Lasky F D
Clinical Products Division, Eastman Kodak Company, Rochester, NY 14650-1252.
Clin Chem. 1992 Jul;38(7):1260-7; discussion 1268-72.
I propose using proficiency testing (PT) to achieve one of the important goals of CLIA: accurate and reliable clinical testing. Routine methods for the clinical laboratory are traceable to Definitive (DM) or Reference Methods (RM) or to Methodological Principles (MP) through a modification of the National Reference System for the Clinical Laboratory. PT is the link used to monitor consistent field performance. Although PT has been effective as a relative measure of laboratory performance, the technical limitations of PT fluids and of routine methods currently in use make it unlikely that PT alone can be used as a reliable measure of laboratory accuracy. Instead, I recommend calibration of routine systems through correlation to DM, RM, or MP with use of patients' specimens. The manufacturer is in the best position to assume this responsibility because of also being responsible for consistent, reliable product. Analysis of different manufactured batches of reagent would be compared with predetermined goals for precision and accuracy, as illustrated with data from product testing of Kodak Ektachem clinical chemistry slides. Adoption of this proposal would give manufacturers of PT materials, manufacturers of analytical systems, PT providers, and government agencies time to understand and resolve sources of error that limit the utility of PT for the job required by law.
我提议使用能力验证（PT）来实现临床实验室改进修正案（CLIA）的一个重要目标：准确可靠的临床检测。临床实验室的常规方法可通过对国家临床实验室参考系统的修改追溯到决定性方法（DM）或参考方法（RM）或方法学原理（MP）。PT是用于监测现场一致性能的环节。尽管PT作为实验室性能的相对度量是有效的，但PT检测液和当前使用的常规方法的技术局限性使得仅靠PT不太可能用作实验室准确性的可靠度量。相反，我建议通过使用患者标本与DM、RM或MP进行相关性分析来校准常规系统。由于制造商还需对产品的一致性和可靠性负责，因此他们最适合承担这一责任。不同生产批次试剂的分析结果将与预先确定的精密度和准确度目标进行比较，就像柯达爱克发临床化学玻片产品检测的数据所示。采纳这一提议将使PT材料制造商、分析系统制造商、PT供应商和政府机构有时间去理解和解决那些限制PT在法律要求工作中效用的误差来源。
