Article ; Online: Accuracy of point-of-care HbA1c testing in pregnant women.
The Australian & New Zealand journal of obstetrics & gynaecology
2018 Volume 58, Issue 6, Page(s) 643–647
Abstract: Background: In New Zealand, it is recommended that all pregnant women have a haemoglobin A1c (HbA1c) test performed with their booking antenatal bloods to identify previously unrecognised diabetes. However, screening rates in some groups are low. Use of ...
| Abstract | Background: In New Zealand, it is recommended that all pregnant women have a haemoglobin A1c (HbA1c) test performed with their booking antenatal bloods to identify previously unrecognised diabetes. However, screening rates in some groups are low. Use of a point-of-care device may improve compliance with screening. Aim: To assess the accuracy of the COBAS b101 point-of-care system referenced against a laboratory method, for measurement of HbA1c levels in pregnant women. Materials and methods: Convenience sample of 40 obese pregnant women enrolled in a clinical trial. HbA1c was assayed in paired capillary and venous whole blood samples using the COBAS b101 point-of-care system and Primus Ultra2 high performance liquid chromatography laboratory analyser, respectively. The accuracy of the point-of-care system was assessed by Bland-Altman analysis. Results: The mean (SD) laboratory HbA1c was 35.9 (2.0) mmol/mol. The COBAS b101 point-of-care system, compared with the laboratory reference method, had a small negative bias for HbA1c (-1.0 mmol/mol, 95% CI -2.0 to -0.03, P = 0.03) and relatively wide 95% limits of agreement (-7.2 to 5.1 mmol/mol). Conclusion: In conclusion, we found that in pregnancy, the COBAS b101 point-of-care system has a small negative bias and modest point accuracy for HbA1c. When used to screen for previously unrecognised diabetes in pregnancy, appropriate COBAS b101 HbA1c point-of-care HbA1c thresholds for a negative and positive result are 7 mmol/mol below and 5 mmol/mol above the clinical threshold, respectively. Values between these limits should be confirmed by laboratory testing. |
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| MeSH term(s) | Adult ; Clinical Laboratory Techniques ; Diabetes Mellitus/blood ; Diabetes Mellitus/diagnosis ; Diabetes, Gestational/blood ; Diabetes, Gestational/diagnosis ; Female ; Glycated Hemoglobin A/metabolism ; Humans ; Mass Screening/methods ; Point-of-Care Systems ; Point-of-Care Testing ; Pregnancy ; Prenatal Care ; Reproducibility of Results ; Young Adult | |||||
| Chemical Substances | Glycated Hemoglobin A ; hemoglobin A1c protein, human | |||||
| Language | English | |||||
| Publishing date | 2018-02-22 | |||||
| Publishing country | Australia | |||||
| Document type | Journal Article | |||||
| ZDB-ID | 390815-x | |||||
| ISSN | 1479-828X ; 0004-8666 | |||||
| ISSN (online) | 1479-828X | |||||
| ISSN | 0004-8666 | |||||
| DOI | 10.1111/ajo.12786 | |||||
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| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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