评价ALT1快速检测试剂对肝病患者的诊断价值

Evaluation on the diagnostic value of ALT1 rapid detection reagent in patients with liver diseases

目的通过与速率法检测结果进行比较,评价肝病人群中丙氨酸转氨酶1(alanine aminotransferase 1, ALT1)快速检测试剂检测血清ALT酶活性的真实性、可靠性和预测值。方法采用诊断试验的横断面研究设计,选取江苏省人民医院感染病科2019年10月—2020年1月就诊的肝病患者作为研究对象,调查研究对象一般情况并采集全血标本进行测试。通过诊断试验评价方法,计算肉眼判读与仪器检测下试剂检测血清ALT酶活性的诊断试验指标。结果本研究共纳入患者233人。其中男性占60.94%(142/233),女性占39.06%(91/233);门诊患者占50.64%(118/233),住院患者占49.36%(115/233);研究对象中位年龄为51(四分位间距:40~60)岁。肉眼判读试剂的灵敏度为99.28%(137/138),特异度为22.11%(21/95),准确度为67.81%(158/233),约登指数为0.213 9,阳性预测值为64.93%(137/211),阴性预测值为95.45%(21/22)。仪器检测下试剂的灵敏度为99.28%(137/138),特异度为45.26%(43/95),准确度为77.25%(180/233),约登指数为0.445 4,阳性预测值为72.49%(137/189),阴性预测值为97.73%(43/44)。肉眼判读下试剂重测的Kappa值为0.654 7,仪器检测下试剂重测的Kappa值为0.557 0。结论 ALT1快速检测试剂的特异度和阳性预测值较低,真实性有待进一步验证,但可靠性较好,或将用于肝病患者居家自行检测。

Objective To evaluate the validity, reliability and predictive value of ALT1 rapid detection reagent testing serum alanine aminotransferase(ALT) enzyme activity. Methods This study adopted the cross-sectional design of the diagnostic test.Patients were recruited from the Department of Infectious Disease of Jiangsu Provincial Hospital from October, 2019 to January, 2020.The general information of the study subjects was collected through questionnaires and then the whole blood specimens were collected for the reference standard and the target test.By the diagnostic test evaluation method, this study calculated the diagnostic test indexes. Results A total of 233 patients were included in this study and among them, males accounted for 60.94%(142/233) and females 39.06%(91/233);outpatients accounted for 50.64%(118/233) and inpatients 49.36%(115/233).The median age was 51(interquartile range: 40-60).Under the visual interpretation, the sensitivity was 99.28%(137/138) while the specificity was 22.11%(21/95), the accuracy was 67.81%(158/233);the Youden′s index was 0.213 9, the positive predictive value was 64.93%(137/211), the negative predictive value was 95.45%(21/22).Under the instrumental detection, the sensitivity was 99.28%(137/138) and the specificity was 45.26%(43/95), the accuracy was 77.25%(180/233), the Youden′s index was 0.445 4, the positive predictive value was 72.49%(137/189), the negative predictive value was 97.73%(43/44).The retested Kappa value was 0.654 7 under the visual interpretation.The retested Kappa value was 0.557 0 under the instrumental detection. Conclusions The specificity and positive predictive value of ALT1 rapid detection reagent are relatively low,but the reliability is good.