Analytical and clinical comparison of Viasure (CerTest Biotec) and 2019-nCoV CDC (IDT) RT-qPCR kits for SARS-CoV2 diagnosis.
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SciScore for 10.1101/2020.06.29.20131367: (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:Although the main limitation of our study is the sample size (104 specimens), our results support that Viasure SARS-CoV-2 RT-qPCR kit had a great performance in terms on sensitivity and specificity compared to 2019-nCoV CDC …
SciScore for 10.1101/2020.06.29.20131367: (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:Although the main limitation of our study is the sample size (104 specimens), our results support that Viasure SARS-CoV-2 RT-qPCR kit had a great performance in terms on sensitivity and specificity compared to 2019-nCoV CDC EUA, with values up to 97.5 and 100%, respectively. According to Viasure SARS-CoV-2 kit manufacturer’s manual, when a sample only yields amplification for N probe but Orf1ab is negative, the result should be SARS-CoV-2 negative and a possible infection by other coronavirus must be considered (6). However, on our hands, all the Viasure SARS-CoV-2 N positive/Orf1ab negative were confirmed as SARS-CoV-2 positive by CDC protocol (1,2), and thus we referred to this samples as presumptive positive. Moreover, Viasure SARS-CoV-2 kit manufacturer’s manual set a limit of detection of 10 viral copies/uL for its product. With the only exception of sample 448 (viral load of 4.300 copies/uL), all the Viasure SARS-CoV-2 kit presumptive positive and negative samples yield viral loads below 10 copies/uL, confirming the expected limit of detection of the kit. The lack of any probe for RNA extraction quality control like RNaseP is a limitation to be considered when using Viasure SARS-CoV-2 kit. Although in our experience, samples failing to yield any RNA after extraction are below 1%, an extra RT-qPCR reaction for a RNA extraction quality control probe would be recommended for laboratories starting SARS-CoV-2 diagnosis. On the other hand, Viasure SARS-CoV-2 kit is provided o...
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.
- No funding statement was detected.
- No protocol registration statement was detected.
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