Development and validation of an ELISA kit (YF MAC-HD) to detect IgM to yellow fever virus.
Yellow fever virus (YFV) is endemic in tropical and sub-tropical regions of the world, with around 180,000 human infections a year occurring in Africa. Serologic testing is the chief laboratory diagnostic means of identifying an outbreak and to inform the decision to commence a vaccination campaign. The World Health Organization disseminates the reagents for YFV testing to African reference laboratories, and the US Centers for Disease Control and Prevention (CDC) is charged with producing and providing these reagents. The CDC M-antibody capture ELISA is a 2-day test, requiring titration of reagents when new lots are received, which leads to inconsistency in testing and wastage of material. Here we describe the development of a kit-based assay (YF MAC-HD) based upon the CDC method, that is completed in approximately 3.5h, with equivocal samples being reflexed to an overnight protocol. The kit exhibits >90% accuracy when compared to the 2-day test. The kits were designed for use with a minimum of equipment and are stored at 4°C, removing the need for freezing capacity. This kit is capable of tolerating temporary sub-optimal storage conditions which will ease shipping or power outage concerns, and a shelf life of >6 months was demonstrated with no deterioration in accuracy. All reagents necessary to run the YF MAC-HD are included in the kit and are single-use, with 8 or 24 sample options per kit. Field trials are envisioned for the near future, which will enable refinement of the method. The use of the YF MAC-HD is anticipated to reduce materials wastage, and improve the quality and consistency of YFV serologic testing in endemic areas.
Division of Vector-Borne Infectious Diseases, Centers for Disease Control and Prevention, 3156 Rampart Road, Fort Collins, CO 80521, USA. Electronic address: ajj1@cdc.gov.
Alison Jane
AJ
Basile
Division of Vector-Borne Infectious Diseases, Centers for Disease Control and Prevention, 3156 Rampart Road, Fort Collins, CO 80521, USA.
Christin
C
Goodman
Division of Vector-Borne Infectious Diseases, Centers for Disease Control and Prevention, 3156 Rampart Road, Fort Collins, CO 80521, USA.
Kalanthe
K
Horiuchi
Division of Vector-Borne Infectious Diseases, Centers for Disease Control and Prevention, 3156 Rampart Road, Fort Collins, CO 80521, USA.
Janeen
J
Laven
Division of Vector-Borne Infectious Diseases, Centers for Disease Control and Prevention, 3156 Rampart Road, Fort Collins, CO 80521, USA.
Amanda J
AJ
Panella
Division of Vector-Borne Infectious Diseases, Centers for Disease Control and Prevention, 3156 Rampart Road, Fort Collins, CO 80521, USA.
Olga
O
Kosoy
Division of Vector-Borne Infectious Diseases, Centers for Disease Control and Prevention, 3156 Rampart Road, Fort Collins, CO 80521, USA.
Robert S
RS
Lanciotti
Division of Vector-Borne Infectious Diseases, Centers for Disease Control and Prevention, 3156 Rampart Road, Fort Collins, CO 80521, USA.
Barbara W
BW
Johnson
D000349:Africa; D000914:Antibodies, Viral / Q000097:blood*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D006801:Humans; D007075:Immunoglobulin M / Q000097:blood*; D011933:Reagent Kits, Diagnostic; D012698:Serologic Tests / Q000379:methods*; D013696:Temperature; D015004:Yellow Fever / Q000175:diagnosis*; D015005:Yellow fever virus / Q000276:immunology*
D000914:Antibodies, Viral; D007075:Immunoglobulin M; D011933:Reagent Kits, Diagnostic
Diagnostic; ELISA; IgM; Kit; Yellow fever virus