Lateral Flow Assays in Infectious Disease Diagnosis

Abstract

Background Lateral flow immunoassays are widely used as diagnostic tests in many applications in human and other diagnostic areas. Assays for human applications have been commercially available since the 1980s and initially were primarily used to identify pregnancy by measuring human chorionic gonadotropin in urine and serum/plasma. Content The first infectious disease lateral flow assays were commercialized in the late 1980s identifying the presence of Group A Streptococcus pyogenes collected with throat swabs; innumerable other applications followed in the intervening decades. The severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) pandemic has brought a vast number of new assays for which emergency use authorization (EUA) has been requested in the USA. These assays have been designed for detection of the antibody response to an infection and viral antigens in respiratory samples. In view of the onslaught of new tests, this review will focus on the use of rapid lateral flow immunoassays for infectious diseases. Principles of lateral flow assays and approaches to the production of high-sensitivity point-of-care assays are presented. Market trends, customer requirements, and future directions of lateral flow assay technology and its applications in the infectious disease diagnostic space are discussed. Summary Lateral flow immunoassays play an important role in infectious disease diagnostics. Advancements in technology have led to improved performance of these assays and acceptance by professional users. With the advent of the SARS-CoV-2 pandemic, the market has reached new levels requiring hundreds of millions of tests per year for professional and even home use.

Investigation of the “Antigen Hook Effect” in Lateral Flow Sandwich Immunoassay: The Case of Lumpy Skin Disease Virus Detection

“…Among analytical strategies involved in POCTs, the most diffuse and successful technique is the immunochromatographic strip test, also known as the lateral flow immunoassay (LFIA). Many POCTs in the LFIA format are routinely employed to monitor infectious diseases by the Centers for Disease Control and Prevention (CDC) [ 5 , 6 ]. As well as any kind of immunoassay, the LFIA exploits the affinity of specific antibodies to detect antigens from viruses, fungi, or bacteria, thus enabling the direct diagnosis of the infection.…”

A handheld intelligent single-molecule binary bioelectronic system for fast and reliable immunometric point-of-care testing

“…This enables the screening of a population against a given disease, quickly identifying the subset of the diseased individuals with an error (false positives or false negatives) below 1%. Such a platform outperforms all the available POC systems ( 2 , 4 , 7 – 13 , 16 , 26 , 27 , 43 ) (section S9) and fully complies with the latest WHO recommendations for POC devices ( 6 ). REASSURED is the acronym adopted by WHO to characterize a POC device ideally encompassing real-time connection, ease specimen collection, be affordable, sensitive, specific, user-friendly, rapid, robust, equipment-free, and allow for a straightforward delivery to end-users.…”

“…In progressive noncommunicable diseases, early detection and/or continuous monitoring can improve treatment efficacy and quality of life. However, until very recently, typical POC testing drawbacks included limit of detections (LOD) ( 3 ) higher than 10 4 markers per milliliter, corresponding to femtomolar (10 −15 M) concentrations ( 4 ), and a high incidence of false negatives ( 5 ).…”

Quantum Dot-Based Lateral Flow Immunoassay as Point-of-Care Testing for Infectious Diseases: A Narrative Review of Its Principle and Performance

“…In addition, a large plethora of body fluid could be reduced by utilising POCT compared to the gold standard (culture method) and molecular method (PCR), suggesting the powerful feature of POC devices. Currently, a wide range of LFIAs are now available for the detection of various biomarkers of communicable and non-communicable diseases, as well as toxins in food samples [ 11 ].…”