Multiplex PCR Test Identifies Seven STI Pathogens in One Hour

To support flexible, standardized testing, a new IVDR-compliant multiplex PCR system offers customizable detection of up to seven STI pathogens with about a one-hour run time.

Altona Diagnostics (Hamburg, Germany) announced its FlexStar STI Panel has obtained CE marking under Regulation (EU) 2017/746, completing the company’s transition of its modular STI portfolio to the IVDR framework. The panel supports qualitative detection and differentiation of up to seven pathogens in a single sample: Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma genitalium (MG), Trichomonas vaginalis (TV), Ureaplasma urealyticum (UU), Ureaplasma parvum (UP), and Mycoplasma hominis (MH). The design allows laboratories to configure the combination of targets according to clinical needs or guidelines.

The FlexStar approach uses adaptive multiplex PCR with a single amplification mix and interchangeable detection modules, such as CT/NG, MG/UU/TV, and UP/MH. The assay is validated for urine and genital swab specimens and integrates into the AltoStar Molecular Diagnostic Workflow from sample preparation through detection and analysis. Following sample preparation, the workflow delivers PCR results in about one hour.

CE marking in accordance with the IVDR demonstrates conformity with safety, performance, and clinical evidence requirements for the product. Alignment with AltoStar instrumentation and software is intended to standardize processing, increase throughput efficiency, and simplify routine operations. The optional AltoStar Analysis software can automate PCR result interpretation to reduce hands-on time, standardize review, and support reproducible, traceable reporting.

“With the launch of our first CE marked FlexStar® panel, we are entering the field of syndromic testing with flexible, compliant diagnostics designed to meet the evolving needs of modern laboratory workflows,” said Dr. Sönke Friedrichsen, General Manager of altona Diagnostics.