-2 IgG Calibrator (anti-SARS-CoV-2 IgG in anti-SARSCoV- 2 IgG negative human serum with antimicrobial agent, 1 mL)

• Lot calibration card

• Protocol card

• 8 calibrator bar code labels
  Calibrator Handling

• Use only with reagent packs of the same lot number. Mix thoroughly by inversion and bring to 15–30 °C (59–86 °F) before use.

• Handle calibrator in original stoppered containers to avoid contamination and evaporation. To avoid evaporation, limit the amount of time the calibrator is on the system. Refer to the operating instructions for your system. Return to 2–8 °C (36– 46 °F) as soon as possible after use, or load only sufficient volume for a single determination.

Calibrator Storage and Preparation

• The VITROS Immunodiagnostic Products Anti‑SARS-CoV-2 IgG Calibrator is supplied frozen.
• The VITROS Immunodiagnostic Products Anti‑SARS-CoV-2 IgG Calibrator is suitable for use until the expiration date on the carton when stored and handled as specified. Do not use beyond the expiration date.
• DO NOT REFREEZE.
• The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test uses 20 μL of calibrator for each determination. Transfer an aliquot of the calibrator into a sample container (taking account of the minimum fill volume of the container), which may be bar coded with the labels provided. For details on minimum fill volume of sample cups or containers, refer to the operating instructions for your system.
• The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator is automatically processed in duplicate.

Specimen Collection, Preparation and Storage

Patient Preparation
No special patient preparation is necessary.

Specimens Recommended

• Serum
• K2-EDTA Plasma
• K3-EDTA Plasma

Specimens Not Recommended
The VITROS Immunodiagnostic Products Anti‑SARS-CoV-2 IgG test is intended to be used ONLY with the specimen types recommended in this document.

Special Precautions

IMPORTANT : Certain collection devices have been reported to affect other analytes and tests. 11 Owing to the variety of specimen collection devices available, Ortho Clinical Diagnostics is unable to provide a definitive statement on the performance of its products with these devices. Confirm that your collection devices are compatible with this test.

Specimen Collection and Preparation

• Collect specimens using standard procedures. 12
• Follow the instructions provided with your blood collection tube for use and processing of the sample. 13
• Samples should be thoroughly separated from all cellular material. Failure to do so may lead to an erroneous result.

INSTRUCTIONS FOR USE

Testing Procedure
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test uses 20 μL of sample for each determination. This does not take account of the minimum fill volume of the chosen sample container. For details on minimum fill volume of sample cups or containers, refer to the operating instructions for your system.

Handling and Storage Conditions

• Handle samples in stoppered containers to avoid contamination and evaporation.
• Follow procedures within your laboratory to avoid cross contamination of patient specimens.
• The amount of time samples are on the system prior to analysis should be limited to avoid evaporation. Refer to the operating instructions for your system.
• Return to 2–8 °C (36–46 °F) as soon as possible after use or load sufficient volume for a single determination.
• Samples may be stored for up to 24 hours at room temperature 15–30 °C (59–86 °F) or 7 days at 2–8 °C (36–46 °F).
• Samples that will not be tested within 24 hours at room temperature or 7 days refrigerated should be stored frozen at ≤-20 °C (≤-4 °F). Serum and plasma samples may be subjected to up to one freeze-thaw cycle.
• Thoroughly mix samples by inversion and bring to 15–30 °C (59–86 °F) before use.

Specimen Storage and Stability

Testing Procedure

Materials Provided

• VITROS Immunodiagnostic Products Anti‑SARS-CoV-2 IgG Reagent Pack
• VITROS Immunodiagnostic Products Anti‑SARS-CoV-2 IgG Calibrator

Materials Required but Not Provided

• VITROS ECi/ECiQ Immunodiagnostic Systems
• VITROS 3600 Immunodiagnostic Systems
• VITROS 5600 Integrated Systems
• VITROS XT 7600 Integrated Systems
• VITROS Immunodiagnostic Products Signal Reagent
• VITROS Immunodiagnostic Products Universal Wash Reagent
• Quality control materials such as VITROS Immunodiagnostic Products Anti‑SARS-CoV-2 IgG Controls
• VITROS Immunodiagnostic Products Reagent Pack Storage Box with desiccant

Operating Instructions
Check the inventory regularly to aid the management of reagents and ensure that sufficient VITROS Signal Reagent, VITROS Universal Wash Reagent and calibrated reagent lots are available for the work planned. When performing panels of tests on a single sample, ensure that the sample volume is sufficient for the tests ordered. For detailed information refer to the operating instructions for your system.

Note: Do not use visibly damaged product.

Default Test Name
The default test name which will appear on patient reports is SARS-CoV-2 IgG. The default short name that will appear on the test selection menus and laboratory reports is CV2G. These defaults may be reconfigured, if required. For detailed information refer to the operating instructions for your system.

