Kyle C. McKenna, M. Rohall, Daniel Kissinger, Matthew Evans, Elizabeth Wright, Evelyn Nick, Monica Calkins
{"title":"验证符合伦理的 COVID-19 抗体测试,恪守支持生命的原则","authors":"Kyle C. McKenna, M. Rohall, Daniel Kissinger, Matthew Evans, Elizabeth Wright, Evelyn Nick, Monica Calkins","doi":"10.1177/00243639241258538","DOIUrl":null,"url":null,"abstract":"We describe validation of a COVID-19 antibody test for detection of anti-SARS-CoV-2 receptor-binding domain (RBD) IgG antibodies in blood plasma utilizing ethically sourced reagents not derived from aborted fetal cell lines. The test demonstrated specificity of 100% (95% confidence intervals 77.2–100%) and sensitivity of 100% (95% confidence intervals 79.6–100%) when evaluating blood specimens previously determined to be negative ( n = 13) or positive for anti-SARS-CoV-2 RBD IgG antibodies due to natural SARS-CoV-2 exposure ( n = 13) or COVID-19 vaccination ( n = 15). The test was used to screen 230 blood specimens from individuals with unknown SARS-CoV-2 exposure ( n = 103) or that were naturally exposed to SARS-CoV-2 ( n = 44), received a COVID-19 vaccine ( n = 66), or received a COVID-19 vaccine before or after SARS-CoV-2 exposure ( n = 17). Ninety-nine percent (95% confidence intervals 95.7–100%) of the 127 blood specimens from individuals that were naturally exposed, vaccinated, or both vaccinated and naturally exposed were positive for anti-SARS-CoV-2 RBD IgG which was consistent with the high sensitivity of our test. This COVID-19 antibody test, now named the PL COVID-19 RBD IgG antibody test, represents an effective and ethical alternative to commercially available COVID-19 antibody tests that utilize reagents derived from aborted fetal lines.","PeriodicalId":505854,"journal":{"name":"The Linacre Quarterly","volume":"315 6","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Validation of Ethical COVID-19 Antibody Testing that Adheres to Pro-Life Principles\",\"authors\":\"Kyle C. McKenna, M. Rohall, Daniel Kissinger, Matthew Evans, Elizabeth Wright, Evelyn Nick, Monica Calkins\",\"doi\":\"10.1177/00243639241258538\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"We describe validation of a COVID-19 antibody test for detection of anti-SARS-CoV-2 receptor-binding domain (RBD) IgG antibodies in blood plasma utilizing ethically sourced reagents not derived from aborted fetal cell lines. The test demonstrated specificity of 100% (95% confidence intervals 77.2–100%) and sensitivity of 100% (95% confidence intervals 79.6–100%) when evaluating blood specimens previously determined to be negative ( n = 13) or positive for anti-SARS-CoV-2 RBD IgG antibodies due to natural SARS-CoV-2 exposure ( n = 13) or COVID-19 vaccination ( n = 15). The test was used to screen 230 blood specimens from individuals with unknown SARS-CoV-2 exposure ( n = 103) or that were naturally exposed to SARS-CoV-2 ( n = 44), received a COVID-19 vaccine ( n = 66), or received a COVID-19 vaccine before or after SARS-CoV-2 exposure ( n = 17). Ninety-nine percent (95% confidence intervals 95.7–100%) of the 127 blood specimens from individuals that were naturally exposed, vaccinated, or both vaccinated and naturally exposed were positive for anti-SARS-CoV-2 RBD IgG which was consistent with the high sensitivity of our test. This COVID-19 antibody test, now named the PL COVID-19 RBD IgG antibody test, represents an effective and ethical alternative to commercially available COVID-19 antibody tests that utilize reagents derived from aborted fetal lines.\",\"PeriodicalId\":505854,\"journal\":{\"name\":\"The Linacre Quarterly\",\"volume\":\"315 6\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-06-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"The Linacre Quarterly\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/00243639241258538\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"The Linacre Quarterly","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/00243639241258538","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Validation of Ethical COVID-19 Antibody Testing that Adheres to Pro-Life Principles
We describe validation of a COVID-19 antibody test for detection of anti-SARS-CoV-2 receptor-binding domain (RBD) IgG antibodies in blood plasma utilizing ethically sourced reagents not derived from aborted fetal cell lines. The test demonstrated specificity of 100% (95% confidence intervals 77.2–100%) and sensitivity of 100% (95% confidence intervals 79.6–100%) when evaluating blood specimens previously determined to be negative ( n = 13) or positive for anti-SARS-CoV-2 RBD IgG antibodies due to natural SARS-CoV-2 exposure ( n = 13) or COVID-19 vaccination ( n = 15). The test was used to screen 230 blood specimens from individuals with unknown SARS-CoV-2 exposure ( n = 103) or that were naturally exposed to SARS-CoV-2 ( n = 44), received a COVID-19 vaccine ( n = 66), or received a COVID-19 vaccine before or after SARS-CoV-2 exposure ( n = 17). Ninety-nine percent (95% confidence intervals 95.7–100%) of the 127 blood specimens from individuals that were naturally exposed, vaccinated, or both vaccinated and naturally exposed were positive for anti-SARS-CoV-2 RBD IgG which was consistent with the high sensitivity of our test. This COVID-19 antibody test, now named the PL COVID-19 RBD IgG antibody test, represents an effective and ethical alternative to commercially available COVID-19 antibody tests that utilize reagents derived from aborted fetal lines.