Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens
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Abstract
Several point-of-care (POC) molecular tests have received emergency use authorization (EUA) from the Food and Drug Administration (FDA) for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The test performance characteristics of the Accula (Mesa Biotech) SARS-CoV-2 POC test need to be evaluated to inform its optimal use. The aim of this study was to assess the test performance of the Accula SARS-CoV-2 test. The performance of the Accula test was assessed by comparing results of 100 nasopharyngeal swab samples previously characterized by the Stanford Health Care EUA laboratory-developed test (SHC-LDT), targeting the envelope ( E ) gene.
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SciScore for 10.1101/2020.05.12.092379: (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:Education of health care professionals on the limitations of SARS-CoV-2 POCT should also be implemented to ensure optimal interpretation and management of negative results. Our study has several limitations. First, NP swabs were …
SciScore for 10.1101/2020.05.12.092379: (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:Education of health care professionals on the limitations of SARS-CoV-2 POCT should also be implemented to ensure optimal interpretation and management of negative results. Our study has several limitations. First, NP swabs were placed in VTM or saline at the patient bedside before loading the Accula test cassette, which may have decreased sensitivity by diluting the viral inoculum. Although this is discordant with the best recommended practice by the manufacturer, it is in line with the practice at multiple institutions with clinical laboratories that have assessed SARS-CoV-2 POCT due to biosafety concerns from risk of aerosolization (8–10, 18, 19). Second, it is possible that the use of saline instead of VTM led to poorer performance of the Accula. However, aliquots from the same sample were used for parallel testing with the EUA method, which minimizes sources of variation, and represents a pragmatic comparison given widespread VTM shortages. Finally, the lateral-flow read-out of the Accula test is generally easy to interpret; however, faint lines may be more challenging to interpret and lead to result discrepancies. In summary, this study demonstrated that the Accula POCT lacks sensitivity compared to a reference EUA SARS-CoV-2 LDT. Careful consideration should be given to balance the potential advantages of rapid POCT to lower diagnostic accuracy. Individuals with moderate to high pre-test probability who initially test negative on the Accula test should undergo confirma...
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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