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SARS-CoV-2 Antigen, Client Inactivated

CPT: 87426

Synonyms

  • Antigen
  • Client Inactivated
  • COVID-19

Special Instructions

Please note: Labcorp does not currently collect specimens for this test. Patients for whom testing has been ordered should not be sent to a Labcorp location to have a specimen collected. Instead, an appropriate specimen should be collected at the health care facility where the patient was seen and the test was ordered. The specimen should be sent to Labcorp using standard procedures.


Expected Turnaround Time

1 - 3 days


Related Documents

For more information, please view the literature below.

SARS-CoV-2 Antigen, Client Inactivated Specimen Collection Instructions


Specimen Requirements


Specimen

Nasopharyngeal (NP) swab or anterior nasal swab


Volume

0.5 mL


Minimum Volume

0.4 mL (Note: This volume does not allow for repeat testing)


Container

Provided pre-filled tube containing inactivation buffer. Any swab of appropriate size and configuration with a synthetic tip can be used except for calcium alginate tips, swabs with preservatives, and swabs with wood shafts.


Collection

Collect the samples using the swab. Place the swab in the provided pre-filled tube containing the sample inactivation buffer and snap off the swab shaft at the indicated break line. Cap the sample inactivation tube and label with patient information. Refrigerate for transport to the lab.


Storage Instructions

Refrigerate.


Stability Requirements

Temperature

Period

Room temperature

24 hours (stability determined by manufacturer or literature reference)

Refrigerated

6 days (stability determined by manufacturer or literature reference)

Frozen

30 days (stability determined by manufacturer or literature reference)

Freeze/thaw cycles

Stable x3 (stability determined by manufacturer or literature reference)


Causes for Rejection

Specimens submitted in containers other than the provided tube; room temperature specimens greater than 24 hours old; improperly labeled, heat-inactivated, grossly contaminated, broken or leaking transport device


Test Details


Use

Qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in individuals suspected to have COVID-19 by their healthcare provider within the first 10 days from the onset of symptoms. Antigen tests can be used for screening testing in high-risk congregate settings in which repeat testing could quickly identify persons with a SARS-CoV-2 infection to inform infection preventation and control measures, thus preventing transmission. Additionally, there are increasing amounts of data to help guide the use of antigen tests as screening tests on asymptomatic persons to detect or exclude COVID-19, or to determine whether a person who previously was diagnosed with COVID-19 remains infectious. See FDA's Recommendations for healthcare providers using SARS-CoV-2 diagnostic tests for screening asymptomatic individuals for COVID-19. Also see information from the Centers for Medicare and Medicaid Services (CMS) on Enforcement discretion for the use of SARS-CoV-2 point-of-care testing on asymptomatic individuals. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient's recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. Positive results in a person who has symptoms associated with COVID-19, indicating that pretest probability is high, can generally be interpreted to indicate that the person is infected with SARS-CoV-2. Positive results in a person who is asymptomatic and has had exposure to a person with COVID-19 within the last 14 days, indicating that the pretest probability is moderate, be confirmed with an FDA-authorized NAAT. In instances of higher pretest probability, such as high incidence of infection in the community, or a person with household or continuous contact to a person with COVID-19, clinical judgement should determine if a positive antigen result for an asymptomatic person should be followed by a confirmatory NAAT.


Limitations

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

This test detects both viable (live) and non-viable, SARS-CoV, and SARS-CoV-2. Test performance depends on the amount of virus (antigen) in the sample and may or may not correlate with viral culture results performed on the same sample.

Performance has not been established for use with specimens other than those collected in the upper and lower respiratory tract in humans.

A negative test result may occur if the level of antigen in a sample is below the detection limit of the test or if the sample was collected or transported improperly.

If the differentiation of specific SARS viruses and strains is needed, additional testing, in consultation with state or local public health departments, is required.

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 is especially important if the patient has had recent exposure to COVID-19, or clinical presentation indicates that COVID-19 is likely and diagnostic tests for other causes of illness (eg, other respiratory illness) are negative. In this case, direct testing for the SARS-CoV-2 virus (eg, PCR testing) should be considered.

Positive results do not rule out co-infections with other pathogens.

Positive test results do not differentiate between SARS-CoV-2 and SARS-CoV.


Methodology

Chemiluminescent Immunoassay


References

Centers for Disease Control and Prevention (CDC). Antigen Testing Algorithm. CDC web site: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html. Accessed February 2021.
Centers for Disease Control and Prevention (CDC). Coronavirus Disease 2019: Evaluation and Testing page. CDC web site: http://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html. Accessed February 2021.
U.S. Food and Drug Administration (FDA). Coronavirus Disease 2019 (COVID-19). FDA web site: https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19. Accessed February 2021.
World Health Organization. Coronavirus disease (COVID-19) technical guidance: Laboratory testing for 2019-nCoV in humans. World Health Organization web site: http://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/laboratory-guidance. Accessed February 2021.

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