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用于SARS-CoV-2血清学检测的毛细血管血和唾液自我微量采样的性能及可行性

Performance and feasibility of self-microsampling of capillary blood and saliva for serological testing of SARS-CoV-2.

作者信息

Morales Ivonne, Bueggeln Josh, Denzler Anna, Sonntag-Buck Vera, Börner Kathleen, Chlanda Petr, Koeppel Lisa, Deckert Andreas, Bärnighausen Till, Knop Michael, Denkinger Claudia M

机构信息

Department of Infectious Disease and Tropical Medicine, Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.

Heidelberg Institute of Global Health (HIGH), Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.

出版信息

PLoS One. 2025 Jul 11;20(7):e0327821. doi: 10.1371/journal.pone.0327821. eCollection 2025.

DOI:10.1371/journal.pone.0327821
PMID:40644438
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12250565/
Abstract

BACKGROUND

Serology is a valuable tool to estimate infections, case-fatality rates, and immunity. However, venipuncture and clinical infrastructure hinder scalability. This study evaluated the performance, feasibility and user experience of using a microsampling device for self-collected capillary blood and saliva to determine total SARS-CoV-2 S RBD antibodies.

METHODS

It included 149 participants with (n = 48) or without (n = 101) a known history of SARS-CoV-2 infection and confirmed antibodies. Venous and capillary blood were self- or professionally collected from all, and saliva was self-collected by 46/48 participants with antibodies. The detection of SARS-CoV-2 S RBD antibodies in all sample types was tested using a high-throughput platform and agreement was calculated. Intra- and inter-rater agreement between serum and capillary blood in participants with an unknown antibody status was also assessed. Participants evaluated the device's user-friendliness through questionnaires.

RESULTS

Among the 48 participants with known past infection and antibodies, agreement was 100% (95% CI: 92.6-100) between serum and capillary blood (self-collected or professionally collected). Self-collected saliva had slightly lower agreement with paired serum samples (95.7%, CI: 85.2-99.5). For the 101 participants without prior evidence of antibodies or infection, serum and self-collected capillary blood had good intra-rater agreement and serum and professionally collected capillary blood had almost perfect intra-rater agreement. Inter-rater agreement was also almost perfect. While 81.8% found the self-finger prick easy, 53.4% found using the microsampler easy. Among those who collected saliva, 84.8% found capillary blood easier to collect compared to saliva (52.2%).

CONCLUSIONS

Our results show that detecting SARS-CoV-2 antibodies from capillary blood and saliva collected with the VAMS microsampling device is feasible and yields valid results. To ensure accuracy and reliability, additional training in self-sampling techniques may be essential. The positive user experience further underscores the microsampling device's potential for scalable serosurveillance and strengthening pandemic preparedness efforts.

摘要

背景

血清学是评估感染情况、病死率和免疫力的一项重要工具。然而,静脉穿刺和临床基础设施阻碍了其大规模应用。本研究评估了使用微量采样设备自行采集毛细血管血和唾液来检测新冠病毒刺突蛋白受体结合域(S RBD)总抗体的性能、可行性及用户体验。

方法

研究纳入了149名参与者,其中48名有新冠病毒感染史且已确认有抗体,101名无新冠病毒感染史。所有参与者的静脉血和毛细血管血均由其自行采集或由专业人员采集,46/48名有抗体的参与者自行采集了唾液。使用高通量平台检测所有样本类型中的新冠病毒S RBD抗体,并计算一致性。还评估了抗体状态未知的参与者血清与毛细血管血之间的评分者内一致性和评分者间一致性。参与者通过问卷调查评估了该设备的用户友好性。

结果

在48名有既往感染史且有抗体的参与者中,血清与毛细血管血(自行采集或专业采集)之间的一致性为100%(95%置信区间:92.6 - 100)。自行采集的唾液与配对血清样本的一致性略低(95.7%,置信区间:85.2 - 99.5)。对于101名无抗体或感染既往证据的参与者,血清与自行采集的毛细血管血之间有良好的评分者内一致性,血清与专业采集的毛细血管血之间有近乎完美的评分者内一致性。评分者间一致性也近乎完美。虽然81.8%的人觉得自行手指采血容易,53.4%的人觉得使用微量采样器容易。在采集唾液的人中,84.8%的人觉得采集毛细血管血比采集唾液更容易(52.2%)。

结论

我们的结果表明,使用VAMS微量采样设备从毛细血管血和唾液中检测新冠病毒抗体是可行的,且结果有效。为确保准确性和可靠性,可能有必要对自行采样技术进行额外培训。积极的用户体验进一步凸显了微量采样设备在大规模血清学监测和加强大流行防范工作方面的潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5745/12250565/37f09ab76aad/pone.0327821.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5745/12250565/e5ab77afe1e4/pone.0327821.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5745/12250565/5e0cd141e395/pone.0327821.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5745/12250565/3f4ab58466b4/pone.0327821.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5745/12250565/37f09ab76aad/pone.0327821.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5745/12250565/e5ab77afe1e4/pone.0327821.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5745/12250565/5e0cd141e395/pone.0327821.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5745/12250565/3f4ab58466b4/pone.0327821.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5745/12250565/37f09ab76aad/pone.0327821.g004.jpg

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