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Communication: Evaluation of the Humasis COVID-19 Antigen Rapid Diagnostic Test for the Diagnosis of SARS-CoV-2 Infection.
Yoon, Eungjun; Kang, Minhee; Shim, Hyang Jin; Choi, Suk-Jin; Jang, Mi-Ae; Jang, Ja-Hyun; Kim, Tae Yeul; Huh, Hee Jae; Lee, Nam Yong.
Afiliación
  • Yoon E; Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • Kang M; Biomedical Engineering Research Center, Smart Healthcare Research Institute, Samsung Medical Center, Seoul, Korea.
  • Shim HJ; Department of Medical Device Management and Research, Samsung Advanced Institute for Health Sciences and Technology, Sungkyunkwan University, Seoul, Korea.
  • Choi SJ; Center for Clinical Medicine, Samsung Biomedical Research Institute, Samsung Medical Center, Seoul, Korea.
  • Jang MA; Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • Jang JH; Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • Kim TY; Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • Huh HJ; Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea voltaire0925@gmail.com.
  • Lee NY; Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea pmhhj77@gmail.com.
Ann Clin Lab Sci ; 54(1): 126-130, 2024 Jan.
Article en En | MEDLINE | ID: mdl-38514052
ABSTRACT

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 flow immunoassay.

METHODS:

85 SARS-CoV-2-positive and 155 SARS-CoV-2-negative nasopharyngeal swab specimens confirmed by rRT-PCR were tested using the Humasis and PBCheck Ag-RDTs. The analytical specificity of the Humasis Ag-RDT was evaluated using 27 strains of human respiratory pathogens.

RESULTS:

The overall sensitivity and specificity were 72.9% and 99.4% for the Humasis Ag-RDT and 64.7% and 100% for the PBCheck Ag-RDT, respectively. The sensitivity for specimens with Ct≤25 was 100% for both Ag-RDTs. The 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.
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: COVID-19 Límite: Humans Idioma: En Revista: Ann Clin Lab Sci Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Buscar en Google
Añadir a Mi BVS
Imprimir
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PubMed Links

Colección: 01-internacional Base de datos: MEDLINE Asunto principal: COVID-19 Límite: Humans Idioma: En Revista: Ann Clin Lab Sci Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos