GeneXpert IV

"While some POCTs for C. trachomatis and N. gonorrhoeae have achieved regulatory clearance, challenges remain, including the need to expand specimen type clearance to include extragenital specimens, to further improve turnaround times, and to decrease cost for adoption. There is need to optimize the use of POCTs in acute care settings to manage sexually transmitted infections."

"Our study brings to the fore the significance of integrating AI software X-vision with bacteriological diagnosis in detecting TB among vulnerable groups in Romania. This underscores the imperative at the global level to develop solutions in the prompt diagnosis of TB, particularly within vulnerable groups."

"This trial will provide evidence for a more intensive approach which is hypothesised to increase cost-effectiveness of TB case finding. In addition, it will provide evidence for high TB burden countries with inherently different cost structures compared to intermediate and low burden settings where previous cost-effectiveness analyses have been undertaken."

"The pharmacokinetic-pharmacodynamic modelling results suggest that delpazolid adds efficacy on top of bedaquiline, delamanid, and moxifloxacin; and that a dose of 1200 mg once daily would result in exposures with maximum efficacy. That dose was shown to be safe, raising hope that linezolid toxicities could be averted in long-term treatment. Delpazolid is a promising drug for future tuberculosis treatment regimens and could be widely usable if safety and efficacy are confirmed in larger trials."

"This case underscores the need to consider TB even in isolated laryngeal lesions, particularly in TB-endemic areas, as early diagnosis and treatment ensure favorable outcomes."

"The findings highlight the importance of tailored interventions for high-risk populations, and the model is replicable in other regions and contexts."

"Vasculitic infarcts in TBM were strongly associated with seizure occurrence."

"Primary iliac bone TB remains a rare clinical entity, even in endemic regions. It requires a rigorous approach combining clinical evaluation, advanced medical imaging and microbiological analyses to achieve an accurate diagnosis. Recent advances in molecular biology, in particular with the advent of the GeneXpert®, have considerably improved patient management, providing microbiological evidence in less than 2 h, thereby allowing early initiation of anti-TB treatment. Analysing the journey that concluded with the diagnosis of primary bone TB in our patient, we were able to highlight the challenges encountered in the early diagnosis of this condition, often masked by atypical clinical presentations."

"Xpert MTB/XDR can serve as a useful tool to rapidly identify resistance to INH, FLQ, SLID and ETM, thus offering targeted therapy to the patients of TBM."

"Urine Ultra shows promise as a supplementary point-of-care TB test among inpatients with HIV."

"This study underscores the high STI prevalence among key populations in San Pedro Sula, Honduras. Results show that point-of-care NAAT implementation is beneficial, appreciated, and feasible in this context and can successfully be integrated into basic clinic diagnostics. The added testing capacity improved diagnostic and management capacity of the clinic, especially regarding asymptomatic STIs, and thus improved quality of care for key populations."

"The Flash10 molecular POCT system demonstrates analytical performance and result consistency comparable to established molecular diagnostic methods [GeneXpert and real-time quantitative PCR (RT-PCR)] for the detection of FluA and FluB viruses. Its substantially shorter turnaround time supports its potential utility for rapid molecular testing in clinical point-of-care settings."

"The MiniDock test using tongue swabs and sputum provides a rapid, reliable, and noninvasive point-of-care testing diagnostic option for TB. Although the tongue swab MiniDock has lower sensitivity, its high acceptability makes it a valuable supplementary tool for individuals unable to produce sputum."

"MTB Ultima and MiniDock MTB exceed minimum World Health Organisation accuracy targets for sputum- and non-sputum-based near-point-of-care TB tests and offer strong potential to make universal molecular testing for TB a reality."

"In this population, the performance of both MiniDock MTB and MTB Ultima on tongue and sputum swabs was similar to target product profile thresholds for near point of care TB tests. Further studies to evaluate performance in diverse populations and settings are needed."

"Overall, the QIAstat-Dx GIP 2 assay is comparable to the commercially available nucleic acid amplification assays [Cepheid Xpert C. difficile, BD MAX Cdiff, Verigene CDF, and BioFire GI panel] for the detection of C. difficile, and the rapid assay setup time offers an efficient laboratory testing workflow."

The editorial in BMC Infectious Diseases (2025) concludes that point-of-care tests (POCTs) are essential for replacing presumptive syndromic management with accurate, pathogen-specific STI control. Based on the ProSPeRo Project's large-scale evaluations, the authors highlight that while devices like the GeneXpert system (for chlamydia, gonorrhoea, and trichomoniasis), the OSOM® Trichomonas Rapid Test, and dual HIV/syphilis rapid tests offer significant potential, their real-world performance in clinics often falls short of laboratory standards. This gap necessitates robust quality assurance, staff training, and the development of affordable, multiplex molecular tools to effectively combat antimicrobial resistance and improve patient outcomes in diverse global health settings.

"In this clinical evaluation of the STANDARD M10 MDR-TB and MTB/NTM assays in a clinical setting of low TB incidence, the M10 MDR-TB assay demonstrated clinical performance equivalent to the established Xpert MTB/RIF Ultra assay. However, the M10 MTB/NTM assay performed slightly weaker in detecting MTB and missed one-third of all NTM cases, showing little potential for reliable screening of NTM. Both assays showed excellent performance with SSM-positive samples. While the M10 MDR-TB assay exhibited great potential in rapid detection of MTB and its RIF/INH resistance, its suitability for any clinical setting may be somewhat limited by biosafety concerns related to weak inactivation of MTB during sample pretreatment. Further clinical evaluation studies are needed to establish its status as a relevant competitor for the Xpert MTB/RIF Ultra assay."

