Exciting News: Bioer Technology’s CT/NG/UU Nucleic Acid Detection Kit Achieves CE-IVDR Registration

Bioer Technology is pleased to announce that its Neisseria Gonorrhoeae, Chlamydia Trachomatis, Ureaplasma Urealyticum Nucleic Acid Detection Kit (Fluorescent PCR) has successfully achieved CE-IVDR registration, marking another important milestone in the expansion of our molecular diagnostic portfolio and our commitment to supporting global infectious disease testing.

Addressing the Growing Need for STI Molecular Testing

Sexually transmitted infections (STIs) remain a significant global public health challenge, affecting millions of people worldwide. Among the major bacterial pathogens associated with STIs, Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Ureaplasma urealyticum (UU) are important causes of urogenital infections.

Infections caused by NG and CT can contribute to reproductive tract complications and infertility, while CT and UU are also associated with nongonococcal urethritis. Because these pathogens may cause similar or asymptomatic infections, accurate laboratory detection and differentiation are important for appropriate clinical management.

As molecular diagnostics continue to play an increasingly important role in infectious disease testing, laboratories are seeking solutions that can provide multiplex detection, reliable results, and efficient workflows from a single test.

Introducing the CT/NG/UU Nucleic Acid Detection Kit

The Neisseria Gonorrhoeae, Chlamydia Trachomatis, Ureaplasma Urealyticum Nucleic Acid Detection Kit (Fluorescent PCR) is a qualitative molecular assay designed for the simultaneous detection of Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), and Ureaplasma urealyticum (UU).

By combining three targets into one multiplex assay, the kit enables laboratories to obtain comprehensive pathogen information from a single testing workflow, supporting efficient molecular testing for urogenital infections.

Strong Clinical Performance

The kit demonstrated strong clinical performance across the three target pathogens.

Neisseria gonorrhoeae: Sensitivity 100%; Specificity 100%; Accuracy 100%

Chlamydia trachomatis: Sensitivity 100%; Specificity 99.83%; Accuracy 99.88%

Ureaplasma urealyticum: Sensitivity 99.77%; Specificity 99.73%; Accuracy 99.75%

The assay supports male urine swab and female cervical swab specimens, with a detection limit of 1,000 bacteria/mL for NG, 1,000 copies/mL for CT, and 1,000 CCU/mL for UU.

With the successful CE-IVDR registration of the CT/NG/UU Nucleic Acid Detection Kit, Bioer Technology continues to expand its global molecular diagnostics portfolio and contribute to more accessible and efficient infectious disease testing worldwide.