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Antibody Testing for Coronavirus (COVID-19) SARS-CoV-2 IgM
Test Code: 32001
IgG and IgM blood-based serology testing may help to identify people who have been exposed to COVID-19 SARS-CoV-2, and may have developed some level of immunity but potentially have mild to no symptoms.
To build this test in your HL7 Interface, please reach out to HL7Support@viracor-eurofins.com for the build information.
Patients, you must contact your physician to order antibody testing for Coronavirus COVID-19.
Viracor will not see patients at our facility or collect samples on site.
An account must be set up to order testing. See Specimen Information Section for more information.
Clinical Utility
The Coronavirus SARS-CoV-2 IgM lab test is for the detection of IgM antibodies against SARS-CoV-2 from human clinical specimen.
Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic assay should be considered to rule out infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
About Coronavirus SARS-CoV-2 RT-PCR and COVID-19
Please refer to the CDC website for the most up to date information on SARS-CoV-19 or COVID-19 at https://www.cdc.gov/coronavirus/2019-ncov/summary.html.
At the end of 2019, an outbreak of the virus initially referred to as 2019 novel Coronavirus, later identified as SARS-CoV-2, occurred in Wuhan, Hubei Province, China. A betacrononvirus, like MERS-CoV and SARS-CoV, the virus originates from bats. As of January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization declared a “public health emergency of international concern.”
The disease caused by SARS-CoV-2 has been named coronavirus disease 2019, abbreviated as COVID-19. Main symptoms of the disease include fever, cough and shortness of breath. The CDC recommends reaching out to a physician if you develop symptoms and have been in close contact with a person known to have COVID-19; or if you have recently traveled from an area with widespread or ongoing community spread of COVID-19. The virus is spread via person-to-person contact through respiratory droplets produced when a person coughs or sneezes. The best preventative measures are to avoid close contact with people who are sick; avoid touching nose, eyes and mouth; cover a cough or sneeze with a tissue and discard immediately; and clean and disinfect frequently touched objects and surfaces using a household cleaning spray or wipe. Washing your hands with soap and water for at least 20 seconds frequently is one of the best preventative measures and hand sanitizer can be used when soap and water are not available.
About SARS-CoV-2 COVID-19 Antibody Testing
Unlike RT-PCR tests, which directly detect the presence of SARS-CoV-2 for approx. 1 – 3 weeks after infection, blood-based serology assays detect antibody responses to this virus. Serological testing has the ability to consistently identify people who were recently infected or exposed, even if they are no longer shedding the virus. Individuals will typically have detectable antibodies for weeks to months after infection regardless if mild or no clinical signs were present. Antibodies to SARS-CoV-2 may also provide immunity to COVID-19 although the antibody levels required for protection and the duration of this immunity has not been defined. IgM testing is recommended as early as 5 days after infection, and IgG testing is recommended at least 12-14 days after potential exposure – giving the body the time it needs to build an immune response and produce antibodies. Over time, antibody testing is likely to become a crucial next step in fighting the spread of the virus.
Procedure
The Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit is intended for the qualitative detection of IgM antibodies to SARS-CoV-2 virus in human serum to aid in the diagnosis of Coronavirus (COVID-19).
During the test procedure, antibodies to SARS-CoV-2, if present in the human serum sample will bind to the antigens coated onto the wells forming antigen-antibody complexes. Excess antibodies are removed by washing. A conjugate of goat anti-human IgM antibodies conjugated with horseradish peroxidase are then added, which binds to the antigen-antibody complexes. Excess conjugate is removed by washing. This is followed by the addition of a chromogenic substrate, tetramethylbenzidine (TMB). If specific antibodies to the antigen are present in the patients’ serum, a blue color will develop. The enzymatic reaction is then stopped with a stopping solution causing the contents of the well to turn yellow. The wells are read photometrically with a microplate reader at 450nm.
This test was developed and its performance characteristics determined by Viracor Eurofins. It has not been reviewed, cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. Results should be used in conjunction with clinical findings, and should not form the sole basis for a diagnosis or treatment decision.
Specificity
The specificity was determined by testing healthy blood donor samples which were collected prior to the COVID-19 outbreak (collected before 2019) on the Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit. The specificity was 100.0% for donors in the US and 98.7% for donors in Germany.
During this unprecedented time of high volume, the turnaround time for most Coronavirus SARS-CoV-2 (COVID-19) samples is 24 hours from receipt of specimen in the lab, Monday through Saturday. As daily volume can have an impact on workflow, we are monitoring this closely and will provide updates as the situation changes.
| Specimen Type | Order Code | CPT Code | NY Approved | Volume | Assay Range | Special Instructions |
|---|---|---|---|---|---|---|
| Serum | 32001 | 86769 | Yes | 1 mL (0.5 mL minimum) |
Unit value of less than 9.0 indicates there was no detectable antibody present. The result does not rule out SARS-CoV-2 infection. Follow-up testing with a molecular diagnostic should be considered to rule out infection. Unit values between 9.0 and 11.0 indicate initial evidence for detection of antibodies and additional testing is recommended. Serological evidence is best obtained by testing of paired acute and convalescent phase samples obtained several weeks apart. A value of greater than 11.0 indicates antibodies have been detected. |
|
| plasma | 32001 | 86769 | Yes | 1 mL (0.5 mL minimum) |
Unit value of less than 9.0 indicates there was no detectable antibody present. The result does not rule out SARS-CoV-2 infection. Follow-up testing with a molecular diagnostic should be considered to rule out infection. Unit values between 9.0 and 11.0 indicate initial evidence for detection of antibodies and additional testing is recommended. Serological evidence is best obtained by testing of paired acute and convalescent phase samples obtained several weeks apart. A value of greater than 11.0 indicates antibodies have been detected. |
|
Shipping
To Setup an Account:
Prior to sending samples for the first time, all new clients must set up a Viracor Account. Please visit our Account Setup page to begin this process.
Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor Eurofins test requisition form must accompany each specimen. For additional testing, please send a separate specimen. Refer to our website for refer to our website for accepted specimen types. Ship specimens FedEx Priority Overnight® to: Viracor Eurofins, 1001 NW Technology Dr, Lee's Summit, MO 64086.
Causes for Rejection
Whole blood frozen, specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed. Hyperlipemic and moderate to grossly hemolyzed specimens.
Specimens are approved for testing in New York only when indicated in the Specimen Information field above.
The CPT codes provided are based on the performing laboratory's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor Eurofins assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.
We will continue to follow federal and state requirements for both notification of results and any confirmatory testing that is required by another agency.
References
Center for Disease Control and Prevention. https://www.cdc.gov/