NGSP News Archive

New Certification Criteria beginning in 2019

The NGSP certification criteria have been tightened beginning with January 2019 certifications; the changes are summarized in the table below.

Certification
Type

2014-2018 Certification Criterion

New Certification Criterion (2019)

Manufacturer

37 of 40 results within ± 6%

36 of 40 results within ± 5%

Level I Lab

38 of 40 results within ± 6%

37 of 40 results within ± 5%

Level II Lab

37 of 40 results within ± 6%

36 of 40 results within ± 5%

 

HbA1c Recommended for Diagnosis

An international expert committee that includes representatives from the American Diabetes Association (ADA), International Diabetes Federation (IDF), and European Association for the Study of Diabetes (EASD) has officially endorsed the use of HbA1c to diagnose diabetes. The recommended cutoff is HbA1c ≥ 6.5%. The recommendation has been officially endorsed by the American Diabetes Association and endorsed with qualifications by the American Association of Clinical Endocrinologists/American College of Endocrinologists, the Endocrine Society. the World Health Organization and the International Diabetes Federation.

2010 Consensus Statement on the Worldwide Standardization of HbA1c

The American Diabetes Association, the European Association for the Study of Diabetes, the International Diabetes Federation, the International Federation of Clinical Chemistry and the International Society for Pediatric and Adolescent Diabetes recently published an updated consensus statement regarding HbA1c standardization (the original consensus statement was issued in 2007). The recommendations are:

  1. HbA1c test results should be standardised worldwide, including the reference system and results reporting.
  2. The IFCC reference system for HbA1c represents the only valid anchor to implement standardisation of the measurement.
  3. HbA1c results are to be reported by clinical laboratories worldwide in SI (Système International) units (mmol/mol – no decimals) and derived NGSP units (% - one decimal), using the IFCC-NGSP master equation (DCCT units).
  4. HbA1c conversion tables including both SI (IFCC) and NGSP units should be easily accessible to the diabetes community.
  5. Editors of journals and other printed material are strongly recommended to require that submitted manuscripts report HbA1c in both SI (IFCC) and NGSP/DCCT units.
  6. The reportable term for glycated hemoglobin is HbA1c, although other abbreviations may be used in guidelines and educational material (A1C).
  7. The above consensus recommendations apply through 2011, when they will be discussed again at the next consensus meeting at the IDF meeting in Dubai December 2011.