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Reviews of "SARS-CoV-2 serological tests can generate false positive results for samples from patients with chronic inflammatory diseases"

Reviewers: Sarah Wheeler (University of Pittsburgh) | 📒📒📒◻️◻️ • Marcelo Fruehwirth, Robson Michael Delai (Itaiguapy Foundation) | 📗📗📗📗◻️ • 📗📗📗📗◻️ • Kouji H. Harada, Zhaoqing Lyu, Mariko Harada Sassa (Kyoto University) | 📗📗📗📗◻️

Published onJan 15, 2021
Reviews of "SARS-CoV-2 serological tests can generate false positive results for samples from patients with chronic inflammatory diseases"
key-enterThis Pub is a Review of
SARS-CoV-2 serological tests can generate false positive results for samples from patients with chronic inflammatory diseases
Description

Abstract Objectives Patients with chronic inflammatory diseases are often treated with immunosuppressants and therefore are of particular concern during the SARS-CoV-2 pandemic. Serological tests will improve our understanding of the infection and immunity in this population, unless the tests give false positive results. The aim of this study was to evaluate the specificity of SARS-Cov-2 serological assays with samples from patients with chronic inflammatory diseases collected before April 2019, thus defined as negative.Methods Samples from patients with multiple sclerosis (MS, n=10), rheumatoid arthritis (RA, n=47) with or without rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibodies (anti-CCP2) and RF +/- systemic lupus erythematosus (SLE, n=10), were tested with 17 commercially available lateral flow assays (LFA), two ELISA kits and one in-house developed multiplex bead-based assay.Results Six LFA and the in-house IgG assay gave the correct negative results for all samples. However, the majority of assays (n=13), gave false positive signal with samples from patients with RA and SLE. This was most notable in RF positive RA samples. MS samples did not give any false positive in any of the assays.Conclusion The majority of the verified serological assays were sensitive to interfering antibodies in samples from patients with chronic inflammatory diseases and therefore may have poor specificity in this context. For these patients, the risk of false positivity should be considered when interpreting results of the SARS-CoV-2 serological assays.

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Summary of Reviews: This potentially reliable study suggests certain serologic assays for viral antibodies may have increased false-positives in patients with chronic inflammatory diseases. Additional independent verification in well-defined cohorts is needed.

Reviewer 1 (Sarah Wheeler) | 📒📒📒 ◻️◻️

Reviewer 2 (Marcelo Fruehwirth, Robson Michael Delai) | 📗📗📗📗◻️

Reviewer 3 | 📗📗📗📗◻️

Reviewer 4 (Kouji H. Harada, Zhaoqing Lyu, Mariko Harada Sassa) | 📗📗📗📗◻️

RR:C19 Strength of Evidence Scale Key

📕 ◻️◻️◻️◻️ = Misleading

📙📙 ◻️◻️◻️ = Not Informative

📒📒📒 ◻️◻️ = Potentially Informative

📗📗📗📗◻️ = Reliable

📘📘📘📘📘 = Strong

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