COVID-19 tests continue to be frequent topics, as does cholera testing:

• The U.S. Food and Drug Administration (FDA) issued a bulletin about a COVID-19 test recall by manufacturer Detect.
• To further increase the availability of fast and reliable at-home COVID-19 tests, FDA has approved four more over-the-counter antigen tests.
• The FDA also has updated the emergency use authorizations of all COVID-19 antigen tests to revise the authorized uses and require updates to product labeling regarding repeat or serial testing.
• And as a cholera outbreak continues in Haiti, the U.S. Centers for Disease Control and Prevention (CDC) has recommended that clinical laboratory professionals review cholera diagnosis and detection information.

Find details below, and share these messages with your networks.

COVID-19 UPDATE

Three COVID-19 Test Lots Recalled by Maker Detect

The U.S. Food and Drug Administration (FDA) recently distributed a bulletin reporting that manufacturer Detect is recalling three specific lots of the Detect COVID-19 Test because there is an increased chance that the tests may give false negative results.

Detect has issued a voluntary recall for lots HB264, HY263, and HY264. The recall affects a total of 11,102 tests shipped to customers from July 26, 2022, through August 26, 2022. The lot number can be found on the side of each test box along with the Use By date.

The Detect COVID-19 Test is a molecular, over-the-counter test used to identify SARS-CoV-2 (the virus that causes COVID-19) in self-collected nasal swabs. To date, Detect has not received reports of false negative results related to the affected lots. The reliability of positive test results is not affected.

The recall recommends that anyone in possession of unused tests from the affected lots should dispose of the tests and contact the manufacturer about refunds. Test users who attempt to use recalled tests will be notified in the Detect App that the test has been recalled. Detect Hubs are not affected by the recall and do not need to be discarded.

Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

FDA Authorizes Four New COVID-19 Over-the-Counter At-Home Antigen Tests

The U.S. Food and Drug Administration (FDA) recently authorized four additional over-the-counter (OTC) at-home COVID-19 antigen tests.

• On November 21, 2022, the FDA authorized the Fastep COVID-19 Antigen Home Test. Manufactured by Azure Biotech Inc., the OTC COVID-19 antigen diagnostic test shows results in 15 minutes. The test can be used as a serial test for people within the first five days of symptom onset or for people who do not have symptoms. The Fastep test was validated with data that was gathered through the FDA’s collaboration with the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP).
• On November 21, 2022, the FDA authorized the CorDx COVID-19 Ag Test that is manufactured by CorDx, Inc. The OTC COVID-19 antigen diagnostic test shows results in 10 minutes. The test can be used as a serial test for people within the first seven days of symptom onset or for people who do not have symptoms.
• On November 17, 2022, the FDA authorized the Hotgen COVID-19 Antigen Home Test. Manufactured by Beijing Hotgen Biotech Co., Ltd., the OTC COVID-19 antigen diagnostic test shows results in 15 minutes. The test can be used as a serial test for people within the first seven days of symptom onset or for people who do not have symptoms.
• On November 17, 2022, the FDA authorized the NIDS COVID-19 Antigen Home Test. Manufactured by ANP Technologies, Inc., the OTC COVID-19 antigen diagnostic test shows results in 15 minutes. The test can be used as a serial test for people within the first five days of symptom onset or for people who do not have symptoms. The NIDS test was validated with data that was gathered through the FDA’s collaboration with the NIH ITAP.

These tests should always be repeated if a negative result is found – at least two times over three days, with at least 48 hours between tests if the person has symptoms, or at least three times over five days with at least 48 hours between tests if the person does not have symptoms.

These tests can be used for people:

• Age 14 years or older with a self-collected nasal swab sample.
• Age 2 years or older when an adult collects the nasal swab sample.

The Emergency Use Authorizations (EUAs) issued for these tests represents the FDA’s ongoing commitment to increase the availability of appropriately accurate and reliable at-home COVID-19 diagnostic tests, and to facilitate access to these tests for all Americans.

Updated Emergency Use Authorizations for All COVID-19 Antigen Tests

On November 1, 2022, the U.S. Food and Drug Administration (FDA) updated the emergency use authorizations (EUAs) of all COVID-19 antigen tests to revise the authorized uses and require updates to product labeling regarding repeat or serial testing. The letter also eliminates a Condition of Authorization concerning the collection of additional data to evaluate the performance of authorized antigen in vitro diagnostics for serial testing.

The EUA revision requires these revisions from test developers:

1. Update product labeling to include the revised authorized uses:

• Repeat testing at least two times over three days with at least 48 hours between tests for people with COVID-19 symptoms.

• Repeat testing at least three times over five days with at least 48 hours between tests for people without COVID-19 symptoms.

2. Submit a supplemental EUA request to the FDA with the updated labeling.

The FDA has a revised its web page for In Vitro Diagnostics EUAs – Antigen Diagnostic Tests for SARS-CoV-2.

Additional COVID-19 Resources

• CDC COVID-19 Homepage
• CDC Laboratory Outreach Communication System (LOCS) updates

Cholera Updates

CDC Recommends Lab Staffs Review Cholera Information

Cholera infections continue to occur worldwide, including large outbreaks in Haiti, Malawi, and Syria since early 2022. The outbreak in Haiti began in early October, and confirmed cholera cases are spreading across the country.

Although the risk of a travel-associated cholera case is low, CDC recommends that clinical laboratory professionals review cholera diagnosis and detection information.

Clinical laboratory staff who isolate Vibrio cholerae or detect a possible Vibrio cholerae infection using a culture-independent diagnostic test (CIDT) should take these steps:

1. Quickly culture (within three days) any CIDT-positive specimens from the original specimen on the appropriate media.
2. Inform the state public health laboratory staff through standard channels if Vibrio cholerae is detected.
3. Send the isolate (or CIDT-positive sample, if unable to culture) to the state public health laboratory using appropriate shipping conditions.

Isolates of confirmed Vibrio cholerae can be submitted to CDC by state public health laboratories as soon as possible. (For more information, refer to CDC Test Code 10119: Vibrio cholerae Identification and Subtyping.)

Additional Cholera Resources

• Cholera Information for Public Health & Medical Professionals
• Guidelines for Submitting Specimens to CDC
• Health Promotion Materials
• Cholera – Chapter 4 – 2020 Yellow Book | Travelers’ Health | CDC

Laboratory Questions?

• If you are a clinical or public health laboratory professional, contact LOCS.
• For media inquiries, contact the CDC Newsroom.

For all other questions, contact CDC-INFO.

Here to Help

Accreditation Commission for Health Care (ACHC) supports your efforts to deliver safe, high-quality patient care and appreciates hearing from you. Email [email protected] or call (855) 937-2242.