Cobas Liat POC RT-PCR for SARS-CoV-2 and Influenza Shows Over 98% Agreement with Central Lab Testing
A multicentre US study across 10 healthcare facilities compared the Cobas Liat SARS-CoV-2 and Influenza A/B point-of-care RT-PCR assay with centralised testing in 2,247 samples. Overall percent agreement exceeded 98% for SARS-CoV-2 across both nasal and nasopharyngeal specimens, and was 99.5% or higher for influenza A with 100% for influenza B. The assay performed consistently regardless of specimen type, collection method, symptom status, or vaccination status, supporting its deployment for rapid respiratory pathogen differentiation at the point of care.
The original study
A multicenter study to assess the performance of the point-of-care RT-PCR Cobas SARS-CoV-2 & Influenza A/B nucleic acid test for use on the Cobas Liat system in comparison with centralized assays across healthcare facilities in the United States.
- Authors
- Robbins EM, Bertuzis R, Chiu H-C, Miller L, Noutsios C
- Journal
- Journal of clinical microbiology
- Type
- Journal Article, Multicenter Study, Comparative Study, Evaluation Study
- PMID
- 40600702
Original abstract
UNLABELLED: Respiratory diseases can share many of the same symptoms, highlighting the need for timely and accurate differentiation to facilitate effective clinical management and reduce transmission. Compared with centralized testing, molecular point-of-care tests (POCTs) can provide a faster time to result. We evaluated the RT-PCR POCT Cobas® SARS-CoV-2 & Influenza A/B qualitative assay for use on the Cobas Liat system (the POC SARS-CoV-2 & Influenza A/B test) in nasal and nasopharyngeal swab samples from 10 diverse healthcare facilities in the United States. A composite comparator design consisting of three centralized tests was used to analyze severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), while performance vs a single centralized test was used for analysis of influenza A and B. Evaluations included performance stratified by sample type (prospective/retrospective and nasal/nasopharyngeal [paired by subject]), collection method (self/healthcare worker-collected [alternated and approximately balanced]), symptom status (symptomatic/asymptomatic), and SARS-CoV-2 vaccination status, as well as assay inclusivity and system ease of use. A total of 2,247 samples were tested. For SARS-CoV-2, the overall percent agreement (OPA) was 98.8% (95% confidence interval [CI]: 97.9, 99.3) in nasal swab samples and 99.0% (95% CI: 98.2, 99.4) in nasopharyngeal swab samples. Regression analysis showed that cycle threshold values from paired nasal and nasopharyngeal swab samples were highly correlated (correlation coefficient 0.83). The OPA was ≥99.5% (sample type dependent) and 100.0% for influenza A and B, respectively. The POC SARS-CoV-2 & Influenza A/B test was easy to use. These results support the use of the POCT in various sample types and by various operators in the intended-use setting. IMPORTANCE: This study highlights the benefits of RT-PCR point-of-care tests, namely comparable performance to centralized testing in multiple sample types and ease of use. Utilizing assays such as the POC Cobas SARS-CoV-2 & Influenza A/B test may improve the timely differentiation of respiratory diseases that share similar symptoms.