Sitoe Nádia, Sambo Júlia, Nguenha Neuza, Chilaule Jorfelia, Chelene Imelda, Loquiha Osvaldo, Mudenyanga Chishamiso, Viegas Sofia, Cunningham Jane, Jani Ilesh
Instituto Nacional de Saúde, Marracuene 3943, Mozambique.
Clinton Health Access Initiative, Maputo City 592, Mozambique.
Diagnostics (Basel). 2022 Feb 12;12(2):475. doi: 10.3390/diagnostics12020475.
(1) Background: Laboratory-based molecular assays are the gold standard to detect SARS-CoV-2. In resource-limited settings, the implementation of these assays has been hampered by operational challenges and long turnaround times. Rapid antigen detection tests are an attractive alternative. Our aim is to evaluate the clinical performance of two SARS-CoV-2 rapid antigen tests during a high transmission period. (2) Methods: A total of 1277 patients seeking SARS-CoV-2 diagnosis were enrolled at four health facilities. Nasopharyngeal swabs for rapid antigen and real time PCR testing were collected for each patient. Sensitivity, specificity, positive and negative predictive values, misclassification rate, and agreement were determined. (3) Results: The overall sensitivity of Panbio COVID-19 was 41.3% (95% CI: 34.6-48.4%) and the specificity was 98.2% (95% CI: 96.2-99.3%). The Standard Q had an overall sensitivity and specificity of 45.0% (95% CI: 39.9-50.2%) and 97.6% (95% CI: 95.3-99.0%), respectively. The positive predictive value of a positive test was 93.3% and 95.4% for the Panbio and Standard Q Ag-RDTs, respectively. A higher sensitivity of 43.2% and 49.4% was observed in symptomatic cases for the Panbio and Standard Q Ag-RDTs, respectively. (4) Conclusions: Despite the overall low sensitivity, the two evaluated rapid tests are useful to improve the diagnosis of symptomatic SARS-CoV-2 infections during high transmission periods.
(1) 背景：基于实验室的分子检测是检测严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的金标准。在资源有限的环境中，这些检测的实施受到操作挑战和较长周转时间的阻碍。快速抗原检测是一种有吸引力的替代方法。我们的目的是评估两种SARS-CoV-2快速抗原检测在高传播期的临床性能。(2) 方法：在四个医疗机构招募了总共1277名寻求SARS-CoV-2诊断的患者。为每位患者采集用于快速抗原检测和实时聚合酶链反应（PCR）检测的鼻咽拭子。确定了敏感性、特异性、阳性和阴性预测值、错误分类率以及一致性。(3) 结果：Panbio COVID-19的总体敏感性为41.3%（95%置信区间：34.6 - 48.4%），特异性为98.2%（95%置信区间：96.2 - 99.3%）。标准Q的总体敏感性和特异性分别为45.0%（95%置信区间：39.9 - 50.2%）和97.6%（95%置信区间：95.3 - 99.0%）。Panbio和标准Q抗原快速检测试验（Ag-RDTs）阳性检测的阳性预测值分别为93.3%和95.4%。在有症状的病例中，Panbio和标准Q Ag-RDTs的敏感性分别较高，为43.2%和49.4%。(4) 结论：尽管总体敏感性较低，但这两种评估的快速检测对于在高传播期改善有症状的SARS-CoV-2感染的诊断是有用的。
