Smartphone-based automated estimation of plasma creatinine from finger-pricked blood on a paper strip via single-user step sample-to-result integration

Abstract

Measuring creatininelevels in blood plasma is one of the most commonly used means of routine monitoring of renal function. Point-of-care devicesfor creatinine level estimation potentially allow rapid measurement, facilitating continuous monitoring of vulnerable patients. However, a majority of such devices currently available is constrained by several factors such as lack of simplicity in fabrication and operation (including plasma separation), a limited regime of efficacy, compromised reagent stability, and elevated costs. Here, we report the invention of a simple-to-fabricate and easy-to-use paper strip for rapid evaluation of plasma creatinine levels (ranging from 0.1 to 15 mg dL-1) in an integrated single-step process. For the testing, one drop of whole blood is first dripped onto the calcium salt-functionalized sample pad of the strip. Subsequently, blood plasma separation occurs due to spontaneous aggregation of red blood cells (RBCs) in the presence of calcium ions. The plasma spontaneously traverses into the reaction zone of the test-strip via capillary action where it reacts with previously dispensed alkaline picrate reagent, resulting in a colorimetric signal. Smartphone-interfaced imaging and image analytics of the reaction spot renders the dissemination of the test result in a turn-around time of about 2–3 min, without necessitating additional device interfacing. High efficacy of performance is established by validating with the results obtained from laboratory-benchmarked biochemical auto-analyzer, exhibiting an accuracy of 94%, and the coefficient of variation ranging from 0.64 to 6.4%. Suitability of use in extreme resource-limited settings is established by favorable stability of the reagents outside controlled laboratory ambience and engagement of unskilled personnel to execute the testing procedure with uncompromised accuracy.