Malvano R, Pilloton E, Pizzocolo G, Tanzi E, Signorini C
Istituto di Chimica, Facoltà di Medicina, Università degli Studi, Brescia.
Ann Ist Super Sanita. 1991;27(3):437-41.
For qualitative (2-class) tests, which provide binary (yes/no) information, the correctness of specimen classification remains the most important criterion for performance evaluation. However, a more informative picture emerges from the relationship between percentage of positive results and analyte concentration, which allows some inherent test characteristics to be derived (the positive/negative discrimination concentration and the "grey zone" around it). The information content of evaluation approaches is decidedly improved by the availability of numerical results (counts per minute, absorbance) in most situations of clinical interest. The concentration/response functions underlying the quality of individual tests may thus be derived and compared, and laboratory staff given a more objective criterion to judge individual performance. Examples are drawn from the authors' experience in running external quality assessment programs for tests for infectivity markers.
对于提供二元（是/否）信息的定性（两类）检测，样本分类的正确性仍然是性能评估的最重要标准。然而，从阳性结果百分比与分析物浓度之间的关系中可以得出更具信息量的情况，这使得一些固有的检测特性得以推导出来（阳性/阴性判别浓度及其周围的“灰色区域”）。在大多数临床相关情况下，由于可获得数值结果（每分钟计数、吸光度），评估方法的信息含量得到了显著提高。因此，可以推导和比较各个检测质量所依据的浓度/响应函数，并为实验室工作人员提供一个更客观的标准来判断个人表现。实例取自作者在开展传染性标志物检测外部质量评估项目方面的经验。