"We evaluated the analytical performance of three commercial molecular assays for rapid detection of Clostridioides difficile toxin B in stool samples. The results were compared with results from the BD MAX™ Cdiff assay. We analyzed forty negative and thirty-two positive stool samples with three rapid assays: Roche cobas® Liat® Cdiff, SD Biosensor STANDARD™ M10 C. difficile and Cepheid Xpert® C. difficile BT. The assays demonstrated a sensitivity of 96.9 %, 96.9 % and 100.0 % and a specificity of 100 %, 97.5 % and 97.5 %, respectively. There is limited data available on the analytical performance of the newly introduced STANDARD™ M10 C. difficile assay. In this study, all three rapid assays demonstrated similarly high analytical performance and can be used for detection of toxigenic C. difficile."

The QIAstat-Dx® GIP2 demonstrates high diagnostic accuracy compared to the Allplex™ GI, BIOFIRE® GI, and Xpert® Norovirus assays. With an overall 95.02% PPA and 99.98% PNA, the GIP2 proved exceptionally reliable for bacterial and parasitic targets, showing lower CT values than the Allplex™ assays. Despite a slightly lower viral sensitivity of 88.3%, the GIP2 remains a robust tool for rapid syndromic testing from Fecalswab® specimens.

" All 3 assays [BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel (BioMérieux), Xpert® Xpress SARS-CoV-2/Flu/RSV assay (Cepheid) and Cobas® SARS-CoV-2 & Influenza A/B assay (Roche) to detect Flu A/ B, SARS CoV-2 and RSV from nasopharyngeal swabs (NPS)] showed 95 % agreement for Flu A and B detection; performance for SARS-CoV-2 detection varied. SPOTFIRE provides an advantage of detecting additional respiratory pathogens. Overall, the assays were easy to perform with minimum technical skill."

"The Xpert HIV Qual XC assay shows excellent performance across diverse HIV-1 subtypes and is well-suited for decentralized diagnostic settings, supporting improved early diagnosis of HIV and treatment efforts."

"In diagnostic core biopsies, there was a good agreement between STRAT4 mRNA measurements and centrally assessed IHC measurements of ER, and moderate agreement for PR and Ki67."

"The Xpert HIV-1 viral load assay demonstrates high efficacy in accurately identifying and quantifying HIV-1 viral loads, making it a valuable tool for HIV diagnosis and monitoring. This reliability makes it particularly suitable for critical populations requiring timely and accurate viral load monitoring."

"This multiplex LAMP assay offers a rapid, accurate, and field-deployable tool for species-level identification of MTBC and major NTM pathogens. Its simplicity, stability, and compatibility with low-resource settings support its application in routine diagnostics and decentralized tuberculosis programs."

"Rapid turnaround time, ease of use and high acceptability make the Xpert CT/NG testing system a strategic tool for increasing testing frequency, reaching those not yet tested and offering the possibility of immediate treatment if needed. The assay showed good negative likelihood ratios and confirms its use to rule out CT/NG infections. Sensitivity varied across sites and pathogens. Periodic staff training at the testing sites should be mandatory."

"The performance of TB-LAMP assay is comparable to GeneXpert® in diagnosing TBM, and it may be used as a substitute for CSF GeneXpert® in resource-limited settings."

"TB and fungal OIs, including co-infection, were common in PLHIV in Paraguay and had high associated mortality. Laboratories and health facilities need access to CD4 + T-cell testing and rapid diagnostic assays."

"The present study validated a simplified and portable DNA extraction procedure from sputum samples, suitable for point-of-care qPCR screening of individuals suspected of TB infection. We suggest that the simplified extraction protocol coupled with a portable qPCR instrument might be used in low-infrastructure settings or in areas where people lack access to healthcare centers or are highly vulnerable (such as prisons), thus effectively making molecular TB screening accessible to everyone."

"This research supports the adoption of PCR sequencing approach as an efficient tool in detecting MDR-TB, counting the higher sensitivity and specificity as well as the short period to produce the results."

"This case study shows that provision of POC HPV testing and colposcopy at a rural community event setting is possible through cross-sector collaboration. This service was acceptable to rural transient workers who face barriers to healthcare in a high-income country."

The study demonstrates that the GeneXpert HBV assay is a highly sensitive, accurate, and rapid tool for quantifying HBV DNA in both plasma and DBS samples within sub-Saharan Africa. By leveraging the existing GeneXpert infrastructure in The Gambia - comprising 20 machines and 84 trained staff - this platform can effectively bypass traditional barriers such as high costs and technical complexity. Despite minor limitations with low-viremia DBS samples, the system’s simplified workflow and accessibility offer a viable pathway for scaling up HBV screening, monitoring, and treatment in resource-limited and rural settings through enhanced stakeholder collaboration.

"The Xpert Xpress CoV-2/Flu/RSV plus test allows for rapid and accurate diagnostic results, leading to reductions in testing costs and downstream healthcare resource utilization compared to other testing strategies. Compared to POC antigen testing strategies, PCR strategies were more efficient due to improved diagnostic accuracy and reduced use of confirmatory testing."