VITROS Immunodiagnostic 619 9919 Anti-SARS-CoV-2 IgG Reagent Pack Instructions

Immunodiagnostic 619 9919 Anti-SARS-CoV-2 IgG Reagent Pack
Instructions Manual

Rx ONLY
For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.

Intended Use

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 test intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum. The VITROS Anti-SARS-CoV2 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. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The VITROS Anti-SARS-CoV-2 IgG test should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate or high complexity tests.

Results are for the detection of SARS-CoV-2 antibodies. IgG antibodies to SARS-CoV-2 are generally detectable in the blood several days after initial infection,  although the duration of time antibodies are present post- infection is not well characterized. Individuals may have detectable viruses present for several weeks following seroconversion.

Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.

The sensitivity of the VITROS Anti-SARS-CoV-2 IgG test in early infection is unknown. Negative results do not preclude acute SARS-CoV-2 infection. If the acute infection is suspected, direct testing for SARS-CoV-2 is necessary.

False-positive results for the VITROS Anti-SARS-CoV-2 IgG test may occur due to cross-reactivity from pre-existing I ng antibodies or other possible causes.

Samples should only be tested from individuals that are 15 days or more post- sym pt om onset

The VITROS Anti-SARS-CoV-2 IgG test is only for use under the Food and Drug Administration’s Emergency Use Authorization.

Summary and Explanation of the Test

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is a beta coronavirus thatcauses the Coronavirus Disease 2019 (COVID-19) and pandemic. SARS-CoV-2 is mainly transmitted through droplets and contact routes, and the virus infects human cells via binding to angiotensin-converting enzyme 2 (ACE2). 1-2 People who are infected with SARS- CoV-2 may express signs and symptoms of acute respiratory illness, such as fever, cough, shortness of breath, but can also be asymptomatic. Symptomatic, pre-symptomatic, and asymptomatic SARS-CoV-2 carriers all can be potential sources for viral transmission. 3Currently, no specific treatments or vaccines are available for COVID-19. Real-time reverse transcription-polymerase chain reaction (RRT-PCR) detecting viral genes is the current gold standard for the diagnosis of COVID-19. Upper respiratory specimens, such as nasopharyngeal swab and oropharyngeal swab, are commonly used for diagnostic testing. 2

Principles of the Procedure

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is performed using the VITROS Anti-SARS-CoV-2 IgG Reagent Pack and the VITROS 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 wells. The unbound sample is removed by washing. In the second stage horseradish peroxidase (HRP)-labeled murine monoclonal anti-human IgG antibodies are added in 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.

INSTRUCTIONS FOR USE

Warnings and Precautions

The bound HRP conjugate is measured by a luminescent reaction4. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent are added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system.
The amount of HRP conjugate bound is indicative of the amount of SARS-CoV-2 IgG antibody present.

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

WARNING

Potentially Infectious Material
Treat as if capable of transmitting infection.
Use caution when handling material of human origin. Consider all samples potentially infectious. Notestmethodcan offer complete assurancethathepatitisB virus, hepatitis C virus (HCV), human immunodeficiency virus(HIV1+2), or other infectious agents that are absent Handle, use, store and dispose of solid and liquid waste from samples arm testco MPO nets, in accordance with procedures defined by appropriate national biohazard safety guideline or regulation (e.g. CLSI document M29). 5
VI TROS A nti-SA RS-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 antiopn_ and In rantihndipstn hepatitis C virus (HC V) and HIV using-
VITROS Anti-SARS-CoV-2 IgG Calibrator, in addition, contains SARS-CoV-2 IgG antibody. Handle as if capable of transmitting infection.

WARNING
Contains ProClin 300 (CAS 55965-84-
The VI TROSA fit-SARS-CoV-2 IgG ReagentPack contains 1.0% ProClin 300. H317:May cause an allergic skin reaction.P280:Wearprotective glo yes. 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.

