The HemeChip project is a multi-phase clinical trial of the HemeChip device, a prototype point-of-care device developed by Case Western Reserve University and HemexHealth Inc. for diagnosis of sickle cell disease.
International Foundation Against Infectious Diseases in Nigeria (IFAIN)
Design and partner in public health laboratory research conducted in internationally certified, eHA-supported laboratories
Increase access to timely and quality diagnostic services for providers of maternal and child health services.
The HemeChip device does not require electricity onsite to function. More importantly, this device completely eliminates the ambiguity in result interpretation by displaying the test results digitally in percentages of the hemoglobin type present.
The first phase ended in 2018 and was designed to validate the suitability, effectiveness, and efficiency of the HemeChip device in low resource settings. During this phase, the sensitivity and specificity of HemeChip were measured against the gold standard—High Performance Liquid Chromatography (HPLC). The overall accuracy of HemeChip was 97.2% in comparison to HPLC.
In the next phase, an electronic medical record application will be developed and integrated with this device, for patient management during follow-up visits to health facilities.
The device will greatly increase the diagnostic capacity for sickle cell anemia in health facilities and significantly reduce turn-around time for this test, especially in the low-resource settings.
As an implementing partner, eHA’s role is focused on the clinical trial of this device as well as comparing the results generated against gold-standard (high-performance liquid chromatography):
Testing of samples collected from 3 health facilities using the HemeChip device.
Daily lab data management and updates on the University of Nebraska Medical Center (UNMC) REDCap database
Transportation of tested samples to International Foundation Against Infectious Diseases in Nigeria (IFAIN) lab in Abuja by cold chain shipment in accordance with UN3373 regulations
Children under 5 in Kano state
Sickle cell patients in the selected state health facilities
Samples tested with HemeChip.