Correlation of SARS-CoV-2 Nucleocapsid Antigen and RNA Concentrations in Nasopharyngeal Samples from Children and Adults Using an Ultrasensitive and Quantitative Antigen Assay
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Abstract
Diagnosis of COVID-19 by PCR offers high sensitivity, but the utility of detecting samples with high cycle threshold ( C T ) values remains controversial. Currently available rapid diagnostic tests (RDTs) for SARS-CoV-2 nucleocapsid antigens (Ag) have sensitivity well below PCR.
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SciScore for 10.1101/2020.11.10.20227371: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: This study was performed under approval from the Boston Children’s Hospital IRB with waiver of informed consent; only fully deidentified data were analyzed. 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:Our study has some limitations. First, this was a retrospective study using …
SciScore for 10.1101/2020.11.10.20227371: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: This study was performed under approval from the Boston Children’s Hospital IRB with waiver of informed consent; only fully deidentified data were analyzed. 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:Our study has some limitations. First, this was a retrospective study using frozen samples previously tested by PCR; future studies will test fresh samples prospectively, but the tight correlation between Ag and Ct values suggests that freezing was not a significant issue. We note that the sensitivity in the pediatric sample set was lower than in the adult sample set, but ascribe this to a higher Ct value distribution in the pediatric samples and, possibly, to a higher proportion extracted in saline relative to UTM. For some of the patients who provided samples, the time between onset of symptoms and testing was long, but this reflects real life clinical test use. The majority of the patients whose samples were included in our study were symptomatic, so the results will need confirmation in asymptomatic individuals [31]. In summary, we have shown that an ultrasensitive Ag assay is able to detect Ag throughout the range of viral load in clinical samples in adults and children infected with SARS-CoV-2. The assay has high sensitivity and specificity, offering an alternative to PCR and a clear analytical advantage over Ag RDT. Future prospective studies evaluating test performance in programmatic screening of symptomatic and asymptomatic individuals will demonstrate whether the S-PLEX Ag assay can offer a diagnostic alternative that is inexpensive, rapid, and high-throughput, thus contributing a novel diagnostic tool for management of this pandemic.
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.
- Thank you for including a protocol registration statement.
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