Miesse Peyton K, Collier Bradley B, Grant Russell P
Center for Esoteric Testing, Laboratory Corporation of America Holdings, Burlington, NC, USA.
Sci Rep. 2022 Apr 6;12(1):5812. doi: 10.1038/s41598-022-09699-4.
The utilization of vaccines to fight the spread of SARS-CoV-2 has led to a growing need for expansive serological testing. To address this, an EUA approved immunoassay for detection of antibodies to SARS-CoV-2 in venous serum samples was investigated for use with dried blood spot (DBS) samples. Results from self-collected DBS samples demonstrated a 98.1% categorical agreement to venous serum with a correlation (R) of 0.9600 while professionally collected DBS samples demonstrated a categorical agreement of 100.0% with a correlation of 0.9888 to venous serum. Additional studies were performed to stress different aspects of at-home DBS collection, including shipping stability, effects of interferences, and other sample-specific robustness studies. These studies demonstrated a categorical agreement of at least 95.0% and a mean bias less than ± 20.0%. Furthermore, the ability to track antibody levels following vaccination with the BioNTech/Pfizer vaccine was demonstrated with serial self-collected DBS samples from pre-dose (Day 0) out to 19 weeks.
利用疫苗抗击新冠病毒(SARS-CoV-2)的传播导致对广泛的血清学检测的需求不断增加。为解决这一问题,对一种经紧急使用授权(EUA)批准的用于检测静脉血清样本中新冠病毒抗体的免疫测定法进行了研究,以用于干血斑(DBS)样本。自我采集的DBS样本结果显示与静脉血清的分类一致性为98.1%,相关性(R)为0.9600,而专业采集的DBS样本与静脉血清的分类一致性为100.0%,相关性为0.9888。还进行了其他研究以强调家庭DBS采集的不同方面,包括运输稳定性、干扰影响以及其他样本特异性稳健性研究。这些研究显示分类一致性至少为95.0%,平均偏差小于±20.0%。此外,通过从接种前(第0天)到19周的系列自我采集DBS样本,证明了跟踪接种辉瑞/BioNTech疫苗后抗体水平的能力。