Novel “Digital‐Style” Rapid Test Simultaneously Detecting Heart Attack and Predicting Cardiovascular Disease Risk

Abstract

An early cardiac marker, heart-type fatty-acid binding protein (H-FABP), and an established risk marker for heart attack, C-reactive protein (CRP), were combined in a simple, rapid, and semiquantitative "digital-style" lateral flow assay. There is a vital need for developing a relatively simple and rapid test to confirm or exclude suspected acute myocardial infraction (AMI) patients and simultaneously to identify apparent non-AMI patients at risk of developing cardiovascular events at an early stage. To interpret different clinical outcomes, monoclonal antibodies specific to H-FABP and CRP were employed to a "digital-style" rapid test with more than one line shown on the test zones. Plasma samples (162) from Country Brandenburg Hospital in Bernau (Germany) with CRP concentration between 0.03 and 283.2 mg/ L were assessed using an in-house enzyme-linked immunosorbent assay (ELISA) and a newly developed "digital-style" assay. There was a good linearity (r(2) = 0.9392) and agreement by Bland and Altman statistic plot between these two methods. The calculated intra-assay and interassay coefficients of variation (CV) for the four CRP concentration ranges < 1 mg/L, 1-3 mg/L, > 3-10 mg/L and > 10 mg/L were 8-13% and 8-12%, respectively. The "digital-style" assay with high stability provides long storage time and allows mass production and preparation of large batches. In conclusion, a novel "digital-style" semiquantitative lateral flow assay simultaneously detecting heart attack and predicting early cardiovascular disease risk, just by simply counting the number of red lines in the test without any expensive reading instrument, has been successfully developed. Medical doctors can predict early the extent of the risk and prescribe heart-attack-preventing therapy