A-104 Evaluation of Hemoglobin, Hematocrit, and Hemoglobin A1c in BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ Hemoglobin and Hematocrit Capillary Blood Collection Tube Compared with Capillary and Venous Comparators

Abstract Background Hemoglobin and Hematocrit (Hb and Hct) are primary indicators in the diagnosis of anemia, and Hemoglobin A1c (HbA1c) is widely used to screen and monitor patients for diabetes. Patients with these conditions may require frequent blood testing for disease management. Capillary blood collection offers a less invasive alternative to traditional venipuncture with possible expanded access to new sampling locations, including retail pharmacies. Innovative technologies have been developed that enable capillary blood collection by trained healthcare workers, in accordance with state laws, at non-traditional healthcare settings. This study evaluated the BD® MiniDraw™ Capillary Blood Collection System with the BD® MiniDraw™ Hemoglobin & Hematocrit (H&H) Capillary Blood Collection Tube with K2EDTA (BD MiniDraw™ H&H) for Hb, Hct, and HbA1c in comparison with respective comparator capillary and venous tubes. Methods A total of 126 participants were enrolled at three sites representative of various ancillary healthcare settings (i.e., retail pharmacies or patient service centers). The study population included apparently healthy participants and patient populations that covered a range of disease states (e.g., diabetes, anemia). Blood was collected from each participant into the BD MiniDraw™ H&H, comparator capillary and venous study tubes. Contrived specimens were also prepared to cover the medically relevant range. Specimens collected at the ancillary sites were transported to the laboratory for analysis within four hours of collection end time. Testing was performed on the Sysmex XN-1000 Automated Hematology Analyzer for Hb and Hct and then on the Bio-Rad D-100™ Hemoglobin Testing System for HbA1c. Bias between-tube types at pre-determined medical decision levels were estimated with two one-sided 95% confidence intervals (95% limits). For each tube comparison, clinical equivalence was demonstrated if the biases and 95% limits were within the specified clinical acceptance limit for each parameter/analyte (Hct – 5%; Hb – 3%; HbA1c – 0.5% applied on the %unit scale). Results The biases and 95% limits at each medical decision level were within the clinical acceptance limit for each parameter/analyte for the BD MiniDraw™ H&H vs the capillary and venous comparators except Hb vs the venous comparator. For this comparison, the biases were within the CAL, but the 95% upper limits exceeded the CAL at the upper end of the reference range and the high critical value. This was considered clinically acceptable, as the result would not have a significant impact on patient treatment or diagnosis. Conclusion The BD MiniDraw™ Capillary Blood Collection System demonstrated clinical equivalence for HbA1c and Hct when compared with the capillary and venous comparators and for Hb when compared with the capillary comparator. Clinically acceptable performance for Hb was shown vs the venous comparator. This system provides a viable option for the collection of capillary blood at non-traditional healthcare settings, such as pharmacies and patient service centers. Notes: The BD MiniDraw™ Capillary Blood Collection System is not currently cleared for HbA1c by the FDA. Bio-Rad D-100™ System is only currently cleared by the FDA for testing whole blood specimens collected in vacuum collection tubes containing various anticoagulant additives including K2EDTA.