cobas liat

"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."

"The impact of PCR interference from commercially available CG-containing nasal sprays highlights the importance of a thorough medical history when treating patients to ensure accurate laboratory results are received. In high-risk settings, it would be helpful to adjust NP sampling protocols, for examples collecting swabs a minimum of 30 minutes after using a CG nasal spray, in order to minimize the effect of PCR inhibitors. We demonstrate here that CG has an inhibitory impact on RT-qPCR, similar to that seen in the presence of heparin (Figs 1–4). To our knowledge, this is the first study to demonstrate CG-mediated PCR interference, and raises a red flag regarding the impact of these products in the context of future public health responses. In addition, it suggests that the results of studies investigating the efficacy of carrageenan-based products using PCR assays should be further scrutinized. Our results also suggest that the use of any nasal products should be considered when looking at the validity of clinical results obtained via PCR test methods with NP samples. However, further clinical studies are required to validate these findings. In addition, more research is required into the mechanistic action of GAGs in PCR interference and specifically, how this interference can be reliably overcome in a diagnostic setting."

This study validates the DNA/RNA Defend Pro (DRDP) buffer as a versatile tool for diagnostic optimization, offering excellent viral RNA stability for Influenza A, SARS-CoV-2, and RSV A across various temperatures for up to seven days. By demonstrating strong compatibility with both extraction-free RT-qPCR and rapid antigen testing, DRDP streamlines the diagnostic workflow and eliminates the need for complex processing. Consequently, it represents a highly effective solution for enhancing testing efficiency, particularly in time-critical or resource-limited settings.

"Our research confirms that heparin-mediated PCR interference occurs in simulated NP samples, and that the degree of interference varies between testing platforms. Of the platforms tested, the Hologic Panther demonstrated no evidence of heparin-mediated interference. We also demonstrated that treatment with heparinase I can overcome the inhibition caused by the presence of heparin, which gives confidence in the results produced in the context of the INHERIT study. Further research is required to..."

" 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 CovidNudge is a simple and easy to use laboratory-free, POC test for SARS-CoV-2. The percent overall agreement between the CovidNudge and the cobas® Liat® was reasonable (84.62 %). Our laboratory based PCR for SARS-CoV-2 agreed with the CovidNudge for half of the discordant samples. A major limiting factor in the widespread clinical use of the CovidNudge is the time taken to run a single test, which is significantly longer than that of other molecular POC tests currently available. The ..."

This study evaluated the performance of saliva versus nasopharyngeal (NP) swabs for detecting SARS-CoV-2, influenza A/B, and RSV using the Roche cobas® Liat® platform. Testing 138 episodes within an adult cohort in Guatemala, researchers found a 90.3% agreement for SARS-CoV-2. While saliva samples exhibited higher median cycle threshold values than NP swabs, indicating a lower viral load, saliva remained a reliable alternative for SARS-CoV-2 detection in point-of-care settings.

"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."

"Commercial multiplex respiratory virus assays [ cobas 6800/8800 SARS-CoV-2 & Influenza A/B, Xpert Xpress SARS-CoV-2/Flu/RSV, and cobas Liat SARS-CoV-2 & Influenza A/B] have good performance for samples with medium to high viral loads (Ct values <33). Laboratories should consider appropriate test result review and confirmation protocols to optimize sensitivity, and may consider reporting samples with additional interpretive comments when low viral loads are detected."

"POCTs [cobas SARS-CoV-2 & Influenza A/B assay with the cobas Liat RT-qPCR system (Roche Diagnostics), ID NOW COVID-19 and COVID-19 2.0 (Abbott), and SARS-CoV-2 Rapid Antigen Test (RAT) (Roche Diagnostics)] enable the detection of SARS-CoV-2 RNA or antigen in BAL fluid samples and may provide additional information to decide if donor lungs are suitable for transplantation. Detection of respiratory pathogens with POCTs at the time of donor lung procurement is a potential strategy to increase safety in LTx by preventing iatrogenic transmission and severe postoperative infections."

This study compared the performance of cobas® Liat® RT-PCR and eazyplex® RT-LAMP for SARS-CoV-2 testing in emergency departments using 378 Liat-positive samples. Results showed that 14% of positive Liat® findings—primarily from asymptomatic patients (26.8%) versus symptomatic patients (3.8%)—could not be confirmed by reference RT-PCR. The eazyplex® assay identified 90.6% of confirmed symptomatic cases but only 62% of asymptomatic cases, with false negatives correlating to Ct values > 30. While both assays are effective for symptomatic patients, their utility for asymptomatic screening depends on whether the clinical goal is to exclude any infection or specifically identify high-risk transmitters.

"Overall, compared with standard of care RADTs [Quick Chaser Flu A,B (Mizuho Medy Co. Ltd., Saga, Japan), BD VeritorTM System Flu A+B (Becton, Dickinson and Company, Sparks, Maryland, USA), BRIGHTPOC® FluNeo (Shionogi, Osaka, Japan), Quick NaviTM-Flu/Quick NaviTM-Flu2 (Otsuka, Chiyoda, Japan), and ImunoAce Flu (Tauns Laboratories, Inc. Shizuoka, Japan)], the Liat test was more sensitive and specific in children and adults, particularly in the early stages of infection. Greater sensitivity can enable earlier diagnosis and may better inform appropriate antiviral treatment decisions."

