Field evaluation of the performance of a SARS-CoV-2 antigen rapid diagnostic test in Uganda using nasopharyngeal samples.
Field evaluation of the performance of a SARS-CoV-2 antigen rapid diagnostic test in Uganda using nasopharyngeal samples.
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乌干达使用鼻咽样本对SARS-CoV-2抗原快速诊断试验性能的现场评价
DOI：
10.1016/j.ijid.2020.10.073
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发表时间：
2021-03
期刊：
影响因子：
--
通讯作者：
Kaleebu P
中科院分区：
文献类型：
--
作者：
Nalumansi A;Lutalo T;Kayiwa J;Watera C;Balinandi S;Kiconco J;Nakaseegu J;Olara D;Odwilo E;Serwanga J;Kikaire B;Ssemwanga D;Nabadda S;Ssewanyana I;Atwine D;Mwebesa H;Bosa HK;Nsereko C;Cotten M;Downing R;Lutwama J;Kaleebu P
对SARS-CoV-2检测以确定新冠肺炎病例的需求很高。实时定量聚合酶链式反应(qRT-PCR)是推荐的诊断试验，但包括成本在内的许多限制因素阻碍了它的广泛实施。本研究的目的是评价一种低成本、易用的快速抗原检测方法在新冠肺炎的急诊诊断中的应用。对新冠肺炎疑似病例和低危人群的鼻咽拭子进行Q新冠肺炎银染检测，并与QRT-PCR法进行比较。总共收集了262份样本，其中90份为qRT-PCR阳性。大多数样本来自男性(%)，平均年龄为34岁，只有13例(14%)阳性者有轻度症状。抗原检测的敏感性和特异性分别为70.0%(95%可信区间：60~79)和92%(95%可信区间：87~96)，诊断准确率为84%(95%可信区间：79~88)。QRT-PCRCt值为≤29的标本抗原检测更有可能呈阳性，敏感性为92%。在这项评估中，标准的Q新冠肺炎银检表现不佳。然而，当不能及时获得分子检测时，检测仍可能在感染的早期发挥重要作用，但结果应通过qRT-PCR确认。
There is a high demand for SARS-CoV-2 testing to identify COVID-19 cases. Real-time quantitative PCR (qRT-PCR) is the recommended diagnostic test but a number of constraints prevent its widespread implementation, including cost. The aim of this study was to evaluate a low cost and easy to use rapid antigen test for diagnosing COVID-19 at the point of care. Nasopharyngeal swabs from suspected COVID-19 cases and low-risk volunteers were tested with the STANDARD Q COVID-19 Ag Test and the results were compared with the qRT-PCR results. In total, 262 samples were collected, including 90 qRT-PCR positives. The majority of samples were from males (89%) with a mean age of 34 years and only 13 (14%) of the positives were mildly symptomatic. The sensitivity and specificity of the antigen test were 70.0% (95% confidence interval (CI): 60–79) and 92% (95% CI: 87–96), respectively, and the diagnostic accuracy was 84% (95% CI: 79–88). The antigen test was more likely to be positive for samples with qRT-PCR Ct values ≤29, with a sensitivity of 92%. The STANDARD Q COVID-19 Ag Test performed less than optimally in this evaluation. However, the test may still have an important role to play early in infection when timely access to molecular testing is not available but the results should be confirmed by qRT-PCR.
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19.7
作者：
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