Establishing the clinical reportable range of hemiluminscence immunoassay in detection of AFP

[Objective] To establish the clinicl reportable range of chemiluminscence immunoassay in detection of AFP. [Methods] Referring to NCCLS EP6-P2 evaluation protocols and pertinent literature. We performed the validate experiments of analytical measurement rang and max dilution limit by Bayer Centaur 240 chemiluminscence immunoassay system. Which results combining functional sensitivity would be established the clinical reportable range. [Results] The analytical measurement rang of AFP was 1.00~912 ng/mL, the max dilution limit was 1∶50, both were compared with the declaration of the Manufacturer. And the clinical reportable range was 3.65~45600 ng/mL. [Conclusions] It is important to establish clinical reportable range for the items, which have special significance at high levels.