Bernadette Kutima, Eunice Wageci Kagucia, Kennedy Mwai, Makobu Kimani, Antipa Sigilai, Daisy Mugo, Henry Karanja, John N Gitonga, Angela Karani, Donald Akech, Monica Toroitich, Boniface Karia, James Tuju, Abdhalah K Ziraba, Godfrey Bigogo, Caroline Ochieng, Clayton Onyango, Shirley Lidechi, Patrick K Munywoki, Sophie Uyoga, Ifedayo M O Adetifa, Lynette I Ochola Oyier, Philip Bejon, J Anthony G Scott, Ambrose Agweyu, George M Warimwe, James Nyagwange
{"title":"InBios SCoV-2检测TM IgG ELISA与KWTRP ELISA检测肯尼亚人群SARS-CoV-2刺突IgG抗体的比较","authors":"Bernadette Kutima, Eunice Wageci Kagucia, Kennedy Mwai, Makobu Kimani, Antipa Sigilai, Daisy Mugo, Henry Karanja, John N Gitonga, Angela Karani, Donald Akech, Monica Toroitich, Boniface Karia, James Tuju, Abdhalah K Ziraba, Godfrey Bigogo, Caroline Ochieng, Clayton Onyango, Shirley Lidechi, Patrick K Munywoki, Sophie Uyoga, Ifedayo M O Adetifa, Lynette I Ochola Oyier, Philip Bejon, J Anthony G Scott, Ambrose Agweyu, George M Warimwe, James Nyagwange","doi":"10.12688/wellcomeopenres.20240.2","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The InBios SCoV-2 Detect™ IgG ELISA (InBios) and the in-house KWTRP ELISA (KWTRP) have both been used in the estimation of SARS-CoV-2 seroprevalence in Kenya. Whereas the latter has been validated extensively using local samples, the former has not. Such validation is important for informing the comparability of data across the sites and populations where seroprevalence has been reported.</p><p><strong>Methods: </strong>We compared the assays directly using pre-pandemic serum/plasma collected in 2018 from 454 blood donors and 173 malaria cross-sectional survey participants, designated gold standard negatives. As gold standard SARS-CoV-2 positive samples: we assayed serum/plasma from 159 SARS-CoV-2 PCR-positive patients and 166 vaccination-confirmed participants.</p><p><strong>Results: </strong>The overall agreement on correctly classified samples was >0.87 for both assays. The overall specificity was 0.89 (95% CI, 0.87-0.91) for InBios and 0.99 (95% CI, 0.97-0.99) for KWTRP among the gold standard negative samples while the overall sensitivity was 0.97 (95% CI, 0.94-0.98) and 0.93 (95% CI, 0.90- 0.95) for InBios and KWTRP ELISAs respectively, among the gold standard positive samples. In all, the positive predictive value for InBios was 0.83 (95% CI, 0.79-0.87) and 0.98 (95% CI, 0.96-0.99) for KWTRP while the negative predictive value was 0.98 (95% CI, 0.97- 0.99) and 0.97 (95% CI, 0.95-0.98) for InBios and KWTRP respectively.</p><p><strong>Conclusions: </strong>Overall, both assays showed sufficient sensitivity and specificity to estimate SARS-CoV-2 antibodies in different populations in Kenya.</p>","PeriodicalId":23677,"journal":{"name":"Wellcome Open Research","volume":"9 ","pages":"349"},"PeriodicalIF":0.0000,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12368485/pdf/","citationCount":"0","resultStr":"{\"title\":\"Comparative performance of the InBios SCoV-2 Detect <sup>TM</sup> IgG ELISA and the in-house KWTRP ELISA in detecting SARS-CoV-2 spike IgG antibodies in Kenyan populations.\",\"authors\":\"Bernadette Kutima, Eunice Wageci Kagucia, Kennedy Mwai, Makobu Kimani, Antipa Sigilai, Daisy Mugo, Henry Karanja, John N Gitonga, Angela Karani, Donald Akech, Monica Toroitich, Boniface Karia, James Tuju, Abdhalah K Ziraba, Godfrey Bigogo, Caroline Ochieng, Clayton Onyango, Shirley Lidechi, Patrick K Munywoki, Sophie Uyoga, Ifedayo M O Adetifa, Lynette I Ochola Oyier, Philip Bejon, J Anthony G Scott, Ambrose Agweyu, George M Warimwe, James Nyagwange\",\"doi\":\"10.12688/wellcomeopenres.20240.2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The InBios SCoV-2 Detect™ IgG ELISA (InBios) and the in-house KWTRP ELISA (KWTRP) have both been used in the estimation of SARS-CoV-2 seroprevalence in Kenya. Whereas the latter has been validated extensively using local samples, the former has not. Such validation is important for informing the comparability of data across the sites and populations where seroprevalence has been reported.</p><p><strong>Methods: </strong>We compared the assays directly using pre-pandemic serum/plasma collected in 2018 from 454 blood donors and 173 malaria cross-sectional survey participants, designated gold standard negatives. As gold standard SARS-CoV-2 positive samples: we assayed serum/plasma from 159 SARS-CoV-2 PCR-positive patients and 166 vaccination-confirmed participants.