WARNING
Contains ProClin 950 (CAS 2682-20-
The VITROS Anti-S ARS -CoV-2 IgG Calibrator contains 0.5% ProClin 950.
H317: May cause an allergic skin reaction. P280: Wear protective Glo v es.
P302 + P352: IF ON SKIN: Wash with plenty of soap and water. P333 + the rash occurs: Get medical advice/attention. P363: Wash contaminated clothing before reuse.
Refer towww.orthoclinicaldiagnostics.com for the Safety Data Sheets and for Ortho Clinical Diagnostics contact information.

WARNING

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.

General

• For Emergency Use Authorization only.
• For in Vitro diagnostic use only.
• This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under a EUA for use by laboratories certified under CLIA, that meet requirements to perform moderate or high complexity tests.
• This test has been authorized only for detecting IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1) unless the declaration is terminated or authorization is revoked sooner

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 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 it 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. The store opened refrigerated reagent packs in a sealed

VITROS Immunodiagnostic Products Reagent Pack Storage Box with desiccant.

Calibrator Contents

• 2 vials of VITROS Anti-SARS-CoV-2 IgG Calibrator (anti-SARS-CoV-2 IgG in anti-SARS-CoV-2 IgG negative human serum with an antimicrobial agent, 1 mL)
• Lot calibration card
• Protocol card
• 8 calibrator bar code labels

Calibrator Handling

• Use only with a reagent pack 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

• VITROS Anti-SARS-CoV-2 IgG Calibrator is supplied frozen.
• VITROS 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 it beyond the expiration date.
• DO NOT REFREEZE.
• The VITROS Anti-SARS-CoV-2 IgG test uses 20!IL of a calibrator for each determination. Transfer an aliquot of each 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 the minimum fill volume of sample cups or containers, refer to the operating instructions for your system.
• The VITROS 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

Specimens Not Recommended
No specimen limitations were identified. Refer to the Limitations of the Procedure section.
Special Precautions

IMPORTANT

Certain collection devices have been reported toaffectot heranaly and tests. 7 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. Confirmthatyourcollection devices are compatible with this test

Specimen Collection and Preparation

• Collect specimens using standard procedures. b
• Follow the instructions provided with your collection device for the use and processing of the sample.°
• Samples should be thoroughly separated from all cellular material. Failureto may so lead to an erroneous result
• The VITROS Anti-SARS-CoV-2 IgG test uses201AL of samples for each determination. This does not take account of the minimum fill volume of the chosen sample container. For details on the 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 number of time samples is 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 (up to 30 °C [86 OFD or 7 days at 2-8 °C (36-46 °F).
• Samples that will not be tested within the timeframes outlined above should be stored at <-20 °C [< -4 °F] and may be subjected to 1 freeze-thaw cycle
• As an alternative to the above, sample stability may be established by each laboratory.

Testing Procedure

Materials Provided

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

Materials Required but Not Provided

• VITROS Immunodiagnostic Products Signal Reagent
• VITROS Immunodiagnostic Products Universal Wash Reagent
• Quality control materials such as VITROS Immunodiagnostic Products VITROS Anti-SARS-CoV-2 IgG Controls
• VITROS Immunodiagnostic Products Reagent Pack Storage Box (optional) 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 products.

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 CoV2G. 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 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 that 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 Anti‑SARS-CoV-2 IgG test is traceable to an in-house reference calibrator which has been valuing 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 Anti‑SARS-CoV-2 IgG Controls are recommended for use with the VITROS Immunodiagnostic and VITROS Integrated Systems. There are 2  VITROS Anti‑SARS- CoV-2 IgG Controls (anti‑SARS-CoV-2 IgG negative and anti‑SARS-CoV-2 IgG positive. The performance of other commercial control fluids should be evaluated for compatibility with this test before they are used for quality control.
Control materials may show a difference when compared with other anti‑SARS- CoV-2 IgG methods if they contain high concentrations of preservatives, stabilizers, or other non-physiological additives, or otherwise depart from a true human sample matrix.
Appropriate quality control value ranges must be established for all quality control materials used with the VITROS Anti‑SARS-CoV-2 IgG test.

