No abstract

Chlamydia screening for all pregnant women aged 16-25 years during an antenatal visit is cost effective.

fThe detection of Mycoplasma genitalium was evaluated on 1,080 urine samples by the use of a Panther instrument. Overall sensitivity, specificity, positive predictive values, and negative predictive values were 100%, 99.4%, 93.6%, and 100%, respectively. Detection of M. genitalium by the use of the Panther transcription-mediated amplification assay offers a simple, accurate, and sensitive platform for diagnostic laboratories. Mycoplasma genitalium is a common cause of nongonococcal urethritis (NGU) in men and currently accounts for 10% to 35% of NGU cases globally (1, 2). In women, it has been associated with cervicitis, pelvic inflammatory disease, and infertility (1,(3)(4)(5)(6)(7) and studies have also suggested that it plays an important role in HIV acquisition and transmission (8, 9). The exact rates of M. genitalium prevalence have been reported in a limited number of studies, with prevalences of 0.8% to 2.3% among young women and 1.1% to 6.9% among young men (10)(11)(12)(13)(14).As this organism is highly fastidious and slow growing, culture is not feasible for diagnosis and is performed in only a small number of laboratories worldwide for research purposes. Diagnosis relies on nucleic acid amplification tests (NAAT); however, as there have been limited commercial assays available, most laboratories have utilized in-house NAATs, utilizing quantitative PCR (qPCR) assays with various targets (15-21). For some time, a research-use-only transcription-mediated amplification assay for detection of M. genitalium (MG-TMA) has been available from Hologic (Bedford, MA, USA) for use on either the manual or automated TIGRIS DTS system; however, this has recently been introduced onto the Panther platform utilizing the open-channel software feature, with the manufacturer package insert indicating a sensitivity of 0.01 CFU/ml (equivalent to 0.004 copies per reaction). The assay has received the CE mark for in vitro diagnosis (CE-IVD) in Europe and is becoming accredited through other regulatory bodies for utilization in diagnostic laboratories. In this study, we evaluated the performance of the MG-TMA on the Panther platform for the detection of M. genitalium 16S rRNA by comparison to three assays: an alternative 16S rRNA target assay (Alt-TMA) available on Panther and two previously described PCR assays, one targeting a 78-bp region of the M. genitalium adhesion (MgPa) gene with sensitivity of five copies per reaction (18) and the other targeting a 517-bp region of the 16S rRNA gene with sensitivity of 10 copies per reaction (21). To our knowledge, this is the first clinical evaluation of the Panther assay for detection of M. genitalium.From February to May 2015, consecutive urine samples received for M. genitalium testing were utilized for this evaluation. Ethical approval for this study was granted by the Royal Women's Hospital Research and Ethics Committees. The patient population included 664 men and women attending Melbourne Sexual Health Centre for management of NGU or sexual contacts of infected partners, 309 co...