HbA1c screening in the community: Lessons for safety and quality management of a point of care programme
| Autor: | Sue Wells, Timothy Kenealy, Geoffrey Herd, Samarina M A Musaad |
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| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
Nutrition and Dietetics Quality management business.industry Endocrinology Diabetes and Metabolism Point-of-care testing 030209 endocrinology & metabolism Roche Diagnostics law.invention 03 medical and health sciences 0302 clinical medicine Risk screening Randomized controlled trial law Pre diabetes Internal Medicine Medicine Medical physics 030212 general & internal medicine Family Practice business Quality assurance Point of care |
| Zdroj: | Primary Care Diabetes. 13:170-175 |
| ISSN: | 1751-9918 |
| Popis: | Aim To describe quality management processes and appropriate interpretation with respect to HbA1c point-of-care (POC) testing in a national diabetes and cardiovascular risk screening programme. Methods We compared HbA1c results from capillary blood, measured by the cobas b 101 (Roche Diagnostics) POC testing system, with results from venous blood measured by accredited laboratory analysers to inform national screening practice and a (separately-reported) randomised controlled trial. Difference plots and regressions were used to aid interpretation around 40 and 50 mmol/mol, the cut-offs used to identify “pre-diabetes” and diabetes in New Zealand. Results After initial acceptable tests, subsequent batches delivered POC results that varied from laboratory HbA1c by +6 to −14 mmol/mol around the clinical cut-offs. Ten faulty batches of discs were recalled worldwide. POC testing was suspended in one region, as was the planned trial. The manufacturing defect was rectified, accuracy of the new batches was confirmed, and testing resumed. Conclusion POC testing must be conducted within stringent quality assurance processes prior to and while in use. Within such a system, POC testing for HbA1c can be sufficiently accurate for screening and diagnosis of diabetes. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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