Validation of rapid antibody (IgG-IgM) test kit for SARS COV-2 infection in Qatar

Background: In response to the growing coronavirus disease 2019 (COVID-19) pandemic and the shortage of laboratory based molecular testing capacity and reagents, multiple diagnostic test manufacturers have developed rapid and easy to use devices to facilitate testing outside laboratory settings. Th...

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Autores principales:	Jesha Mundodan, Samina Hasnain, Hayat Khogali, Soha Shawqi Al Bayat, Dina Ali, Saif Alateeg, Hamad Al-Romaihi, Mohammed Hamad J. Al-Thani
Formato:	article
Lenguaje:	EN
Publicado:	PAGEPress Publications 2021
Materias:	Rapid test kits validity IgG/IgM antibody detection predictive value Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/cd4741b01f3b4b069c5784bd30b87647
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spelling	oai:doaj.org-article:cd4741b01f3b4b069c5784bd30b876472021-11-16T09:04:08ZValidation of rapid antibody (IgG-IgM) test kit for SARS COV-2 infection in Qatar10.4081/jphr.2021.24212279-90282279-9036https://doaj.org/article/cd4741b01f3b4b069c5784bd30b876472021-11-01T00:00:00Zhttps://www.jphres.org/index.php/jphres/article/view/2421https://doaj.org/toc/2279-9028https://doaj.org/toc/2279-9036 Background: In response to the growing coronavirus disease 2019 (COVID-19) pandemic and the shortage of laboratory based molecular testing capacity and reagents, multiple diagnostic test manufacturers have developed rapid and easy to use devices to facilitate testing outside laboratory settings. These kits are either based on detection of proteins from SARS-CoV-2 virus or detection of antigen or human antibodies generated in response to the infection. However, it is important to understand their performance characteristics and they must be validated in the local population setting. Design and Methods: The objective is to assess the validity of the rapid test for IgG and IgM immunoglobulins compared to the current gold standard reverse transcription polymerase chain reaction (RT-PCR) test. A total of 16951 asymptomatic individuals were tested by the Ministry of Public Health track-and-trace team using both rapid immunodiagnostic test and RT-PCR as part of screening across various random settings with potential risk of community interaction prior to gradual lifting of restrictions in Qatar. Rapid test was considered to be posiive if both IgG and IgM are positive, while only IgG/IgM positive was considered as rapid test negative. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated. Results: The sensitivity of rapid test kit was found to be 0.9%, whereas the specificity was found to be 97.8%. the PPV was found to be 0.3% whereas the NPV was found to be 99.4%. Conclusion: Based on the outcome and results of the study, it appears that the sensitivity and PPV of the rapid antibody test are low. As such, this test is not recommended for use to assist in taking clinic-based decisions or decisions related to quarantine/isolation. Jesha MundodanSamina HasnainHayat KhogaliSoha Shawqi Al BayatDina AliSaif AlateegHamad Al-RomaihiMohammed Hamad J. Al-ThaniPAGEPress PublicationsarticleRapid test kitsvalidityIgG/IgMantibody detectionpredictive valuePublic aspects of medicineRA1-1270ENJournal of Public Health Research (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Rapid test kits validity IgG/IgM antibody detection predictive value Public aspects of medicine RA1-1270
spellingShingle	Rapid test kits validity IgG/IgM antibody detection predictive value Public aspects of medicine RA1-1270 Jesha Mundodan Samina Hasnain Hayat Khogali Soha Shawqi Al Bayat Dina Ali Saif Alateeg Hamad Al-Romaihi Mohammed Hamad J. Al-Thani Validation of rapid antibody (IgG-IgM) test kit for SARS COV-2 infection in Qatar
description	Background: In response to the growing coronavirus disease 2019 (COVID-19) pandemic and the shortage of laboratory based molecular testing capacity and reagents, multiple diagnostic test manufacturers have developed rapid and easy to use devices to facilitate testing outside laboratory settings. These kits are either based on detection of proteins from SARS-CoV-2 virus or detection of antigen or human antibodies generated in response to the infection. However, it is important to understand their performance characteristics and they must be validated in the local population setting. Design and Methods: The objective is to assess the validity of the rapid test for IgG and IgM immunoglobulins compared to the current gold standard reverse transcription polymerase chain reaction (RT-PCR) test. A total of 16951 asymptomatic individuals were tested by the Ministry of Public Health track-and-trace team using both rapid immunodiagnostic test and RT-PCR as part of screening across various random settings with potential risk of community interaction prior to gradual lifting of restrictions in Qatar. Rapid test was considered to be posiive if both IgG and IgM are positive, while only IgG/IgM positive was considered as rapid test negative. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated. Results: The sensitivity of rapid test kit was found to be 0.9%, whereas the specificity was found to be 97.8%. the PPV was found to be 0.3% whereas the NPV was found to be 99.4%. Conclusion: Based on the outcome and results of the study, it appears that the sensitivity and PPV of the rapid antibody test are low. As such, this test is not recommended for use to assist in taking clinic-based decisions or decisions related to quarantine/isolation.
format	article
author	Jesha Mundodan Samina Hasnain Hayat Khogali Soha Shawqi Al Bayat Dina Ali Saif Alateeg Hamad Al-Romaihi Mohammed Hamad J. Al-Thani
author_facet	Jesha Mundodan Samina Hasnain Hayat Khogali Soha Shawqi Al Bayat Dina Ali Saif Alateeg Hamad Al-Romaihi Mohammed Hamad J. Al-Thani
author_sort	Jesha Mundodan
title	Validation of rapid antibody (IgG-IgM) test kit for SARS COV-2 infection in Qatar
title_short	Validation of rapid antibody (IgG-IgM) test kit for SARS COV-2 infection in Qatar
title_full	Validation of rapid antibody (IgG-IgM) test kit for SARS COV-2 infection in Qatar
title_fullStr	Validation of rapid antibody (IgG-IgM) test kit for SARS COV-2 infection in Qatar
title_full_unstemmed	Validation of rapid antibody (IgG-IgM) test kit for SARS COV-2 infection in Qatar
title_sort	validation of rapid antibody (igg-igm) test kit for sars cov-2 infection in qatar
publisher	PAGEPress Publications
publishDate	2021
url	https://doaj.org/article/cd4741b01f3b4b069c5784bd30b87647
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Validation of rapid antibody (IgG-IgM) test kit for SARS COV-2 infection in Qatar

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