The establishment of highly sensitive monoclonal antibodies for influenza viruses and development of the new lateral flow test strip device

Abstract

Fujirebio succeeded in establishing highly sensitive, anti-influenza virus type A&B monoclonal antibodies and developed a new lateral flow assay device (EL INFLUENZA A&B Improved Test) using the newly established monoclonal antibodies. The EL INFLUENZA A&B Improved Test showed superior performance at sensitivity and specificity in clinical studies. The testing principle is a lateral flow assay with the enzyme reaction. Nasal swab, aspirate and throat swab specimens can be tested. The ESPLINE INFLUENZA A&B (current version, developed and manufactured by Fujirebio, Tokyo, Japan) was launched as the in vitro diagnostic test kit for detecting and classifying the influenza type A and B viral antigens in 15 min or less in 2002. Cell culture and PCR assay are reference methods, which are more sensitive than in vitro testing in general. However, the reference methods are not fit for clinician's requirement because of complicated and time-consuming processes. Highly sensitive and rapid in vitro testing is required from the clinician side.