In Vitro Diagnostic Industry in China - Clinical Chemistry XVIII

4.3 Focusing on the Quality Control

As an important reference for clinical diagnosis and treatment, high sensitivities and accuracies are very important for the control over the error of test results. The metrological traceability can provide important support for the accuracy of test results by verifying the entire testing system, including reagents, instruments, personnel and operating procedures, so that the test results can be traced to international and domestic certified reference materials or reference methods, which is an important approach to standardize the medical testing.

The Clinical Laboratory Center of the National Health Commission of the PRC conducts external quality assessment (EQA) for various biochemical reagents every year. EQA is a process in which multiple laboratories analyze the same specimen, and the results reported by the laboratories are collected and fed back by an external independent organization to evaluate the laboratory operations. The inter-laboratory comparisons can reflect the testing abilities of laboratories and monitor their continuity. The EQA program can provide objective evidence for assessing the data reliability and validity. BSBE’s homocysteine is the product that is tested most by laboratories and ranks the first.

Presently, since no perfect testing process and standards have been established between different test institutions and the technicians have different levels, the test results cannot be mutually recognized among different medical institutions, so repeated testing is very common. With the continuous deepening of national medical reform and the gradual improvement of testing standardization, it is an inevitable trend for medical institutions to mutually recognize the test results. In the future, the establishment of a metrological traceability system will become an important competitive advantage for enterprises.

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