From best practices for collecting suspected monkeypox specimens to dealing with possible false negatives on COVID-19 testing, the CDC and the FDA provide updates and advice. Review the topics below and share the information with your networks.

News About Monkeypox

CDC Issues Select Agent Gram for Monkeypox Virus

On September 14, 2022, the Centers for Disease Control and Prevention (CDC) Division of Select Agents and Toxins (DSAT) posted a Select Agent (SA) Gram to clarify the regulatory status of materials (e.g., patient specimens, cultures, diagnostic materials) related to the 2022 U.S. monkeypox outbreak.

Additional Resources

• Preparation and Collection of Specimens
• Information For Laboratory Personnel
• Laboratory Procedures and Biosafety Guidelines
• How to Report Test Results
• S. Monkeypox 2022: Situation Summary

Best Practices for Suspected Monkeypox Lesion Specimen Collection

The CDC has created a new resource, titled Tips for Adequate Collection of a Lesion Specimen from a Suspect Monkeypox Virus Case, to optimize lesion specimen collection and improve diagnostic results.

Be sure to update the individuals who submit or collect specimens at your facilities:

• Swab lesion specimens vigorously to collect as much human DNA as possible. Specimens that do not contain enough human DNA may lead to inconclusive test results.
• Follow recommended infection prevention and control practices.
• Wear personal protective equipment.
• Prevent sharps injury: Do not unroof or aspirate lesions or otherwise use sharp instruments for monkeypox virus lesion specimen collection.
• Refer to Tips for Adequate Collection of a Lesion Specimen from Suspect Monkeypox Virus Case for step-by-step instructions for swabbing lesion surfaces and collecting crusts from healing lesions.

Additional Resources

• Preparation and Collection of Specimens
• Information For Laboratory Personnel
• Laboratory Procedures and Biosafety Guidelines
• How to Report Test Results
• 2022 Outbreak Cases and Data

News About COVID-19 Testing

Extended Expiration Date for Flowflex COVID-19 Antigen Home Tests

ACON Laboratories, Inc., Flowflex COVID-19 Antigen Home Tests that are U.S. Food and Drug Administration (FDA)-authorized under emergency use authorization now have a longer shelf-life than previously authorized. The expiration dates have been extended to reflect the longer shelf-life. The extension is based on additional data provided by the manufacturer showing how long the test can be used with the same expected accuracy.

You can check whether your Flowflex COVID-19 Antigen Home Test has a new expiration date.

Extended Expiration Dates for Access Bio and OSANG COVID-19 Tests

Access Bio, Inc. CareStart COVID-19 Antigen Home Tests and OSANG LLC OHC COVID-19 Self Tests that are FDA authorized under emergency use authorization now have a longer shelf-life than previously authorized. The expiration dates for these tests have been extended to reflect the longer shelf-life. The extension is based on additional data provided by the manufacturer showing how long the test can be used with the same expected accuracy.

An FDA webpage allows you to check whether your Access Bio, Inc. CareStart COVID-19 Antigen Home Test, OSANG LLC OHC COVID-19 Self-Test, or another test has a new expiration date

Repeat Testing Advised to Reduce False Negatives with COVID-19 Antigen Tests

The FDA has issued a safety communication that advises people to perform repeat testing following a negative result with any COVID-19 antigen self-test. COVID-19 antigen self-tests are less likely to detect the SARS-CoV-2 virus than nucleic acid amplification tests, such as polymerase chain reaction (PCR) tests. This is especially true early in an infection or for people who do not have COVID-19 symptoms.

The FDA safety communication provides specific repeat testing recommendations depending on whether a person has COVID-19 symptoms. The FDA also recommends that the tested person follow up with a repeat test (such as a self-test) if they have a negative result with a point-of-care antigen test.

Additional Resources

• Guidance for Antigen Testing for SARS-CoV-2 for Healthcare Providers Testing Individuals in the Community
• Guidance for SARS-CoV-2 Rapid Testing Performed in Point-of-Care Settings
• Self-Testing at Home or Anywhere
• CDC Laboratory Outreach Communication System (LOCS)

Here to Help

As always, Accreditation Commission for Health Care (ACHC) is here to help. For more information, contact your Account Advisor, email [email protected], or call (855) 937-2242.