Background Mycoplasma genitalium (MG), an STI of renewed interest, is associated with urethritis in men and cervicitis in women. Epidemiologic studies of MG infection outcomes have been limited by diagnostic capabilities. Recent molecular technologies have been applied to detection of MG-specific nucleic acid sequences. Use of commercially available assays leads to comparability across studies if the performance chacteristics of these assays are known. The Aptima MG assay is available in some settings but requires access to assay-specific instrumentation. BioGX (Birmingham AL, USA) offers a custom lyophilized reagent for MG detection that is platform-agnostic and can be used in many clinical diagnostic settings. We compared the performance of the BioGX reagents to the Aptima MG (AMG) assay using specimens collected in support of a study of infertility in Cameroon.

Methods Vaginal samples were collected using Dacron swabs and stored in M4 transport medium. 200 uL of M4 was loaded into an AMG transport tube or a BD MAX SBT transport tube. Nucleic acid extraction and real-time PCR was performed on the BD MAX instrument using the BioGX Mycoplasma-Ureaplasma reagent. In this analysis we evaluated only the detection of MG.

Results Genital samples from 416 women were tested using both the AMG and BioGX reagents. The overall agreement was 99.3% (κ=.876) with 402 negative and 11 positive samples in agreement. Two samples were positive only using the BioGX reagents and one specimen was only positive with AMG.

Conclusion In this MG detection study, we showed good performance of BioGX reagents on the BD MAX platform. The BioGX reagents can be used with any real-time PCR system, thus expanding diagnostic capacity to many laboratories. The performance in this study was very similar to that of AMG. Reagents capable of wider testing can facilitate epidemiologic studies designed to understand the impact of MG infection.

Disclosure No significant relationships.