Workflow and Throughput of Commercial Assays to Detect Mycoplasma genitalium and Macrolide Resistance-Mediating Mutations.

ABSTRACT: Aptima Mycoplasma genitalium (MG) required the shortest and STD6 the longest time to detect MG in clinical samples. ResistancePlus MG detected MG and macrolide resistance-mediating mutations simultaneously. Times were influenced by specimen numbers. M. genitalium positives from the other 2 assays required increased time for macrolide resistance-mediating mutation sequencing.

Comparison of Assays for the Diagnosis of Mycoplasma genitalium and Macrolide Resistance Mutations in Self-Collected Vaginal Swabs and Urine.

BACKGROUND: The objective was to compare commercial assays on clinical specimens for Mycoplasma genitalium (MG) detection and macrolide resistance mutation (MRM) frequency. METHODS: Three self-collected vaginal swabs (VS) and a first-void urine (FVU) from 300 consented women were tested by Aptima MG (AMG), ResistancePlus MG (RPMG) and Seeplex STD6 ACE (STD6) for detection of MG. Aptima MG and STD6 MG positives were tested for MRM using MG 23S rRNA polymerase chain reaction with Sanger sequencing (23SMGSS) compared with MRM determination in the RPMG assay. Unique AMG positives were tested with confirmatory Aptima assays. RESULTS: M. genitalium prevalence ranged from 7.1% to 19.7%, influenced by the assay used and the specimen tested. Overall agreements for MG detection were 96.3% (κ = 0.91) for VS and 93.3% (κ = 0.72) for FVU between AMG and RPMG with lower agreements with STD6. Using a rotating reference standard, sensitivities on VS and FVU were 100% and 100% for AMG, 100% and 83.3% for RPMG, and 54.2% and 48.4% for STD6. Specificities were high for RPMG and STD6 and AMG detected extra positives, most of which were confirmed. Macrolide resistance mutation frequency rates testing VS and FVU were 50% (24/48) and 58.1% (18/31) by RPMG compared with 52.5% (31/59) and 23.5% (12/51) by 23SMGSS. MRM overall agreements between RPMG and 23SMGSS were 73.2% (κ = 0.41) for VS and 76.0% (κ = 0.52) for FVU. CONCLUSIONS: Aptima MG detected more cases of MG infections. ResistancePlus MG detection was more effective on VS than on FVU. Seeplex STD6 ACE performance was inferior. The MRM detection component of RPMG agreed with results from 23SMGSS most of the time.

Providing crisis care in a pandemic: a virtual based crisis stabilization unit.

Background: Winnipeg, Canada operates a 16-bed subacute unit, the Crisis Stabilization Unit (CSU), for voluntary patients in crisis not requiring hospital admission. The virtual CSU (vCSU) launched in March 2020 as an adjunct to the in-person CSU during the COVID-19 pandemic, providing the same resources virtually, allowing patients to remain at home. Methods: Program data were collected for vCSU admissions between April 1, 2020 and April 7, 2021 (n = 266) to examine patient characteristics and discharge outcomes. Data were retrieved from the electronic patient record (EPR) for both in-person and vCSU admissions during the same period for comparison (n = 712). vCSU admissions (n = 191) were summarized by patient demographics, clinical factors/outcomes, and compared on the same measures to in-person CSU admissions (n = 521) using binary logistic regression. Results: 30.1% of patients admitted to the vCSU received initial mental health assessment virtually (phone/videoconference), therefore receiving all care at home. Clinical symptoms at assessment included depression/anxiety (39.0%), psychosis/mania (2.7%), suicidal behaviour/self-harm (27.4%), psychosocial event/stressor (19.8%). Average stay was 4.9 days. Compared to the in-person CSU, vCSU referrals were associated with the absence of psychosis [odds ratio (OR).40, 95% confidence interval (CI).18-0.89] and no prior 1-year contact with referral site (OR.43, 95% CI.28-0.64). Those living farther away from the referral site were more likely to receive a vCSU referral. Conclusion: The vCSU model is feasible for a diverse group of patients experiencing mental health crises. Future work is needed to better determine who the model is right for and examine longer term outcomes.

Comparison of Alinity m HPV and cobas HPV assays on cervical specimens in diverse storage media.

OBJECTIVE: To assess the concordance of high-risk HPV (HR-HPV) testing with the Alinity assay on cervical samples collected with diverse collection/storage protocols (ThinPrep, SurePath, Cervicollect) and to assess inter-assay concordance of HR-HPV testing of cervical cell specimens with Alinity m HR HPV assay (Alinity) vs cobas® 4800 HPV assay (cobas). METHODS: Specimens were obtained from 560 women attending a Women's Health clinic. Two specimens were obtained from each woman with combinations of two of the three collection devices and aliquots were tested by the two assays. RESULTS: Alinity showed an agreement of 93.9%, Kappa = 0.89 (263/280) between ThinPrep and SurePath specimens; 97.5%, Kappa = 0.95 (347/356) and 92.9%, Kappa = 0.85 (104/112) between ThinPrep and SurePath aliquots taken before or after cytology processing, respectively. Cervi-Collect specimens showed an agreement of 94.6%, Kappa = 0.89 (265/280) with ThinPrep specimens. Compared to cobas, Alinity showed agreements of 94.3%, Kappa = 0.88 (395/419) and 91.8%, Kappa = 0.82 (257/280) between ThinPrep and SurePath specimens, respectively. Alinity and cobas detected genotypes 16/18 and other high-risk HPV types at similar rates and showed similar correlations with cytology grades. CONCLUSIONS: Compared to cobas, Alinity performed equally well for detecting HPV in cervical specimens obtained with ThinPrep and SurePath. The Cervi-Collect device compared well to the other collection methods. Alinity is a reliable assay for simultaneous detection of HPV-16/18 and other high-risk genotypes in cervical specimens.