{"id":5818,"date":"2023-03-29T10:52:54","date_gmt":"2023-03-29T08:52:54","guid":{"rendered":"https:\/\/www.jphres.org\/?p=5818"},"modified":"2023-04-02T13:58:16","modified_gmt":"2023-04-02T11:58:16","slug":"validation-of-rapid-antibody-igg-igm-test-kit-for-sars-cov-2-infection-in-qatar","status":"publish","type":"page","link":"https:\/\/www.jphres.us.com\/index.php\/jphres\/article\/view\/2421\/","title":{"rendered":"Validation of rapid antibody (IgG-IgM) test kit for SARS COV-2 infection in Qatar"},"content":{"rendered":"<div class=\"item doi\"><span class=\"value\"><a href=\"https:\/\/doi.org\/10.4081\/jphr.2021.2421\">https:\/\/doi.org\/10.4081\/jphr.2021.2421<\/a><\/span><\/div>\n<ul class=\"item authors\">\n<li><span class=\"name\"><strong>Jesha Mundodan<\/strong><br \/>\n<\/span><span class=\"affiliation\">Public Health Department, Ministry of Public Health, Doha, Qatar.<\/span><\/li>\n<li><span class=\"name\"><strong>Samina Hasnain<\/strong><br \/>\n<\/span><span class=\"affiliation\">Public Health Department, Ministry of Public Health, Doha, Qatar.<\/span><span class=\"orcid\"><br \/>\n<a href=\"https:\/\/orcid.org\/0000-0003-0832-810X\" target=\"_blank\" rel=\"noopener\">https:\/\/orcid.org\/0000-0003-0832-810X<\/a><\/span><\/li>\n<li><span class=\"name\"><strong>Hayat Khogali<\/strong><br \/>\n<\/span><span class=\"affiliation\">Vaccination section \/ National COVID Track \u2018n Trace Team, Public Health Department, Ministry of Public Health, Doha, Qatar.<\/span><\/li>\n<li><span class=\"name\"><strong>Soha Shawqi Al Bayat<\/strong><br \/>\n<\/span><span class=\"affiliation\">Vaccination section \/ National COVID Track \u2018n Trace Team, Public Health Department, Ministry of Public Health, Doha, Qatar.<\/span><\/li>\n<li><span class=\"name\"><strong>Dina Ali<\/strong><br \/>\n<\/span><span class=\"affiliation\">Primary Health Care Corporation, Doha, Qatar.<\/span><\/li>\n<li><span class=\"name\"><strong>Saif Alateeg<\/strong><br \/>\n<\/span><span class=\"affiliation\">Contact tracing, Health Protection and Communicable Diseases Control (HP-CDC), Public Health Department, Ministry of Public Health, Doha, Qatar.<\/span><\/li>\n<li><span class=\"name\"><strong>Hamad Al-Romaihi<\/strong><br \/>\n<\/span><span class=\"affiliation\">Director of Health Protection and Communicable Diseases (HP-CDC), Public Health Department, Ministry of Public Health, Doha, Qatar.<\/span><\/li>\n<li><span class=\"name\"><strong>Mohammed Hamad J. Al-Thani<\/strong><br \/>\n<\/span><span class=\"affiliation\">Public Health Department, Ministry of Public Health, Doha, Qatar.<\/span><\/li>\n<\/ul>\n<h3 class=\"label\">ABSTRACT<\/h3>\n<p><strong>Background<\/strong>: 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.<br \/>\n<strong>Design and\u00a0<\/strong><strong>Methods<\/strong>: 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. \u00a0Rapid 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.<br \/>\n<strong>Results<\/strong>: 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%.<br \/>\n<strong>Conclusion<\/strong>: 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.<\/p>\n<h3 class=\"label\">REFERENCES<\/h3>\n<div class=\"value\">\n<p>Long C, Xu H, Shen Q, et al. Diagnosis of the Coronavirus disease (COVID-19): rRT-PCR or CT? Eur J Radiol 2020;126:108961. DOI:\u00a0<a href=\"https:\/\/doi.org\/10.1016\/j.ejrad.2020.108961\">https:\/\/doi.org\/10.1016\/j.ejrad.2020.108961<\/a><\/p>\n<p>Cassaniti I, Novazzi F, Giardina F, et al. Performance of VivaDiag COVID-19 IgM\/IgG Rapid Test is inadequate for diagnosis of COVID-19 in acute patients referring to emergency room department. J Med Virol 2020;92:1724-7. DOI:\u00a0<a href=\"https:\/\/doi.org\/10.1002\/jmv.25800\">https:\/\/doi.org\/10.1002\/jmv.25800<\/a><\/p>\n<p>Lee HK, Lee BH, Seok SH, et al. Production of specific antibodies against SARS\u2010coronavirus nucleocapsid protein without cross reactivity with human coronaviruses 229E and OC43. J Vet Sci 2010;11:165\u201067. DOI:\u00a0<a href=\"https:\/\/doi.org\/10.4142\/jvs.2010.11.2.165\">https:\/\/doi.org\/10.4142\/jvs.2010.11.2.165<\/a><\/p>\n<p>Wan ZY, Zhang X, Yan XG. IFA in testing specific antibody of SARS coronavirus. South China J Prev Med 2003;29:36\u20107.