Hancock J S, Taylor R N, Johnson C A, Gerber A R, Schalla W O
Centers for Disease Control and Prevention, US Department of Health and Human Services, Atlanta, Ga.
Arch Pathol Lab Med. 1993 Nov;117(11):1148-55.
To identify factors that may affect the quality of laboratory performance of human immunodeficiency virus type 1 (HIV-1) antibody testing, the Centers for Disease Control and Prevention Model Performance Evaluation Program surveyed laboratories in 1989 that performed enzyme immunoassay (EIA) and Western blot tests for HIV-1 antibody. Panels of 10 HIV-1-antibody-positive and antibody-negative plasma samples, some of which were duplicates, were mailed to program-participating laboratories. Laboratories were also mailed survey questionnaires to ascertain their laboratory characteristics and testing practices. Using 1988 data, researchers previously found that the overall analytic performance of laboratories performing HIV-1 antibody testing was independently associated with the following: (1) requiring a minimum degree of testing personnel; (2) having written criteria for identifying unsatisfactory specimens; (3) requiring in-house training for testing personnel; (4) having tested more than 10,000 specimens; (5) being identified as an "other" laboratory type; (6) having more than 24 months of testing experience; (7) laboratory uses specific (Abbott) materials for EIA; and (8) testing specimens collected by family-planning clinics. To verify these findings, we performed multivariate analysis on 1989 performance data. For the 1989 EIA analytic sensitivity, significant positive (P < or = .05) associations were detected with having written criteria for identifying unsatisfactory specimens and with having tested more than 10,000 specimens. For the 1989 overall EIA analytic performance, a significant negative (P < or = .05) association was found with using specific (Abbott) EIA materials, and a significant positive (P < or = .05) association was found with having tested more than 10,000 specimens. For Western blot results, the only significant (P < or = .05) associations were for both analytic sensitivity and overall analytic performance and having tested more than 10,000 specimens.
为确定可能影响1型人类免疫缺陷病毒（HIV-1）抗体检测实验室检测质量的因素，疾病控制和预防中心的标准检测性能评估项目于1989年对进行HIV-1抗体酶免疫测定（EIA）和免疫印迹检测的实验室开展了调查。将10份HIV-1抗体阳性和抗体阴性血浆样本组成的样本组（其中一些为重复样本）邮寄给参与该项目的实验室。同时还向实验室邮寄了调查问卷，以确定其实验室特征和检测方法。研究人员利用1988年的数据先前发现，进行HIV-1抗体检测的实验室的总体分析性能与以下因素独立相关：（1）要求检测人员具备最低学历；（2）有识别不合格样本的书面标准；（3）要求对检测人员进行内部培训；（4）检测样本超过10000份；（5）被认定为“其他”实验室类型；（6）有超过24个月的检测经验；（7）实验室使用特定（雅培）材料进行EIA检测；（8）检测计划生育诊所采集的样本。为验证这些发现，我们对1989年的检测性能数据进行了多变量分析。对于1989年EIA分析灵敏度，发现与有识别不合格样本的书面标准以及检测样本超过10000份存在显著正相关（P≤0.05）。对于1989年EIA总体分析性能来说，发现与使用特定（雅培）EIA材料存在显著负相关（P≤0.05），与检测样本超过10000份存在显著正相关（P≤0.05）。对于免疫印迹结果，唯一显著（P≤0.05）的相关性是分析灵敏度和总体分析性能二者均与检测样本超过10000份有关。
