VITROS CV2TN Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Reagent Pack Instruction Manual

VITROS CV2TN Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Reagent Pack Instruction Manual

Intended Use

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 Total N Antibody Calibrators is a chemiluminescent immunoassay test intended for the qualitative detection of total antibodies to SARS-CoV-2 in human serum and plasma (dipotassium EDTA). The VITROS Anti-SARS-CoV-2 Total N Antibody 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 Total N Antibody test should not be used to diagnose or exclude 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 the requirements to perform moderate or high complexity tests.

Results are for the detection of total SARS-CoV-2 antibodies. Total 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.

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 Total N Antibody test in early infection is unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.

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

The VITROS Anti-SARS-CoV-2 Total N Antibody 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 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 m-free ) and asymptote mastic SARS-Co V -2 carriers all can be potential sources for viral transmission n. 3 Real-time reverse transcription polymerase chain reaction (rate-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-Co V -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 SARSCoV-2 infection produce antibodies to multiple viral antigens including the spike protein and the nucleocapsid protein. 7 Notably, it is not currently known if the presence of antibodies confers protection from re-infection.

Principles of the Procedure

The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody test is performed using the VITROS AntiSARS-CoV-2 Total N Antibody Reagent Pack and the VITROS Anti-SARS-CoV-2 Total N Antibody Calibrators on VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and 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 nucleocapsid protein antigen coated on the well. Unbound sample is removed by washing. In the second stage horseradish peroxidase (HRP)-labelled recombinant SARS-CoV-2 nucleocapsid protein antigen is added in the conjugate reagent. The conjugate binds specifically to any anti-SARS-CoV-2 antibodies captured on the well in the first stage. Unbound conjugate is removed by a subsequent wash step.

The bound HRP conjugate is measured by a luminescent t reaction 8. A reagent containing luminogenic substrate s (a luminol derivative and a peraclid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyses 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. Bound HRP
conjugate is indicative of the presence of SARS-CoV-2 antibody.

Reaction Sample

Warnings and Precautions

INSTRUCTIONS FOR USE

Reagents

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.

• For prescription use only.

• This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA
  for use by authorized laboratories certified under CLIA, that meet requirements to perform moderate or high complexity tests.

• This product has been authorized only for detecting total antibodies to 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 diagnostic tests for 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 (streptavidin, bacterial; binds 3 ng biotin per well; recombinant SARS-CoV-2 nucleocapsid antigen 14 ng/well)
• 6.0 mL assay reagent (buffer with bovine protein stabilizers and antimicrobial agent)
• 16.2 mL conjugate reagent (HRP-recombinant SARS-CoV-2 nucleocapsid antigen) 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

Intended for Use in the United States
CV2TN

Reagent Pack Storage and Preparation

• The VITROS Immunodiagnostic Products AntiSARS-CoV-2 Total N Antibody 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 AntiSARS-CoV-2 Total N Antibody Calibrators (anti-SARS-CoV-2 in buffer with bovine serum albumin and antimicrobial agent, 1.0 mL)

Calibrator Handling

• Use only with reagent packs of the same lot number. Mix thoroughly by inversion and bring to 15­30°C (59­86°F) before use.
• Handle calibrators in original stoppered containers to avoid contamination and evaporation. To avoid evaporation, limit the amount of time the calibrators are on the system. Refer to the operating instructions for your system. Return to 2­8°C (36­46°F) as soon as possible after use, or load only sufficient volume for a single determination.

Calibrator Storage and Preparation

• VITROS Immunodiagnostic Products AntiSARS-CoV-2 Total N Antibody Calibrators are supplied frozen.

• The VITROS AntiSARS-CoV-2 Total N Antibody Calibrators are 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 AntiSARS-CoV-2 Total N Antibody test uses 80 L of calibrator for each determination. Transfer an aliquot
  of each calibrator into a sample container (taking account of the minimum fill volume of the container). For details on minimum fill volume of sample cups or containers, refer to the operating instructions for your system.

