Key result
Point-of-care qLabs device shows ~92% clinical agreement with laboratory INR despite slightly lower readings.
Why the study?
Point-of-care INR testing plays an important role in monitoring patients on long-term warfarin therapy in settings with limited healthcare access, but the accuracy and precision of the new handheld qLabs POC device needed evaluation.
Does the qLabs POC device accurately measure INR compared to a standard laboratory analyzer in patients on long-term warfarin therapy?
Observational (n=262)
Does the qLabs POC device accurately measure INR compared to a standard laboratory analyzer in patients on long-term warfarin therapy?
The qLabs POC device provides accurate and precise INR measurements for values within and below the target range, but shows reduced clinical agreement for values above 3.5.
Answers are grounded in this paper and cite their sources.
Caution advised for qLabs POC INR above target range; leaves open need for larger prospective validation before routine use.
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.
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Mbokota et al. (2018) conducted an observational in Patients on long-term warfarin therapy (n=262). qLabs POC device vs. Stago STA R Max coagulation analyzer was evaluated on Mean INR (MD -0.13%, 95% CI -0.19 to -0.06, p=< .0001). The qLabs POC device showed high clinical agreement (92.37%) compared to laboratory INR, though the mean INR was slightly lower (2.38 vs 2.50, P<0.0001).
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