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

Article Article scientifique Article Performance and usability of cardiometabolic point of care devices in Nepal : A prospective, quantitative, accuracy study eng 2024-10-03 2024-10-03 author Giachino Marina 0000-0003-0797-3318 837966 Département de santé et médecine communautaire (MECOM) author Vetter Beatrice 0000-0002-7898-472X author Aebischer Perone Sigiriya 911614 author Correia Jorge 0000-0002-7020-0695 637865 author Erkosar Berra 0000-0003-1152-6772 author Heller Olivia 0009-0003-7090-1365 634637 author Khanal Vijay Kumar 0000-0001-7883-9568 author Lab Bruno 913820 author Pataky Zoltan 0000-0002-8720-3833 105295 Département de médecine (DEMED) author Poudel Sagar 0000-0002-0021-897X author Rai Mamit 0009-0001-1423-4778 author Sharma Sanjib Kumar 0000-0002-8392-8028 e0003760 10.1371/journal.pgph.0003760 39361597 2767-3375 PMC11449279 https://dx.plos.org/10.1371/journal.pgph.0003760 <p>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.</p> <p> Trial registration: NCT05257564 (ClinicalTrials.gov). </p> Dewey 613 Dewey 616 International Committee of the Red Cross ICR-NCDS01 German Federal Ministry of Education and Research KFW-TBBU02 56 Département de médecine 221 64 Département de santé et médecine communautaires 22A false 334 Education thérapeutique du patient, diabète et obésité 600 1392 Pied diabétique 1043 PLOS global public health 4 10 98283b12-20f9-4735-aa24-5b81294d33a5 Article (Published version) Public journal.pgph.0003760.pdf 1802496 application/pdf CC BY-4.0 8071b1b976051d7c7131555b05e759fb2f115d265adeb7be9cf965fade131670 4055be18-92a1-417d-ac81-31f83e11cfa3 Supplemental data Public pgph.0003760.s001.pdf 199829 application/pdf 27556e6836a4393b16b3e7bfc0679f0f5fda5c071c5513829f881c393998db55 da9eaf5a-2714-4550-a7b0-bb855850b986 Supplemental data Public pgph.0003760.s002.xlsx 246527 application/vnd.openxmlformats-officedocument.spreadsheetml.sheet 55bbeaa3a13ac6e1f03c422172f3330122fc04c34f4c0779a93e9443dbf10861 openAccess Faculté de médecine / Section de médecine clinique / Département de médecine Faculté de médecine / Section de médecine clinique / Département de santé et médecine communautaires

Title	Published in	Access level	OA Policy	Year	Views	Downloads

Performance and usability of cardiometabolic point of care devices in Nepal : A prospective, quantitative, accuracy study	PLOS global public health			2024	77	355

Archive ouverte UNIGE

Giachino, Marina