37 巻 (2008) 1 号 p. 68-74
This guideline describes the procedure of reliability evaluation on hemoglobin Alc (HbAlc) measurement to meet the traceability chain in HbAlc reference systern in Japan. The accuracy of routine measurement procedures shall be validated by manufacturers according to manufacturer's standard operating procedures. Routine laboratories shall maintain accuracy of measurement based on the manufacturer's validation.
The accuracy of measurement is expressed by uncertainty estimated according to ISO Guide 33. Performance evaluation of routine measurement procedures should be based on the measurements which are composed of ten runs of measurement a day or two runs of measurements per day and continue to ten days against the evaluation material in this guideline. The material to be used for the performanceevaluation for HbAlc measurement (QRM HbAlc) is prepared and distributed by HECTEF Standard Reference Center. This material has five concentration levels and assigned values by using JSCC reference measurement procedure using KO500 method calibrated by JCCLS CRM-004.
Validation criterion is determined for each evaluation procedure. These criteria suggest how manufacturer's validation should maintain traceability to the working reference material (JCCLS CRM-004). The internal quality control system in the routine measurement laboratory is required to maintain ±0.2% (JDS value) as an uncertainty.