溶血指数对干化学分析仪检测结果的影响及溶血干扰阈值的验证。

Department of Clinical Laboratory, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.

Clinical Laboratory Center, Beijing You'an Hospital, Capital Medical University, Beijing, China.

Ann Palliat Med. 2022 Apr;11(4):1381-1390. doi: 10.21037/apm-22-292.

BACKGROUND

This study verified and assessed 26 biochemical indicators tested by a dry chemistry analyzer using the hemolytic index test function to determine the degree of interference and the trends among the hemolysis samples on the test results. This study also sought to ensure that reasonable test reports could be issued taking into account practical clinical needs.

METHODS

The samples were manually divided into the control group and the test group. The hemolytic index and biochemical indicators of the samples were tested using the Ortho Vitros 5600 to compare the deviation of the test results between the 2 groups. The judgment standard was set as 1/3 of the total error allowable as required by the quality assessment criterion of the National Center for Clinical Laboratories. The interference degree of hemolysis on the dry chemistry-based biochemical indicators was assessed, and the hemolytic thresholds of 26 biochemical indicators provided by the manufacturer were verified in terms of their validity and rationality.

RESULTS

The hemolytic thresholds of 26 dry chemistry-based biochemical indicators were verified to analyze the degree of interference. The results revealed that hemolysis interfered with 17 indicators. Hemolysis positively interfered with the test results of phosphorus, creatine kinase, gamma glutamyl transpeptidase (γ-GGT), magnesium, iron, total protein, potassium, total bilirubin, lactate dehydrogenase, albumin, and aspartate aminotransferase, but negatively interfered with cholinesterase, direct high-density lipoprotein cholesterol, glucose, elevated carbon dioxide alkaline phosphatase, and alanine aminotransferase. A negative deviation of γ-GGT by hemoglobin was described in the manufacturer's statement, but our test data showed a positive deviation by hemolysis. The hemolytic threshold verification results of the other biochemical indicators were consistent with the manufacturer's statement.

CONCLUSIONS

The hemolytic index test function was used to determine which samples were interfered with by hemolysis to make an analytical judgment according to the hemolytic interference thresholds of the different test items, verify the validity of the hemolytic thresholds of the test items, perform reasonable tests on the hemolytic samples, and issue valid reports to reduce the rejection rate of the hemolytic samples, shorten the turnaround time (TAT) of laboratories.

背景

本研究使用干化学分析仪的溶血指数测试功能验证和评估了 26 项生化指标，以确定溶血样本对测试结果的干扰程度和趋势。本研究还旨在确保考虑到实际临床需求，能够发出合理的测试报告。

方法

将样本手动分为对照组和测试组。使用 Ortho Vitros 5600 测试样本的溶血指数和生化指标，比较两组之间的测试结果偏差。判断标准设定为按照国家临床检验中心质量评估标准要求的总允许误差的 1/3。评估了溶血对基于干化学的生化指标的干扰程度，并验证了制造商提供的 26 项生化指标的溶血阈值的有效性和合理性。

结果

验证了 26 项基于干化学的生化指标的溶血阈值以分析干扰程度。结果表明，溶血干扰了 17 项指标。溶血对磷、肌酸激酶、γ-谷氨酰转肽酶（γ-GGT）、镁、铁、总蛋白、钾、总胆红素、乳酸脱氢酶、白蛋白和天冬氨酸氨基转移酶的测试结果有正向干扰，但对胆碱酯酶、直接高密度脂蛋白胆固醇、葡萄糖、高碳酸酶和丙氨酸氨基转移酶有负向干扰。制造商的声明中描述了血红蛋白对 γ-GGT 的负偏差，但我们的测试数据显示了溶血的正偏差。其他生化指标的溶血阈值验证结果与制造商的声明一致。