Evaluation of a Novel Immunochromatographic Assay Using Monoclonal Antibodies Against the Matrix Protein of Human Metapneumovirus.

Background: The aim of this study was to determine the sensitivity and specificity of a novel immunochromatographic (IC) assay (APD1806) using monoclonal antibodies against the matrix (M) protein of human metapneumovirus (hMPV) for detection of hMPV from nasopharyngeal swab samples based on the results of real-time RT-PCR. Methods: Nasopharyngeal swab samples taken from 189 patients aged 0 -5 years who were suspected of having respiratory tract infections associated with hMPV were used in this study. The samples were tested both by the IC assay and by real-time RT-PCR for detection of hMPV. Results: The sensitivity and specificity of the IC assay for detection of hMPV were 88.8% (95/107) and 92.7% (76/82), respectively. Conclusions: The IC assay using monoclonal antibodies against the M protein of hMPV is an accurate and fast assay that is suitable as a diagnostic tool for hMPV infection. The optimal timing of the IC assay is 12 hours or more after the onset of fever due to hMPV infection. (Clin. Lab. 2021;67:2363-2368. DOI: 10.7754/Clin.Lab.2021.210232)