Both transcription-mediated amplification (TMA)-based MG assays had a highly superior sensitivity compared to the mgpB qPCR. The prevalence of MG and azithromycin resistance was high. Validated and quality-assured molecular tests for MG, routine resistance testing of MG-positive samples and antimicrobial resistance surveillance are crucial.

We identified the first two cases of the Finnish new variant of Chlamydia trachomatis (F-nvCT) beyond Finland in two clinical urogenital specimens in Örebro County, Sweden. These Aptima Combo 2 assay-negative specimens were Aptima Chlamydia trachomatis (CT) assay positive and had the characteristic C1515T mutation in the 23S rRNA gene. From 22 March to 31 May 2019, 1.3% (2/158) of the CT-positive cases in Örebro County were missed because of the F-nvCT. International awareness, investigations and actions are essential.

Background Four new variants of Chlamydia trachomatis (nvCTs), detected in several countries, cause false-negative or equivocal results using the Aptima Combo 2 assay (AC2; Hologic). We evaluated the clinical sensitivity and specificity, as well as the analytical inclusivity and exclusivity of the updated AC2 for the detection of CT and Neisseria gonorrhoeae (NG) on the automated Panther system (Hologic). Methods We examined 1004 clinical AC2 samples and 225 analytical samples spiked with phenotypically and/or genetically diverse NG and CT strains, and other potentially cross-reacting microbial species. The clinical AC2 samples included CT wild type (WT)-positive (n = 488), all four described AC2 diagnostic-escape nvCTs (n = 170), NG-positive (n = 214), and CT/NG-negative (n = 202) specimens. Results All nvCT-positive samples (100%) and 486 (99.6%) of the CT WT-positive samples were positive in the updated AC2. All NG-positive, CT/NG-negative, Trichomonas vaginalis (TV)-positive, bacterial vaginosis-positive, and Candida-positive AC2 specimens gave correct results. The clinical sensitivity and specificity of the updated AC2 for CT detection was 99.7 and 100%, respectively, and for NG detection was 100% for both. Examining spiked samples, the analytical inclusivity and exclusivity were 100%, i.e., in clinically relevant concentrations of spiked microbe. Conclusions The updated AC2, including two CT targets and one NG target, showed a high sensitivity, specificity, inclusivity and exclusivity for the detection of CT WT, nvCTs, and NG. The updated AC2 on the fully automated Panther system offers a simple, rapid, high-throughput, sensitive, and specific diagnosis of CT and NG, which can easily be combined with detection of Mycoplasma genitalium and TV.

Introduction: Mycoplasma genitalium (MG) is a frequent aetiology of urethritis and cervicitis, which can result in severe reproductive complications. Resistance in MG to first-line (azithromycin) and second-line (moxifloxacin) treatment has rapidly increased. The new CE-marked APTIMA MG assay (Hologic) is now commercially available. Our aims were to evaluate the clinical and analytical sensitivity and specificity of the new APTIMA MG assay and an APTIMA MG RUO assay, and describe the prevalence of MG, N. gonorrhoeae, C. trachomatis and resistance to azithromycin and moxifloxacin in Sweden, Denmark and Norway in 2016.MethodsFrom January 2016 to March 2017, first-void urine (from males) and vaginal swabs were collected from consecutive attendees at 3 STD clinics in Sweden, Denmark and Norway. All samples were tested with the APTIMA MG assay, APTIMA MG RUO assay, APTIMA CT/NG assay, and a quantitative mgpB PCR. Resistance was determined by sequencing of the 23S rRNA gene and parC. For analytical evaluation, isolates of diverse genome-sequenced MG and other mycoplasma species in different concentration were tested.ResultsIn total, 5269 patients were included. The rate of MG infected patients was 7.3%, however, the rate significantly varied in the different countries. The sensitivity of the APTIMA MG assay, APTIMA MG RUO assay and mgpB PCR ranged between 95.8%–100%, 95.8%–100%, and 73.2%–81.6%, respectively, in the countries. The specificity of the APTIMA MG assay, APTIMA MG RUO assay and mgpB PCR ranged between 99.6%–100%, 100%, and 99.7%–100%, respectively. The resistance level to azithromycin was 40% (18%–56% in the countries) and multidrug resistance (to both azithromycin and moxifloxacin) was found in all countries.ConclusionBoth the APTIMA MG assays had a significantly superior sensitivity compared to the mgpB PCR. The prevalence of MG as well as azithromycin resistance was high. Increased testing using validated and quality assured molecular tests for MG, antimicrobial resistance surveillance and routine resistance testing in MG-positive samples is crucial.