RHM Rolls Out COVID-19 Antibody Testing

On May 1, 2020, RHM Physicians will begin offering COVID-19 (SARS-CoV2) antibody testing. This is a fully-automated process, which benefits both patients and physicians.

Our test currently has a 98% sensitivity and a 98% specificity. This means that the RHM test is one of the, if not the, most accurate test on the market today.

covid-test

Why Test Antibodies?

Antibodies have been found to be highly sensitive biomarkers in infectious disease diagnosis.

Previous studies on SARS, MERS, and, more recently, the studies on SARS-CoV2 have shown IgM antibodies to appear about the 3rd day from infection and IgG antibodies appear after 8 days.

Profiling an individual’s antibody response is currently the only way to determine infections with few or no symptoms.

Studies of the 3 subclasses of antibodies in the patient population in China showed that IgM and IgA developed first in individuals and could possibly serve as early markers. The IgG response, which is more durable, was found even 40 days after injection.

This test is a highly sensitive and accurate serum assay for COVID-19 viral antibodies.

The RHM test was internally designed and validated according to FDA EUA requirements.

The independent review of this validation by the FDA is pending.

This test does not require confirmation by CDC prior to reporting results.

Why an RHM Lab?

The following information is about the Labs in association with the RHM COVID-19 Antibody Testing:

RHM network of Labs has developed a novel test for COVID-19. This is a highly sensitive and accurate serum assay for COVID-19 viral antibodies.

Our test was internally developed and validated according to FDA EUA requirements. The independent review of this validation by the FDA is pending.

While most tests have sensitivity and specificity ratings as low as 20% and some as high as 70%. Our tests has a 98% sensitivity and a 98% specificity. This puts Vibrant’s test as one of the, if not the, most accurate readings on the market today.

Because this is a highly sensitive test, it must be done in the lab. That takes some time. Once the test is completed, they are sent via overnight to the an RHM associated lab. Results are provided to physicians within 48 hours of the lab receiving the test. Patients are contacted when Physicians receive the lab results.

What does the RHM COVID-19 Test include?

IgG, IgA, and IgM antibodies are tested against the following antigens:

  • S1 Spike Protein – The S1 subunit of the ectodomain mediates biding of the virion to host cell-surface receptors through is receptor-binding domain (RBD)
  • Receptor Binding Domain – Part of the S1 Spike subunit that actually binds to the ACE2 receptor of the human epithelial cell
  • S2 Spike Protein – The S2 subunit fuses with both host and viral membranes, by undergoing dramatic structural changes
  • Nucleoprotein – Packages the positive strand viral genome RNA into a helical ribonucleocapsid (RNP) and plays a fundamental role during virion assembly through its interactions with the viral genome and membrane protein M Plays an important role in enhancing the efficiency of subgenomic viral RNA transcription as well as viral replication

Test Methodology:

Qualitative chemiluminescence-based antibody detection using an array of 4 COVID-19 antigens.

Clinical Utility of Antibodies in COVID-19:

  • The median duration of IgM and IgA detection were 5 days while IgG was detected in 14 days in most individuals. It is important to note that different individuals will produce variations of these timelines. A better idea of the immune system modulation in an individual can be gauged based on testing them twice or as appropriate to see the production of stable IgG response. (This information comes from the Report from the American Society for Microbiology COVID-19 International Summit, 23 March 2020; Value of Diagnostic Testing for SARS-CoV-2/COVID-19. Robin Patel, Esther Babady, Elitza S. They, Gregory A. Scorch, Benjamin A. Pinsky, Kirsten St. George, Tara C. Smith, Stefan Bertuzzi mBio Mar 2020, 11(2) e00722-20; DOI: 10.1128/mBio.00722-20)
  • IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV02 become detectable later following infections. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection.
  • If a positive IgM or IgA result is detected, it is recommended to retest the patient in 10-14 days to assess whether IgG antibodies appear and whether IgM or IgA antibodies return to normal level, signaling progression toward infection resolution or establishment of immune tolerance.

Regulatory Statement

The US-based labs that RHM contracts with are certified under the Clinical Laboratory Improvements Amendment of 1988 (CLIA ’88), accredited by the College of American Pathologists (CAP), and has over 5 years’ experience designing, validating, and performing Laboratory Developed Tests (LDTs) for physicians and patients. Maintaining accreditation through the CAP requires that LDTs are validated to standards exceeding those listed in CLIA ’88 which defines the minimum standards that must be met in order to perform LDTs for diagnostic purposes.

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 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. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. Not for the screening of donated blood.

RHM Advisors now performing Covid-19 Antibody Test

Registration available for physicians, organizations and patients.

Sign up here to perform or to receive the test. 

Why Does the test cost $249 while others are less expensive?

The base cost of this highly sensitive and specialized test is $149. The remaining $100 pays for the efficient technology platform, the blood draw, and the time and advice of your physician.

Resources

Informational Booklet – SARS – COV2

Validation Study Report

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