Quality Control Procedure Recommendations

• Good laboratory practice requires that controls be processed to verify the performance of the test.
• Choose control levels that check the clinically relevant concentrations.
• 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 your acceptable range, investigate the cause before deciding whether to report patient results.
• Refer to published guidelines for general quality control recommendations. 10

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

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

Result

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-r e act I ve ” (negative) or “Reactive” (positive) label. Numerical results should not be reported outside the laboratory to individual patients or their physicians.

The following table summarizes the interpretation of results obtained with the VITROS Anti‑SARS-CoV-2 IgG test on the VITROS Immunodiagnostic and  VITROS Integrated Systems. The magnitude of the measured result above the cutoff is not indicative of the total amount of antibody present in the sample and no clinical utility of significance has been validated for the magnitude of the measured result above the cutoff. Linearity of results has not been demonstrated (for example S/C result of 20 does not necessarily contain twice as much antibody as a result of 10 S/C).

Limitations of the Procedure

VITROS Anti-SARS-CoV-2 IgG
Test Result (S/C)| Interpretation
---|---
<1.00| The specimen is non-reactive (negative) for anti-SARS-CoV-2 IgG

1.00| The specimen is reactive (positive) for anti-SARS-
CoV-2 IgG

Limitations of the Procedure

Known Interferences
The VITROS Anti‑SARS-CoV-2 IgG test was evaluated for interference consistent with CLSI document EP7.11
Commonly encountered substances were tested on two lots of reagents. Of the compounds tested, none was found to interfere with the clinical interpretation of the test. Refer to “Substances that do not Interfere” for a list of compounds tested that did not show interference.

Other Limitations

• Samples should only be tested from individuals that are 15 days or more post-symptom onset.
• Heterophilic antibodies in serum samples may cause interference in immunoassays. 12 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.
• A negative result can occur if the quantity of antibodies for the SARS-CoV-2 virus present in the specimen is below the detection limit of the assay, or the virus has undergone minor amino acid mutation(s) in the epitope recognized by the antibody detected by the test.
• The results obtained with this test should only be interpreted in conjunction with clinical findings, and the results from other laboratory tests and evaluations.
• This test should not be used for screening of donated blood for the purpose of preventing void-19 transmission.
• A positive result may not indicate a 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.
• 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 of the degree of protection from infection after vaccination.
• The performance of this test was established based on the evaluation of a limited number of clinical specimens. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time

Conditions of Authorization for the Laboratory The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack test Letter of Authorization, along with the authorized Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Patients, and authorized labeling are available on the FDA website: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19- emergency-use-authorizations-medical-devices/Vitro-diagnostics-as. However, to assist clinical laboratories using the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 lgG test (“your product” in the conditions below), the relevant Conditions of Authorization are listed below:

• Authorized laboratories using your product must include with result reports of your product, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media
• Authorized laboratories using your product must use your product as outlined in the Instructions for Use. Deviations from the authorized procedures, including the authorized instruments, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents, and authorized materials required to use your product are not permitted.
• Authorized laboratories that receive your product must notify the relevant public health authorities of their intent to run your product prior to initiating testing.
• Authorized laboratories using your product must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate.
• Authorized laboratories must collect information on the performance of your product and report to DMD/OHT7- 01R/OPEQ/ CDR H (via email: CDRH-EUA-Reporting@fda.hhs.gov) and Ortho-Clinical Diagnostics, Inc. (OrthoCareTechnicalSolutions@orthoclinicaldiagnostics.com) any suspected occurrence of false positive or false negative results and significant deviations from the established performance characteristics of your product of which they become aware.
• All laboratory personnel using your product must be appropriately trained in automated immunoassay techniques and use appropriate laboratory and personal protective equipment when handling this kit, and use your product in accordance with the authorized labeling. All laboratory personnel using the assay must also be trained in and be familiar with the interpretation of results of the product
• Ortho-Clinical Diagnostics, Inc., authorized distributors, and authorized laboratories using your product must ensure that any records associated with this EUA are maintained until otherwise notified by FDA. Such records will be made available to FDA for inspection upon request
  *The letter of authorization refers to, Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate or high complexity tests” as authorized laboratories:’

