SARS-CoV-2 Antibody Testing

Ranch View Family Medicine is receiving a lot of phone calls and questions from our patients on coronavirus antibody tests for current or past infection.  We recommend against these tests at this time, as these are the equivalent of “snake oil” products sold by wagons of passing magicians.  These tests may promote false confidence of prior COVID-19 infection or create mass panic about false-belief of current COVID-19 infection.

While we hope a more reliable antibody test may be available soon, we believe these newly released tests to be intended for profit-based purposes by healthcare agencies who promote them.  Nasopharyngeal and oropharyngeal swab PCR testing through labs (rather than rapid fingerstick or other blood tests) to be the only tests with utility at this time.  Currently, persons or agencies selling promises of coronavirus testing that informs you of past or current infection within a few minutes, are selling you a false and confusing product.

Avoid these tests at this time.  During this time of health pandemic and economic crises, your money could be much better utilized elsewhere.

Here are the facts:

• Newly available tests to identify antibodies to SARS-CoV-2 are of uncertain reliability and are inadequate in diagnosing acute COVID-19 infection.

• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus species, such as coronavirus HKU1, NL63, OC43, or 229E; keep in mind that coronavirus species circulate as a “common cold” every spring and fall —> this means that if antibodies are positive, it reflects history of coronavirus common cold variety or COVID.  It is not specific to COVID

• The Food and Drug Administration (FDA) is now allowing manufacturers to distribute diagnostic serology test kits as long as the manufacturers state that the assay has “ not been validated”

• The FDA is not independently assessing these tests for reliability, sensitivity, or specificity, or requiring an Emergency Use Authorization.

To address their possible limitations, the FDA requires all serology test reports include the following messages:

• The test is not FDA-approved, may not reliably assess exposure to SARS-CoV-2, and should not be used as the sole basis to diagnose or exclude infection.

• Negative results do not rule out SARS-CoV-2 infection. If prior exposure is suspected, use follow-up testing with a molecular diagnostic to rule out infection.

• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus species, such as coronavirus HKU1, NL63, OC43, or 229E