Calibration

Calibration Procedure

• Calibration is lot specific; reagent packs and calibrator are linked by lot number. Reagent packs from the same lot may use the same calibration.
• A Master Calibration is established for each new reagent lot by performing multiple tests. This is the process by which a lot-specific parameter [a] which links the signal at the cutoff (cutoff value) to the calibrator signal is determined.
• Cutoff value = (a x Signal of Cal 1)
• Ensure that the Master Calibration for each new reagent lot is available on your system.
• Process calibrator in the same manner as samples. Load sufficient volume for the automatic duplicate determination. Calibration need not be programmed if bar code labels are used; calibration will be initiated automatically.
• When the calibrator is processed, the validity of the calibration is assessed against quality parameters which compare the actual signal of the calibrator with the expected signal. If the calibration is acceptable the cutoff value is calculated and stored for use with any reagent pack of that lot.
• The quality of calibration cannot be completely described by a single parameter. The calibration report should be used in conjunction with acceptable control values to determine the validity of the calibration.
• Recalibration is required after a pre-determined calibration interval, or when a different reagent lot is loaded.
• Calibration results are assessed against a range of quality parameters. Failure to meet any of the defined quality parameter ranges will be coded in the calibration report. For actions to be taken following a failed calibration refer to the operating instructions for your system.
• Refer to the operating instructions for your system for detailed instructions on the calibration process.

When to Calibrate

• Calibrate when the reagent pack and calibrator lot changes.
• Calibrate every 28 days.
• After specified service procedures have been performed.
• If quality control results are consistently outside of your acceptable range.
• For additional information on when to calibrate, refer to the operating instructions for your system.

Traceability of Calibration
Calibration of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is traceable to an in-house reference calibrator, which has been value- assigned to optimize clinical sensitivity and specificity.

Calibration Model
Results are calculated as a normalized signal, relative to a cutoff value. During the calibration process a lot-specific parameter is used to determine a valid stored cutoff value for the VITROS Immunodiagnostic and VITROS Integrated Systems.

Quality Control

Quality Control Material Selection
VITROS Immunodiagnostic Products Anti‑SARS-CoV-2 IgG Controls are recommended for use with the VITROS Immunodiagnostic and VITROS Integrated Systems. There are 2 VITROS Immunodiagnostic Products Anti‑SARS-CoV-2 IgG Controls (non- reactive and reactive).

Quality Control Procedure Recommendations

• Good laboratory practice requires that controls be processed to verify the performance of the test.
• To verify system performance, analyze control materials:
  • After calibration
  • If the system is turned off for more than 2 hours
  • After reloading reagent packs that have been removed from the MicroWell Supply and stored for later use
  • According to local regulations or at least once each day that the test is being performed
  • After specified service procedures are performed
• If quality control procedures within your laboratory require more frequent use of controls, follow those procedures.
• Analyze quality control materials in the same manner as patient specimens.
• If control results fall outside the acceptable range, investigate the cause before deciding whether to report patient results.
• Refer to published guidelines for general quality control recommendations.

For more detailed information, refer to the operating instructions for your system.

Quality Control Material Storage
Refer to the manufacturer’s product literature for storage and stability information.

Results
Results are automatically calculated by the VITROS Immunodiagnostic and VITROS Integrated Systems.

Result Calculation

Interpretation of Results
Patient sample results will be displayed with a “Non-reactive” (negative) or “Reactive” (positive) label.

The following table summarizes the interpretation of results obtained with the VITROS Immunodiagnostic Products Anti‑SARS-CoV-2 IgG test on the VITROS Immunodiagnostic and VITROS Integrated Systems.

VITROS Immunodiagnostic Products Anti‑SARS-CoV-2 IgG Test Result (S/C)| Interpretation
---|---
<1.00| Specimen is non-reactive (negative) for anti‑SARS-CoV-2 IgG
≥1.00| Specimen is reactive (positive) for anti‑SARS-CoV-2 IgG

Limitations

• SARS-CoV-2 serology tests should not be used to diagnose acute COVID-19. An assay that directly detects the virus should be used to evaluate symptomatic individuals for acute COVID-19, particularly those who have been in contact with the virus.
• Samples should only be tested from individuals that are 15 days or more post-symptom onset.
• The sensitivity of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test in early infection is unknown.
• At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test should not be used to diagnose acute SARS-CoV-2 infection. Results are for the detection of SARS-CoV-2 antibodies. IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.
• The performance characteristics for that analyte were established when the original B.1 lineage of the Wuhan-Hu-1 strain was prevalent and that due to the propensity of the virus to mutate, new strains emerge over time which may affect the performance of this device and have serious public health implications.
• Heterophilic antibodies in serum or plasma samples may cause interference in immunoassays. 15 These antibodies may be present in blood samples from individuals regularly exposed to animals or who have been treated with animal serum products. Results that are inconsistent with clinical observations indicate the need for additional testing.
• There is a risk of erroneous results (i.e., negative results) due to the presence of novel emerging viral variants circulating in the intended use population.
• A negative or non-reactive result can occur if the quantity of antibodies for the SARS-CoV-2 virus present in the specimen is below the cutoff of the assay, or the virus has undergone minor amino acid mutation(s) in the epitope recognized by the antibody detected by the test.
• A negative or non-reactive result can occur if the antibodies that are detected are not present during the stage of disease in which a sample is collected.
• A negative test result indicates that antibodies to SARS-CoV-2 were not detected in the samples. Acute infection should not be excluded based on negative antibody test results. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
• The results obtained with this test should only be interpreted in conjunction with clinical findings, and the results from other laboratory tests and evaluations.
• A positive result may not indicate previous SARS-CoV-2 infection. Consider other information including clinical history and local disease prevalence, in assessing the need for a second but different serology test to confirm an immune response.
• False positive results for VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test may occur due to cross-reactivity from preexisting antibodies or other possible causes.
• Positive and negative predictive values are highly dependent on prevalence.

