Six decades of lateral flow immunoassay: from determining metabolic markers to diagnosing COVID-19

Abstract

Technologies based on lateral flow immunoassay (LFIA), known in some countries of the world as immunochromatographic tests, have been successfully used for the last six decades in diagnostics of many diseases and conditions as they allow rapid detection of molecular ligands in biosubstrates. The popularity of these diagnostic platforms is constantly increasing in healthcare facilities, particularly those facing limited budgets and time, as well as in household use for individual health monitoring. The advantages of these low-cost devices over modern laboratory-based analyzers come from their availability, opportunity of rapid detection, and ease of use. The attractiveness of these portable diagnostic tools is associated primarily with their high analytical sensitivity and specificity, as well as with the easy visual readout of results. These qualities explain the growing popularity of LFIA in developing countries, when applied at small hospitals, in emergency situations where screening and monitoring health condition is crucially important, and as well as for self-testing of patients. These tools have passed the test of time, and now LFIA test systems are fully consistent with the world's modern concept of 'point-of-care testing', finding a wide range of applications not only in human medicine, but also in ecology, veterinary medicine, and agriculture. The extensive opportunities provided by LFIA contribute to the continuous development and improvement of this technology and to the creation of new-generation formats. This review will highlight the modern principles of design of the most widely used formats of test-systems for clinical laboratory diagnostics, summarize the main advantages and disadvantages of the method, as well as the current achievements and prospects of the LFIA technology. The latest innovations are aimed at improving the analytical performance of LFIA platforms for the diagnosis of bacterial and viral infections, including COVID-19.

Keywords: clinical laboratory diagnostics; concept; lateral flow immunoassays (LFIA); ‘point-of-care testing’.

Figure 1.. The authors of the principle of the method and the first constructed immunochromatographic rapid test for determination of insulin in human blood plasma (1959) R. Yalou and S. Berson.

Figure 2.. Schematic representation of the lateral flow immunoassay (LFIA) mechanism. A sample containing the test antigen (analyte) is applied to the pad to apply the sample and migrates to the conjugate. A specific reagent with the target analyte migrates to the test line, where it forms a complex with antibodies (author's figure).