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 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.
Thubian et al. (Wed,) studied this question.
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