Comparison of Four Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2 in Nasopharyngeal Specimens
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Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the novel human coronavirus that causes coronavirus disease 2019 (COVID-19), was first discovered in December 2019 as the cause of an outbreak of pneumonia in the city of Wuhan, Hubei province, China. The clinical presentation of COVID-19 is fairly nonspecific, and symptoms overlap those of other seasonal respiratory infections concurrently circulating in the population. Furthermore, it is estimated that up to 80% of infected individuals experience mild symptoms or are asymptomatic, confounding efforts to reliably diagnose COVID-19 empirically.
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SciScore for 10.1101/2020.04.17.20069864: (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:One important limitation to mention is that sensitivity using Probit analysis could not be calculated for GenMark since Ct values are not available as part of the ePlex system result interpretation. The clinical correlation was …
SciScore for 10.1101/2020.04.17.20069864: (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:One important limitation to mention is that sensitivity using Probit analysis could not be calculated for GenMark since Ct values are not available as part of the ePlex system result interpretation. The clinical correlation was also consistent with LoD findings, where both the DiaSorin Molecular and Hologic assays had 100% sensitivity and detected all specimens deemed positive by the consensus standard (interpretation of three of four evaluated assays as “gold standard”), whereas GenMark missed two positive specimens (which were subsequently detected by GenMark upon repeat). DiaSorin Molecular and GenMark showed 100% specificity, while Hologic and the CDC assay initially had two and one discordant results, respectively. Repeat testing of these three specimens showed that for Hologic, NW-83 repeated as positive a second time and was therefore potentially a false positive and NW-85 was negative upon repeat, meaning this result could have previously been a false positive as well. The continued discordant result from NW-83 could potentially be attributed to specificity issues, since the assay did not prove to be the most sensitive assay among those used in the study, with DiaSorin Molecular showing a slightly lower LoD. Repeat testing of NW-104 on the modified CDC assay was negative. Considering the LoD of the modified CDC assay, coupled with the fact that both DiaSorin Molecular and Hologic resulted NW-104 as negative, this was likely a false-positive result. While all 4 assays ...
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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