Clinical evaluation of a SARS-CoV-2 RT-PCR assay on a fully automated system for rapid on-demand testing in the hospital setting
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SciScore for 10.1101/2020.04.07.20056234: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Similar issues were reported early on in China, where testing could not be performed for all suspected cases due to limitations in capacity (13). In a recent study we demonstrated that a previously published TaqMan based …
SciScore for 10.1101/2020.04.07.20056234: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Similar issues were reported early on in China, where testing could not be performed for all suspected cases due to limitations in capacity (13). In a recent study we demonstrated that a previously published TaqMan based SARS-CoV-2 RT-PCR assay, endorsed by ECDC and WHO, can be adapted to run on an automated batch-based high-throughput system, the cobas6800 (11). Utilizing this assay, more than 10,000 samples were tested for SARS-CoV-2 during the month of March 2020 while maintaining all other routine diagnostics in our laboratory, proving the potency of rapid automation to cope with massive surges in demand. However, taking into consideration sample registration, pretreatment, preparation of batches, and generating reports, it usually takes more than 5 hours before results can be made available to clinicians (14). Consequently, alternative workflows are required to enable fast-tracking of high-priority samples. The NeuMoDx 96 system is a fully automated RT-PCR platform, performing extraction, amplification and signal detection without requiring any human interaction. it provides random-access capabilities and turn-around times of 80 minutes for RNA targets. In this study we have adapted the SARS-CoV-2 RT-PCR assay by Corman et al. (6) for use on the NeuMoDx 96 automated system. Analytical and clinical performance was comparable to the cobas6800-based reference assay (11), showing an LoD of approximately 100 copies/ml and positive and negative agreement of 100% and 99.2% resp...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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