Performance Characteristics

Clinical Performance Characteristics

Sensitivity
58 samples collected from patients confirmed to be SARS-CoV-2 positive by PCR were tested. Of the 58 PCR positive samples, 51 were Reactive in the  VITROS Anti-SARS-CoV-2 IgG assay and 7 were Non-reactive. Reactivity was correlated with elapsed days after the onset of symptoms. For the 40 samples collected greater than 15 days after symptoms were reported 36 were Reactive for a Positive Percent Agreement to PCR of 90.0%.
The results are summarized in the table below.

Days between Symptom Onset and Serum Collection| Number
Reactive | Number
NonReactive| Total Number
Tested| PPA (95% CI)
---|---|---|---|---
12–15| 15| 3| 18| 83.3% (58.6–96.4%)

15| 36| 4| 40|  90.0%(76.3-97.2%)

Clinical Specificity
Four hundred and seven presumed SARS-CoV-2 negative samples from healthy blood donors collected prior to the COVID-19 pandemic were tested resulting in 100% clinical specificity (95% CI: 99.1–100.0%).

Potentially Cross-reacting Subgroups
The VITROS 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| Non-
reactive| Reactive
---|---|---|---
Adenovirus Antibody| 2| 2| 0
Influenza A IgG| 5| 5| 0
Influenza A IgM| 3| 3| 0
Influenza B IgG| 5| 5| 0
Influenza B IgM| 1| 1| 0
Coxsackie Virus Antibody| 5| 5| 0
Echovirus Antibody| 5| 5| 0
Polio Virus| 4| 4| 0
Anti-respiratory syncytial virus (RSV)| 3| 3| 0
HCV Antibody| 5| 5| 0
Anti Nuclear Antibody| 5| 5| 0

A large proportion of the general population has been exposed to common coronaviruses (beta-coronavirus OC43 and HKU1 and alpha-coronavirus NL63 and 229E) causing respiratory infections. 13
407 healthy blood donors were tested with VITROS Anti-SARS-CoV-2 IgG with no reactivity observed.

Specificity

Substances that do not Interfere
The VITROS Anti-SARS-CoV-2 IgG test was evaluated for interference consistent with CLSI document EP7.11
Of the compounds tested, none was found to interfere with the clinical interpretation of the test is negative and weakly reactive samples at the concentrations indicated.

pmol/L
Bilirubin,
unconjugated| 40.0 mg/dL| 684
μmol/L
Biotin| 3510 ng/mL| 14.3 pmol/L
Hemoglobin| 1000 mg/dL| 0.156 mmol/L
Intralipid| 2000 mg/dL| N/A

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

References

1. Modes of transmission of virus causingCOVID-19: implications for IPC precaution recommendations
   (http://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. Summers M. et al.: Luminogenic Reagent Using 3-Chloro 4-Hydroxy Acetanilide to Enhance Peroxidase/Luminol Chemiluminescence. Clinical Chemistry 41. S73; 1995.

5. CLSI Protection of laboratory workers From OccupationallyAcquired Infections; ApprovedGuideline—Fourth Edition. CLSI document M29-A4. Wayne, PA: Clinical and Laboratory Standards Institute; 2014.

6. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labeling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.

7. Calam RR. Specimen ProcessingSeparator Gels: An Update. J Clin Immunoassay. 11:86-90; 1988.

8. CLSI. Collection of Diagnostic Venous Blood Specimens. 7th ed. CLSI standard GP41. Wayne, PA: Clinical and Laboratory Standards Institute; 2017.

