FDA Roundup: New Tests for Zika Antibody, Chlamydia and Gonorrhea
The FDA has cleared new tests for the detection of antibodies to the Zika virus and the detection of chlamydia- and gonorrhea-causing bacteria from throat and rectum samples.
The ZIKV Detect 2.0 IgM Capture ELISA is the first diagnostic test for Zika allowed by the FDA in the US, as previous Zika tests were only authorized for emergency use.
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The safety and efficacy of the ZIKV Detect 2.0 IgM Capture ELISA were demonstrated in a review of data from a clinical study of 807 test samples.
The test is for use only in patients with clinical signs and symptoms consistent with Zika, and/or those who meet the CDC’s Zika virus epidemiological criteria.
The FDA has also cleared two tests for the detection of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause chlamydia and gonorrhea, respectively.
The Aptima Combo 2 Assay and the Xpert CT/NG are the first tests cleared for extragenital diagnostic testing of these infections via the throat and rectum. Previously, the tests were cleared for testing urine, vaginal, and endocervical samples.
The safety and efficacy of the tests were demonstrated in an FDA review of data from a collaborative, multi-site clinical study of more than 2500 patients evaluating the diagnostic accuracy of multiple commercially available nucleic acid amplification tests for detection of the bacteria that causes chlamydia and gonorrhea from throat and rectal samples.
—Michael Potts
References:
FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies [press release]. May 23, 2019. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-diagnostic-test-detecting-zika-virus-antibodies.
FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea [press release]. May 23, 2019. https://www.fda.gov/news-events/press-announcements/fda-clears-first-diagnostic-tests-extragenital-testing-chlamydia-and-gonorrhea.