Monkeypox Updates

FDA Authorizes First Commercial Monkeypox Test Kit

The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to Abbott Molecular, Inc., for the Alinity m MPXV, a real-time polymerase chain reaction (PCR) test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection.

The Alinity m MPXV test is the first commercial test kit to be authorized for detection of monkeypox.

The Alinity m MPXV test is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of PCR and in vitro diagnostic procedures. Testing is limited to laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) 42 U.S.C. §263a and that meet the requirements to perform moderate- or high-complexity tests.

COVID-19 Updates

Expiration Date Extended for QuickVue At-Home OTC Tests

Quidel Corporation QuickVue At-Home OTC COVID-19 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.

FDA Updates COVID-19 Test Policy

The FDA is announcing updates to its COVID-19 test policy to address public health testing needs during this phase of the COVID-19 public health emergency.

Over the past two years, more than 400 COVID-19 tests have been granted emergency use authorization, and there are generally enough at-home tests, tests that can be used at the point-of-care locations such as health clinics, and laboratory-based tests to meet testing needs. The FDA is revising its COVID-19 test policy to encourage most COVID-19 test developers to pursue a traditional premarket review pathway for their tests rather than to seek emergency use authorization.

The FDA intends to prioritize its review of emergency use authorization requests on COVID-19 diagnostic tests that are likely to have a significant public health benefit or are likely to fulfill an unmet need. This could include novel technologies like the use of breath samples or perhaps unique features like the ability of a test to detect a new SARS-CoV-2 virus variant.

Additional COVID-19 Testing Resources

The FDA actions include:

• Reissuing the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised).
• Updating the FAQs on Testing for SARS-CoV-2.

Ebola Virus Updates

Guidance for Transport and Shipment of Specimens for Ebola Virus Testing

Although the risk of a travel-associated Ebola case in the United States is low, the Centers for Disease Control and Prevention (CDC) recommends that clinical laboratories review information on specimen collection and transport and on transporting infectious substances safely for specimens suspected to contain Ebola virus.

CDC recommends that Ebola testing should be ordered and performed only for patients who meet the criteria for Persons Under Investigation for Ebola virus disease. Before collecting specimens for Ebola testing, clinical laboratories must first contact their state health department. State health departments must consult CDC to determine if testing for Ebola virus is warranted.

If testing is needed, CDC will provide guidance on specimen collection and shipping instructions to select public health laboratories that are members of the Laboratory Response Network.

The designated public health laboratory can work directly with the clinical laboratory on procedures or specimen collection and shipping. Please follow all requirements for packaging and shipping Category A infectious substances following the 49 CFR 173.196 “Category A Infectious Substances.

These specimens are not considered Select Agents because they have not been identified to contain Ebola virus, and the APHIS/CDC Form 2: Request to Transfer Select Agents and Toxins does not need to be completed.

You can opt in to receive updates from the CDC Laboratory Outreach Communication System (LOCS).

Additional Ebola Resources

Various agencies and organizations provide guidance on Ebola and infectious substances.

• CDC Health Alert Network (HAN)
• CDC Ebola Virus Disease Website
• Guidance for Collection, Transport and Submission of Specimens for Ebola Virus Testing
• Department of Transportation Transporting Infectious Substances Overview
• Department of Transportation Transporting Infectious Substances Safely
• eCFR :: 49 CFR 173.196 – Category A infectious substances