• Katherine Culliney, McCowan Lesley M E LME Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand. , Karaponi Okesene-Gafa, Rinki Murphy, Janet Rowan, Rennae S Taylor, Christopher J D Mckinlay, and HUMBA Study Group.
• Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand.
• Aust N Z J Obstet Gynaecol. 2018 Dec 1; 58 (6): 643-647.

BackgroundIn 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.AimTo 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 MethodsConvenience 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.ResultsThe 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).ConclusionIn 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.© 2018 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

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