<\/p>\n<p>Deeks JJ, Dinnes J, Takwoingi Y, et al. Antibody tests for identification of current and past infection with SARS-CoV-2. Cochrane Database Syst Rev 2020;6:CD013652. DOI:\u00a0<a href=\"https:\/\/doi.org\/10.1002\/14651858.CD013652\">https:\/\/doi.org\/10.1002\/14651858.CD013652<\/a><\/p>\n<p>Biomedomics [Internet]. COVID-19 IgM\/IgG Rapid Test. Accessed on: 29 Dec 2020. Available from:\u00a0<a href=\"https:\/\/www.biomedomics.com\/products\/infectious-disease\/covid-19-rt\/\">https:\/\/www.biomedomics.com\/products\/infectious-disease\/covid-19-rt\/<\/a><\/p>\n<p>D\u00f6hla M, Boesecke C, Schulte B, et al. Rapid point-of-care testing for SARS-CoV-2 in a community screening setting shows low sensitivity. Public Health 2020;182:170-2. DOI:\u00a0<a href=\"https:\/\/doi.org\/10.1016\/j.puhe.2020.04.009\">https:\/\/doi.org\/10.1016\/j.puhe.2020.04.009<\/a><\/p>\n<p>Li Z, Yi Y, Luo X, et al. Development and clinical application of a rapid IgM\u2010IgG combined antibody test for SARS\u2010CoV\u20102 infection diagnosis. J Med Virol 2020;92:1518-24. DOI:\u00a0<a href=\"https:\/\/doi.org\/10.1002\/jmv.25727\">https:\/\/doi.org\/10.1002\/jmv.25727<\/a><\/p>\n<p>Shen B, Zheng Y, Zhang X, et al. Clinical evaluation of a rapid colloidal gold immunochromatography assay for SARS-Cov-2 IgM\/IgG. Am J Transl Res 2020;12:1348\u201354.<\/p>\n<p>Prazuck T, Colin M, Giach\u00e8 S, et al. Evaluation of performance of two SARS-CoV-2 Rapid IgM-IgG combined antibody tests on capillary whole blood samples from the fingertip. PLoS One 2020;15:e0237694. DOI:\u00a0<a href=\"https:\/\/doi.org\/10.1371\/journal.pone.0237694\">https:\/\/doi.org\/10.1371\/journal.pone.0237694<\/a><\/p>\n<p>Wan WY, Lim SH, Seng EH. Cross-reaction of sera from COVID-19 patients with SARS-CoV assays. Ann Acad Med Singap 2020;49:523-6. DOI:\u00a0<a href=\"https:\/\/doi.org\/10.47102\/annals-acadmedsg.2020120\">https:\/\/doi.org\/10.47102\/annals-acadmedsg.2020120<\/a><\/p>\n<p>World Health Organization. Advice on the use of point of care immunodiagnostic tests for COVID-19: scientific brief. 8 April 2020. Available from:\u00a0<a href=\"https:\/\/apps.who.int\/iris\/handle\/10665\/331713\">https:\/\/apps.who.int\/iris\/handle\/10665\/331713<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>https:\/\/doi.org\/10.4081\/jphr.2021.2421 Jesha Mundodan Public Health Department, Ministry of Public Health, Doha, Qatar. Samina Hasnain Public Health Department, Ministry of Public Health, Doha, Qatar. https:\/\/orcid.org\/0000-0003-0832-810X Hayat Khogali Vaccination section \/ National COVID Track \u2018n Trace Team, Public Health Department, Ministry of Public Health, Doha, Qatar. Soha Shawqi Al Bayat Vaccination section \/ National COVID Track \u2018n &#8230; <a title=\"Validation of rapid antibody (IgG-IgM) test kit for SARS COV-2 infection in Qatar\" class=\"read-more\" href=\"https:\/\/www.jphres.us.com\/index.php\/jphres\/article\/view\/2421\/\" aria-label=\"More on Validation of rapid antibody (IgG-IgM) test kit for SARS COV-2 infection in Qatar\">Read more<\/a><\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"open","ping_status":"open","template":"","meta":{"footnotes":""},"class_list":["post-5818","page","type-page","status-publish"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Validation of rapid antibody (IgG-IgM) test kit for SARS COV-2 infection in Qatar - Journal of Public Health Research<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.jphres.us.com\/index.php\/jphres\/article\/view\/2421\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Validation of rapid antibody (IgG-IgM) test kit for SARS COV-2 infection in Qatar - Journal of Public Health Research\" \/>\n<meta property=\"og:description\" content=\"https:\/\/doi.org\/10.4081\/jphr.2021.2421 Jesha Mundodan Public Health Department, Ministry of Public Health, Doha, Qatar. 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Samina Hasnain Public Health Department, Ministry of Public Health, Doha, Qatar. https:\/\/orcid.org\/0000-0003-0832-810X Hayat Khogali Vaccination section \/ National COVID Track \u2018n Trace Team, Public Health Department, Ministry of Public Health, Doha, Qatar. Soha Shawqi Al Bayat Vaccination section \/ National COVID Track \u2018n ... 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