IVD is a vital reference frame for making decisions to clinical diagnosis, to ensuring the precision of the testing result is the first priority. Traceability of value of quantity can trace back to the most standard international certified reference materials for 

Traceability of value of quantity is to verify the whole testing systems including instruments, reagents, calibrators and operating procedure, any of steps above have problem will lead to the inaccurate result. However, most of enterprises are not willing to invest into it due to the reason of that in one way it needs technology accumulation year by year, on the other hand it could not generate economic benefits directly, which let the ability of traceability of value of quantity in most domestic IVD enterprises stays on a low level.

On the big trend of medical reform, traceability of value of quantity will become an important index in IVD industry. At present, the testing result in different hospitals cannot be mutual recognized and repeated testing happens frequently. With the gradually medical reform deepening, to promote medical institute recognizing mutual laboratory result is an inexorable trend. The essential precondition to push the test result mutual recognizing is to adopt the same testing standard in separate labs with international common standard of ISO15189 (The Requirements of Quality and Ability For Medical Laboratory). Testing result presented by laboratory of ISO15189 certificate can be mutual recognized, and the quality system construction guaranteed by traceability of value of quantity is a necessary requirement to pass the ISO15189 certificate. Therefore, under the big background of medical reform, traceability of value of quantity will become a key competitive index and necessary quality in IVD enterprise.

Difficult assessment of traceability of value of quantity, less enterprise will take the lead:

1. JCTLM is the premier accrediting and validating agency in global for ability of traceability of value of quantity, only 14 medical reference laboratory has been permitted including, for enterprises, it just has the international IVD giant Roche and China Maccura Bio, and Maccura has passed 6 enzymologies and 2 metabolins testing items, Roche has passed 2 metabolins through JCTLM.

2. CNAS is the premier agency for medical reference laboratory certificate in domestic, only two IVD enterprises Maccura and Mindray passed the permission, because CNAS and ILCA signed the mutual recognizing agreement, so both of the companies testing result can be recognized by the same industries in worldwide.

3. The quality evaluating activities among RELA laboratories organized by IFCC annually builds a optimal platform for global laboratory presenting ability of traceability of value of quantity. There are several enterprises participate it in domestic, judging from the integrated index of aspects, participating times, amount of participation and  passing rate we thought the best enterprises for Rela testing are Maccura, Mindray and MedicalSystem.