The Evaluation of a Rapid Microfluidic Immunofluorescence Antigen Test in Detecting the Infectiousness of COVID-19 Patients

Overview

Journal BMC Infect Dis

Publisher Biomed Central

Specialty Infectious Diseases

Date 2023 Nov 23

PMID 37996783

Authors

Kenji Ota

Hina Kodama

Yasuhide Kawamoto

Daisuke Sasaki

Fujiko Mitsumoto-Kaseida

Kei Sakamoto

Kosuke Kosai

Hiroo Hasegawa

Takahiro Takazono

Koichi Izumikawa

Hiroshi Mukae

Mya Myat Ngwe Tun

Kouichi Morita

Katsunori Yanagihara

Affiliations

Soon will be listed here.

Abstract

Background: A test-based strategy against coronavirus disease 2019 (COVID-19) is one of the measures to assess the need for isolation and prevention of infection. However, testing with high sensitivity methods, such as quantitative RT-PCR, leads to unnecessary isolation, whereas the lateral flow antigen test shows low sensitivity and false negative results. The purpose of this study was to evaluate the performance of the LumiraDx SARS-CoV-2 Ag test (Lumira Ag), a rapid microfluidic immunofluorescence method, in assessing infectivity.

Methods: This study was performed from March 2022 to July 2022. A pair of nasopharyngeal swab samples were obtained from each patient with mild COVID-19. One swab was used for Lumira Ag testing, and the other for quantitative RT-PCR testing and virus culture.

Results: A total of 84 patients were included in the study. Among them, PCR, Lumira Ag test, and virus culture indicated positivity for 82, 66, and 24 patients, respectively. When comparing the Lumira Ag test to virus culture, its sensitivity was 100.0% (24/24), specificity, 30.0% (18/60); positive predictive value, 36.3% (24/66); and negative predictive value (NPV), 100.0% (18/18). The positive sample for virus culture was observed until the ninth day from the onset of symptoms, while the Lumira Ag test was observed until day 11.

Conclusions: The Lumira Ag test showed high sensitivity and NPV (100% each) compared to virus culture. A test-based strategy using the Lumira Ag test can effectively exclude COVID-19 infectiousness.

Citing Articles

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