9. 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.

10. 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.

11. CLSI. Interference Testing Clinical Chemistry. 3rd ed. CLSI guideline EP07. Wayne, PA: Clinical and Laboratory Standards Institute; 2018.

12. Levinson SS. The Nature of Heterophilic Antibodies and Their Role in Immunoassay Interference.] Clin Immunoassay. 15:108-115; 1992.

13. . Severance EG. et al. Development of a Nucleocapsid-Based Human Coronavirus Immunoassay and Estimates of Individuals Exposed to Coronavirus in a U.S. Metropolitan Population. Clin. Vaccine Immuno1.15 (12):1805-1810; 2008.

Glossary of Symbols
The following symbols may have been used in the labeling of this product.

Revision History

•Calibrator Storage and Preparation: changed to frozen
2020-10-16| 4.| •Warnings and Precautions: added a new section
•Conditions of Authorization for the Laboratory: updated email address
2020-09-04| 4.| Other Limitation: added new limitation
2020-05-13| 4.0| •Conditions of Authorization for the Laboratory: updated email address
•Sensitivity: updated table
•Clinical Agreement: removed section
•Potentially Cross-reacting Subgroups: paragraph added

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

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

Signatur

Obsolete

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.

Ortho-Clinical Diagnostics,
Inc. 100 Indigo Creek Drive
Rochester, NY 14626, USA

VITROS is a trademark of Ortho Clinical Diagnostics.
© Ortho Clinical Diagnostics, 2020

Intended Use
For in vitro diagnostic and Laboratory Professional use.
For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to  SARS- CoV-2.

Warnings and Precautions
Potentially Infectious Material
Treat as if capable of transmitting infection.
Use caution when handling material of human origin. Consider all samples potentially in fact us. No test method can offer complete assurance that hepatitis B virus, hepatitis C virus (If CV), human immunodeficiency virus (HI V1 +2)o rather infectious agents are absent. Handle, use, store and dispose o solid and liquid waste from samples and test MPO nets, in accordance with procedures defined by appropriate national biohazard safety guidelines or regulations (e.g. CLSI document M29).’
VITROS A nti-SA RS-CoV-2 IgG Co ntrols1 and 2 contain SA RS-CoV-2 IgG negative matrix obtained from donors who were tested in and who were found to benegativeforhepatitisBsurfaceantigen, and In ran the cline to hottie vim c Inn/land cina an nrunni
VI TROS Anti-SARS-CoV-2 IgG Control 2, in addition, contains SARS-CoV2 IgG. No testing method can rule out the risk of potential infection, handle it as if capable of transmitting infection.

WARNING
Contains ProClin 950 (CA52682-20-4)2
The VITROS Anti-SARS-CoV-2 IgG Controls contain 0.5% ProClin 950.1-1317: May cause an allergic skin reaction. P280: Wearprotectiyeglo yes. P302+ P352:I FON SKIN: Wash with plenty of soap and water. P333 4- P313: If skin irritation or rash occurs: Get medical advice/attention. P363.: Wash contaminated clothing before reuse.
Refer to www.orthoclinicaldiagnostics.com for the Safety Data Sheets and for Ortho contact information.

WARNING

• For Emergency Use Authorization only
• For in vitro diagnostic use only.
• This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under a EUA for use by laboratories certified under CLIA, that meet requirements to perform moderate or high complexity tests.
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1) unless the declaration is terminated or authorization is revoked sooner.

Materials Provided
3 sets of VITROS Anti-SARS-CoV-2 IgG Controls 1 and 2 (human matrix with an anti-microbial agent, 2 mL)
Materials Required but Not Provided
Pipette, sample containers.
Control Storage, Preparation, and Handling

• VITROS Anti-SARS-CoV-2 IgG Controls are supplied frozen.

• VITROS Anti-SARS-CoV-2 IgG Controls are suitable for use until the expiration date on the carton when stored and handled as specified. Do not use it beyond the expiration date.
  