In summary, the comparison shows that while most molecular platforms are highly reliable, the Cepheid Xpert Xpress and Roche Cobas Liat emerge as the most sensitive rapid options, consistently meeting the strictest limits of detection. In contrast, multiplex platforms like the BioMerieux BioFire, Qiagen QIAstat-Dx, and GenMark ePlex offer broader diagnostic reach but sometimes sacrifice sensitivity or fail to provide viral load data (Ct values). While devices such as the Credo Diagnostics VitaPCR and MobiDiag Novodiag provide speed, they show limitations in detecting low viral loads compared to high-throughput laboratory kits like ThermoFisher TaqPath or Seegene Allplex, which remain the gold standard for large-scale, resilient testing.

"MG positivity was high and MG co-infection with CT was common. These findings improve understanding of MG prevalence and may help inform the targeting of MG screening to specific patient populations. Co-infection data support using multiplex testing to facilitate targeted treatment decisions."

This multicenter study demonstrates that the cobas Liat CT/NG/MG assay provides high clinical performance for the rapid detection of three major STI pathogens in a point-of-care (POC) setting. With a turnaround time of approximately 20 minutes, the test delivers laboratory-grade accuracy (specificity >97%) for both clinician- and self-collected samples, regardless of the patient's symptom status. By enabling immediate and precise pathogen identification, this POC solution offers a viable alternative to delayed centralized testing. Its implementation can significantly reduce reliance on empiric treatment, minimize misdiagnosis, and improve patient outcomes through faster, targeted therapy, ultimately lowering healthcare costs and curbing further transmission.

This study confirms that the LabTurbo multiplex RT-PCR kit provides exceptional diagnostic accuracy, achieving 100% agreement with the Cobas Liat SARS-CoV-2/Flu and Cobas RSV reference assays. By effectively differentiating between SARS-CoV-2, influenza A/B, and RSV despite their symptomatic overlap, the LabTurbo kit proves to be a highly sensitive and reliable alternative for clinical settings. Its ability to simultaneously detect these pathogens facilitates rapid diagnosis, ensuring timely treatment and improved management of co-circulating respiratory viruses.

"POC SARS-CoV-2 used in both POC and central laboratory settings showed good overall diagnostic performance relative to 68/8800, a widely used and accurate laboratory-based test, for detecting SARS-CoV-2. Efficient POC testing will help improve the timely management of SARS-CoV-2 infections."

"A POC RT-PCR test that combined measurement of SARS-CoV-2 and influenza subtypes with performance equivalent to routine centralized testing would provide a critical tool to improve the diagnosis and management of COVID-19 and influenza. We found that the performance of the POC SARS-CoV-2 & Influenza A/B test was comparable to centralized testing methods. Centralized testing has long been considered the gold standard. With the ease of use and equivalent performance of the POC SARS-CoV-2 & Influenza A/B test, we are moving toward a reality in which these assays are an equally valuable option. A study of the POC Cobas Influenza A/B test (an RT-PCR test that detects only the influenza analyte) in the emergency department found that POC testing for influenza was useful in improving several metrics, including the indication for treatment with neuraminidase in positive cases (48). It is relevant to note that SARS-CoV-2 and influenza coinfection can increase the risk of severe outcomes compared with those infected with SARS-CoV-2 alone, particularly for those coinfected with influenza A (49). Our study highlights the benefits of molecular multiplex POCTs to help improve the timely differentiation of respiratory diseases that share similar symptoms and support efforts to improve patient management."

"This systematic meta-analysis demonstrated the diagnostic utility of the Multiplex Liat assay, regardless of the inclusion of VOCs and applied rRT-PCR, especially in terms of sensitivity. To the best of our knowledge, this is the first study to report specific pooled values for the performance of the Multiplex Liat assay developed for SARS-CoV-2 and influenza viruses that are persistent and manageable with drugs. These practical findings based on a meta-analysis facilitate the appropriate settings in clinical laboratories, leading to rapid and accurate diagnoses and treatment for patients with respiratory symptoms."

While rapid and point-of-care SARS-CoV-2 testing significantly reduced turn-around times compared to central laboratory testing, this study found no significant impact on emergency department length of stay, inpatient duration, or clinical outcomes for less urgent patients. These results suggest that fast testing strategies should be tailored to specific hospital conditions and patient cohorts rather than applied as a universal measure to improve throughput.

The cobas SARS-CoV-2 Duo assay is a precise and reliable tool for both the qualitative detection and quantitative monitoring of SARS-CoV-2. With a verified analytical range L and a high correlation to existing diagnostic standards, it demonstrates excellent diagnostic performance. Its strong agreement with established assays confirms it as a sensitive and accurate method for managing clinical responses in COVID-19 patients.

"The LiatCOVID/flu assay shows an acceptable performance in the detection of SARS-CoV-2 and influenza viruses using NPS samples."

This study confirms that spring water gargle (SWG) is a reliable, non-invasive alternative to swabs for SARS-CoV-2 detection. The cobas Liat platform demonstrated excellent performance and high diagnostic agreement (kappa ≥ 0.92) compared to standard methods. Despite minor sensitivity limitations in samples with very low viral loads, the system is a highly effective point-of-care solution for rapid testing in high-risk populations.