FDA clears diagnostic tests for chlamydia and gonorrhoea

24 May 2019 (Last Updated May 24th, 2019 09:35)

The US Food and Drug Administration (FDA) has cleared two tests, Aptima Combo 2 Assay and the Xpert CT/NG, for the detection of the Chlamydia trachomatis and Neisseria gonorrhoeae bacteria.

FDA clears diagnostic tests for chlamydia and gonorrhoea
FDA approves new diagnostic tests to detect various infections. Credit: Michael J. Ermarth/The U.S. Food and Drug Administration.

The US Food and Drug Administration (FDA) has cleared two tests, Aptima Combo 2 Assay and the Xpert CT/NG, for the detection of the Chlamydia trachomatis and Neisseria gonorrhoeae bacteria.

Aptima Combo 2 Assay has been developed by Hologic, while Cepheid developed Xpert CT/NG.

“The availability of these two tests will fill an unmet public health need, by allowing for more screening.”

The new devices are intended for extragenital testing of these sexually-transmitted infections using samples from throat and rectum. Previously, the tests were cleared for urine, vaginal and endocervical samples.

FDA Office of In Vitro Diagnostics and Radiological Health director Tim Stenzel said: “Prior to today, there were no chlamydia or gonorrhea tests cleared for use on samples from the throat and rectum. The availability of these two tests will fill an unmet public health need, by allowing for more screening.”

The FDA authorisation comes after review of data from a cross-sectional, collaborative, multi-site clinical study conducted in more than 2,500 patients.

During the study, the diagnostic accuracy of various commercially available nucleic acid amplification tests were assessed for detecting Neisseria gonorrhoeae and Chlamydia trachomatis from throat and rectal sites.

The US regulator has also granted marketing authorisation for InBios International’s ZIKV Detect 2.0 IgM Capture ELISA to diagnose Zika virus infection.

Said to be the first FDA-approved Zika diagnostic, the assay is designed to identify proteins generated by the body’s immune system against the viral infection in the blood.

In addition, CD Diagnostics has received the FDA clearance to market the Synovasure Lateral Flow Test Kit as an aid to identify periprosthetic joint infection.

This test is indicated to detect the infection in the synovial fluid of patients who are being examined for revision surgery, which is performed to replace or compensate a failed implant.