Astles J R, Lipman H B, Schalla W O, Blumer S O, Fehd R J, Smith C, Hearn T L
Division of Laboratory Systems, Public Health Practice Program Office, Centers for Disease Control and Prevention, Atlanta, GA 30341, USA.
Arch Pathol Lab Med. 1998 Aug;122(8):700-7.
To assess use of quality control (QC) material, supplemental to internal kit controls (calibrators), as protection against errors in enzyme immunoassay testing for human immunodeficiency virus type 1 antibodies.
From August 1994 to January 1996, enzyme immunoassay testing accuracy was assessed for laboratories participating in the Centers for Disease Control and Prevention Model Performance Evaluation Program that provided information regarding their use of QC material. Error rates were examined for human immunodeficiency virus type 1 antibody-negative, strongly positive, and weakly positive samples.
The overall error rate with QC (2.20%) was significantly (P = .0023) lower than the error rate without QC (2.90%). With QC use there was a significant reduction in the relative risk of error for negative (P = .014) and weakly positive (P = .0067) samples. After multivariate analysis, use of QC lowered overall error rate by 29% (P = .0009). Laboratories not using QC were at increased risk of systematic error. Following the Clinical Laboratory Improvement Amendments of 1988 guidelines for QC material was relatively more protective against error than lower frequencies/number of levels.
Using QC protected against errors in enzyme immunoassay testing for human immunodeficiency virus type 1 antibodies. Two levels of QC should be used with each run as mandated by the Clinical Laboratory Improvement Amendments of 1988.
评估使用质量控制（QC）材料（作为试剂盒内部对照品（校准品）的补充）对1型人类免疫缺陷病毒抗体酶免疫测定检测中误差的防护作用。
1994年8月至1996年1月，对参与疾病控制和预防中心模型性能评估项目的实验室进行酶免疫测定检测准确性评估，这些实验室提供了其使用QC材料的相关信息。对1型人类免疫缺陷病毒抗体阴性、强阳性和弱阳性样本的错误率进行了检查。
使用QC时的总体错误率（2.20%）显著低于（P = .0023）不使用QC时的错误率（2.90%）。使用QC后，阴性样本（P = .014）和弱阳性样本（P = .0067）的错误相对风险显著降低。多变量分析后，使用QC使总体错误率降低了29%（P = .0009）。未使用QC的实验室出现系统误差的风险增加。遵循1988年《临床实验室改进修正案》，QC材料的使用频率/水平数量相对较低时，对误差的防护作用更强。
使用QC可防止1型人类免疫缺陷病毒抗体酶免疫测定检测中的误差。应按照1988年《临床实验室改进修正案》的要求，每次检测使用两个水平的QC。
