Autor: |
Noble LD; WITS Diagnostic Innovation Hub, University of the Witwatersrand, Johannesburg 2000, South Africa., Dixon C; WITS Diagnostic Innovation Hub, University of the Witwatersrand, Johannesburg 2000, South Africa., Moran A; Loop Medical SA, 1015 Lausanne, Vaud, Switzerland., Trottet C; Loop Medical SA, 1015 Lausanne, Vaud, Switzerland., Majam M; Ezintsha, a Sub-Division of Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg 2000, South Africa., Ismail S; Ezintsha, a Sub-Division of Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg 2000, South Africa., Msolomba VT; Ezintsha, a Sub-Division of Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg 2000, South Africa., Mathobela K; WITS Diagnostic Innovation Hub, University of the Witwatersrand, Johannesburg 2000, South Africa., Queval A; Loop Medical SA, 1015 Lausanne, Vaud, Switzerland., George J; WITS Diagnostic Innovation Hub, University of the Witwatersrand, Johannesburg 2000, South Africa.; National Priority Programmes, National Health Laboratory Service, Johannesburg 2000, South Africa., Scott LE; WITS Diagnostic Innovation Hub, University of the Witwatersrand, Johannesburg 2000, South Africa., Stevens WS; WITS Diagnostic Innovation Hub, University of the Witwatersrand, Johannesburg 2000, South Africa.; National Priority Programmes, National Health Laboratory Service, Johannesburg 2000, South Africa. |
Abstrakt: |
Blood-based diagnostics are critical for many medical decisions, but mostly rely on venepuncture, which can be inconvenient and painful. The Onflow Serum Gel (Loop Medical SA, Vaud, Lausanne, Switzerland) is a novel blood collection device that utilises needle-free technology to collect capillary blood. In this pilot study, 100 healthy participants were enrolled and provided two Onflow collected specimens and one venous blood specimen. Five chemistry analytes (AST, ALT, LDH, potassium, creatinine) and haemolysis were measured per specimen, and laboratory analyte results were compared. Onflow was found to be more acceptable than venepuncture with lower pain ratings, and 96.5% of participants would use the Onflow method again. All phlebotomists (100%) found Onflow intuitive and user-friendly, with ~1 mL of Onflow blood successfully collected from 99% of participants in <12 min (mean: 6 min, 40 s) and 91% collected on the first attempt. ALT and AST analytes showed no difference in performance, while creatinine generated a negative bias (-5.6 µmol/L), and increased variability was noted with potassium (3.6%CV) and LDH (6.7%CV), although none were clinically relevant. These differences may be due to 35% of Onflow collected specimens having "mild" haemolysis. Onflow is a promising alternative blood collection device that should now be evaluated in participants with expected abnormal chemistries and as an option for self-collection. |