PDF(Pubmed)
Abstract：
UNASSIGNED: While real-time reverse transcription PCR (RT-PCR) is the recommended laboratory method to diagnose severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) infection, its use in resource limited settings can be difficult to maintain due to high testing demand and shortage of reagents. The aim of this study was to evaluate the performances of Realy Tech™ and Standard Q™ in comparison to RT-PCR in a relatively low COVID-19 prevalence setting, Mali.
UNASSIGNED: We conducted a cross-sectional study between January and April 2021 in Bamako and Kati regions to evaluate both rapid tests during a large SARS-CoV-2 prevalence study in Mali.
UNASSIGNED: Of the 390 samples tested, the sensitivity and specificity of Realy Tech™ and Standard Q™ were 57.1% (95%CI: 44.1-69.2), 95.8% (95%CI: 93.1-97.5); 61.9% (95%CI: 46.8-75.0), and 94.1% (95%CI: 89.5-96.8) respectively. Using RT-PCR, the global prevalence of SARS-CoV-2 was 14.4% (56/390). In both rapid antigen tests, the performance was better when used in suspected patients compared to positive patients under treatment. Moreover, higher viral loads equivalent to Ct < 25 were associated with better detection rates.
UNASSIGNED: While waiting for more complete data, these preliminary studies suggest that Realy Tech™ and Standard Q™ should not be used alone for COVID-19 diagnosis in Mali.
UNASSIGNED: We conducted a cross-sectional study between January and April 2021 in Bamako and Kati regions to evaluate both rapid tests during a large SARS-CoV-2 prevalence study in Mali.
UNASSIGNED: Of the 390 samples tested, the sensitivity and specificity of Realy Tech™ and Standard Q™ were 57.1% (95%CI: 44.1-69.2), 95.8% (95%CI: 93.1-97.5); 61.9% (95%CI: 46.8-75.0), and 94.1% (95%CI: 89.5-96.8) respectively. Using RT-PCR, the global prevalence of SARS-CoV-2 was 14.4% (56/390). In both rapid antigen tests, the performance was better when used in suspected patients compared to positive patients under treatment. Moreover, higher viral loads equivalent to Ct < 25 were associated with better detection rates.
UNASSIGNED: While waiting for more complete data, these preliminary studies suggest that Realy Tech™ and Standard Q™ should not be used alone for COVID-19 diagnosis in Mali.
摘要：
■虽然实时逆转录PCR（RT-PCR）是诊断严重急性呼吸道综合征冠状病毒2（SARS-CoV-2）感染的推荐实验室方法，由于高测试需求和试剂短缺，其在资源有限的环境中的使用可能难以维持。这项研究的目的是评估RealyTech™和StandardQ™在相对较低的COVID-19患病率环境中与RT-PCR相比的性能，马里。
■我们在2021年1月至4月之间在巴马科和卡蒂地区进行了一项横断面研究，以评估在马里进行的大型SARS-CoV-2流行研究中的两种快速测试。
■在测试的390个样品中，RealyTech™和StandardQ™的敏感性和特异性为57.1%(95CI:44.1-69.2)，95.8%（95CI：93.1-97.5）；61.9%（95CI：46.8-75.0），和94.1%（95CI：89.5-96.8）。使用RT-PCR，SARS-CoV-2的全球患病率为14.4%(56/390)。在两种快速抗原测试中，与接受治疗的阳性患者相比,在疑似患者中使用时的表现更好.此外，相当于Ct<25的较高病毒载量与较好的检出率相关.
■在等待更完整的数据时，这些初步研究表明，RealyTech™和StandardQ™不应单独用于马里的COVID-19诊断。
■我们在2021年1月至4月之间在巴马科和卡蒂地区进行了一项横断面研究，以评估在马里进行的大型SARS-CoV-2流行研究中的两种快速测试。
■在测试的390个样品中，RealyTech™和StandardQ™的敏感性和特异性为57.1%(95CI:44.1-69.2)，95.8%（95CI：93.1-97.5）；61.9%（95CI：46.8-75.0），和94.1%（95CI：89.5-96.8）。使用RT-PCR，SARS-CoV-2的全球患病率为14.4%(56/390)。在两种快速抗原测试中，与接受治疗的阳性患者相比,在疑似患者中使用时的表现更好.此外，相当于Ct<25的较高病毒载量与较好的检出率相关.
■在等待更完整的数据时，这些初步研究表明，RealyTech™和StandardQ™不应单独用于马里的COVID-19诊断。
