Evaluation of Serological SARS-CoV-2 Lateral Flow Assays for Rapid Point-of-Care Testing
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Abstract
Rapid point-of-care tests (POCTs) for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific antibodies vary in performance. A critical need exists to perform head-to-head comparisons of these assays.
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SciScore for 10.1101/2020.07.31.20166041: (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:The limitations to our study included the lack of early infection samples from non-hospitalized patients. Additionally, specificity analysis needs to be performed on hundreds if not thousands of samples to determine factors …
SciScore for 10.1101/2020.07.31.20166041: (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:The limitations to our study included the lack of early infection samples from non-hospitalized patients. Additionally, specificity analysis needs to be performed on hundreds if not thousands of samples to determine factors associated with misclassification and to give better precision of the point estimate. Furthermore, the samples evaluated were from the Baltimore-Washington region of the United States and may not reflect performance of these assays in different parts of the world. Future studies should include samples from different regions of the world, where the underlying host genetics and common viral infections vary to determine the robustness of POCT performance. Additionally, studies using testing algorithms applying different assays in combination, which test different target antigens of the virus should be evaluated, as such methodology has proven highly effective for testing other infections such as HIV. The current “gold standard” test for the diagnosis of COVID-19 is RT-PCR. RT-PCR has disadvantages, including cost, lengthy turn-around-times, and preanalytical variability. Additionally, the sensitivity of this method declines past the first week after onset of symptoms.[33,36] POCTs could be used in parallel with RT-PCR testing as a supplemental diagnostic tool in patients suspected to have infection who are RT-PCR negative who are more than 14 days from onset of symptoms. Serologic assays also facilitate population level monitoring of COVID-19 exposure. Of not...
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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