An evaluation of the diagnostic performance characteristics of the Yellow Fever IgM immunochromatographic rapid diagnostic test kit from SD Biosensor in Ghana
Loading...
Date
2022
Journal Title
Journal ISSN
Volume Title
Publisher
PLOS
Abstract
Yellow fever is endemic in Ghana and outbreaks occur periodically. The prodromal signs
due to Yellow Fever Virus (YFV) infection are non-specific, making clinical signs unreliable
as the sole criteria for diagnosis. Accurate laboratory confirmation of suspected yellow fever
cases is therefore vital in surveillance programs. Reporting of ELISA IgM testing results by
laboratories can delay due to late arrival of samples from the collection sites as well as limited availability of ELISA kits. In this study, the diagnostic performance characteristics of a
rapid immunochromatographic Standard Q Yellow Fever IgM test kit (SD Biosensor) was
evaluated for the rapid diagnosis of Yellow Fever infection in Ghana. A panel of 275 sera,
comprising 81 confirmed YFV positives and 194 negatives were re-tested in this study using
the Standard Q Yellow Fever IgM test kit. Using the CDC/WHO Yellow Fever IgM capture
ELISA as a benchmark, the sensitivity, specificity and accuracy of the Standard Q Yellow
Fever test kit were 96.3%, 97.9% and 97.5%, respectively. The false positivity rate was
5.1% and there was no cross-reactivity when the Standard Q Yellow Fever test kit was
tested against dengue, malaria and hepatitis B and C positive samples. In addition, inter-reader variability and invalid rate were both zero. The results indicate that the diagnostic performance of the Standard Q Yellow Fever IgM test kit on serum or plasma is comparable to
the serum IgM detection by ELISA and can be used as a point of care rapid diagnostic test
kit for YFV infection in endemic areas.
Description
Research Article