Evaluation of the performance of 25 SARS-CoV-2 serological rapid diagnostic tests using a reference panel of plasma specimens at the Uganda Virus Research Institute.
Evaluation of the performance of 25 SARS-CoV-2 serological rapid diagnostic tests using a reference panel of plasma specimens at the Uganda Virus Research Institute.
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DOI：
10.1016/j.ijid.2021.09.020
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发表时间：
2021-11
期刊：
影响因子：
--
通讯作者：
Kaleebu P
中科院分区：
文献类型：
--
作者：
Lutalo T;Nalumansi A;Olara D;Kayiwa J;Ogwang B;Odwilo E;Watera C;Balinandi S;Kiconco J;Nakaseegu J;Serwanga J;Kikaire B;Ssemwanga D;Abiko B;Nsereko C;Cotten M;Buule J;Lutwama J;Downing R;Kaleebu P
需要进行血清学检测才能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。快速诊断测试 (RDT) 已被开发用于检测病毒的特异性抗体、IgM 和 IgG。对其中 25 个 RDT 的性能进行了评估。根据 2016 年收集的 SARS-CoV-2 PCR 和抗体阳性患者以及大流行前 SARS-CoV-2 阴性样本，开发了一个由 50 份阳性和 100 份阴性血浆样本组成的血清学参考组。根据该组对 25 个 RDT 的测试性能进行了评估。总共 10 个 RDT 的敏感性≥98%，13 个 RDT 对抗 SARS-CoV-2 IgG 抗体的特异性≥98%。四种 RDT（Boson、MultiG、Standard Q 和 VivaDiag）对抗 SARS-CoV-2 IgG 抗体的敏感性和特异性均≥98%。只有 3 个 RDT 的敏感性≥98%，而 10 个 RDT 对抗 SARS-CoV-2 IgM 抗体的特异性≥98%。三种 RDT（Autobio、MultiG 和 Standard Q）对组合 IgG/IgM 的敏感性和特异性≥98%。表现良好的 RDT 也具有完美或几乎完美的读者间一致性。该评估确定了三种 RDT 对 IgM/IgG 抗体的敏感性和特异性≥98%，有可能在乌干达进行广泛的抗体检测。
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.
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