In Vitro Diagnostic Industry in China - Immunoassay XI

5.3 Ensure the Result of Automatic Chemiluminescence Detection System More Accurate and Reliable

If Chinese chemiluminescence would eventually replace imported products completely, it must ensure the accuracy and reliability of the test results. In addition to the improvement of equipment system and methodology, the accuracy of results will involve two very core competitions in the future.

5.4 Ensure the Results of Automatic Chemiluminescence Detection More Accurate and Reliable via Metrological Traceability

Currently, the main problem of chemiluminescence immunoassay is that the results of systems from different manufacturers are often distinct, which affects the generality of patient detection results and sometimes causes confusion of doctors and patients; while the metrological traceability is the only way for the standardization of laboratory medicine, which effectively guarantees the accuracy or consistency of in vitro diagnostic detection results. The metrological traceability is based on standard measurement procedures and reference materials to calibrate the whole detection system, including instruments, reagents, calibrators, and operating procedures. Deviations or abnormalities in any link may lead to incorrect detection results. Since the metrological traceability requires many years of technical accumulation and cannot directly produce economic benefits, some enterprises are not motivated to make large-scale investment, resulting in the low metrological traceability of most in vitro diagnostic enterprises in China.

Immunoassay is the most active and widely clinically used technical method in the field of laboratory medicine. Compared with clinical biochemical analysis, the methods for immunoassay items are more complex and diverse, and there are more types of antigen-antibody combinations selected by manufacturers. The corresponding metrological traceability and standardization work, especially for small molecule immunoassay items, is more important and challenging than that for biochemical items. Now, Maccura Biotechnology, Medicalsystem Biotechnology, and other enterprises have built their own metrological traceability platforms which have been accredited by China National Accreditation Service for Conformity Assessment (CNAS) and relevant international organizations.

Last: 5.1 Future Development of Automatic Chemiluminescence Immunoanalyzer

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