A-178 Reduced Hemolysis with a Novel Capillary Collection System as Compared With Conventional Capillary Collection Devices

Abstract

Abstract Background Capillary blood collection is often cumbersome and lacks consistency in the applied pressure during squeezing of the finger. This may result in poor sample quality (i.e., hemolysis and dilution of the sample with interstitial fluid). Standardizing the capillary collection process and thereby making it less technique dependent can enable diagnostic blood testing to be performed in non-traditional settings (e.g., retail pharmacy). A novel capillary blood collection system has been developed to help standardize the process and may enable blood sampling by non-traditional healthcare workers (e.g., pharmacists, pharmacy technicians). Multiple studies were performed to evaluate the performance of this capillary blood collection system on sample quality in comparison with currently marketed capillary and venous blood collection devices. Sample quality was assessed by visual observation of hemolysis and by quantitative assessment of Plasma Free Hemoglobin (PFH). Methods Participants were enrolled at three sites representative of the intended use environment (i.e., retail pharmacy site or patient service center). Phlebotomists performed venipuncture using a currently marketed venous comparator and conventional capillary collection using a capillary comparator. Capillary collection was also performed using the novel capillary device in the same subjects by targeted trained healthcare workers (e.g., retail pharmacists, pharmacy technicians). Blood was collected using each method (venous and two capillary–conventional and novel capillary devices) into serum separator tubes from the same subject within the same timeframe. Data from the studies were pooled in a meta-analysis to assess device performance across multiple studies. Visual assessment of hemolysis was performed post centrifugation using a rating scale (0 = None, 1 = Trace, 2 = Moderate, 3 = Gross). For PFH measurement, a cut-off of >50 mg/dL was selected, as hemolysis interference may be observed at these levels in highly sensitive analytes. Results When compared with the venous comparator, the incidences of hemolysis, as assessed by visual hemolysis and PFH measurements, were higher with capillary collections. However, the incidences were significantly lower with the novel capillary collection system than with the capillary comparator. The overall incidence of visual hemolysis was significantly lower for the new capillary device when compared to the capillary comparator (“None” rating of 94% vs 64.5%). The frequency of trace, moderate and gross hemolysis was also less in the new capillary device when compared to the capillary comparator (4.4% vs 23.2%, 1.2% vs 9.8%, 0.4% vs 2.5%, respectively). For the quantitative measurement of PFH as an indicator of hemolysis, a similar trend was observed. The mean PFH value in the new capillary device was significantly lower than in the capillary comparator (29.87 vs 55.18), and the frequency of PFH >50 mg/dL was also significantly lower in the new capillary device than in the capillary comparator (11.7% vs 42.0%). Conclusions Improved sample quality was demonstrated with a novel capillary blood collection system, as the incidences of hemolysis, as measured visually and quantitatively as PFH measurement, were significantly lower than in conventional capillary blood collection devices. Consequently, this may result in fewer rejected samples in the lab than conventional capillary methods and help meet the demands for more convenient, patient-centric healthcare services.