Peddecord K M, Benenson A S, Hofherr L K, Francis D P, Garfein R S, Ferran K L, Taylor R N, Schalla W O, Ascher M S
College of Health and Human Services, San Diego State University, CA 92182.
Clin Lab Sci. 1992 May-Jun;5(3):165-71.
The use of blind proficiency testing (PT) to examine analytic performance of human immunodeficiency virus type 1 (HIV-1) antibody testing. A total of 32 hospital, blood bank, public health, and commercial laboratories were included in this study. Test sera were introduced as clinical specimens for HIV-1 testing from private practitioners, group practices, clinics, and hospitals in Southern California. A total of 26 laboratories were located throughout California, with six laboratories located in six other states. Results from 306 enzyme immunoassay screening tests and 192 supplemental tests for HIV-1 were reported. Although one positive specimen was reported as indeterminate in almost 30% of results, screening and supplemental testing performances were excellent, with accuracy levels comparable to performance reported on open PT and performance evaluation surveys in the United States. The indeterminate results were attributed to the interpretive criteria used rather than to laboratory errors. Blind PT can be an important tool in improving the quality of total laboratory testing, the usefulness of laboratory results in patient care, and ultimately the health of the public.
使用盲法能力验证(PT)来检测1型人类免疫缺陷病毒(HIV-1)抗体检测的分析性能。本研究共纳入了32家医院、血库、公共卫生机构和商业实验室。检测血清作为来自南加州私人执业医生、团体诊所、诊所和医院的HIV-1检测临床标本引入。共有26家实验室分布在加利福尼亚州各地,另外6家实验室位于其他6个州。报告了306次HIV-1酶免疫分析筛查试验和192次补充试验的结果。尽管在近30%的结果中,有一个阳性标本被报告为不确定,但筛查和补充检测性能优异,准确性水平与美国公开PT和性能评估调查中报告的性能相当。不确定结果归因于所使用的解释标准,而非实验室误差。盲法PT可以成为提高实验室整体检测质量、实验室结果在患者护理中的有用性以及最终公众健康的重要工具。