Cardiometabolic Devices Accuracy Study

NACompletedINTERVENTIONAL
Enrollment

359

Participants

Timeline

Start Date

February 14, 2022

Primary Completion Date

May 29, 2022

Study Completion Date

June 30, 2022

Conditions
Diabetes MellitusChronic Kidney DiseasesHyperlipidemias
Interventions
DEVICE

Determine the accuracy of quantitative measurements of GLU, HbA1c,CHOL and CRE with POC devices compared to a laboratory reference method (Roche)

Fingerstick capillary blood will be collected according to each manufacturer's Instructions for use. The fingerstick capillary blood samples will be used immediately on the point-of-care assays. The venous blood will be collected in specific tubes for plasma (GLU), for whole blood (HbA1c) and for serum (CREP, CHOL). Plasma will be separated by centrifugation at the PHC facility and health post and aliquots will be prepared. Serum will be left to clot prior to centrifugation and serum aliquots will be prepared at the PHC facility and health post. The samples will be stored until transfer to the BPKIHS reference lab.

Trial Locations (1)

56700

B.P Koirala Institute of Health Sciences, Dharān

All Listed Sponsors
collaborator

University Hospital, Geneva

OTHER

collaborator

B.P. Koirala Institute of Health Sciences

OTHER

lead

Foundation for Innovative New Diagnostics, Switzerland

OTHER