Clinical evaluation of multiplex RT-PCR assays for the detection of influenza A/B and respiratory syncytial virus using a high throughput system

Evaluation of a quantitative RT-PCR assay for the detection of the emerging coronavirus SARS-CoV-2 using a high throughput system

“…The system used in this study fully automates nucleic acid extraction, purification, amplification and detection. We, among others, have previously demonstrated that laboratory-developed tests can be adapted for fully automated PCR platforms such as the cobas 6800 system [6,13]. After brief preparation, clinical samples can be loaded directly into the device; required hands-on time and manual steps are reduced by up to 60% (manual steps reduced from 33 to 14, hands-on time reduced from 74 min to 14 min) compared with Dark blue curves: specific SARS-CoV-2 signals of IVT-RNA at 100,000 copies/mL (1), 10,000 copies/ml (2), 1,000 copies/ml (3) and 100 copies/ml (4).…”

“…IVT-RNA obtained by EVAg. conventional workflows which usually involve automated extraction and PCR performed as separate procedures [13]. The inclusion of a full-process control for each reaction further facilitates the handling of results, allowing interpretation by personnel not familiar with RT-PCR diagnostics.…”

Pushing beyond specifications: Evaluation of linearity and clinical performance of the cobas 6800/8800 SARS-CoV-2 RT-PCR assay for reliable quantification in blood and other materials outside recommendations

“…First studies providing clinical evaluation have demonstrated good agreement with established reference assays [ 12 , 15 ]. The benefits of automation for molecular diagnostics have been discussed extensively in previous studies [ 11 , 16 ]. While various sample-to-result systems were already used for SARS-CoV-2 diagnostics utilizing open modes during the early weeks of the pandemic [ 10 , 17 , 18 ], commercial test kits have since been released under emergency use authorization (EUA) for most automated PCR-platforms [ 12 , 19 , 20 ].…”

“…The cobas6800 system is a fully automated sample-to-result high-throughput RT-PCR platform, capable of performing 384 tests in an 8 hour shift and requiring minimal hands-on time [ 11 ]. Until recently, laboratory developed tests (LDT) using the open mode (utility channel) had to be employed to use the system for SARS-CoV-2 testing [ 10 ].…”

Peptide Nucleic Acid (PNA)-Enhanced Specificity of a Dual-Target Real-Time Quantitative Polymerase Chain Reaction (RT-qPCR) Assay for the Detection and Differentiation of SARS-CoV-2 from Related Viruses

“…The emergence of the novel SARS-CoV-2 with its efficient human-to-human transmission and ability to cause asymptomatic infections [ 5 , 14 , 16 , 17 , 18 ] has highlighted the need to develop a highly specific and sensitive viral detection method to mitigate the potential contact with infected individuals and prevent the further spread of infection. At present, real-time quantitative polymerase chain reaction (RT-qPCR) is widely used to detect SARS-CoV-2 and plays a critical role in viral containment [ 13 , 19 , 20 , 21 ]. Other nucleic acid amplification methods such as reverse transcription loop-mediated isothermal amplification (RT-LAMP) [ 22 , 23 ] have been used as supportive molecular diagnostic methods.…”