Department of Laboratory Medicine, The Catholic University of Korea, St. Vincent's Hospital, Suwon, Korea.
Department of Laboratory Medicine, The Catholic University of Korea, Bucheon St. Mary's Hospital, Bucheon, Korea.
Ann Lab Med. 2019 Nov;39(6):552-560. doi: 10.3343/alm.2019.39.6.552.
In Korea, the Korean Laboratory Accreditation Program (KLAP) has set minimum standards for verification of clinical test performance. This verification process is time-consuming and labor-intensive when performed manually. We developed a free, statistical software program for KLAP, using the R language (R Foundation for Statistical Computing, Vienna, Austria).
We used CLSI guidelines for the algorithm. We built graphic user interfaces, including data input, with Embarcadero Delphi EX4 (Embarcadero Technologies, Inc., Texas, USA). The R Base Package and MCR Package for Method Comparison Regression were used to implement statistical and graphical procedures.
Our program LaboStats has six modules: parallel test, linearity, method comparison, precision, reference interval, and cutoff. Data can be entered into the field either manually or by copying and pasting from an MS Excel worksheet. Users can print out precise reports.
LaboStats can be useful for evaluating clinical test performance characteristics and preparing documents requested by KLAP.
在韩国，韩国实验室认可计划 (KLAP) 为临床检验性能的验证设定了最低标准。当手动执行此验证过程时，既耗时又费力。我们使用 R 语言（奥地利维也纳的 R 基金会统计计算）为 KLAP 开发了一个免费的统计软件程序。
我们使用 CLSI 指南作为算法。我们使用 Embarcadero Delphi EX4（美国德克萨斯州的 Embarcadero Technologies，Inc.）构建了包括数据输入在内的图形用户界面。R 基础包和方法比较回归的 MCR 包用于实现统计和图形过程。
我们的程序 LaboStats 有六个模块：平行测试、线性、方法比较、精密度、参考区间和截止值。数据可以手动输入到字段中，也可以从 MS Excel 工作表中复制粘贴。用户可以打印出精确的报告。
LaboStats 可用于评估临床检验性能特征，并准备 KLAP 要求的文件。
