Analysis of the types and causes of invalid results in nucleic acid test for blood screening / 中国输血杂志

ABSTRACT

【Objective】 To analyze the reasons for the invalidity of blood nucleic acid test results, and to explore the countermeasures to reduce the invalidity of the test. 【Methods】 From 2019 to 2021, the number of tests performed in our laboratory for Cobas s201 blood nucleic acid screening system and the number of batches and tests with invalid results were counted, and the types and reasons of invalid results were analyzed. 【Results】 From 2019 to 2021, the Cobas s201 nucleic acid detection system detected a total of 5, 420 batches and 127, 950 pools, and the invalid rate of batches and pools were 1.83% and 1.97%, respectively. The types of invalid results can be summarized as improper operation, sample quality problems, invalid quality control (IQC), equipment failure and others. Among them, IQC and equipment failure were the main reasons for invalid results, accounting for 44.51% and 39.96%, respectively. IQC was mainly related to cross-contamination of samples and insufficient mixing of quality control products. Equipment failures mostly occurred in the robotic arm gripper of the nucleic acid extraction instrument and the TC module of the amplification instrument. 【Conclusion】 The laboratory should conduct quality monitoring for invalid results, and take targeted improvement measures, especially to reduce invalid results caused by invalid quality control and instrument failure.