• DO NOT REFREEZE.
  

• Thoroughly mix controls by inversion and bring to 15–30 °C (59–86 °F) before use.

• Handle controls in stoppered containers to avoid contamination and evaporation. To avoid evaporation, limit the number of time controls 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 for a single determination.

• The expiration date for the controls must be entered into the system. For further information, refer to the operating instructions for your system.

Testing Procedure
Load each control onto the system by transferring an aliquot into a sample container (taking account of the volume required by the test and the minimum fill volume of the container). Process in the same manner as samples, according to the instructions in the appropriate VITROS Immunodiagnostic Products  Reagent Pack and Calibrator instructions for use.

Note: Do not use the visibly damaged product.

For further information on quality control procedures refer to the operating instructions for your system. Not all products and systems are available in all countries.

Baseline Statistics
VITROS Anti-SARS-CoV-2 IgG Control 1 should generate Non-reactive (Negative) results. VITROS Anti-SARS-CoV-2 IgG Control 2 should generate  Reactive (Positive) results.

References

1. CLSI. Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline – Fourth Edition.
   CLSI document M29-A4. Wayne, PA: Clinical and Laboratory Standards Institute;

3. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labeling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.

Glossary of Symbols
The following symbols may have been used in the labeling of this product.

Revision History

• Control Storage, Preparation and Handling: changed to frozen

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

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

Signatur

Obsolete

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.

Ortho-Clinical Diagnostics
1500 Boulevard Sébastien
Brant
B.P. 30335
67411 Illkirch
CEDEX, France

Ortho-Clinical
Diagnostics Felindre
Meadows Pencoed
Bridgend
CF35 5PZ
United Kingdom

VITROS is a registered trademark of Ortho Clinical Diagnostics.
© Ortho Clinical Diagnostics, 2020

Ortho Clinical Diagnostics

Obtaining Printed Instruction for Use Free of Charge

Dear Valued Customer,
Thank you for your order of Product 619 9919 VITROS° Immunodiagnostic Products Anti-SARS-CoV-2IgG Reagent Pack. Below is information on how to obtain printed instruction: for use (IFU) free of charge.
This same information will also be included with each calibrator kit, Product 619 9920 VITROS° Immunodiagnostic Products Anti-SARS-CoV-2IgG Calibrator.
The information below is applicable to the VITROS Immunodiagnostic Products Anti-SARS-CoV-21gG test:

• IVD, Rx-only, For use under the Emergency Use Authorization (EUA) only
• Please contact our Ortho Care™ Technical Solutions Center at 1-800-421-3311 if you require a printed copy of the Instructions for Use, free of charge.
• Product Instructions for Use can be obtained free of charge from our website:
  https://www.orthoclinicaldiagnostics.com, which is the official source of information for all VITROS Products.

o This test has not been FDA cleared or approved, but has been authorized for emergency use by FDA under a EUA for use by authorized laboratories.
o This test has been authorized only for detecting IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
o The emergency use of this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3  (b)(1) unless the declaration is terminated, or authorization is revoked sooner.

Contact If you have any questions, please contact our Ortho Care™ Technical Solutions Center at
Information 1-800-421-3311.

For EUA Only
Printed Instructions for Use may be requested
at no charge at 1 800 421 3311.
Instructions for Use are available on
www.orthoclinicaldiagnostics.com.

This test has not been FDA cleared or approved but has been authorized for emergency use by FDA under a EUA for use by authorized laboratories.
This test has been authorized only for detecting IgG antibodies against SARS- CoV-2, not for any other viruses or pathogens.
The emergency use of this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3 (b) (1), unless the declaration is terminated or authorization is revoked sooner.

Product codes: 619 9919, 619 9920

Issued February 2021
J68786

References

• HHS Accessibility & Section 508 | HHS.gov
• English | QuidelOrtho
• In Vitro Diagnostics Solutions | Ortho Clinical Diagnostics

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