All from Microbiology Division, Public Health Laboratory Services Branch, Centre for Health Protection, Department of Health, Hong Kong Special Administrative Region, China.
All from Microbiology Division, Public Health Laboratory Services Branch, Centre for Health Protection, Department of Health, Hong Kong Special Administrative Region, China.
J Clin Virol. 2020 Aug;129:104500. doi: 10.1016/j.jcv.2020.104500. Epub 2020 Jun 8.
The rapid diagnosis of Coronavirus Disease 2019 (COVID-19) patients is essential to reduce the disease spread. Rapid antigen detection (RAD) tests are available, however, there is scanty data on the performance of RAD tests.
To evaluate the performance of the commercially available BIOCREDIT COVID-19 Ag test and compare it with RT-PCR for detecting Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus. Analytical sensitivity for the detection of SARS-CoV-2 virus was determined for the RAD test using viral culture and RT-PCR as reference methods. The RAD test was further evaluated using respiratory samples collected from confirmed COVID-19 patients. The results were compared with RT-PCR test.
The detection limits between RAD test, viral culture and RT-PCR varied hugely. RAD was 10 fold less sensitive than viral culture while RAD was 10 fold less sensitive than RT-PCR. The RAD test detected between 11.1 % and 45.7 % of RT-PCR-positive samples from COVID-19 patients.
This study demonstrated that the RAD test serves only as adjunct to RT-PCR test because of potential for false-negative results.
快速诊断 2019 年冠状病毒病（COVID-19）患者对于减少疾病传播至关重要。目前已有快速抗原检测（RAD）试验，但关于 RAD 试验性能的数据很少。
评估市售 BIOCREDIT COVID-19 Ag 试验的性能，并将其与 RT-PCR 检测严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）病毒进行比较。使用病毒培养和 RT-PCR 作为参考方法，确定 RAD 试验检测 SARS-CoV-2 病毒的分析灵敏度。RAD 试验还使用从确诊 COVID-19 患者采集的呼吸道样本进行了评估。将结果与 RT-PCR 检测进行比较。
RAD 试验、病毒培养和 RT-PCR 之间的检测限差异很大。RAD 比病毒培养的灵敏度低 10 倍，而 RAD 比 RT-PCR 的灵敏度低 10 倍。RAD 试验检测到 COVID-19 患者中 RT-PCR 阳性样本的 11.1%至 45.7%。
本研究表明，由于潜在的假阴性结果，RAD 试验仅作为 RT-PCR 试验的辅助手段。