CV2G

• Accurate results are dependent on adequate specimen collection, transport, storage, and processing (as applicable). Failure to observe proper procedures in any one of these steps can lead to incorrect results.
• It is unknown at this time if the presence of antibodies to SARS-CoV-2 confers immunity to infection.
• The performance of this test has not been established in individuals that have received a COVID-19 vaccine. The clinical significance of a positive or negative antibody result following COVID-19 vaccination has not been established, and the result from this test should not be interpreted as an indication or degree of protection from infection after vaccination.
• This test should not be used for screening of donated blood for the purpose of preventing COVID-19 transmission.

Performance Characteristics

Clinical Performance Characteristics
The clinical performance of VITROS Immunodiagnostic Products Anti-SARS- CoV-2 IgG test was evaluated at three testing sites using 642 unique retrospective clinical samples acquired from two populations. Population 1 consisted of 338 samples collected from COVID-19 individuals with a prior SARS-CoV-2 positive test result using an FDA EUA authorized RT PCR test. Population 2 consisted of 304 samples collected prior to December 2019 (before the widespread outbreak of COVID-19).

Of the 338 samples in population 1, 24 samples were collected 0–7 days from COVID-19 symptom onset, 21 samples were collected between 8–14 days from COVID-19 symptom onset, and 293 samples were collected ≥15 days from COVID-19 symptom onset. The table below shows the sample distribution and the respective percentages from the total of samples tested per “Days post- symptoms onset” time bin.

Time bin

(n= total number samples tested)

| Days post-symptom onset| Percent (per time bin)
---|---|---
0–7 days (n = 24)| 0–4| 70.83%
5–7| 29.17%
8–14 days (n = 21)| 8–11| 47.62%
12–14| 52.38%

≥15 days (n = 293)

| 15–21| 10.58%
22–30| 10.92%
31–60| 40.61%
61–90| 26.62%
91–195| 11.26%

Positive Percent Agreement (PPA)
A total of 338 samples collected from individual patients confirmed to have a prior SARS-CoV-2 positive result by RT-PCR were tested. Blood samples were collected within the United States between April 2020 and March 2021. Samples were tested with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test on each system (except with the VITROS XT 7600 Integrated System where one sample was not tested due to limited volume). Of the 338 samples included in the study, 169 were EDTA plasma samples and 169 were serum samples.

The performance of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test and 95% Confidence Interval for each VITROS System is summarized in the tables below:

PPA performance of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test and 95% Confidence Interval by System:

In the VITROS ECi/ECiQ Immunodiagnostic Systems:

Days from Symptom Onset

| Number of Subjects Tested

(with prior RT-PCR Positive)

| VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test Results
---|---|---
Reactive| PPA| 95% CI

(Wilson score)

0–7 days| 24| 11| 45.83%| 27.89%–64.93%
8–14 days| 21| 11| 52.38%| 32.37%–71.66%
≥15 days| 293| 275| 93.86%| 90.50%–96.10%
Total| 338| –| –| –

In the VITROS 3600 Immunodiagnostic Systems and the VITROS 5600 Integrated Systems:

Days from Symptom Onset

| Number of Subjects Tested

(with prior RT-PCR Positive)

| VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test Results
---|---|---
Reactive| PPA| 95% CI

(Wilson score)

0–7 days| 24| 10| 41.67%| 24.47%–61.17%
8–14 days| 21| 11| 52.38%| 32.37%–71.66%
≥15 days| 293| 274| 93.52%| 90.10%–95.81%
Total| 338| –| –| –

In the VITROS XT 7600 Integrated Systems:

Days from Symptom Onset

| Number of Subjects Tested

(with prior RT-PCR Positive)

| VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test Results
---|---|---
Reactive| PPA| 95% CI

(Wilson score)

0–7 days| 24| 10| 41.67%| 24.47%–61.17%
8–14 days| 21| 11| 52.38%| 32.37%–71.66%
≥15 days| 292| 273| 93.49%| 90.10%–95.80%
Total| 337| –| –| –

Negative Percent Agreement (NPA)
Three hundred and four (304) presumed SARS-CoV-2 negative samples collected prior to the COVID-19 pandemic within the United States were tested. Of the 304 samples, 138 were EDTA plasma samples and 166 were serum samples. All samples were tested using VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems (except with the VITROS XT 7600 Integrated System where one sample was not tested due to limited volume). The performance of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test and 95% Confidence Interval for each VITROS analyzer is summarized in the table below:

VITROS System

|

Presumed Negative (Collected Pre-COVID)

| VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test Results
---|---|---
Non- Reactive| NPA| 95% CI

(Wilson score)

ECi/ECiQ/3600/5600| 304| 301| 99.01%| 97.14%–99.66%
XT 7600| 303| 300| 99.01%| 97.13%–99.66%

Analytical Performance Characteristics

Analytical Sensitivity
The analytical sensitivity of the VITROS Immunodiagnostic Products Anti‑SARS- CoV-2 IgG test is 17.7 BAU/mL using the First WHO International Standard for anti-SARS-CoV-2 immunoglobulin (human) NIBSC code: 20/136.

