Validation of Two Point of Care Devices for Hemoglobin Estimation in Blood Donors

Abstract

Hemoglobin (Hb) estimation is a critical investigation in prospective blood donors. There are numerous techniques for Hb estimation, choosing an appropriate method is essential. Point of care devices (POC) have made quantification of Hb possible even in the field or community settings. Validation against a standard measure is necessary before implementing it for routine practice. With this background, we aimed to validate two new POC devices against a standard hematology analyzer for Hb estimation. An observational study on 100 donor venous blood samples was conducted. Hemoglobin was estimated using a Sysmex Hematology Analyzer (reference method) along with POC devices (CompoLab TM and True Hb Hemometer). Three statistical techniques were applied to validate Hb by the two POC devices. CompoLab TM measures 0.4 units more than the reference method and True Hb measures 0.4 units less than the reference method. Measures of Hb obtained from both the equipment showed moderate agreement with that of reference method (CompoLab TM ICC-0.74 and True Hb ICC-0.72). There were no systematic or proportional differences in the comparison of the two POC devices with the reference method. Within the limitations of this study, both the devices can be used for Hb estimation, as there was a substantial agreement of the measurements with the reference method. Other factors such as cost, turnaround time (TAT), ease of utilization should be considered to decide on the choice of equipment to be used.