Wijnberg Inge D, Soons Anton J, Reimerink Johan G, Wiersma Marit, Plat Marie Christine J, van Gool Tom, Jansen Gijsbert J, Stijnis Cornelis, Koning Jack G, Meijer Adam
Expertise Centre, (Micro-) Biology and Infectious Diseases Cluster, Coordination Centre for Expertise on Working Conditions and Health (CEAG), Ministry of Defence, Doorn, NLD.
Faculty of Veterinary Medicine, Clinical Sciences, Utrecht University, Utrecht, NLD.
PLoS One. 2024 Dec 31;19(12):e0309091. doi: 10.1371/journal.pone.0309091. eCollection 2024.
At the beginning of the COVID-19 pandemic, diagnostic testing was not accessible for mildly ill or asymptomatic individuals. Military operational circumstances exclude the usage of reference laboratory tests. For that reason, at the beginning of the pandemic alternative test methods were needed in order to gain insight into the SARS-CoV-2 status of military personnel. The objectives of this study are to assess whether SARS-CoV-2 antibody rapid lateral flow assay (LFA) in combination with semi-autonomous SARS-CoV-2 antisense and sense genomic RNA fluorescence in situ hybridization (FISH) could establish disease status in military personnel in a fieldable setting, and to assess how this combination performed and to determine which type of sample performed best. A proof of concept sub-study regarding the SARS-CoV-2 application of the fieldable Biotrack-MED® FISH analyzer, a semi-autonomous multi-sample filter cytometer, preceded this observational prospective cohort pilot study. Dutch military personnel were included in the 26 June 2020-11 May 2021 period. Blood, nasopharyngeal and oropharyngeal swabs and saliva were tested at days 0 and 14. SPSS version 25 descriptive statistics and Cohen's kappa assessed agreement between test methods. Both the sensitivity and specificity of the field tests were calculated with ELISA and PCR as reference. Saliva appeared to be the preferred sample type for FISH, where blood was not useful. FISH analysis and LFA results had a concordance of 42% for testing negative, 30% for recovered from infection, 22% for ongoing-and 58% for acute infection in a reference laboratory lab result outcome (RT-PCR or ELISA respectively). The LFA results on serum and full blood corresponded with the ELISA-obtained results (kappa of 0.61 and 0.63 respectively at day 0 and 0.81 and 0.77 respectively at day 14). LFA (full blood-serum), FISH and RT-PCR on saliva did not reach the 90% sensitivity level advised by WHO, with 64-54, 38 and 71% at day 0 and 80-79, 53 and 24% at day 14 respectively.
在新冠疫情初期，轻症或无症状个体无法进行诊断检测。军事行动环境排除了使用参考实验室检测的可能性。因此，在疫情初期，需要替代检测方法来了解军事人员的新冠病毒感染状况。本研究的目的是评估新冠病毒抗体快速侧向流动分析（LFA）与半自主式新冠病毒反义和正义基因组RNA荧光原位杂交（FISH）相结合，能否在可部署的环境中确定军事人员的疾病状态，评估这种组合的性能，并确定哪种样本类型表现最佳。在这项观察性前瞻性队列试点研究之前，进行了一项关于可部署的Biotrack-MED® FISH分析仪（一种半自主多样本过滤细胞仪）在新冠病毒检测应用方面的概念验证子研究。荷兰军事人员纳入时间为2020年6月26日至2021年5月11日。在第0天和第14天对血液、鼻咽拭子、口咽拭子和唾液进行检测。使用SPSS 25版描述性统计和科恩kappa系数评估检测方法之间的一致性。以酶联免疫吸附测定（ELISA）和聚合酶链反应（PCR）为参考，计算现场检测的敏感性和特异性。唾液似乎是FISH检测的首选样本类型，而血液则不适用。在参考实验室结果（分别为逆转录聚合酶链反应（RT-PCR）或ELISA）中，FISH分析和LFA结果在检测阴性方面的一致性为42%，感染康复方面为30%，正在感染方面为22%，急性感染方面为58%。血清和全血的LFA结果与ELISA获得的结果相符（第0天的kappa系数分别为0.61和0.63，第14天分别为0.81和0.77）。唾液的LFA（全血-血清）、FISH和RT-PCR未达到世界卫生组织建议的90%敏感性水平，第0天分别为64 - 54%、38%和71%，第14天分别为80 - 79%、53%和24%。