• The VITROS AntiSARS-CoV-2 Total N Antibody Calibrators are automatically processed in duplicate.

Specimen Collection, Preparation and Storage

Patient Preparation
No special patient preparation is necessary.

Specimens Recommended

• Serum
• K2-EDTA Plasma

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

Specimen Collection and Preparation

• Collect specimen s using standard procedures .

Testing Procedure

• Follow the instruct on s provided with your specimen 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.
• The VITROS AntiSARS-CoV-2 Total N Antibody test uses 80 L 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 2­8°C (36­46°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°F]) or 7 days at 2­8°C (36­46°F).
• Samples that will not be tested within the time frames outlined above should be stored at -20°C [-4°F] and may be subjected to 5 freeze-thaw cycles.
• As an alternative to the above, sample stability may be established by each laboratory.

Testing Procedure

Materials Provided

• VITROS Immunodiagnostic Products AntiSARS-CoV-2 Total N Antibody Reagent Pack
• VITROS Immunodiagnostic Products AntiSARS-CoV-2 Total N Antibody Calibrators

Materials Required but Not Provided

• VITROS Immunodiagnostic Products Signal Reagent
• VITROS Immunodiagnostic Products Universal Wash Reagent
• VITROS Immunodiagnostic Products AntiSARS-CoV-2 Total Controls

Optional Materials Not Provided

• 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 Immunodiagnostic Products Signal Reagent, VITROS Immunodiagnostic Products 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-CoV2 Tot N. The default short name that will appear on the test selection menus and laboratory reports is CV2TN. 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 calibrators 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 cut-off (cut-off value) to the calibrator signal is determined.
• Cut-off value = a lot 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 which compare the actual signal of the calibrator with the expected signal. If the calibration is acceptable the cut-off 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 AntiSARS-CoV-2 Total N Antibody 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 cut-off value. During the calibration process a lot-specific parameter is used to determine a valid stored cut-off value for the VITROS Immunodiagnostic and VITROS Integrated Systems.

Quality Control

Quality Control Material Selection
VITROS AntiSARS-CoV-2 Total Controls are recommended for use with the VITROS Immunodiagnostic and VITROS Integrated Systems. There are 2 VITROS AntiSARS- CoV-2 Total Controls (antiSARS-CoV-2 Tot Non-reactive and antiSARS-CoV-2 Tot Reactive). 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 antiSARS-CoV-2 Total antibody 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 AntiSARS-CoV-2 Total N Antibody 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, analyse 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 Micro Well 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 recommendation ns . 14 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.

Results

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

Result = Signal for test sample Cut-off value

Interpretation of Results

Limitations of the Procedure

Known Interferences
The VITROS AntiSARS-CoV-2 Total N Antibody test was evaluated for interference. Commonly encountered substances were tested on one lot of reagent. Of the compounds tested, none were 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

• 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.
• 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.
• 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 detection limit of the assay, the antibodies that are detected are not present during the stage of disease in which a sample is collected, or the virus has undergone minor amino acid mutation(s) in the epitopes recognized by the antibodies 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.
• Results from antibody testing should not be used to diagnose or exclude SARS-CoV-2 infection.
• It is unknown at this time if the presence of antibodies to SARS-CoV-2 confers immunity to infection.
• This test should not be used for screening of donated blood for the purpose of preventing COVID-19 transmission.
• 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.
• 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.
• The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between March 2020 and January 2021 for RT-PCR positive samples at multiple sites within the USA. 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 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 Total N Antibody Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 Total N Antibody Calibrators Letter of Authorization, along with the authorized Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Recipients, and authorized labelling are available on the FDA website: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19 -emergencyuse-authorizations-medical-devices/in-vitro-diagnostics-euas. Authorized laboratories using the VITROS Immunodiagnostic Products Anti-SARS- CoV-2 Total N Antibody test (`your product” in the conditions below) must adhere to the Conditions of Authorization indicated in the Letter of Authorization as listed below:

