唾液 SARS-CoV-2 抗原快速检测：一项前瞻性队列研究。

Salivary SARS-CoV-2 antigen rapid detection: A prospective cohort study.

机构信息

Department of Medicine - DIMED, Laboratory Medicine, University Hospital of Padova, Padova, Italy.

出版信息

Clin Chim Acta. 2021 Jun;517:54-59. doi: 10.1016/j.cca.2021.02.014. Epub 2021 Feb 21.

DOI:10.1016/j.cca.2021.02.014

PMID:33626369

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7897404/

Abstract

BACKGROUND AND AIM

SARS-CoV-2 quick testing is relevant for the containment of new pandemic waves. Antigen testing in self-collected saliva might be useful. We compared salivary and naso-pharyngeal swab (NPS) SARS-CoV-2 antigen detection by a rapid chemiluminescent assay (CLEIA) and two different point-of-care (POC) immunochromatographic assays, with results of molecular testing.

METHODS

234 patients were prospectively enrolled. Paired self-collected saliva (Salivette) and NPS were obtained to perform rRT-PCR, chemiluminescent (Lumipulse G) and POC (NPS: Fujirebio and Abbott; saliva: Fujirebio) for SARS-CoV-2 antigen detection.

RESULTS

The overall agreement between NPS and saliva rRT-PCR was 78.7%, reaching 91.7% at the first week from symptoms. SARS-CoV-2 CLEIA antigen was highly accurate in distinguishing positive and negative NPS (ROC-AUC = 0.939, 95%CI:0.903-0.977), with 81.6% sensitivity and 93.8% specificity. This assay on saliva reached the optimal value within 7 days from symptoms onset (Sensitivity: 72%; Specificity: 97%). Saliva POC antigen was limited in sensitivity (13%), performing better in NPS (Sensitivity: 48% and 66%; Specificity: 100% and 99% for Espline and Abbott respectively), depending on viral loads.

CONCLUSIONS

Self-collected saliva is a valid alternative to NPS for SARS-CoV-2 detection by molecular, but also by CLEIA antigen testing, which is therefore potentially useful for large scale screening.

摘要

背景与目的

SARS-CoV-2 快速检测对于控制新的大流行浪潮至关重要。自我采集的唾液抗原检测可能会有所帮助。我们比较了快速化学发光法（CLEIA）和两种不同的即时检测（POC）免疫层析法检测唾液和鼻咽拭子（NPS）SARS-CoV-2 抗原，以及分子检测的结果。

方法

前瞻性纳入了 234 名患者。采集配对的自我采集唾液（Salivette）和 NPS，进行 rRT-PCR、化学发光（Lumipulse G）和 POC（NPS：富士瑞必欧和雅培；唾液：富士瑞必欧）检测 SARS-CoV-2 抗原。

结果

NPS 和唾液 rRT-PCR 的总体一致性为 78.7%，从症状出现的第一周达到 91.7%。SARS-CoV-2 CLEIA 抗原在区分 NPS 阳性和阴性方面具有很高的准确性（ROC-AUC=0.939，95%CI：0.903-0.977），灵敏度为 81.6%，特异性为 93.8%。该检测方法在症状出现后 7 天内达到最佳值（灵敏度：72%；特异性：97%）。唾液 POC 抗原的灵敏度有限（13%），在 NPS 中的性能更好（灵敏度：48%和 66%；特异性：100%和 99%，分别适用于 Espline 和雅培），这取决于病毒载量。