Wang Guojing, Sun Yu, Zhang Kuo, Jia Tingting, Hao Mingju, Zhang Dong, Chang Le, Zhang Lei, Zhang Rui, Lin Guigao, Peng Rongxue, Li Jinming
National Center for Clinical Laboratories, Beijing Hospital of National Health and Family Planning Commission, Beijing, People's Republic of China; Graduate School, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.
National Center for Clinical Laboratories, Beijing Hospital of National Health and Family Planning Commission, Beijing, People's Republic of China.
PLoS One. 2015 Jul 15;10(7):e0132659. doi: 10.1371/journal.pone.0132659. eCollection 2015.
In 2014, Ebola hemorrhagic fever broke out in West Africa. As contact between China and West Africa is frequent, the possibility that Ebola virus would enter China was high. Thus, an external assessment of the quality of Ebola virus detection was organized by the National Center for Clinical Laboratories in China. Virus-like particles encapsulating known sequences of epidemic strains of Ebola virus from 2014 were prepared as positive quality controls. The sample panel, which was composed of seven positive and three negative samples, was dispatched to 19 laboratories participating in this assessment of Ebola virus detection. Accurate detection was reported at 14 of the 19 participating laboratories, with a sensitivity of 91.43% and a specificity of 100%. Four participants (21.05%) reported false-negative results and were classified as "acceptable." One participant (5.26%) did not detect any positive samples and was thus classified as "improvable." Based on the results returned, the ability to detect weakly positive Ebola specimens should be improved. Furthermore, commercial assays and the standard primers offered by the Chinese Centers for Disease Control and Prevention were found to be most accurate and dependable for Ebola detection. A two-target detection approach is recommended for Ebola screening; this approach could reduce the probability of false-negative results. Additionally, standardization of operations and punctual adjustment of instruments are necessary for the control and prevention of Ebola virus.
2014年,埃博拉出血热在西非爆发。由于中国与西非往来频繁,埃博拉病毒传入中国的可能性很大。因此,中国国家临床检验中心组织了对埃博拉病毒检测质量的外部评估。将包裹有2014年埃博拉病毒流行毒株已知序列的病毒样颗粒制备为阳性质量对照品。由7份阳性样本和3份阴性样本组成的样本组被分发给参与此次埃博拉病毒检测评估的19个实验室。19个参与实验室中有14个报告检测结果准确,灵敏度为91.43%,特异性为100%。4名参与者(21.05%)报告了假阴性结果,被归类为“可接受”。1名参与者(5.26%)未检测到任何阳性样本,因此被归类为“有待改进”。根据返回的结果,检测弱阳性埃博拉标本的能力有待提高。此外,发现商业检测方法和中国疾病预防控制中心提供的标准引物在埃博拉检测方面最为准确可靠。建议采用双靶点检测方法进行埃博拉筛查;这种方法可以降低假阴性结果的概率。此外,操作标准化和仪器及时校准对于埃博拉病毒的防控很有必要。