• Authorized laboratories* using your product must include with test result reports, 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 authorized labelling. 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-OIR/ OPEQ/CDRH (via email: CDRH-EUA-Reporting@fda.hhs.gov) and Ortho-Clinical Diagnostics, Inc. (OrthoCareTechnicalSolutions@orthoclinicaldiagnostics.com) any suspected occurrence of false reactive (positive) or false non-reactive (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 labelling. 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

Specificity

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-ipcprecaution-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.
5. Sethuraman N. et al. Interpreting Diagnostic Tests for SARS-CoV-2, . 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 . 205:2342-2350; 2020.
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. Calam RR. Specimen Processing Separator Gels: An Update. J Clin Immunoassay. 11:86­90; 1988.
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. Levinson SS. The Nature of Heterophilic Antibodies and Their Role in Immunoassay Interference. J Clin Immunoassay. 15:108-115; 1992.
16. CLSI. Interference Testing in Clinical Chemistry; Approved Guideline ­Second Edition. CLSI document EP07-A2, Wayne, PA: Clinical and Laboratory Standards Institute; April 2018, corrected March 2021.

Glossary of Symbols

The following symbols may have been used in the labelling of this product

Revision History

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
To 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, 2021

Intended Use

For in vitro diagnostic and laboratory professional use. For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti-SARS -CoV-2 Total N Antibody Calibrators and with the VITROS Immunodiagnostic Products Anti-SARS- CoV-2 Total Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators for the determination of total antibodies to SARS-CoV-2.

Warnings and Precautions

WARNING: Potentially Infectious Material

Treat as if capable of transmitting infection.

Use caution when handling Materia l 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 component ts, in accordance with procedures defined by appropriate national biohazard safety guideline or regulation (e.g. CLSI document M29). 1

VITROS Anti-SARS-CoV-2 Total Controls 1 and 2 contain: 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 method s (enzyme immunoassays).

WARNING:

VITROS Anti-SARS -CoV -2 Total Control 2 in addition contains: SARS-CoV-2 antibody. Handle as if capable of transmitting infection.
Contains ProClin 950 (CAS 2682-20-4) 2

The VITROS Anti-S ARS -Co V-2 Total Controls contain 0.5% ProClin 950. H317: May cause an allergic skin reaction. P261: Avoid breathing dust/fume/g as/ mist/ vapors/spra y. P280: Wear protective gloves. P333 + P313: If skin irritatio n or rash occurs: Get medical advice/atten tio n. P362: Take off contamin a ted clothing and wash 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 contact information.

• For Emergency Use Authorization only.
• For in vitro diagnostic use only
• For prescription use only.
• This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories certified under CLIA, that meet requirements to perform moderate or high complexity tests.
• This product has been authorized for use with a test authorized only for detecting total antibodies toSARS-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 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.

Materials Provided

3 sets of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls 1 and 2 (human matrix with anti-microbial agent, 2 mL)

Materials Required but Not Provided

Pipette, sample containers.

Control Storage, Preparation on and Handling

• VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls are supplied frozen.
• VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls are 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.
• Thoroughly mix controls by inversion and bring to 15­30 °C (59­86 °F) before use.
• Handle controls in stoppered containers to avoid contamination and evaporation. To avoid evaporation, limit the amount of time controls are on the system. Refer to the operating instructions for your system.
• Return to 2­8 °C (36­46 °F) as soon as possible after use, or load only sufficient for a single determination.
• Baseline statistics for controls should be entered onto the system. For further information, refer to the operating instructions for your system.
• The expiration date for the controls must be entered onto 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 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 Total Control 1 should generate Non-reactive (negative) results. VITROS Anti-SARS-CoV-2 Total 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; 2014.
2. 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.

Glossary of Symbols

The following symbols may have been used in the labelling of this product

Revision History

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 Felindre Meadows Pencoed Bridgend CF35 5PZ United Kingdom

Distributed in the US by: Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626 USA
VITROS is a registered trademark of Ortho Clinical Diagnostics. © Ortho Clinical Diagnostics, 2020-2021

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