Clinical evaluation of an automated, rapid mariPOC antigen test in screening of symptomatics and asymptomatics for SARS‐CoV‐2 infection
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Abstract
A novel automated mariPOC SARS‐CoV‐2 antigen test was evaluated in a Health Care Center Laboratory among symptomatic and asymptomatic individuals seeking SARS‐CoV‐2 testing. According to the national testing strategy, reverse transcription polymerase chain reaction (RT‐PCR) was used as a reference method. A total of 962 subjects were included in this study, 4.8% (46/962) of their samples were SARS‐CoV‐2 RT‐PCR‐positive, and 87% (40/46) of these were from symptomatics. Among the symptomatics, the overall sensitivity of the mariPOC SARS‐CoV‐2 test was 82.5% (33/40), though the sensitivity increased to 97.1% (33/34) in samples with a C t < 30. The mariPOC SARS‐CoV‐2 test detected two of six PCR‐positive samples among the asymptomatics, four cases that remained antigen test negative had C t values between 28 and 36. The specificity of the mariPOC SARS‐CoV‐2 test was 100% (916/916). The evaluation showed that the mariPOC SARS‐CoV‐2 rapid antigen test is very sensitive and specific for the detection of individuals who most probably are contagious.
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SciScore for 10.1101/2022.04.22.22273686: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Statistical analysis: The mariPOC® SARS-CoV-2 rapid antigen test sensitivity, including 95% confidence intervals (CI), was determined using MedCalc Software [21]. MedCalcsuggested: (MedCalc, RRID:SCR_015044)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: An explicit section about the limitations of the techniques employed in this study was not found. We …SciScore for 10.1101/2022.04.22.22273686: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Statistical analysis: The mariPOC® SARS-CoV-2 rapid antigen test sensitivity, including 95% confidence intervals (CI), was determined using MedCalc Software [21]. MedCalcsuggested: (MedCalc, RRID:SCR_015044)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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.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.
Results from scite Reference Check: We found no unreliable references.
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