Potentially Cross-reacting Subgroups
The VITROS Immunodiagnostic Products Anti‑SARS-CoV-2 IgG test was evaluated for potential cross-reactivity in Anti‑SARS-CoV-2 negative samples from medical conditions unrelated to SARS-CoV-2 infection. The results are summarized in the table below.

Sample Category

| Number of Samples Tested| VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test Results
---|---|---
Non- reactive| Reactive
Influenza A Antibody| 10| 10| 0
Influenza B Antibody| 12| 12| 0
Hepatitis C Virus (HCV) Antibody| 15| 15| 0
Anti-Nuclear Antibody (ANA)| 10| 10| 0
Adenovirus Antibody| 12| 12| 0
Coxsackie B Virus Antibody| 10| 10| 0
---|---|---|---
Echovirus Antibody| 10| 10| 0
Poliovirus Antibody| 9| 9| 0
Respiratory Syncytial Virus (RSV) Antibody| 10| 10| 0
Hepatitis B Virus (HBV) Antibody| 12| 12| 0
Haemophilus influenzae Antibody| 12| 12| 0
Human coronavirus HKU1 Antibody| 11| 11| 0
Human coronavirus NL63 Antibody| 10| 10| 0
Human coronavirus OC43 Antibody| 21| 21| 0
Human coronavirus 229E Antibody| 24| 24| 0
Human Immunodeficiency Virus (HIV) Antibody| 17| 17| 0
Human Parainfluenza Virus (HPIV) Antibody| 5| 5| 0
Human Metapneumovirus (HMPV) Antibody| 10| 10| 0
Enterovirus Antibody| 10| 10| 0
Rhinovirus Antibody| 11| 11| 0
Epstein-Barr Virus (EBV) Antibody| 11| 11| 0
Epstein-Barr Virus Nuclear Antigen (EBVNA) Antibody| 11| 11| 0
Legionella pneumophila Antibody| 10| 10| 0
Bordetella pertussis Antibody| 15| 15| 0
Mycoplasma pneumoniae Antibody| 14| 14| 0
Chlamydophila pneumoniae Antibody| 10| 10| 0
Cytomegalovirus (CMV) Antibody| 11| 11| 0
Rheumatoid Factor (RF) Antibody| 11| 11| 0
Severe Acute Respiratory Syndrome (SARS) coronavirus Antibody| 13| 13| 0
Middle East Respiratory Syndrome (MERS) coronavirus Antibody| 14| 14| 0
Rubella Virus Antibody| 10| 10| 0
Mycobacterium tuberculosis Antibody| 12| 12| 0
Streptococcus pneumoniae Antibody| 10| 10| 0
Streptococcus pyogenes Antibody| 10| 10| 0
Pneumocystis jirovecii pneumonia (PJP) Antibody| 10| 10| 0
Candida albicans Antibody| 14| 14| 0
Pseudomonas aeruginosa Antibody| 14| 14| 0
Staphylococcus epidermis Antibody| 10| 10| 0
Human Anti-Mouse Antibody (HAMA)| 10| 10| 0

Within-Laboratory Precision
The within-laboratory precision of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test was evaluated with EDTA plasma pools (PP4, PP5, and PP6), negative and positive quality control materials (PP1, PP2), and the calibrator (PP3) on the VITROS ECi/ECiQ and 3600 Immunodiagnostic Systems and the VITROS 5600 and XT 7600 Integrated Systems following the CLSI document EP05-A3. 16 A total of 3 lots of reagent packs, calibrators and controls were included in the study. For each reagent lot, operators ran two replicates of each precision panel sample on two occasions per day for twenty non- consecutive days.

The data presented are a representation of test performance and are provided as a guideline. Variables such as sample handling and storage, reagent handling and storage, laboratory environment, and system maintenance can affect precision of test results.

VITROS

System

| Panel member| Number of Obs.| Grand Mean (S/C)| Repeatability * **(Within Run)| Between- Run| Between- Day| Between- Lot| Within- Laboratory**

---|---|---|---|---|---|---|---|---
SD| CV(%)| SD| CV(%)| SD| CV(%)| SD| CV(%)| SD| CV(%)

ECi/ ECiQ

| PP1| 240| 0.00| 0.000| N/A| 0.000| N/A| 0.000| N/A| 0.001| N/A| 0.001| N/A
PP2| 240| 0.92| 0.018| 2.0| 0.024| 2.6| 0.034| 3.7| 0.030| 3.3| 0.054| 5.9
PP3| 240| 0.25| 0.007| N/A| 0.011| N/A| 0.011| N/A| 0.013| N/A| 0.022| N/A
PP4| 240| 0.94| 0.027| 2.9| 0.032| 3.4| 0.033| 3.5| 0.091| 9.7| 0.106| 11.3
PP5| 240| 3.25| 0.086| 2.6| 0.062| 1.9| 0.084| 2.6| 0.169| 5.2| 0.216| 6.6
PP6| 240| 7.62| 0.063| 0.8| 0.076| 1.0| 0.112| 1.5| 0.208| 2.7| 0.257| 3.4

