Communication: Evaluation of the Humasis COVID-19 Antigen Rapid Diagnostic Test for the Diagnosis of SARS-CoV-2 Infection

被引：0

作者：

Yoon, Eungjun ^{[1
]}

Kang, Minhee ^{[2
,3
]}

Shim, Hyang Jin ^{[4
]}

Choi, Suk-Jin ^{[1
]}

Jang, Mi-Ae ^{[1
]}

Jang, Ja-Hyun ^{[1
]}

Kim, Tae Yeul ^{[1
]}

Huh, Hee Jae ^{[1
,3
]}

Lee, Nam Yong ^{[1
]}

机构：

[1] Sungkyunkwan Univ, Sch Med, Samsung Med Ctr, Dept Lab Med & Genet, 81 Irwon Ro, Seoul 06351, South Korea

[2] Smart Healthcare Res Inst, Biomed Engn Res Ctr, Samsung Med Ctr, Seoul, South Korea

[3] Sungkyunkwan Univ, Dept Med Device Management & Res, Samsung Adv Inst Hlth Sci & Technol, Seoul, South Korea

[4] Samsung Biomed Res Inst, Samsung Med Ctr, Ctr Clin Med, Seoul, South Korea

来源：

ANNALS OF CLINICAL AND LABORATORY SCIENCE | 2024年 / 54卷 / 01期

关键词：

COVID-19; SARS-CoV-2; antigen rapid diagnostic test; Humasis; PBCheck;

D O I：

暂无

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

摘要：

Objective . We assessed the performance of the Humasis COVID-19 AgHS Test (Humasis, Korea), a novel antigen rapid diagnostic test (Ag-RDT) based on lateral fl ow immunoassay. Methods . 85 SARS-CoV-2-positive and 155 SARS-CoV-2-negative nasopharyngeal swab specimens con fi rmed by rRTPCR were tested using the Humasis and PBCheck Ag-RDTs. Th e analytical speci fi city of the Humasis AgRDT was evaluated using 27 strains of human respiratory pathogens. Results . Th e overall sensitivity and speci fi city were 72.9% and 99.4% for the Humasis Ag-RDT and 64.7% and 100% for the PBCheck AgRDT, respectively. Th e sensitivity for specimens with Ct <= 25 was 100% for both Ag-RDTs. Th e Humasis Ag-RDT showed no cross -reactivity with other respiratory pathogens. Conclusion . Our data suggests that the Humasis Ag-RDT can be a useful diagnostic tool for the detection of SARS-CoV-2 infection.

引用

页码：126 / 130

页数：5

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