NEW YORK – The US Food and Drug Administration on Thursday released additional conditions of authorization for certain SARS-CoV-2 tests that have received Emergency Use Authorizations, requiring test makers to update authorized labeling and evaluate the impact of variants on test performance.
The agency also issued recommendations to clinical laboratories and healthcare providers using the tests that the FDA said could be impacted by SARS-CoV-2 mutations.
In
a letter establishing additional Conditions of Authorization on certain molecular, antigen, and serology tests for SARS-CoV-2, the agency is requiring developers to update authorized labeling within three months, submit the updates to the FDA as a supplement to the EUA, and evaluate the impact of viral mutations on test performance.
For multianalyte tests, developers must evaluate the impact of SARS-CoV-2 viral mutations and all other target analytes, the agency said. Evaluations must be ongoing and include any additional data analysis requested by the FDA in response to performance concerns. If viral mutations affect the expected performance of the test, developers are required to notify the agency immediately.
In addition, test labels must be updated within seven calendar days to include additional labeling risk mitigations if requested by the FDA.
The revisions aren't required for IL-6 tests, standalone specimen collection devices, or standalone home collection kits.
The FDA also reiterated
its list of authorized molecular tests whose performances could be impacted by viral mutations.
Those tests are: Mesa Biotech's Accula SARS-CoV-2 Test; Applied DNA Sciences' Linea COVID-19 Assay Kit; Thermo Fisher Scientific's TaqPath COVID-19 Combo Kit; and Cepheid's Xpert Xpress SARS-CoV-2, Xpert Xpress SARS-CoV-2 DoD, and Xpert Omni SARS-CoV-2.
The FDA noted that the impact of mutations on these tests "does not appear to be significant" for overall sensitivity, but that it is providing the info "out of an abundance of caution." The Linea and TaqPath tests include targets that have reduced sensitivity, but both tests detect multiple targets.
For the Cepheid tests, the FDA said that two independent single point mutations reduce the tests' sensitivity for detecting the N2 target. While single point mutations generally won't impact performance for most molecular tests, the FDA said the impact of a single point mutation on the test performance is "associated with the unique chemistry of the Cepheid tests." It added that the impact on test performance didn't appear to be significant.
NEW YORK – Qiagen said on Friday that its rapid portable antigen test developed with Ellume for detecting SARS-CoV-2 has received Emergency Use Authorization from the US Food and Drug Administration.
The QiaReach SARS-CoV-2 Antigen Test can detect the virus in individuals with active infections in two to 15 minutes and can be used with nasal and nasopharyngeal swab samples from as many as eight symptomatic patients simultaneously. It can process an average of about 30 swab samples per hour and has demonstrated a sensitivity of at least 80 percent and specificity of 98 percent in clinical studies, Qiagen said.
It is the second COVID-19 test that the company has developed in partnership with Australian diagnostics company Ellume that runs on the digital eHub and eStick system. In May a test co-developed by the two firms
received EUA from the FDA. That test, called the Anti-SARS-CoV-2 Total Test, is for identifying individuals carrying antibodies against SARS-CoV-2 and also runs on the digital eHub and eStick system.
eHub is a portable reader with backup battery power that can be operated remotely from main power for up to eight hours, while eStick uses nanoparticle fluorescent detection technology to alert for the presence of the SARS-CoV-2 nucleocapsid protein, an antigen which is present on the surface of the virus.
"Knowledge of past and present infections is key to understanding and inhibiting the spread of the disease," said Jenny Howard, head of Qiagen's Immune Monitoring Franchise. "The QiaReach SARS-CoV-2 Antigen Test delivers rapid and highly accurate results and addresses the high-volume testing needs for SARS-CoV-2 antigens – and in combination with QiaReach Anti-SARS-CoV-2 Total Test allows labs to run antigen tests and antibody tests at the same time."
www.genomeweb.com
www.360dx.com
www.reuters.com
