Evaluation of TANBead DNA Extraction Kits for Simultaneous Detection of Mycoplasma genitalium and Macrolide Resistance - with Epidemiological Analysis of Infection Prevalence in Västra Götaland

Abstract

Mycoplasma genitalium is a sexually transmitted pathogen associated with increasing antimicrobial resistance, particularly towards macrolide antibiotics. At Clinical Microbiology, Sahlgrenska University Hospital, detection of Mycoplasma genitalium and macrolide resistance is currently performed through separate diagnostic procedures, increasing turnaround time and laboratory costs. This study evaluated whether Maelstrom 4800 with TANBead Viral and STI extraction kits could replace the current diagnostic workflow by simultaneous detection of Mycoplasma genitalium and macrolide resistance. A secondary aim was to investigate the prevalence of Mycoplasma genitalium and antimicrobial resistance in Västra Götaland during 2025. A total of 85 Mycoplasma genitalium-positive clinical specimens (42 ESwab® and 43 urine samples) were analysed using Maelstrom 4800 and compared with the routine workflow using BDMax™ and magLead. Analytical sensitivity was assessed through dilution series, EQUALIS external quality assessment samples, PCR amplification performance, and bacterial copy number calculations. Epidemiological data from 2764 individuals tested for Mycoplasma genitalium during 2025 were statistically analysed by age, sex, prevalence, and antimicrobial resistance. TANBead Viral and STI demonstrated lower sensitivity than BDMax™ and magLead, particularly in samples with low bacterial load. Detection rates were 88.1% for TANBead Viral and 77.4% for STI, compared with 97.6% for magLead. The overall prevalence of Mycoplasma genitalium was 9.8% (270/2764), significantly higher in men (13.5%) than women (8.2%), with peak prevalence in individuals aged 20–24 years. Macrolide resistance was detected in 23.3% of positive samples, of which 26.9% showed fluoroquinolone resistance-associated mutations, emphasizing the importance of continued resistance surveillance and resistance-guided diagnostics. In conclusion, Maelstrom 4800 with TANBead Viral and STI demonstrated insufficient analytical performance to replace the current diagnostic workflow.