Uganda Virus Research Institute, PO Box 49, Plot 51-59, Nakiwogo Road, Entebbe, Uganda.
Uganda Virus Research Institute, PO Box 49, Plot 51-59, Nakiwogo Road, Entebbe, Uganda; Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine, Uganda Research Unit, PO Box 49, Plot 1-59, Nakiwogo Road, Entebbe, Uganda.
Int J Infect Dis. 2021 Nov;112:281-287. doi: 10.1016/j.ijid.2021.09.020. Epub 2021 Sep 15.
Serological testing is needed to better understand the epidemiology of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. Rapid diagnostic tests (RDTs) have been developed to detect specific antibodies, IgM and IgG, to the virus. The performance of 25 of these RDTs was evaluated.
A serological reference panel of 50 positive and 100 negative plasma specimens was developed from SARS-CoV-2 PCR and antibody positive patients and pre-pandemic SARS-CoV-2-negative specimens collected in 2016. Test performance of the 25 RDTs was evaluated against this panel.
A total of 10 RDTs had a sensitivity ≥98%, while 13 RDTs had a specificity ≥98% to anti-SARS-CoV-2 IgG antibodies. Four RDTs (Boson, MultiG, Standard Q, and VivaDiag) had both sensitivity and specificity ≥98% to anti-SARS-CoV-2 IgG antibodies. Only three RDTs had a sensitivity ≥98%, while 10 RDTs had a specificity ≥98% to anti-SARS-CoV-2 IgM antibodies. Three RDTs (Autobio, MultiG, and Standard Q) had sensitivity and specificity ≥98% to combined IgG/IgM. The RDTs that performed well also had perfect or almost perfect inter-reader agreement.
This evaluation identified three RDTs with a sensitivity and specificity to IgM/IgG antibodies of ≥98% with the potential for widespread antibody testing in Uganda.
血清学检测对于更好地了解严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）病毒的流行病学情况非常重要。已经开发出快速诊断检测（RDT）来检测针对该病毒的特异性抗体，即 IgM 和 IgG。本文评估了其中 25 种 RDT 的性能。
从 SARS-CoV-2 PCR 和抗体阳性患者以及 2016 年采集的大流行前 SARS-CoV-2 阴性标本中开发了一个包含 50 份阳性和 100 份阴性血浆标本的血清学参考面板。针对该参考面板评估了这 25 种 RDT 的检测性能。
共有 10 种 RDT 的抗 SARS-CoV-2 IgG 抗体检测敏感性≥98%，13 种 RDT 的特异性≥98%。4 种 RDT（Boson、MultiG、Standard Q 和 VivaDiag）对 IgG 抗体的敏感性和特异性均≥98%。只有 3 种 RDT 的敏感性≥98%，而 10 种 RDT 的特异性≥98%抗 SARS-CoV-2 IgM 抗体。3 种 RDT（Autobio、MultiG 和 Standard Q）对 IgG/IgM 同时具有高敏感性和特异性。性能良好的 RDT 也具有完美或近乎完美的读者间一致性。
本评价鉴定出了 3 种敏感性和特异性≥98%的 IgM/IgG 抗体 RDT，它们可能在乌干达广泛用于抗体检测。
