R&D Center, GeneMatrix Inc., Seongnam-si, Gyeonggi-do, Republic of Korea.
Samkwang Medical Laboratories, Seoul, Republic of Korea.
J Clin Microbiol. 2020 Jan 28;58(2). doi: 10.1128/JCM.01500-19.
There are several convenient and accurate molecular assays to detect respiratory bacterial infection. The NeoPlex RB-8 detection kit (NeoPlex RB-8) is a new multiplex real-time PCR assay that simultaneously detects , , , , , , , and in a single test. This study compared the clinical concordance of NeoPlex RB-8 with another method, Seeplex PneumoBacter ACE detection assay (Seeplex PB ACE), which simultaneously detects , , , , , and We tested 2,137 nasopharyngeal swab and sputum specimens using both assays. For discordant and specimens, we also performed bidirectional sequencing. For , , , , , and , which are detected by both NeoPlex RB-8 and Seeplex PB ACE, the positive and negative agreement between the two assays ranged from 91.7 to 100% (κ = 0.918 to 1). and were the most discordant targets and measured with higher sensitivity and specificity by NeoPlex RB-8 than Seeplex PB ACE. For and , which are not detected by Seeplex PB ACE, NeoPlex RB-8 sensitivity and specificity were >99%. Overall, NeoPlex RB-8 was highly comparable to Seeplex PB ACE, but NeoPlex RB-8 was more clinically accurate, with higher throughput and more convenience.
有几种方便且准确的分子检测方法可用于检测呼吸道细菌感染。NeoPlex RB-8 检测试剂盒（NeoPlex RB-8）是一种新的多重实时 PCR 检测方法，可在单次检测中同时检测 、 、 、 、 、 、 和 。本研究比较了 NeoPlex RB-8 与另一种方法——Seeplex PneumoBacter ACE 检测试剂盒（Seeplex PB ACE）的临床一致性，后者可同时检测 、 、 、 、 和 。我们使用这两种检测方法测试了 2137 份鼻咽拭子和痰标本。对于不一致的 和 标本，我们还进行了双向测序。对于 、 、 、 、 和 ，这两种方法都可检测到，两种检测方法的阳性和阴性一致性在 91.7%到 100%之间（κ 值为 0.918 到 1）。 和 是最不一致的靶标，NeoPlex RB-8 比 Seeplex PB ACE 检测到的灵敏度和特异性更高。对于 、 ，这些靶标不能被 Seeplex PB ACE 检测到，NeoPlex RB-8 的灵敏度和特异性均>99%。总体而言，NeoPlex RB-8 与 Seeplex PB ACE 高度可比，但 NeoPlex RB-8 更具临床准确性，具有更高的通量和便利性。
