山西某县HIV／HCV感染调查的实验室质量控制

Laboratory quality control for H1V/HCV infection survey in Shanxi, China

目的分析山西某县开展HIV／HCV调查的实验室质量控制方法，探讨质控对调查准确性的影响。方法在整个调查中对现场的HIV、HCV检测实施插入质控品及样本抽检的质控方案。根据预调查质控结果，通过增加人员培训、加强考核频次、提高抽检比例等手段调整质控方案用于主调查。结果HIV感染预调查，现场的插入质控品检测和抽检结果与预期结果一致，预调查有效；在主调查中4份样本结果不一致，结合现场调查和质控记录，判定主调查有效。HCV感染预调查时现场HCV检测插入的质控品与预期结果符合率66．7％，抽检质控符合率95．1％，预调查无效；实施了检测人员HCV强化培训和能力验证考核后主调查HCV质控检测结果和预期结果一致，结果有效。结论质控的实施有助于及时发现现场检测存在的问题、调整质控方案，从而保证调查数据的准确性和可靠性。

Objective The laboratory quality control, QC, for an epidemiological study of HIV/ HCV infection in Shanxi province of China was analyzed, so as to study the influence of laboratory Qc measures upon the quality of epidemiological study result. Methods Laboratory Qc measures, including laboratory Qc samples testing and confirmatory testing on sampled specimens from the site laboratory were carried out during all phases of the epidemiological study. Strengthening measures, including more training for the testing personnel, more frequent testing proficiency evaluation and higher percentage of sampling of the site specimens for confirmatory testing were implemented in the main study. Results HIV specimens for quality control were congruent between the site and QC laboratory during the pilot study. During the main study, all 4 specimens with undetermined testing results were confirmed negative. With site testing procedure checked and quality record analyzed, the validity of all HIV testing results were obtained. During the pilot phase of HCV study, the site laboratory only obtained congruency rates of 66.7% and 95.1% on the QA samples and on the sampled specimens for confirmatory testing, respectively, resulting in the invalidity of all HCV testing results in the pilot study. With corrective QC measures in place, such as adequate personnel training and intensive testing proficiency evaluation, the congruency rate achieved 100% on the QA samples and on the sampling specimens for confirmatdry testing during the HCV main study. Thus the validity of all HCV testing results in the main study was obtained. Conclusion Laboratory QC is especially important in timely identifying deficiencies in laboratory testing, adjusting and optimizing QC protocols, which further guarantee accu- racy and reliability of the studies.