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Clinical performance of the Panbio assay for the detection of SARS‐CoV‐2 IgM and IgG in COVID‐19 patients
Author(s) -
Haguet Hélène,
Douxfils Jonathan,
Eucher Christine,
Elsen Marc,
Cadrobbi Julie,
TréHardy Marie,
Dogné JeanMichel,
Favresse Julien
Publication year - 2021
Publication title -
journal of medical virology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.782
H-Index - 121
eISSN - 1096-9071
pISSN - 0146-6615
DOI - 10.1002/jmv.26884
Subject(s) - virology , covid-19 , betacoronavirus , sars virus , coronavirus infections , medicine , biology , infectious disease (medical specialty) , outbreak , disease , pathology
Abstract Following the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) pandemic, numerous serological tests have been developed, including rapid diagnostic tests. This study aims at assessing the clinical performance of the Panbio immunoglobulin G (IgG)/IgM coronavirus disease 2019 (COVID‐19) test (Abbott), a rapid lateral flow assay for the qualitative detection of IgG and IgM against SARS‐CoV‐2. One hundred and thirty‐eight samples from 95 COVID‐19 patients with a positive SARS‐CoV‐2 reverse‐transcriptase polymerase chain reaction were analyzed to assess the clinical sensitivity. Seventy‐six pre‐COVID‐19 samples were used to evaluate the clinical specificity. Two independent and blinded raters determined visually the presence or absence of the IgG, IgM, and control lines for each test after 10 and 20 min. The sensitivity obtained from collected samples more than 14 days after the onset of symptoms was 95.2% for IgG. IgM was less frequently detected (highest sensitivity of 20.5%). The specificities obtained were 98.7% and 100% for IgG and IgM, respectively. In addition, the sensitivity of the assay was better when the reading was performed at 20 min than at 10 min, whereas the specificity was unchanged. The Panbio COVID‐19 IgG/IgM rapid test detects IgG with high sensitivity 14 days since symptom onset but presents a low sensitivity for IgM. The specificity was excellent for both IgG and IgM.