Journal Article

Comparison of the clinical performance and usefulness of five SARS-CoV-2 antibody tests

Akazawa, Chihiro, Takahashi, Sho, Hinata, Masanobu, Igawa, Gene, Idei, Mayumi, Saito, Kaori, Yamatani, Kotoko, Kadota, Katsuhiko, Ai, Tomohiko, Kurosawa, Taro, Wakita, Mitsuru, Misawa, Shigeki, Takahashi, Kazuhisa, Tabe, Yoko, Ishikawa, Suzuka, Yamamoto, Takamasa, Miida, Takashi, Horiuchi, Yuki, Saito, Takumi, Naito, Toshio

2021

Overview

We examined the usefulness of five COVID-19 antibody detection tests using 114 serum samples at various time points from 34 Japanese COVID-19 patients. We examined Elecsys Anti-SARS-CoV-2 from Roche, and four immunochromatography tests from Hangzhou Laihe Biotech, Artron Laboratories, Chil, and Nadal. In the first week after onset, Elecsys had 40% positivity in Group S (severe cases) but was negative in Group M (mild-moderate cases). The immunochromatography kits showed 40–60% and 0–8% positivity in Groups S and M, respectively. In the second week, Elecsys showed 75% and 50% positivity, and the immunochromatography tests showed 5–80% and 50–75% positivity in Groups S and M, respectively. After the third week, Elecsys showed 100% positivity in both groups. The immunochromatography kits showed 100% positivity in Group S. In Group M, positivity decreased to 50% for Chil and 75–89% for Artron and Lyher. Elecsys and immunochromatography kits had 91–100% specificity. Elecsys had comparable chronological change of cut-off index values in the two groups from the second week to the sixth week. The current SARS-CoV-2 antibody detection tests do not provide meaningful interpretation of severity and infection status. Its use might be limited to short-term epidemiological studies.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Adult / Aged / Antibodies / Antibodies, Viral - immunology / Antigens / Biology and life sciences / Coronaviridae / Coronaviruses / COVID-19 / COVID-19 - diagnosis / COVID-19 - immunology / COVID-19 - virology / COVID-19 Serological Testing - methods / Data analysis / Disease / Editing / Electrochemiluminescence / Emergency medical services / FDA approval / Female / Gastroenterology / Glycoproteins / Graduate schools / Graduate studies / Hematology / Hospitals / Humans / Immune system / Immunoassay / Male / Medical equipment / Medical innovations / Medical laboratories / Medical technology / Medicine / Medicine and Health Sciences / Membrane proteins / Middle Aged / Mutation / Nucleocapsids / Nucleotides / Pandemics / Physical Sciences / Polymerase chain reaction / Proteins / Reagent Kits, Diagnostic / Regulatory agencies / Research and Analysis Methods / Research facilities / Respiratory diseases / RNA viruses / SARS-CoV-2 - physiology / Sensitivity and Specificity / Serology / Severe acute respiratory syndrome / Severe acute respiratory syndrome coronavirus 2 / Spike glycoprotein / Structural proteins / Testing / University faculty / Viral diseases / Viral envelope proteins / Viruses