3600

| PP1| 240| 0.00| 0.000| N/A| 0.000| N/A| 0.001| N/A| 0.002| N/A| 0.002| N/A
PP2| 240| 1.18| 0.024| 2.0| 0.025| 2.1| 0.021| 1.8| 0.240| 20.3| 0.243| 20.6
PP3| 240| 0.32| 0.007| N/A| 0.008| N/A| 0.006| N/A| 0.078| N/A| 0.079| N/A
PP4| 240| 1.18| 0.028| 2.4| 0.034| 2.9| 0.033| 2.8| 0.376| 31.9| 0.380| 32.2
PP5| 240| 3.94| 0.083| 2.1| 0.092| 2.3| 0.072| 1.8| 1.064| 27.0| 1.073| 27.2
PP6| 240| 8.56| 0.099| 1.2| 0.099| 1.2| 0.105| 1.2| 1.610| 18.8| 1.619| 18.9

5600

| PP1| 240| 0.00| 0.000| N/A| 0.000| N/A| 0.000| N/A| 0.001| N/A| 0.001| N/A
PP2| 240| 1.03| 0.020| 1.9| 0.027| 2.6| 0.027| 2.6| 0.058| 5.6| 0.072| 7.0
PP3| 240| 0.28| 0.006| N/A| 0.010| N/A| 0.007| N/A| 0.025| N/A| 0.028| N/A
PP4| 240| 1.02| 0.026| 2.5| 0.036| 3.5| 0.026| 2.5| 0.140| 13.7| 0.149| 14.6
PP5| 240| 3.43| 0.073| 2.1| 0.074| 2.2| 0.095| 2.8| 0.288| 8.4| 0.321| 9.4
PP6| 240| 7.51| 0.097| 1.3| 0.105| 1.4| 0.119| 1.6| 0.276| 3.7| 0.333| 4.4

XT 7600

| PP1| 240| 0.00| 0.000| N/A| 0.000| N/A| 0.000| N/A| 0.001| N/A| 0.001| N/A
PP2| 240| 1.21| 0.043| 3.6| 0.042| 3.5| 0.016| 1.3| 0.153| 12.6| 0.165| 13.6
PP3| 240| 0.32| 0.009| N/A| 0.009| N/A| 0.010| N/A| 0.052| N/A| 0.055| N/A
PP4| 240| 1.19| 0.034| 2.9| 0.042| 3.5| 0.037| 3.1| 0.239| 20.1| 0.248| 20.8
PP5| 240| 3.94| 0.078| 2.0| 0.093| 2.4| 0.088| 2.2| 0.604| 15.3| 0.622| 15.8
PP6| 240| 8.46| 0.113| 1.3| 0.117| 1.4| 0.098| 1.2| 0.896| 10.6| 0.916| 10.8

Repeatability was determined using two replicates per run. Within-Laboratory precision variability contains the Within Run, Between Run, Between Day and Between Lot variance components using three individual reagent lots with a single calibration for each reagent lot.

N/A = Not applicable. % CV is not meaningful for S/C < 0.5.

Reproducibility
The reproducibility of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test was determined with EDTA plasma pools (GRP4, GRP5 and GRP6), quality controls (GRP1 and GRP2) and calibrator (GRP3) using the VITROS ECi/ ECiQ and 3600 Immunodiagnostic Systems, and the VITROS 5600 and XT 7600 Integrated Systems. Samples were measured in triplicate using 3 reagent lots, in 2 runs per day over 5 days at 3 sites, according to CLSI EP05‑A3. 16 Variance components were calculated, and the following results were observed per system

Reproducibility of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test evaluated on VITROS ECi/ECiQ Immunodiagnostic Systems

Panel Member

| ****

Number of

Obs.

| ****

Grand Mean (S/C)

| Repeatability (Within Run)| ****

Between- Run

| ****

Between- Day

| Between- Lot a| Within- Laboratory b| Between- Site c| Reproducibility (Overall) d
---|---|---|---|---|---|---|---|---|---
SD| CV (%)| SD| CV (%)| SD| CV (%)| SD| CV (%)| SD| CV (%)| SD| CV (%)| SD| CV (%)
GRP1| 270| 0.01| 0.002| N/A+| 0.000| N/A+| 0.000| N/A+| 0.003| N/A+| 0.003| N/A+| 0.003| N/A+| 0.006| N/A+
GRP2| 270| 0.98| 0.058| 5.9| 0.000| 0.0| 0.021| 2.2| 0.000| 0.0| 0.062| 6.3| 0.018| 1.8| 0.095| 9.6
GRP3| 270| 0.28| 0.016| N/A+| 0.007| N/A+| 0.010| N/A+| 0.021| N/A+| 0.029| N/A+| 0.000| N/A+| 0.034| N/A+
GRP4| 270| 1.08| 0.059| 5.5| 0.011| 1.0| 0.035| 3.2| 0.206| 19.2| 0.217| 20.2| 0.000| 0.0| 0.225| 21.0
GRP5| 270| 3.59| 0.164| 4.6| 0.040| 1.1| 0.071| 2.0| 0.479| 13.3| 0.513| 14.3| 0.024| 0.7| 0.545| 15.2
GRP6| 270| 7.84| 0.220| 2.8| 0.000| 0.0| 0.091| 1.2| 0.425| 5.4| 0.487| 6.2| 0.311| 4.0| 0.665| 8.5

