CE-marked assay for C. trachomatis and N. gonorrhoeae

Hologic has announced that its Aptim Combo 2 assay for Chlamydia trachomatis and Neisseria gonorrhoeae has received new CE-marked claims in Europe. These additional claims permit testing of both clinician- and patient-collected throat and rectal swabs.

“We developed the throat and rectal claims for Aptima Combo 2 to help clinical teams accurately diagnose and treat these common but potentially serious diseases,” said João Malagueira (VP Sales Diagnostics, EMEA).  “These new samples, which can now be collected by the patient or the clinician using the Aptima Multitest Swab Specimen Collection Kit, broaden the range of patient-collected samples available and allow us to offer the widest range of collection options.”

The excellent performance of the assay across sample types is reflected in throat and rectal samples, where Aptima Combo 2 demonstrates up to 100% sensitivity and specificity in detecting Chlamydia and gonorrhoea.

The APTIMA Combo 2 Assay can be used to test endocervical, throat, rectal and male urethral swab specimens; female and male urine specimens; and cervical samples collected in PreservCyt Solution from symptomatic and asymptomatic individuals. The Aptima Combo 2 assay provides an upfront biological advantage compared to assays that detect DNA – up to 1000-fold more rRNA than DNA per cell. The assay can be run as a standalone test or run simultaneously with other assays, providing clinicians with more flexibility.



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