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

Eungjun Yoon; Minhee Kang; Hyang Jin Shim; Suk Jin Choi; Mi Ae Jang; Ja Hyun Jang; Tae Yeul Kim; Hee Jae Huh; Nam Yong Lee

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

Eungjun Yoon, Minhee Kang, Hyang Jin Shim, Suk Jin Choi, Mi Ae Jang, Ja Hyun Jang, Tae Yeul Kim, Hee Jae Huh, Nam Yong Lee

Department of Laboratory Medicine and Genetics

Sungkyunkwan University

Research output: Contribution to journal › Article › peer-review

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 rRTPCR 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.

Original language	English
Pages (from-to)	126-130
Number of pages	5
Journal	Annals of Clinical and Laboratory Science
Volume	54
Issue number	1
State	Published - Jan 2024

Keywords

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

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Cite this

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

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 rRTPCR 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.",

keywords = "antigen rapid diagnostic test, COVID-19, Humasis, PBCheck, SARS-CoV-2",

author = "Eungjun Yoon and Minhee Kang and Shim, \{Hyang Jin\} and Choi, \{Suk Jin\} and Jang, \{Mi Ae\} and Jang, \{Ja Hyun\} and Kim, \{Tae Yeul\} and Huh, \{Hee Jae\} and Lee, \{Nam Yong\}",

note = "Publisher Copyright: {\textcopyright} 2024 by the Association of Clinical Scientists, Inc.",

year = "2024",

month = jan,

language = "English",

volume = "54",

pages = "126--130",

journal = "Annals of Clinical and Laboratory Science",

issn = "0091-7370",

publisher = "Association of Clinical Scientists",

number = "1",

}

TY - JOUR

T1 - Communication

T2 - Evaluation of the Humasis COVID-19 Antigen Rapid Diagnostic Test for the Diagnosis of SARS-CoV-2 Infection

AU - Yoon, Eungjun

AU - Kang, Minhee

AU - Shim, Hyang Jin

AU - Choi, Suk Jin

AU - Jang, Mi Ae

AU - Jang, Ja Hyun

AU - Kim, Tae Yeul

AU - Huh, Hee Jae

AU - Lee, Nam Yong

PY - 2024/1

Y1 - 2024/1

N2 - 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 rRTPCR 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.

AB - 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 rRTPCR 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.

KW - antigen rapid diagnostic test

KW - COVID-19

KW - Humasis

KW - PBCheck

KW - SARS-CoV-2

UR - https://www.scopus.com/pages/publications/85188637168

M3 - Article

C2 - 38514052

AN - SCOPUS:85188637168

SN - 0091-7370

VL - 54

SP - 126

EP - 130

JO - Annals of Clinical and Laboratory Science

JF - Annals of Clinical and Laboratory Science

IS - 1

ER -

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

Abstract

Keywords

UN SDGs

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