Svensk Förening för Diabetologi med nordiska kollegor tillsammans med Equalis skrev till amerikanska myndigheter för drygt 3 år sedan och klagade över deras förslag till slappa kvalitetskrav på HbA1c

Nu kom det feed-back på våra synpunkter

I den färdiga amerikanska regeltexten skärps kvalitetskravet från +/- 10 % till +/- 8%

Fortfarande vidare gränser än vad vi tillämpar i Skandinavien. Man motiverar valet med att det även ska gå att uppnå med sämre provmaterial än vid vi använder i Skandinavien.

Bästa sommarhälsningar


Gunnar Nordin | Equalis
Box 977, SE 751 09 Uppsala, Sweden

April 4th 2019
To Department ofHealth and Human Services, Baltimore,MDAttention:CMS–3355–P
Regarding proposed new rules under Clinical Laboratory Improvement Amendments (CLIA)

Thanks to its improved standardization, HbA1c has developed to a key tool for the management of diabetes worldwide.

Recently an updated CLIA criterium for acceptable performance in PT for HbA1c was suggested. (Federal Register / Vol. 84, No. 23 / Monday, February 4, 2019 / Proposed Rules). The criterium is proposed to be “the target value ±10 %” (with an estimated miss rate of 1-2 %).

CLIA criteria might affect the accuracy specified by manufacturers of devices for measurement of HbA1c. Therefore, the criteria might also have an indirect impacton the accuracy of assays provided for the market outside the US.

We would therefore like to draw theattention to that a performance criterium of ±10 % from the target value, at a HbA1c level of 6.5 NGSP%, corresponds to ±15 % for HbA1c-values which are traceable to the IFCC reference system and expressed with the unit mmol/mol.

Such level of inaccuracy will not meet general requirements for clinical use of HbA1c in Europe.

For comparison, the current criterium for acceptable performance in the Swedish and Norwegian proficiency testing programmes for HbA1c is ±7 % from the target value (at the HbA1c level of 48 mmol/mol and a miss rate of 5 %), which correspondsto ±5% at 6.5% NGSP.

This criterium was well fulfilled by all hospital methods as well as by the POCT methods on the Swedish and Norwegian market during 2018. 

The reliability of HbA1c that has been achieved is acknowledged by diabetologists as well as patients.If the now suggested wider CLIA criterium should be effective, it must be assured that manufacturers of HbA1c assays will not impair the analytical performance for HbA1c assays marketed outside US.


Gunnar Nordin

External quality assessment inlaboratory medicine in Sweden (Equalis)

David Nathanson

President of Swedish Society for Diabetology SFD

Anna Olivecrona

President of Swedish Society for Pediatric Endocrinology and Diabetes

Hanna Dis Margeirsdottir

Norwegian Study Group of Childhood Diabetes

Sverre Sandberg

Norwegian Organization for Quality Improvement of Laboratory Examinations (Noklus) and Norwegian Diabetes Registry