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
收藏
页码：126 / 130
页数：5
相关论文
共 50 条
  • [1] Clinitest rapid COVID-19 antigen test for the diagnosis of SARS-CoV-2 infection: A multicenter evaluation study
    Merino-Amador, Paloma
    Gonzalez-Donapetry, Patricia
    Dominguez-Fernandez, Mercedes
    Gonzalez-Romo, Fernando
    Angel Sanchez-Castellano, Miguel
    Seoane-Estevez, Alejandro
    Delgado-Iribarren, Alberto
    Garcia, Julio
    Bou, German
    Cuenca-Estrella, Manuel
    Oteo-Iglesias, Jesus
    JOURNAL OF CLINICAL VIROLOGY, 2021, 143
  • [2] Evaluation of a Rapid Antigen Test for the Diagnosis of SARS-CoV-2 during the COVID-19 Pandemic
    Cheng, Chih-Chien
    Liu, Chia-Chen
    Chiu, Ting-Fang
    Chen, Saint Shiou-Sheng
    INQUIRY-THE JOURNAL OF HEALTH CARE ORGANIZATION PROVISION AND FINANCING, 2022, 59
  • [3] Multicenter evaluation of the Panbio™ COVID-19 rapid antigen-detection test for the diagnosis of SARS-CoV-2 infection
    Merino, Paloma
    Guinea, Jesus
    Munoz-Gallego, Irene
    Gonzalez-Donapetry, Patricia
    Carlos Galan, Juan
    Antona, Nerea
    Cilla, Gustavo
    Hernaez-Crespo, Silvia
    Luis Diaz-de Tuesta, Jose
    Gual-de Torrella, Ana
    Gonzalez-Romo, Fernando
    Escribano, Pilar
    Angel Sanchez-Castellano, Miguel
    Sota-Busselo, Mercedes
    Delgado-Iribarren, Alberto
    Garcia, Julio
    Canton, Rafael
    Munoz, Patricia
    Dolores Folgueira, Maria
    Cuenca-Estrella, Manuel
    Oteo-Iglesias, Jesus
    CLINICAL MICROBIOLOGY AND INFECTION, 2021, 27 (05) : 758 - 761
  • [4] Evaluation of COVID-19 Antigen Fluorescence Immunoassay Test for Rapid Detection of SARS-CoV-2
    Kiro, Vandana Vijayeta
    Gupta, Ankesh
    Singh, Parul
    Sharad, Neha
    Khurana, Surbhi
    Prakash, S.
    Dar, Lalit
    Malhotra, Rajesh
    Wig, Naveet
    Kumar, Arvind
    Trikha, Anjan
    Mathur, Purva
    JOURNAL OF GLOBAL INFECTIOUS DISEASES, 2021, 13 (02) : 91 - 93
  • [5] Performance of a rapid antigen test in the diagnosis of SARS-CoV-2 infection
    Ciotti, Marco
    Maurici, Massimo
    Pieri, Massimo
    Andreoni, Massimo
    Bernardini, Sergio
    JOURNAL OF MEDICAL VIROLOGY, 2021, 93 (05) : 2988 - 2991
  • [6] Clinical evaluation of a new COVID-19 antigen rapid test kit for detection of SARS-CoV-2
    Zhang, Wenjing
    Xu, Xiaoliang
    Qi, Liangshuai
    Liu, Mingkai
    Zhao, Xiaoying
    Kong, Lingshang
    Wang, Yingji
    Chen, Fengling
    Zhang, Chao
    Cheng, Jianghua
    Zheng, Weiwei
    DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE, 2024, 108 (02)
  • [7] Evaluation of the performance of Panbio™ COVID-19 antigen rapid diagnostic test for the detection of SARS-CoV-2 in suspected patients in Ethiopia
    Dessalegn, Dejene
    Tola, Edosa Kifle
    Tamiru, Afework
    Zerfu, Biruk
    SAGE OPEN MEDICINE, 2022, 10
  • [8] SARS-CoV-2 antigen rapid immunoassay for diagnosis of COVID-19 in the emergency department
    Moeckel, Martin
    Corman, Victor M.
    Stegemann, Miriam S.
    Hofmann, Joerg
    Stein, Angela
    Jones, Terry C.
    Gastmeier, Petra
    Seybold, Joachim
    Offermann, Ralf
    Bachmann, Ulrike
    Lindner, Tobias
    Bauer, Wolfgang
    Drosten, Christian
    Rosen, Alexander
    Somasundaram, Rajan
    BIOMARKERS, 2021, 26 (03) : 213 - 220
  • [9] Diagnostic Performance of Rapid Antigen Testing for SARS-CoV-2: The COVid-19 AntiGen (COVAG) study
    Wertenauer, Christoph
    Brenner Michael, Geovana
    Dressel, Alexander
    Pfeifer, Caroline
    Hauser, Ulrike
    Wieland, Eberhard
    Mayer, Christian
    Mutschmann, Caren
    Roskos, Martin
    Wertenauer, Hans-Joerg
    Moissl, Angela P.
    Lorkowski, Stefan
    Maerz, Winfried
    FRONTIERS IN MEDICINE, 2022, 9
  • [10] Clinical evaluation of SARS-CoV-2 antigen-based rapid diagnostic test kit for detection of COVID-19 cases in Bangladesh
    Rahman, Md Mahfuzur
    Hoque, Ananya Ferdous
    Karim, Yeasir
    Kawser, Zannat
    Siddik, Abu Bakar
    Sumiya, Mariya Kibtiya
    Siddika, Ayesha
    Alam, Md Shaheen
    Alam, Ahmed Nawsher
    Alam, Muntasir
    Hossain, Mohammad Enayet
    Banu, Sayera
    Qadri, Firdausi
    Shirin, Tahmina
    Rahman, Mustafizur
    Rahman, Mohammed Ziaur
    HELIYON, 2021, 7 (11)
12345