Abstract
We describe the development and clinical evaluation of an automated smartphone-linked sensor capable of chemical-free, quantitative measurement of hemoglobin concentration ([Hb]) in whole blood samples. We have demonstrated that our sensor could analyze an unprocessed blood specimen with a mean processing time of <8 s and provided the [Hb] results with ~99% accuracy against a reference hematology analyzer with coefficient of variation (CV) of 1.21% measured at [Hb] = 11.2 g/dL. Its diagnostic capability for anemia was evaluated by measuring [Hb] of 142 clinical blood specimens and comparing the results with those from an automated hematology analyzer (ADVIA 2120i, Siemens AG, Germany) and a portable hemoglobinomteter (Hb201+, Hemocue, Sweden). The sensor yielded comparable sensitivities and specificities of 87.50% and 100.00% for males, and 94.44% and 100.00% for females, respectively, for anemic detection. The results suggested that our optical sensor based on the intrinsic photothermal response of Hb molecules and advances in consumer electronics, particularly smartphone capabilities, enables a direct, chemical-free [Hb] assay accessible to people in both developed and developing countries.
Highlights
Hemoglobin (Hb) constitutes approximately 96% of red blood cells and is responsible for carrying and transporting oxygen to the organs through the circulatory system
The module is connected to a smartphone and the blood-loaded capillary tube is positioned into the V-mount inside the module (Fig. 1B)
Our sensor is characterized by high precision with its intra and inter-assay precisions of 1.65% and 1.76% at [Hb] = 16.4 g/dL respectively
Summary
Hemoglobin (Hb) constitutes approximately 96% of red blood cells and is responsible for carrying and transporting oxygen to the organs through the circulatory system. Clinical grade hematology analyzers and portable hemoglobinometers are mostly based on such protocols While these methods enable high-accuracy and high-precision [Hb] measurement, some of the employed chemicals are hazardous to human and environment, and the sensors are typically operated by trained operators in controlled sites such as clinical labs. The [Hb] detector based on WHO hemoglobin color scale (HCS) is simple and inexpensive, but its measurement is not quantitative and accurate, and requires large volume of blood (20 μL)[19]. Compared to others, this method is highly attractive in that it is rapid and requires extremely small volume of blood (
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