</p><p><strong>Results: </strong>The overall agreement on correctly classified samples was >0.87 for both assays. The overall specificity was 0.89 (95% CI, 0.87-0.91) for InBios and 0.99 (95% CI, 0.97-0.99) for KWTRP among the gold standard negative samples while the overall sensitivity was 0.97 (95% CI, 0.94-0.98) and 0.93 (95% CI, 0.90- 0.95) for InBios and KWTRP ELISAs respectively, among the gold standard positive samples. In all, the positive predictive value for InBios was 0.83 (95% CI, 0.79-0.87) and 0.98 (95% CI, 0.96-0.99) for KWTRP while the negative predictive value was 0.98 (95% CI, 0.97- 0.99) and 0.97 (95% CI, 0.95-0.98) for InBios and KWTRP respectively.</p><p><strong>Conclusions: </strong>Overall, both assays showed sufficient sensitivity and specificity to estimate SARS-CoV-2 antibodies in different populations in Kenya.</p>\",\"PeriodicalId\":23677,\"journal\":{\"name\":\"Wellcome Open Research\",\"volume\":\"9 \",\"pages\":\"349\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-07-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12368485/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Wellcome Open Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.12688/wellcomeopenres.20240.2\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Wellcome Open Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.12688/wellcomeopenres.20240.2","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"Medicine","Score":null,"Total":0}
Comparative performance of the InBios SCoV-2 Detect TM IgG ELISA and the in-house KWTRP ELISA in detecting SARS-CoV-2 spike IgG antibodies in Kenyan populations.
Background: The InBios SCoV-2 Detect™ IgG ELISA (InBios) and the in-house KWTRP ELISA (KWTRP) have both been used in the estimation of SARS-CoV-2 seroprevalence in Kenya. Whereas the latter has been validated extensively using local samples, the former has not. Such validation is important for informing the comparability of data across the sites and populations where seroprevalence has been reported.
Methods: We compared the assays directly using pre-pandemic serum/plasma collected in 2018 from 454 blood donors and 173 malaria cross-sectional survey participants, designated gold standard negatives. As gold standard SARS-CoV-2 positive samples: we assayed serum/plasma from 159 SARS-CoV-2 PCR-positive patients and 166 vaccination-confirmed participants.
Results: The overall agreement on correctly classified samples was >0.87 for both assays. The overall specificity was 0.89 (95% CI, 0.87-0.91) for InBios and 0.99 (95% CI, 0.97-0.99) for KWTRP among the gold standard negative samples while the overall sensitivity was 0.97 (95% CI, 0.94-0.98) and 0.93 (95% CI, 0.90- 0.95) for InBios and KWTRP ELISAs respectively, among the gold standard positive samples. In all, the positive predictive value for InBios was 0.83 (95% CI, 0.79-0.87) and 0.98 (95% CI, 0.96-0.99) for KWTRP while the negative predictive value was 0.98 (95% CI, 0.97- 0.99) and 0.97 (95% CI, 0.95-0.98) for InBios and KWTRP respectively.
Conclusions: Overall, both assays showed sufficient sensitivity and specificity to estimate SARS-CoV-2 antibodies in different populations in Kenya.
Wellcome Open ResearchBiochemistry, Genetics and Molecular Biology-Biochemistry, Genetics and Molecular Biology (all)
CiteScore
5.50
自引率
0.00%
发文量
426
审稿时长
1 weeks
期刊介绍：
Wellcome Open Research publishes scholarly articles reporting any basic scientific, translational and clinical research that has been funded (or co-funded) by Wellcome. Each publication must have at least one author who has been, or still is, a recipient of a Wellcome grant. Articles must be original (not duplications). All research, including clinical trials, systematic reviews, software tools, method articles, and many others, is welcome and will be published irrespective of the perceived level of interest or novelty; confirmatory and negative results, as well as null studies are all suitable. See the full list of article types here. All articles are published using a fully transparent, author-driven model: the authors are solely responsible for the content of their article. Invited peer review takes place openly after publication, and the authors play a crucial role in ensuring that the article is peer-reviewed by independent experts in a timely manner. Articles that pass peer review will be indexed in PubMed and elsewhere. Wellcome Open Research is an Open Research platform: all articles are published open access; the publishing and peer-review processes are fully transparent; and authors are asked to include detailed descriptions of methods and to provide full and easy access to source data underlying the results to improve reproducibility.
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