Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Center for Clinical Medicine, Samsung Biomedical Research Institute, Samsung Medical Center, Seoul, Korea.
Ann Lab Med. 2020 Jul;40(4):317-320. doi: 10.3343/alm.2020.40.4.317.
The recent increase in severe fever with thrombocytopenia syndrome (SFTS) cases has led to the development of the SFTS-QS kit (MiCoBioMed, Seongnam, Korea) for detecting the SFTS virus (SFTSV, now renamed ). SFTS-QS is a qualitative real-time reverse transcription PCR assay based on lab-on-a-chip technology. We evaluated the performance of the SFTS-QS kit and compared it with that of the PowerChek SFTSV Real-time PCR kit (PowerChek; Kogene Biotech, Seoul, Korea). A total of 117 serum samples were simultaneously assayed using the SFTS-QS and PowerChek kits. Sanger sequencing targeting the S and M segments of SFTSV was performed as the reference method. The total turnaround time of the two kits was compared. The SFTS-QS results agreed with those of PowerChek with a kappa value of 0.92. The diagnostic sensitivity and specificity of the SFTS-QS kit were both 100% (14/14 and 103/103, respectively), whereas those of the PowerChek kit were 100% (14/14) and 98.1% (101/103), respectively. The results of SFTS-QS and PowerChek were comparable; however, the SFTS-QS kit required a shorter total turnaround time. The SFTS-QS kit produced accurate and fast results and thus could serve as a useful tool for detecting SFTSV.
最近严重发热伴血小板减少综合征（SFTS）病例有所增加，导致了 SFTS-QS 试剂盒（韩国城南市的 MiCoBioMed）的开发，用于检测 SFTS 病毒（SFTSV，现已更名为 ）。SFTS-QS 是一种基于芯片实验室技术的定性实时逆转录 PCR 检测方法。我们评估了 SFTS-QS 试剂盒的性能，并将其与 PowerChek SFTSV 实时 PCR 试剂盒（PowerChek；韩国首尔的 Kogene Biotech）进行了比较。使用 SFTS-QS 和 PowerChek 试剂盒同时对 117 份血清样本进行了检测。针对 SFTSV 的 S 和 M 片段进行 Sanger 测序作为参考方法。比较了两种试剂盒的总周转时间。SFTS-QS 结果与 PowerChek 的结果一致，kappa 值为 0.92。SFTS-QS 试剂盒的诊断灵敏度和特异性均为 100%（分别为 14/14 和 103/103），而 PowerChek 试剂盒的灵敏度和特异性分别为 100%（14/14）和 98.1%（101/103）。SFTS-QS 和 PowerChek 的结果相当；然而，SFTS-QS 试剂盒所需的总周转时间更短。SFTS-QS 试剂盒产生准确且快速的结果，因此可以作为检测 SFTSV 的有用工具。
