COVID-19: Information for Providers

Recent Guidance and NYC Case Data

Reliability Concerns With New SARS-CoV-2 Antibody Testing

Tests to identify antibodies to SARS-CoV-2 are coming into the marketplace but are of uncertain reliability. Under a new policy, the Food and Drug Administration (FDA) is allowing manufacturers to distribute diagnostic serology test kits as long as the manufacturers state that the assays have been validated. Because the FDA has not reviewed validation data for any of these assays, they have not been assessed for reliability, sensitivity or specificity by a nonpartial regulatory agency.

The NYC Health Department is alerting providers and clinical laboratories to the unusual manner in which SARS-CoV-2 antibody testing is entering the marketplace. Manufacturers are not pursuing Emergency Use Authorization (EUA) from the FDA for these assays.

The FDA is requiring serology testing reports to include the following messages:

• This test has not been reviewed by the FDA and may not reliably determine whether a person has been exposed to SARS-CoV-2.
• Negative results do not rule out SARS-CoV-2 infection, particularly in people for whom prior SARS-CoV-2 exposure is suspected. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
• 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.
• Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection.

FDA: FAQ on Diagnostic Testing for SARS-CoV-2

FDA: Emergency Use Authorizations Granted for COVID-19 Diagnostic Tests

Testing and PPE

Outpatient testing must not be encouraged, promoted or advertised

• Instruct people with COVID-like illness not requiring hospitalization to stay home.
  • Minimizes risk of transmission to others, especially health care workers.
  • Testing does not currently change clinical management.
  • Preserves personal protective equipment (PPE) for HCWs providing medically necessary care for hospitalized patients.


• There is a critical shortage of PPE, collection swabs and viral transport media supplies.
• Prioritize testing for hospitalized patients.
• PPE stockpile supplies in NYC are extremely limited and released based on strict criteria to preserve health care functions.
• Refer to NYC Health Department and CDC guidance (PDF) on crisis strategies for preserving PPE.

NYC Health Advisory #8: COVID-19 Updates for New York City — Do not test non-hospitalized patients and preserve PPE (PDF, March 20)

Daily Syndromic and Case Data Update

This information is now available on our COVID-19: Data webpage.

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