Recently, according to the Jiaxing Disease Control and Prevention Center that the nucleic acid detection test kit of COVID-19 has obtained the EU's CE marking. It indicated that the test kit has obtained the qualification to sell in all member countries within the EU.

The principal of the key laboratory project of the pathogenic microorganism of Jiaxing Disease Control and Prevention Center introduced that this project was started in early February and finished in early March.

According to the introduction, the greatest advantage of this test kit was that it did not need the nucleic acid extraction steps. The specimen was directly put in the reaction tube and the nucleic acid release was conducted by the cracking agent in the tube. The released nucleic acid was detected in real-time by fluorescent RT-PCR. "Hence, the test kit could simultaneously release nucleic acid and detect a nucleic acid. It could detect the specimen directly and truly achieve the closed tube detection of "sample in and result out". It could effectively solve the problems caused by the aerosol and reduce indoor pollution and personnel infection opportunities." The principal said.

It was acknowledged that this test kit had high sensitivity and rapid detection speed. The whole process of detection could be finished within 1 hour and it only took 40 minutes with the fastest detection speed. The required time was 1/3 of the fluorescent PCR reagent with the same kind, which was especially suitable for the on-site rapid detection for epidemiological investigators.

日前，记者从嘉兴市疾控中心获悉，该中心参与合作研发的新冠核酸检测试剂盒获得欧盟CE认证，这标志着该试剂盒已获得在欧盟各成员国销售的资格。

嘉兴市疾控中心病原微生物重点实验室项目负责人介绍，该项目于2月初启动，3月初完成。

据介绍，该免试剂盒最大的优点是不需要核酸提取步骤，标本直接放入反应管，通过管内裂解剂进行核酸释放，释放出的核酸通过荧光RT-PCR进行实时检测。“因此，该试剂盒同步进行核酸释放与核酸检测，直接对标本进行检测，真正实现‘样品进、结果出’闭管检测，有效解决气溶胶产生问题，减少室内污染与人员感染机会。”该负责人表示。

据了解，该试剂盒不但灵敏度高，且检测速度快，全程检测1小时内完成，最快只要40分钟，所需时间是其他同类商品荧光PCR试剂的1/3，尤其适合用于流行病学调查人员现场快速检测。

(Executive Editor: Ye Ke)