Self-sampling strategies (with/without digital innovations) in populations at risk of Chlamydia trachomatis and Neisseria gonorrhoeae: a systematic review and meta-analyses.

BACKGROUND: Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) resulted in over 200 million new sexually transmitted infections last year. Self-sampling strategies alone or combined with digital innovations (ie, online, mobile or computing technologies supporting self-sampling) could improve screening methods. Evidence on all outcomes has not yet been synthesised, so we conducted a systematic review and meta-analysis to address this limitation. METHODS: We searched three databases (period: 1 January 2000-6 January 2023) for reports on self-sampling for CT/GC testing. Outcomes considered for inclusion were: accuracy, feasibility, patient-centred and impact (ie, changes in linkage to care, first-time testers, uptake, turnaround time or referrals attributable to self-sampling).We used bivariate regression models to meta-analyse accuracy measures from self-sampled CT/GC tests and obtain pooled sensitivity/specificity estimates. We assessed quality with Cochrane Risk of Bias Tool-2, Newcastle-Ottawa Scale and Quality Assessment of Diagnostic Accuracy Studies-2 tool. RESULTS: We summarised results from 45 studies reporting self-sampling alone (73.3%; 33 of 45) or combined with digital innovations (26.7%; 12 of 45) conducted in 10 high-income (HICs; n=34) and 8 low/middle-income countries (LMICs; n=11). 95.6% (43 of 45) were observational, while 4.4% (2 of 45) were randomised clinical trials.We noted that pooled sensitivity (n=13) for CT/GC was higher in extragenital self-sampling (>91.6% (86.0%-95.1%)) than in vaginal self-sampling (79.6% (62.1%-90.3%)), while pooled specificity remained high (>99.0% (98.2%-99.5%)).Participants found self-sampling highly acceptable (80.0%-100.0%; n=24), but preference varied (23.1%-83.0%; n=16).Self-sampling reached 51.0%-70.0% (n=3) of first-time testers and resulted in 89.0%-100.0% (n=3) linkages to care. Digital innovations led to 65.0%-92% engagement and 43.8%-57.1% kit return rates (n=3).Quality of studies varied. DISCUSSION: Self-sampling had mixed sensitivity, reached first-time testers and was accepted with high linkages to care. We recommend self-sampling for CT/GC in HICs but additional evaluations in LMICs. Digital innovations impacted engagement and may reduce disease burden in hard-to-reach populations. PROSPERO REGISTRATION NUMBER: CRD42021262950.

Self-tests for COVID-19: What is the evidence? A living systematic review and meta-analysis (2020-2023).

COVID-19 self-testing strategy (COVIDST) can rapidly identify symptomatic and asymptomatic SARS-CoV-2-infected individuals and their contacts, potentially reducing transmission. In this living systematic review, we evaluated the evidence for real-world COVIDST performance. Two independent reviewers searched six databases (PubMed, Embase, Web of Science, World Health Organization database, Cochrane COVID-19 registry, Europe PMC) for the period April 1st, 2020, to January 18th, 2023. Data on studies evaluating COVIDST against laboratory-based conventional testing and reported on diagnostic accuracy, feasibility, acceptability, impact, and qualitative outcomes were abstracted. Bivariate random effects meta-analyses of COVIDST accuracy were performed (n = 14). Subgroup analyses (by sampling site, symptomatic/asymptomatic infection, supervised/unsupervised strategy, with/without digital supports) were conducted. Data from 70 included studies, conducted across 25 countries with a median sample size of 817 (range: 28-784,707) were pooled. Specificity and DOR was high overall, irrespective of subgroups (98.37-99.71%). Highest sensitivities were reported for: a) symptomatic individuals (73.91%, 95%CI: 68.41-78.75%; n = 9), b) mid-turbinate nasal samples (77.79%, 95%CI: 56.03-90.59%; n = 14), c) supervised strategy (86.67%, 95%CI: 59.64-96.62%; n = 13), and d) use of digital interventions (70.15%, 95%CI: 50.18-84.63%; n = 14). Lower sensitivity was attributed to absence of symptoms, errors in test conduct and absence of supervision or a digital support. We found no difference in COVIDST sensitivity between delta and omicron pre-dominant period. Digital supports increased confidence in COVIDST reporting and interpretation (n = 16). Overall acceptability was 91.0-98.7% (n = 2) with lower acceptability reported for daily self-testing (39.5-51.1%). Overall feasibility was 69.0-100.0% (n = 5) with lower feasibility (35.9-64.6%) for serial self-testing. COVIDST decreased closures in school, workplace, and social events (n = 4). COVIDST is an effective rapid screening strategy for home-, workplace- or school-based screening, for symptomatic persons, and for preventing transmission during outbreaks. These data will guide COVIDST policy. Our review demonstrates that COVIDST has paved the way for self-testing in pandemics worldwide.

Comparative analytical profiling of bevacizumab biosimilars marketed in India: a national control laboratory study.

In this study, analytical profiling of the bevacizumab (BVZ) biosimilars (N = 3) approved in India were evaluated for charge heterogeneity, isoelectric focusing, aggregation and in vitro potency analysis. The charge variants were characterized using high performance cation-exchange chromatography (CEX-HPLC), capillary zone electrophoresis (CZE) and capillary isoelectric focusing (cIEF). cIEF was also used for estimation of isoelectric point (pI value). In addition, aggregate analysis was done using size exclusion high performance chromatography (SEC-HPLC). The cell-based inhibition of proliferation assay using HUVEC cells, indirect ELISA and Western blot were performed for in vitro biological activity. In addition of cell-based cytotoxicity assay was also performed and found no cytotoxic effect on both HuT78 and WIL2S cells by bevacizumab biosimilars. The significant variations in acidic (p < 0.0001) and basic variants (p < 0.0001), pI value (p = 0.0035), aggregates (p = 0.0306) of biosimilars were found as compared to innovator product; however, cell-based potency analysis (p = 0.6047) and indirect ELISA (p = 0.1611) have shown no significant difference in the biological activity. The banding patterns of all biosimilars in western blot were found similar to the innovator product. The comparatively higher basic variants in the biosimilars were attributing to the high pI value of biosimilars to that of innovator product, although these variations were not affecting the biological activity of the biosimiars. This is a unique study, wherein the independent analysis by a National Control Laboratory (NCL) will not only help the National Regulatory Authority (NRA) to assess the quality and consistency in manufacturing of BVZ biosimilars marketed in India but also facilitate the uptake of BVZ biosimilars, and sustainable access to new medicines against the anti-angiogenic therapy.