EQA Program for HbA1c Analyzes Lyophilized Human Blood Monthly

A new cycle of an external quality assessment (EQA) program checks whether laboratories are obtaining accurate results for glycated hemoglobin (HbA1c) testing.

Laboratories worldwide receive samples that they can analyze as if they were patient samples. Each laboratory's test results are compared to the overall results of the group so that laboratories can assess their performance against others using the same analyzers and reagents.

Introduced by Randox (Crumlin, UK), the new cycle of tests is known as the Randox International Quality Assessment Scheme (RIQAS), and is an international EQA scheme used by 7,000 laboratories worldwide, participating in up to nine programs.

The HbA1c program from RIQAS uses lyophilized human blood, which should be analyzed monthly. The EQA samples range from 4-14%, include a linearity series, and cover clinically important decision levels. Once reconstituted, the EQA samples are stable at 2-8 °C for three months and can be used for internal quality control purposes. Participants will receive additional added-value samples during the course of the 12-month cycle.

Comprehensive reports compare participant performance to the overall results of all laboratories using the same instrument and method. Participants register as International Federation of Clinical Chemistry (IFCC) and laboratory medicine-aligned, Diabetes Control and Complications Trial/National Glycohemoglobin Standardization Program (DCCT/NGSP)-aligned, or non-aligned. RIQAS reports are sent by e-transfer within two days of the final date for submission of results or posted within three days of the final date.

HbA1c is used to evaluate diabetics' average blood glucose levels over the preceding six to eight weeks. Elevated HbA1c levels are associated with an increased risk of diabetes complications. Different methods of determining HbA1c can produce varying laboratory results, illustrating the importance of EQA in HbA1c measurement. EQA plays a vital role in the harmonization of HbA1c results worldwide.


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