N Mbokota1, E Schapkaitz1, S Louw1. 1. Department of Molecular Medicine and Haematology, University of Witwatersrand Medical School, Johannesburg, South Africa.
Abstract
INTRODUCTION: In the developing world, point-of-care (POC) testing for international normalized ratio (INR) plays an important role in the monitoring of patients on long-term warfarin therapy with limited access to healthcare ensuring safe and effective anticoagulation. A newly developed POC device for INR measurement by healthcare workers is the handheld qLabs POC device® (Micropoint Biotechnologies Incorporated, Guangdong, China). METHODS: The qLabs POC device® was evaluated in 262 patients attending an anticoagulation clinic with regards to accuracy and precision of the INR results. The results were compared to the results obtained on the Stago STA R Max® coagulation analyzer (Stago Diagnostica, Paris, France) on a wide range of normal and abnormal results of clinical relevance. RESULTS: The mean laboratory INR (2.50 ± 1.08) was significantly higher than the qLabs POC device® INR (2.38 ± 1.07) (P < .0001). The correlation coefficient (r) was .88, the slope coefficient was 1.0 (CI, 0.8-1.2), and the intercept was -0.10 (CI, -0.50 to 0.30). The mean of the differences was -0.13% (CI, -0.19 to -0.06). Dosage concordance was 85.46% and clinical agreement was 92.37%. However, clinical agreement was 42.42% in the subgroup above the target range (>3.5). The imprecision was within acceptable limits (<5%) and the error message rate was 4.38%. CONCLUSION: In conclusion, the qLabs POC device® is accurate and precise with high levels of dosage concordance and clinical agreement for INR values within and below the target range.
INTRODUCTION: In the developing world, point-of-care (POC) testing for international normalized ratio (INR) plays an important role in the monitoring of patients on long-term warfarin therapy with limited access to healthcare ensuring safe and effective anticoagulation. A newly developed POC device for INR measurement by healthcare workers is the handheld qLabs POC device® (Micropoint Biotechnologies Incorporated, Guangdong, China). METHODS: The qLabs POC device® was evaluated in 262 patients attending an anticoagulation clinic with regards to accuracy and precision of the INR results. The results were compared to the results obtained on the Stago STA R Max® coagulation analyzer (Stago Diagnostica, Paris, France) on a wide range of normal and abnormal results of clinical relevance. RESULTS: The mean laboratory INR (2.50 ± 1.08) was significantly higher than the qLabs POC device® INR (2.38 ± 1.07) (P < .0001). The correlation coefficient (r) was .88, the slope coefficient was 1.0 (CI, 0.8-1.2), and the intercept was -0.10 (CI, -0.50 to 0.30). The mean of the differences was -0.13% (CI, -0.19 to -0.06). Dosage concordance was 85.46% and clinical agreement was 92.37%. However, clinical agreement was 42.42% in the subgroup above the target range (>3.5). The imprecision was within acceptable limits (<5%) and the error message rate was 4.38%. CONCLUSION: In conclusion, the qLabs POC device® is accurate and precise with high levels of dosage concordance and clinical agreement for INR values within and below the target range.