Differential Performance of CoronaCHEK SARS-CoV-2 Lateral Flow Antibody Assay by Geographic Origin of Samples

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1. Version published to 10.1128/jcm.00837-21

   Jun 18, 2021
2. 

   ScreenIT

   Apr 24, 2021

   SciScore for 10.1101/2021.04.12.21255284: (What is this?)

   Please note, not all rigor criteria are appropriate for all manuscripts.

   Table 1: Rigor

   Ethics	IRB: Ethics statement: The use of samples from Baltimore was approved by The Johns Hopkins University School of Medicine Institutional Review Board (IRB00247886, IRB00250798, and IRB00091667). Consent: The parent studies were conducted according to the ethical standards of the Helsinki Declaration of the World Medical Association, where all subjects provided written informed consent.
   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 was performed with STATA 14.2 (Statacorp College Station, Texas, USA), and 95% confidence intervals (95% CI) for …

   SciScore for 10.1101/2021.04.12.21255284: (What is this?)

   Please note, not all rigor criteria are appropriate for all manuscripts.

   Table 1: Rigor

   Ethics	IRB: Ethics statement: The use of samples from Baltimore was approved by The Johns Hopkins University School of Medicine Institutional Review Board (IRB00247886, IRB00250798, and IRB00091667). Consent: The parent studies were conducted according to the ethical standards of the Helsinki Declaration of the World Medical Association, where all subjects provided written informed consent.
   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 was performed with STATA 14.2 (Statacorp College Station, Texas, USA), and 95% confidence intervals (95% CI) for sensitivity and specificity were calculated with the Clopper-Pearson exact method.	STATA suggested: (Stata, RRID:SCR_012763) Statacorp suggested: None

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   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).

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   Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:

   There are a number of limitations of our study. First, the samples from Uganda of SARS-CoV-2 infected patients were limited, with only six samples within the first week post first PCR positive test and no serial samples for a given individual. Additionally, these samples from known infected Ugandan individuals had limited symptoms, while the Baltimore samples from known SARS-CoV-2 positive individuals were all hospitalized subjects. The pre-pandemic samples from Baltimore were not matched to those from Uganda based on symptomology, though historically, individuals attending the ED in the United States have a high prevalence of fever and viral infections (17). Samples from the JHH ED do have a high burden of chronic viral infections, as demonstrated by a seroprevalence of 6%, 12% and 50% for HIV, HCV and HSV-2 respectively (18). In summary, the geographical origin of the samples appeared to impact the performance of the CoronaCHEK LFA. IgM reactivity was the main cause for the false positive results. Given that IgM responses generally appear a couple days before IgG, it may be useful not to measure IgM at all in serological studies given the improvement in specificity. Further evaluations of serologic assays are needed to find appropriate tools for sero-surveillance in an African setting.

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   Results from TrialIdentifier: No clinical trial numbers were referenced.

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   Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

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   Results from JetFighter: We did not find any issues relating to colormaps.

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   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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3. 

   Version published to 10.1101/2021.04.12.21255284 on medRxiv

   Apr 19, 2021