• Between lot: Variability of the test performance from lot to lot.
• Within-laboratory variability contains the Within Run, Between Run, Between Day and Between Lot variance components.
• Between site: Variability of the test performance from site to site.
• Reproducibility: Variability of the test incorporating factors of site, lot, run and day. + % CVs are not meaningful for S/C results <0.50.

Reproducibility of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test evaluated on VITROS 3600 Immunodiagnostic Systems

Panel Member

| ****

Number of

Obs.

| ****

Grand Mean (S/C)

| Repeatability (Within Run)| ****

Between- Run

| ****

Between- Day

| Between- Lot a| Within- Laboratory b| Between- Site c| Reproducibility (Overall) d
---|---|---|---|---|---|---|---|---|---
SD| CV (%)| SD| CV (%)| SD| CV (%)| SD| CV (%)| SD| CV (%)| SD| CV (%)| SD| CV (%)
GRP1| 270| 0.00| 0.001| N/A+| 0.000| N/A+| 0.001| N/A+| 0.001| N/A+| 0.002| N/A+| 0.001| N/A+| 0.002| N/A+
GRP2| 270| 1.05| 0.046| 4.4| 0.000| 0.0| 0.029| 2.8| 0.051| 4.9| 0.074| 7.1| 0.010| 1.0| 0.089| 8.5
GRP3| 270| 0.29| 0.012| N/A+| 0.003| N/A+| 0.012| N/A+| 0.026| N/A+| 0.032| N/A+| 0.008| N/A+| 0.038| N/A+
GRP4| 270| 1.08| 0.043| 4.0| 0.012| 1.1| 0.017| 1.5| 0.230| 21.4| 0.235| 21.9| 0.033| 3.1| 0.245| 22.8
GRP5| 270| 3.57| 0.108| 3.0| 0.040| 1.1| 0.049| 1.4| 0.575| 16.1| 0.588| 16.5| 0.082| 2.3| 0.615| 17.3
GRP6| 270| 7.53| 0.132| 1.8| 0.031| 0.4| 0.055| 0.7| 0.445| 5.9| 0.468| 6.2| 0.000| 0.0| 0.509| 6.8

• Between lot: Variability of the test performance from lot to lot.
• Within-Laboratory variability contains the Within Run, Between Run, Between Day and Between Lot variance components.
• Between site: Variability of the test performance from site to site.
• Reproducibility: Variability of the test incorporating factors of site, lot, run and day. + % CVs are not meaningful for S/C results <0.50.

Reproducibility of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test evaluated on VITROS 5600 Integrated Systems

Panel Member

| ****

Number of

Obs.

| ****

Grand Mean (S/C)

| Repeatability (Within Run)| ****

Between- Run

| ****

Between- Day

| Between- Lot a| Within- Laboratory b| Between- Site c| Reproducibility (Overall) d
---|---|---|---|---|---|---|---|---|---
SD| CV (%)| SD| CV (%)| SD| CV (%)| SD| CV (%)| SD| CV (%)| SD| CV (%)| SD| CV (%)
GRP1| 270| 0.00| 0.000| N/A+| 0.000| N/A+| 0.001| N/A+| 0.001| N/A+| 0.001| N/A+| 0.002| N/A+| 0.002| N/A+
GRP2| 270| 1.05| 0.085| 8.1| 0.000| 0.0| 0.000| 0.0| 0.045| 4.3| 0.097| 9.2| 0.000| 0.0| 0.119| 11.3
GRP3| 270| 0.29| 0.015| N/A+| 0.002| N/A+| 0.004| N/A+| 0.020| N/A+| 0.025| N/A+| 0.002| N/A+| 0.031| N/A+
GRP4| 270| 1.08| 0.050| 4.6| 0.009| 0.8| 0.027| 2.5| 0.204| 18.9| 0.212| 19.7| 0.000| 0.0| 0.221| 20.5
GRP5| 270| 3.58| 0.103| 2.9| 0.017| 0.5| 0.099| 2.8| 0.483| 13.5| 0.504| 14.1| 0.000| 0.0| 0.538| 15.1
GRP6| 270| 7.55| 0.137| 1.8| 0.006| 0.1| 0.161| 2.1| 0.251| 3.3| 0.328| 4.3| 0.000| 0.0| 0.484| 6.4

• Between lot: Variability of the test performance from lot to lot.
• Within-laboratory variability contains the Within Run, Between Run, Between Day and Between Lot variance components.
• Between sites: Variability of the test performance from site to site.
• Reproducibility: Variability of the test incorporating factors of site, lot, run and day. + % CVs are not meaningful for S/C results <0.50.

