Evaluation of a Novel Capillary Blood Collection System for Blood Sampling in Nontraditional Settings as Compared...

Nontraditional sites for blood collection, including retail pharmacies, can expand access to laboratory testing. Three studies assessed the BD® MiniDraw™ Capillary Blood Collection System (BD MiniDraw) along with the BD MiniDraw SST™ Capillary Blood Collection Tube (BD MiniDraw SST tube). This system allows trained healthcare workers to collect capillary blood without requiring phlebotomy experience, in accordance with state laws.

Studies 1 and 2 evaluated clinical equivalence for selected serum chemistry analytes in the BD MiniDraw compared with currently marketed capillary and venous comparators. Study 3 evaluated within-tube stability for selected analytes up to 48 h in BD MiniDraw SST tubes following storage (2°-8°C). Contrived specimens were prepared to cover medically relevant ranges. Testing was performed on one general chemistry core laboratory analyzer in each study. Clinical equivalence was demonstrated if the biases and 95% limits were within a predefined clinical acceptance limit at all medical decision levels and time points for stability.

Clinical equivalence was demonstrated for all analytes for BD MiniDraw vs capillary and venous comparators except alanine aminotransferase and chloride for the venous comparator in study 1. Both showed clinical equivalence at the upper limit of the reference range; the confidence interval exceeded the clinical acceptance limit at the lower limit. Within-tube stability was demonstrated in BD MiniDraw SST tubes up to 48 h for all selected analytes.

The BD MiniDraw presents an option for blood collection in nontraditional settings that is clinically equivalent to conventional capillary and venous collection for the specified analytes.