Comparative evaluation of SARS-CoV-2 IgG assays in India
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SciScore for 10.1101/2020.08.12.20173856: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: All enrollments were made after an informed consent process and the study protocol was approved by the Institute Ethics Committees of the participating research institutes and hospitals.
IRB: All enrollments were made after an informed consent process and the study protocol was approved by the Institute Ethics Committees of the participating research institutes and hospitals.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable The COVID-19 negative standard panel was built from sera samples collected in the pre-pandemic period (184 from pregnant women enrolled in a pregnancy cohort) to ensure a clean set … SciScore for 10.1101/2020.08.12.20173856: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: All enrollments were made after an informed consent process and the study protocol was approved by the Institute Ethics Committees of the participating research institutes and hospitals.
IRB: All enrollments were made after an informed consent process and the study protocol was approved by the Institute Ethics Committees of the participating research institutes and hospitals.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable The COVID-19 negative standard panel was built from sera samples collected in the pre-pandemic period (184 from pregnant women enrolled in a pregnancy cohort) to ensure a clean set of negative samples[4-6]. Table 2: Resources
Software and Algorithms Sentences Resources All analyses were done using the STATA-SE-15 software (Texas, USA) and the Kappa coefficient and related indices were estimated using Cohenkap package for STATA [10]. Cohenkapsuggested: NoneSTATAsuggested: (Stata, RRID:SCR_012763)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:To overcome the limitation of an imperfect positive reference standard and to improve inferences, the relative performance of these tests was evaluated by head-to-head comparison. RBD ELISA and DiaSorin CLIA were able to identify more positive IgG sera/plasma than Zydus Kavach. However, RBD ELISA is an in-house ELISA developed using similar sample collections. While the sample panel used for evaluation was independent of that used in the development of the RBD ELISA, its true test would be when it is evaluated externally. Highly sensitive serological assays can assess immune response to SARS-CoV-2 and are needed to determine the extent of spread of the virus, which in turn is critical for assessing case fatality rates and herd immunity. Serological assays also help in assessing development of herd immunity to devise community management strategies that are of crucial importance at this time, and will continue to be relevant in the coming years. Other uses of serological assays can be to assess exposure in high-risk populations such as healthcare workers and assess vaccination strategy at state or national level. Cross-reactivity with SARS-CoV and seasonal coronaviruses in different population and timing of IgM and IgG responses need to continue to be considered. Till date, studies on comparative performance serological assays for SARS-CoV-2 show a range of sensitivity of 84-98% and specificity of 96-99% [12-29]. Two of the three IgG assays in this study used the Spike protein...
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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