验证符合伦理的 COVID-19 抗体测试,恪守支持生命的原则

Kyle C. McKenna, M. Rohall, Daniel Kissinger, Matthew Evans, Elizabeth Wright, Evelyn Nick, Monica Calkins
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摘要

我们介绍了一种 COVID-19 抗体检测方法的验证情况,该方法利用符合道德标准的试剂检测血浆中的抗 SARS-CoV-2 受体结合域 (RBD) IgG 抗体,试剂并非来自流产胎儿细胞系。在评估因自然 SARS-CoV-2 暴露(13 人)或接种 COVID-19 疫苗(15 人)而导致的抗 SARS-CoV-2 RBD IgG 抗体阴性(n = 13)或阳性的血液标本时,该检测方法的特异性为 100%(95% 置信区间为 77.2-100%),灵敏度为 100%(95% 置信区间为 79.6-100%)。该试验用于筛查不明SARS-CoV-2暴露者(103人)或自然暴露于SARS-CoV-2者(44人)、接种过COVID-19疫苗者(66人)或在SARS-CoV-2暴露前后接种过COVID-19疫苗者(17人)的230份血液标本。在自然暴露、接种疫苗或既接种疫苗又自然暴露的 127 份血液标本中,99%(95% 置信区间 95.7-100%)的抗 SARS-CoV-2 RBD IgG 呈阳性,这与我们检测的高灵敏度是一致的。该 COVID-19 抗体检测试剂盒现被命名为 PL COVID-19 RBD IgG 抗体检测试剂盒,它是一种有效且符合道德规范的检测方法,可替代市面上使用流产胎儿试剂的 COVID-19 抗体检测试剂盒。
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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.
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