全国首期立克次体实验室质量评估

Quality control assessment of laboratory diagnostic tests for Rickettsia in China

目的评估全国9省、市CDC实验室(排名不分先后)立克次体检测技术质量。方法国家实验室统一向参加单位发放3种血清及5种PCR质控品及必要相关试剂,各单位在本实验室现有仪器设备、常规使用试剂及各种量器等条件下按质控要求采用间接免疫荧光实验和PCR进行检测,规定时间内反馈检测结果。我们对IgG抗体滴度值和PCR的特异性、灵敏度进行评估。结果9个参加单位,除一个单位对S3血清质控品不合格外,其他均合格。除一个单位对P4PCR质控品检测不合格外,其他检测均达到要求。结论参加本次质控的9个实验室,7个通过此次考核。2个实验室须进一步实验室优化调整。

Objective To assess the quality control of diagnostic tests for Rickettsia in medical laboratories of 9 provinces and municipalities in China. Methods Three kinds of serum reference materials, 5 PCR reference materials and necessary primers were distributed to 9 laboratories by the national laboratory. Indirect immunofluorescence assay and PCR were conducted in each laboratory with devices, instruments and regular preparations it had possessed according to the requirements of quality control. Each participant was asked to submit its numerical detecting results in appointed time. IgG antibody titer and PCR performance including specificity and sensitivity were evaluated respectively. Results Seven laboratories reached the requirements made for the diagnostic tests for Rickettsia, while one was unqaulified with the detection of IgG antibody in S3 serum reference material, and one was unqaulified with the sensitivity of PCR amplification in detecting P4 reference materials. Conclusion Of 9 laboratories, 7 have passed the quality control assessment and the other two need to improve their quality and competence.