Performance and usability of cardiometabolic point of care devices in Nepal: A prospective, quantitative, accuracy study

Non-communicable diseases (NCDs), such as cardiovascular disease and diabetes, represent a serious global health concern. There is an urgent need for prompt diagnosis and effective monitoring at point of care, especially in low- and middle-income countries. Here we present the results of a study assessing the quantitative accuracy of two devices that may fit the target product profile for a cardiometabolic point-of-care device. This prospective, quantitative, accuracy study (NCT05257564) was conducted between March to May 2022, investigating the performance of the JanaCare Aina Blood Monitoring System (JCAina) and the Tascom SimplexTAS 101 device (TAS101) compared with local standard laboratory methods in rural Nepal. Using fingerstick capillary blood, cardiometabolic parameters were analysed using both devices. The quantitative accuracy was compared against a local laboratory reference assay. System usability was also assessed. For JCAina, the mean absolute biases (Bland-Altman analysis) for glucose, HbA1c and total cholesterol tests were -3.87 mg/dL (95% CI: -7.52--0.22), 1.34% (95% CI: 1.21-1.47), and -9.52 mg/dL (95% CI: -11.9--7.2), respectively, corresponding to mean percentage biases of 2.0%, 18.5%, and -6.4%. These indicate clinically small (<10% biases) differences from laboratory results for glucose and cholesterol, and a moderate (10-20%) positive bias for HbA1c. For TAS101, the mean absolute biases for glucose, HbA1c, total cholesterol and creatinine tests were 18.7 mg/dL (95% CI: 15.8-21.5), -0.2% (95% CI: -0.26--0.14), 29.8 mg/dL (95% CI: 27.0-32.6), and -0.02 mg/dL (95% CI: -0.05-0.01), respectively, corresponding to mean percentage biases of 12.1%, -2.6%, 15.8%, and -4.5%. These indicate clinically small differences for HbA1c and creatinine, and moderate positive biases for glucose and cholesterol. Both systems exhibited usability challenges. The JCAina and TAS101 point-of-care cardiometabolic devices were shown to have promising accuracy in environmental conditions such as in Nepal, though improvements are still needed for some parameters and for ease of use. Trial registration: NCT05257564 (ClinicalTrials.gov).