CLIA immunoassay as an alternative and accurate method to detect Sars-Cov-2 antigen compared to ELISA

IF 2.1 4区医学 Q3 INFECTIOUS DISEASES

Diagnostic microbiology and infectious disease Pub Date : 2025-04-03 DOI:10.1016/j.diagmicrobio.2025.116828

Keilla Gomes Machado, Vitória Bertelli, Rafaele Frassini, André Felipe Streck, Mariana Roesch Ely

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引用次数: 0

Abstract

Background

COVID-19 has caused moderately severe infections in humans over the past few years, leading to >759 million confirmed cases. This situation highlights an urgent need to develop accurate diagnostic tests to monitor infectious disease and to adopt alternative methods such as CLIA to achieve low detection levels of proteins on diagnostic platforms.

Objectives

Develop in-house immunoassay for ELISA and CLIA to diagnose COVID-19.

Methods

200 nasopharyngeal samples were collected using swabs, placed in tubes with 3 mL of PBS. 1 mL from each sample was used to perform qRT-PCR and was considered positive in samples with CT < 38. The remaining volume was used for in-house sandwich immunoassay ELISA and CLIA.

Results

The results showed that CLIA was able to detect active disease in samples containing N protein concentrations greater than 16 ng/mL, with a sensitivity of 90 % and specificity of 94.5 %, and an area under the ROC curve (AUROC) of 0.943 (95 % CI: 0.909–0.977). ELISA showed an AUROC = 0.709 (95 % CI: 0.639–0.778), with a sensitivity of 54.4 % and specificity of 87.2 %.

Conclusions

The CLIA results in this study outperformed the traditional ELISA and proved to be a suitable platform for monitoring the progression of disease stages, including the diagnosis of active COVID-19 infection.

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来源期刊

Diagnostic microbiology and infectious disease 医学-传染病学

CiteScore

5.30

自引率

3.40%

发文量

149

审稿时长

56 days

期刊介绍： Diagnostic Microbiology and Infectious Disease keeps you informed of the latest developments in clinical microbiology and the diagnosis and treatment of infectious diseases. Packed with rigorously peer-reviewed articles and studies in bacteriology, immunology, immunoserology, infectious diseases, mycology, parasitology, and virology, the journal examines new procedures, unusual cases, controversial issues, and important new literature. Diagnostic Microbiology and Infectious Disease distinguished independent editorial board, consisting of experts from many medical specialties, ensures you extensive and authoritative coverage.