An evaluation of the diagnostic performance characteristics of the Yellow Fever IgM immunochromatographic rapid diagnostic test kit from SD Biosensor in Ghana.

Lawrence Henry Ofosu-Appiah,Julius Abraham Addo Mingle,Bright Ayensu,Godfred Owusu-Okyere,Ernest Akyereko,Nafisah Issah Rabiwu,Dodzi Kofi Amelor,Dennis Odai Laryea,Franklin Asiedu-Bekoe,David Opare,Gheyath K Nasrallah

doi:10.1371/journal.pone.0262312

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.

Highlights

Yellow fever is an acute febrile illness caused by the Yellow Fever Virus (YFV)
The Aedes aegypti mosquito is the primary vector of the YFV and is geographically restricted to the tropical regions of the world due to its inability to survive in colder climates [5]
If human anti-Yellow Fever IgM exists in the test sample, the individual test line appears as a visible band respectively forming the complex with anti-human IgM, human IgM, inactivated Yellow fever virus, and anti-Yellow fever-env-gold, which indicates a positive test result

Summary

Introduction

Yellow fever is an acute febrile illness caused by the Yellow Fever Virus (YFV). The symptoms of infection generally occur 3–6 days after exposure to the virus. The virus belongs to the family Flaviviridae and genus Flavivirus. It is an enveloped virus and its genome consists of a single-stranded positive sense RNA (approximately 11 kb). YFV contributes to a significantly high disease burden in the tropical regions of Africa and South America where outbreaks occur from time to time [2, 6,7,8]

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Conclusion