Portable, affordable, quantitative microchip electrophoresis system for integrated anemia and hemoglobin variant testing - PROJECT SUMMARY
Anemia is characterized by low blood hemoglobin levels and has high prevalence affecting over one-third of the
world's population or about 2.5 billion people. Anemia has numerous causes, including nutritional deficiencies,
oncologic conditions, and hematologic diseases, including hemoglobin gene variants. More than 7% of the
world's population carry hemoglobin gene variants, one of which is Sickle Cell Disease (SCD). SCD or sickle cell
anemia is one of the most commonly inherited blood anemias. Anemia and SCD diagnosis/monitoring are
challenging in low and middle income countries due to lack of laboratory infrastructure and skilled personnel. In
a 2019 report, World Health Organization has listed hemoglobin testing (diagnosis and monitoring of anemia) as
an essential in vitro diagnostic tests for primary care in low and middle income countries. We have developed a
point-of-care (POC) microchip electrophoresis hemoglobin variant testing system, HemeChip. HemeChip has
been extensively validated in the US, Africa, India, and South-East Asia, for hemoglobin variants. In this STTR
Phase I project, we plan to add total hemoglobin quantification and anemia testing capability to HemeChip
system and develop HemeChip+. The proposed HemeChip+ is the first and only single test, POC platform for
portable, affordable, accurate, and quantitative hemoglobin quantification, anemia detection, and hemoglobin
variant identification. Based on our preliminary findings, we hypothesize that rapid, affordable, integrated, POC
testing of anemia and hemoglobin variants is feasible with the proposed HemeChip+ system. To test this
hypothesis, we propose the following distinct but interrelated aims: Aim1: To develop the HemeChip+ platform
for integrated quantitative hemoglobin testing, anemia detection, and quantitative hemoglobin variant
identification. Aim 1 milestone is to achieve, in a single test, accurate total hemoglobin quantification (g/dL),
hemoglobin variant identification, and hemoglobin variant percent (%) quantification using a drop of blood, in
less than 10 minutes. Aim 2: To perform clinical testing of the integrated HemeChip+ anemia and
hemoglobin variant testing system. Aim 2 Milestone is to validate the HemeChip+ performance as an
integrated assay for anemia and hemoglobin variant testing platform. Quantitative hemoglobin test performance
target is >90% correlation (Pearson correlation coefficient >0.90, p<0.01) with the results of clinical gold standard
method, Complete Blood Count. Hemoglobin variant identification performance target is >95% accuracy; and
hemoglobin variant % quantification performance target is >90% correlation (Pearson correlation coefficient >
0.90, p<0.01) compared with the results of the clinical gold standard method, High Performance Liquid
Chromatography. The proposed HemeChip+ system is the first of its kind, single test solution, which offers an
accurate, affordable, portable, and rugged platform for anemia and hemoglobin variant testing in low- and middle-
income countries.