Reproducibility of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test evaluated on VITROS XT 7600 Integrated Systems

Panel Member

| ****

Number of

Obs.

| ****

Grand Mean (S/C)

| Repeatability (Within Run)| ****

Between- Run

| ****

Between- Day

| Between- Lot a| Within- Laboratory b| Between- Site c| Reproducibility (Overall) d
---|---|---|---|---|---|---|---|---|---
SD| CV (%)| SD| CV (%)| SD| CV (%)| SD| CV (%)| SD| CV (%)| SD| CV (%)| SD| CV (%)
GRP1| 270| 0.00| 0.001| N/A+| 0.000| N/A+| 0.001| N/A+| 0.001| N/A+| 0.001| N/A+| 0.001| N/A+| 0.002| N/A+
GRP2| 270| 1.06| 0.035| 3.4| 0.000| 0.0| 0.010| 0.9| 0.039| 3.7| 0.053| 5.1| 0.009| 0.9| 0.061| 5.7
GRP3| 270| 0.29| 0.012| N/A+| 0.000| N/A+| 0.007| N/A+| 0.023| N/A+| 0.027| N/A+| 0.003| N/A+| 0.029| N/A+
GRP4| 270| 1.09| 0.037| 3.4| 0.000| 0.0| 0.013| 1.2| 0.220| 20.2| 0.224| 20.6| 0.013| 1.1| 0.229| 21.1
GRP5| 270| 3.59| 0.097| 2.7| 0.000| 0.0| 0.000| 0.0| 0.510| 14.2| 0.519| 14.5| 0.018| 0.5| 0.537| 15.0
GRP6| 270| 7.54| 0.118| 1.6| 0.000| 0.0| 0.032| 0.4| 0.380| 5.0| 0.399| 5.3| 0.000| 0.0| 0.457| 6.1

• Between lot: Variability of the test performance from lot to lot.
• Within-Laboratory variability contains the Within Run, Between Run, Between Day and Between Lot variance components.
• Between site: Variability of the test performance from site to site.
• Reproducibility: Variability of the test incorporating factors of site, lot, run and day. + % CVs are not meaningful for S/C results <0.50.

Interference
Interferents
The VITROS Immunodiagnostic Products Anti SARS-CoV-2 IgG test was evaluated for potential interference consistent with CLSI document EP07. 17 Commonly encountered substances were tested on one lot of reagent using either a VITROS 3600 Immunodiagnostic System or a VITROS 5600 Integrated System in 3 reactive (low positive) and 3 non-reactive (negative) samples. All potentially interfering substances have been shown to not interfere (<10% bias for low reactive samples and bias <0.22 S/C for non-reactive samples) with the test performance at the concentration listed in the table below.

Endogenous interferants evaluated with VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG test

Substance| Test Concentration

Concentration Units SI Units

---|---
|
Anti-Nuclear Antibody (ANA)| >8 AI| N/A
Bilirubin, conjugated| 40 mg/dL| 475 μmol/L
Bilirubin, unconjugated| 40 mg/dL| 684 μmol/L
Cholesterol| 400 mg/dL| 10.3 mmol/L
Hemoglobin| 1000 mg/dL| 10 g/L
Human anti-Mouse Antibody (HAMA)| 3600 ng/mL| 0.024 μmol/L
Ig (total)| 6 g/dL| 60 g/L
Rheumatoid Factor| 35.7–61.7 IU/mL| NA
Total Protein| 15 g/dL| 150 g/L
Triglycerides| 1500 mg/dL| 16.94 mmol/L

N/A = Not Applicable (alternate units are not provided)

Exogenous interferants evaluated with VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG test

Substance| Test Concentration

Conventional Units SI Units

---|---
|
Abacavir| 1.27 mg/dL| 44.4 μmol/L
Acetaminophen| 15.6 mg/dL| 1.03 mmol/L
Amoxicillin| 1.35 mg/dL| 37 μmol/L
Aspirin| 3 mg/dL| 0.167 mmol/L
Atorvastatin| 75 μg/dL| 1.34 μmol/L
Azithromycin| 1.1 mg/dL| 14.8 μmol/L
Biotin| 3510 ng/mL| 14.3 μmol/L
Cefoxitin| 660 mg/dL| 15.5 mmol/L
Ceftriaxone| 84 mg/dL| 1.51 mmol/L
Dextromethorphan| 1.56 μg/dL| 0.0575 μmol/L
---|---|---
EDTA| 0.099 mg/dL| 3.39 μmol/L
Gentamicin| 3.0 mg/dL| 62.8 μmol/L
Guaifenesin| 450 μg/dL| 22.7 μmol/L
Heparin| 330 units/dL| 330 units/dL
Ibuprofen| 21.9 mg/dL| 1.06 mmol/L
Intralipid| 2000 mg/dL| N/A
Levofloxacin| 3.6 mg/dL| 99.7 μmol/L
Levothyroxine| 429 μg/dL| 0.552 μmol/L
Lisinopril| 24.6 μg/dL| 0.607 μmol/L
Lopinavir| 57.17 μg/mL| 90.89 μmol/L
Loratadine| 8.7 μg/dL| 0.271 μmol/L
Losartan| 1155 ng/mL| 2.505 μmol/L
Meropenem| 33.9 mg/dL| 884 μmol/L
Metformin| 1.2 mg/dL| 92.9 μmol/L
Metoprolol| 150 μg/dL| 5.61 μmol/L
Naproxen| 36.0 mg/dL| 1.56 mmol/L
Omeprazole| 840 μg/dL| 24.3 μmol/L
Oseltamivir| 39.9 μg/dL| 1.28 μmol/L
Peramivir| 183,600 ng/mL| 559 μmol/L
Prednisone| 10 μg/dL| 0.276 μmol/L
Ritonavir| 10.98 mg/dL| 126.42 mmol/L
Theophylline| 6.0 mg/dL| 333 μmol/L
Vancomycin| 12.0 mg/dL| 82.8 μmol/L
Zanamivir| 1089 ng/mL| 3.28 μmol/L

