Centre de Recherche et de Formation en Infectiologie de Guinée (CERFIG), Université Gamal Abder Nasser de Conakry, Conakry, Guinea.
Institut de Recherche pour le Développement (IRD), INSERM, TransVIHMI, University of Montpellier, Montpellier, France.
Virol J. 2024 Aug 1;21(1):171. doi: 10.1186/s12985-024-02442-7.
This study aimed to demonstrate that the genomic material of SARS-CoV-2 can be isolated from strips of COVID-19 rapid diagnostic test cassettes.
It was a prospective cross-sectional study involving patients admitted to treatment centers and sampling sites in the city of Conakry, Guinea. A total of 121 patients were double sampled, and 9 more patients were tested only for RDT. PCR was conducted according to the protocol of the RunMei kit. Sequencing was performed by using the illumina COVIDSeq protocol. Nine COVID-19 RDTs without nasopharyngeal swabs were in addition tested.
Among the 130 COVID-19 RDTs, forty-seven were macroscopically positive, whereas seventy-two were positive according to PCR using RDT strip, while among the 121 VTM swabs, sixty-four were positive. Among eighty-three negative COVID-19 RDTs, twenty-seven were positive by PCR using RDT strip with a geometric mean Ct value of 32.49 cycles. Compared to those of PCR using VTM, the sensitivity and specificity of PCR using RDT strip were estimated to be 100% and 85.96%, respectively, with 93.39% test accuracy. Among the fifteen COVID-19 RDT extracts eligible for sequencing, eleven had sequences identical to those obtained via the standard method, with coverage between 75 and 99.6%.
These results show that COVID-19 RDTs can be used as biological material for the genomic surveillance of SARS-CoV-2.
本研究旨在证明可以从 COVID-19 快速诊断检测试剂盒的条带上分离出 SARS-CoV-2 的基因组物质。
这是一项涉及几内亚科纳克里市治疗中心和采样点的患者的前瞻性横断面研究。总共对 121 名患者进行了双样本采集，另外对 9 名患者仅进行了 RDT 检测。PCR 按照 RunMei 试剂盒的方案进行。测序采用 illumina COVIDSeq 方案进行。此外，还对 9 个没有鼻咽拭子的 COVID-19 RDT 进行了测试。
在 130 个 COVID-19 RDT 中，有 47 个宏观上呈阳性，而根据 RDT 条带的 PCR 有 72 个呈阳性，而在 121 个 VTM 拭子中，有 64 个呈阳性。在 83 个阴性 COVID-19 RDT 中，有 27 个通过 RDT 条带 PCR 呈阳性，几何平均 Ct 值为 32.49 个循环。与 VTM-PCR 相比，RDT 条带 PCR 的敏感性和特异性估计分别为 100%和 85.96%，检测准确率为 93.39%。在可用于测序的 15 个 COVID-19 RDT 提取物中，有 11 个与通过标准方法获得的序列相同，覆盖率在 75%至 99.6%之间。
这些结果表明，COVID-19 RDT 可作为 SARS-CoV-2 基因组监测的生物材料。
