Performance evaluation of Automated Fluorescent Immunoassay System ROTA and NORO for detection of rotavirus and norovirus: A comparative study of assay performance with RIDASCREEN^® Rotavirus and Norovirus

Abstract

Background The Automated Fluorescent Immunoassay System ROTA (AFIAS‐Rota) and NORO (AFIAS‐Noro) assays (Boditech Med Inc.) are newly developed diagnostic tests for rotavirus and norovirus infections. Methods Performance of AFIAS‐Rota/Noro assays was evaluated in comparison with RIDASCREEN® Rotavirus and Norovirus ELISA kits (R‐Biopharm) using clinical stool samples submitted from November 2018 to January 2019. Multiplex real‐time reverse transcription‐polymerase chain reaction was used as reference method. Results A total of 256 clinical specimens were analyzed. AFIAS‐Rota and RIDASCREEN Rotavirus had almost perfect agreement (Kappa value = 0.95), and substantial agreement was observed between AFIAS‐Noro and RIDASCREEN Norovirus (Kappa value = 0.80). For detection of rotavirus, AFIAS and RIDASCREEN assays showed satisfactory diagnostic sensitivity (100% and 97.8%, respectively) and specificity (99.5% and 99.1%). For detection of norovirus, the RIDASCREEN assay showed significantly higher sensitivity than the AFIAS‐Noro (86.0% and 66.0%, respectively; P = .002). Analytic specificity of AFIAS‐Rota/Noro assays showed no cross‐reactivity against any other bacteria (14 strains) or viruses (2 strains). Hands‐on time (6 minutes) and turnaround time (26 minutes) required to perform AFIAS assays were much shorter than those required for RIDASCREEN assays (20 and 150 minutes, respectively). Conclusion The AFIAS‐Rota/Noro assays showed overall excellent agreement with the RIDASCREEN assays. Although the AFIAS‐Noro assay exhibited lower sensitivity than the RIDASCREEN Norovirus assay for detection of norovirus, the AFIAS‐Rota/Noro assays could be useful as a rapid initial screening test in clinical laboratories due to its convenience and rapid turnaround time.

Development of a rapid homogeneous immunoassay for detection of rotavirus in stool samples

“…In addition to rotavirus, other viruses can cause acute gastroenteritis ( 15 – 17 ). For the cross-reactivity evaluation of the detection method used in this study, stool samples with rotavirus, adenovirus, astrovirus, norovirus genogroup I, and norovirus genogroup II were tested using the AlphaLISA method.…”

Acute Infectious Gastroenteritis: The Causative Agents, Omics-Based Detection of Antigens and Novel Biomarkers

“…ELISA can also be used in the detection of rotavirus-specific IgM [ 29 ]. Other methods in detection of rotavirus antigen were immunochromatography [ 25 , 27 ] and latex agglutination [ 23 , 92 , 95 ]. In addition, polyacrylamide gel electrophoresis (PAGE) was carried out to determine the electropherotype of rotavirus strains [ 10 , 19 , 92 ].…”

“…RIDASCREEN ® Norovirus 3rd Generation is an example of ELISA that is still currently in use [ 108 , 109 ]. For FIA, the Automated Fluorescent Immunoassay System NORO (AFIAS-Noro) assays (Boditech Med Inc, Gangwon-do, South Korea) are newly developed diagnostic tests for norovirus infections [ 95 ].…”