Clinical evaluation of fully automated molecular diagnostic system \u201cSimprova\u201d for influenza virus, respiratory syncytial virus, and human metapneumovirus

Ikuyo Takayama,Kota Yokono,Yuji Segawa,Tsugunori Notomi,Atsushi Kaida,Keiichi Kiya,Hidenobu Watanabe ,Katsushi Kaji,Kunihiro Oba,Toshihiro Yonekawa,Mina Nakauchi,Masashi Shiomi,Akihiro Terada,Shohei Semba,Hideyuki Kubo,Sadasaburo Asai,Shinji Saito,Yoshitaka Sawada,Kiyotaka Murakami,Tsutomu Kageyama

doi:10.1038/s41598-020-70090-2

Abstract

Influenza virus, respiratory syncytial virus, and human metapneumovirus commonly cause acute upper and lower respiratory tract infections, especially in children and the elderly. Although rapid antigen detection tests for detecting these infections have been introduced recently, these are less sensitive than nucleic acid amplification tests. More recently, highly sensitive point-of-care testings (POCTs) have been developed based on nucleic acid amplification tests, which are easy to use in clinical settings. In this study, loop-mediated isothermal amplification (LAMP)-based POCT “Simprova” to detect influenza A and B viruses, respiratory syncytial virus, and human metapneumovirus was developed. Simprova system is fully automated and does not require skilled personnel. In addition, positive results can be achieved faster than with PCR. In this study, the accuracy of the POCT was retrospectively analyzed using 241 frozen stocked specimens. Additionally, the usability of the Simprova at clinical sites was assessed in a prospective clinical study using 380 clinical specimens and compared to those of real-time PCR and rapid antigen detection test. The novel LAMP-based POCT demonstrated high sensitivity and specificity in characterizing clinical specimens from patients with influenza-like illnesses. The Simprova is a powerful tool for early diagnosis of respiratory viral infections in point-of-care settings.

Highlights

Influenza virus, respiratory syncytial virus, and human metapneumovirus commonly cause acute upper and lower respiratory tract infections, especially in children and the elderly
Highly sensitive point-of-care testings (POCTs) based on nucleic acid amplification tests (NAATs) that are easy to use in clinical settings have been developed
A total of 241 clinical specimens collected from 132 male and 109 female child patients who presented with influenza-like illnesses were used

Summary

Introduction

Respiratory syncytial virus, and human metapneumovirus commonly cause acute upper and lower respiratory tract infections, especially in children and the elderly. Highly sensitive point-of-care testings (POCTs) have been developed based on nucleic acid amplification tests, which are easy to use in clinical settings. Influenza virus (IV), respiratory syncytial virus (RSV), and human metapneumovirus (hMPV) infections are the most common causes of acute upper and lower respiratory tract infections such as pneumonia and bronchiolitis, and lead to hospitalization, especially in children and the elderly[3–6] Diagnosis of these infections is important in the clinical management of patients and for the reduction in healthcare c osts[7]. RADTs can be used in point-of-care (POC) settings, but they are less sensitive than molecular diagnostic tests such as PCR and other nucleic acid amplification tests (NAATs)[14,15]. Highly sensitive point-of-care testings (POCTs) based on NAAT that are easy to use in clinical settings have been developed. The usability of Simprova-RV at clinical sites was assessed in a prospective clinical study. rPCR was used as the gold standard test for comparison in the retrospective validation and the prospective clinical study

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