Collaborative study for the characterization of a chikungunya virus RNA reference reagent for use in nucleic acid testing

• Published in: Vox sanguinis 2015-11, Vol.109 (4), p.312-318
• Main Authors: Añez, G., Jiang, Z., Heisey, D. A. R., Kerby, S., Rios, M.
• Format: Article
• Language: English
• Subjects: Base Sequence; Blood & organ donations; Chikungunya virus; Chikungunya virus - chemistry; Chikungunya virus - genetics; Hematology; Humans; Indicators and Reagents; Medical screening; Molecular Diagnostic Techniques - methods; Molecular Diagnostic Techniques - standards; Molecular Sequence Data; Nucleic Acid Amplification Techniques - methods; Nucleic Acid Amplification Techniques - standards; nucleic acid amplification tests; Reference Standards; Ribonucleic acid; RNA; RNA, Viral - blood; Viruses
• ISSN: 0042-9007; 1423-0410
• DOI: 10.1111/vox.12297

Background and Objectives Infections with the mosquito‐borne chikungunya virus (CHIKV) can cause febrile illness or be asymptomatic. Laboratory diagnosis of CHIKV is often made with laboratory‐developed nucleic acid amplification technology (NAT) assays because there are no U.S. Food and Drug Administration (FDA)‐approved diagnostic or blood screening assays. We aimed to produce a well‐characterized CHIKV RNA reference reagent (CHIKV‐RR) for use in NAT assays. Materials and Methods A CHIKV RNA‐RR consisting of cell culture‐grown, heat‐inactivated CHIKV diluted in human plasma was assessed by 8 laboratories in a collaborative study. The participants were asked to test the CHIKV‐RR using their NAT assay(s) by qualitative testing (determination of RNA end‐point by testing log and half‐log dilutions followed by calculation of estimated NAT‐detectable units/ml, after adjustment for the sample volume used for testing), and by quantitative testing, when available. Results Results from the testing showed that the CHIKV‐RR had an estimated overall mean of 7·56 log10 detectable units/ml, ranging from 6·2 log10 to 8·6 log10. Conclusions The Center for Biologics for Evaluation and Research/FDA CHIKV RNA‐RR for NAT was established with a concentration of 7·56 log10 detectable units/ml.