N/A = Not Applicable (alternate units are not provided)

When amlodipine was tested at a concentration of 1.88 μg/dL, a negative bias (-11.1% change of the S/C value) was observed in reactive samples.

References

1. Modes of transmission of virus causing COVID-19: implications for IPC precaution recommendations (https://www.who.int/news-room/commentaries/detail/modes-of-transmission-of-virus-causing-covid-19-implications-for-ipc-precaution-recommendations).
2. IFCC Information Guide on COVID-19 (https://www.ifcc.org/ifcc-news/2020-03-26-ifcc-information-guide-on-covid-19/).
3. Lai et al. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. International Journal of Antimicrobial Agents. 55:3; 2020.
4. Ciottia M. et al, SARS-CoV-2 Infection and the COVID-19 Pandemic Emergency: The Importance of Diagnostic Methods, Chemotherapy, 2021, https://doi.org/10.1159/000515343.
5. Sethuraman N. et al. Interpreting Diagnostic Tests for SARS-CoV-2, JAMA May 6, 2020.
6. Padoan A. et al. IgA-Ab response to spike glycoprotein of SARS-CoV-2 in patients with COVID-19: A longitudinal study, Clinica Chimica Acta. 507:164; 2020.
7. Baumgarth N., et al, Antibody Responses to SARS-CoV-2: Let’s Stick to Known Knowns, J Immunol 2020; 205:2342-2350; doi: 10.4049/jimmunol.2000839.
8. Summers M. et al.: Luminogenic Reagent Using 3-Chloro 4-Hydroxy Acetanilide to Enhance Peroxidase/Luminol Chemiluminescence. Clinical Chemistry. 41. S73; 1995.
9. CLSI Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline—Fourth Edition. CLSI document M29-A4. Wayne, PA: Clinical and Laboratory Standards Institute; 2014.
10. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
11. Bowen RAR, Remaley AT. Interferences from Blood Collection Tube Components on Clinical Chemistry Assays. Biochemia Medica. 24(1):31–44; 2014.
12. CLSI. Collection of Diagnostic Venous Blood Specimens. 7th ed. CLSI standard GP41. Wayne, PA: Clinical and Laboratory Standards Institute; 2017.
13. CLSI. Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard—Sixth Edition. CLSI document GP39-A6. Wayne, PA: Clinical and Laboratory Standards Institute; 2010.
14. CLSI. Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline – Fourth Edition. CLSI guideline C24, Wayne, PA: Clinical and Laboratory Standards Institute; 2016.
15. Tate J, Ward G. Interferences in Immunoassay. Clin Biochem Rev. Vol 25: 105–120; May 2004.
16. CLSI. Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition. CLSI document EP05-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2014.
17. CLSI. Interference Testing in Clinical Chemistry. 3rd ed. CLSI Guideline EP07. Wayne, PA: Clinical and Laboratory Standards Institute; 2018.

Glossary of Symbols

Revision History

Date of Revision| Version| Description of Technical **Changes***
---|---|---
2023-08-31| 1.0| Initial version of Instructions for Use

• The change bars indicate the position of a technical amendment to the text with respect to the previous version of the document.

When this Instructions For Use is replaced, sign and date below and retain as specified by local regulations or laboratory policies, as appropriate.

• Signature
• Obsolete Date

Conditions of supply: all supplies are made subject to the standard terms and conditions of Ortho Clinical Diagnostics or its distributors. Copies of these are available on request.

Distributed in the US by : Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626

Ortho-Clinical Diagnostics Felindre Meadows Pencoed Bridgend CF35 5PZ United KingdomTo obtain a paper copy free of charge contact: OrthoCareTechnicalSolutions@ orthoclinicaldiagnostics.com 1 800 421 3311 VITROS is a trademark of Ortho Clinical Diagnostics. © Ortho Clinical Diagnostics, 2023

References

• English | QuidelOrtho
• English | QuidelOrtho
• SARS-CoV-2 Infection and the COVID-19 Pandemic Emergency: The Importance of Diagnostic Methods | Chemotherapy | Karger Publishers

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