背景:临床实验室测试正在以参考间隔(RI)进行评估。因此,重要的是,每个实验室确定和分类自己的可靠的RI为每个测试,以确保准确和有效的解释。建议的确定RI的方法是“直接”方法,但这很困难,麻烦,耗时,和昂贵的方法。另一种方法是“间接”方法。在这项研究中,我们的目的是比较间接方法从钙(Ca)中确定的RI值,镁(Mg),磷酸盐(P),25-羟基维生素D(25(OH)D),和甲状旁腺激素(PTH)测试结果与制造商提供的RI。
方法:总共1,520,314Ca,Mg,P,25(OH)D,和PTH测试结果,2022年1月至11月在我们实验室进行的研究也纳入了研究.对年龄在18-89岁之间的个体进行数据清理,并且只允许一个记录。Tukey方法用于确定和排除极值。Ca和Mg测试分为年龄组(18-59岁和60-89岁),P,25(OH)D,PTH测试分为女性-男性组。RI是通过使用Bhattacharya和Hoffmann方法计算的。CLIA19可接受限值用于评估制造商RI的合规性。
结果:发现通过应用Bhattacharya和Hoffmann方法获得的RI结果显着一致且相互兼容。根据制造商的RI,Ca和Mg在两种方法中均与RI相容,在Bhattacharya方法中,P被认为与PTH和25(OH)D参考上限兼容,在霍夫曼方法中,P被认为与25(OH)D参考下限和PTH参考上限相容,虽然在Bhattacharya方法中发现25(OH)D参考下限不同,在霍夫曼方法中,发现25(OH)D参考上限和PTH参考下限在P男性组中不同。
结论:我们认为,对于每个实验室来说,确定他们所服务人群的特异性RI,并根据年龄和性别选择他们使用的分析方法,同时定期更新它们以正确解释测试结果非常重要。
BACKGROUND: Clinical laboratory tests are being evaluated with reference intervals (RI). Therefore, it is important that each laboratory determines and classifies its own reliable RI for each test to ensure an accurate and effective interpretation. The proposed method for determining RI is the \"direct\" approach, but it is a difficult, troublesome, time-consuming, and expensive method. An alternative approach is the \"indirect\" approach. In this study, we aimed to compare the RI values determined by the indirect method from the Calcium (Ca), Magnesium (Mg), Phosphate (P), 25-Hydroxy Vitamin D (25(OH)D), and Parathyroid hormone (PTH) test results with the RI provided by the manufacturer.
METHODS: A total of 1,520,314 Ca, Mg, P, 25(OH)D, and PTH test results, which were studied in our laboratory between January and November 2022, were included in the study. Data cleaning was done for individuals between the ages of 18 - 89, and only one record was allowed. The Tukey method was used to determine and exclude extreme values. Ca and Mg tests were divided into age groups (18 - 59 and 60 - 89 years), P, 25(OH)D, and PTH tests were divided into female - male groups. RI was calculated by using the Bhattacharya and Hoffmann methods. CLIA 19 acceptable limits were used to evaluate the compliance with the manufacturer\'s RI.
RESULTS: The RI results obtained by applying the Bhattacharya and Hoffmann methods were found to be significantly consistent and compatible with each other. According to the manufacturer\'s RI, Ca and Mg were compatible with RI in both methods, P was considered compatible with PTH and 25(OH)D upper reference limit in the Bhattacharya method, P was considered compatible with 25(OH)D lower reference limit and PTH upper reference limit in the Hoffmann method, while 25(OH)D lower reference limit was found to be different in the Bhattacharya method, and 25(OH)D upper reference limit and PTH lower reference limit were found to be different in the P male group in the Hoffmann method.
CONCLUSIONS: We believe that it is of great importance for each laboratory to determine the RI specific for the population they serve and to choose the analytical method they use according to age and gender while periodically updating them to interpret the test results correctly.