Performance Evaluation of the AiDx Multi-Diagnostic Automated Microscope For the Detection of Lymphatic Filariasis in Ogun State, Nigeria

A Technical Report

Report (2022)

Authors

Louise Makau-Barasa The Ending Neglected Diseases (END) Fund
Moses O. Aderogba Independent Consultant
David Bell Independent Consultant
Samuel Popoola Aidx Medical BV
T.E. Agbana Aidx Medical BV
Jan-Carel Diehl Design for Sustainability - IDE
Jan Carel Diehl Design for Sustainability - IDE
J.C. Diehl Design for Sustainability - IDE
Gleb Vdovin Team Michel Verhaegen - Mechanical, Maritime and Materials Engineering
Research Group
Team Michel Verhaegen (Mechanical, Maritime and Materials Engineering) (TU Delft)
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Published Date

2022

Language

English

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Faculty

Mechanical, Maritime and Materials Engineering

Department

Delft Center for Systems and Control

Research Group

Team Michel Verhaegen

Abstract

To achieve the WHO’s goal of sustained elimination of Lymphatic Filariasis disease, there is the need for accurate diagnostic device especially in areas of low-intensity infections. This project, which is a collaboration of the Nigerian Federal Ministry of Health (FMoH), AiDx and funded by THE END FUND is exploring the performance capacity of the novel AiDx_NTDx Assist automated microscope in the detection of microfilaria – Wuchereria bancrofti in prepared blood samples (glass slides) using standard microscopy as a reference. The prevalence of circulating Wuchereria bancrofti microfilaria in blood was assessed using automated Image based microscopy analysis for the detection of microfilariae in prepared blood smears.

1250 people in four LGAs of Ogun state, Nigeria participated in this study. All prepared blood samples analyzed by both expert manual microscopy and the AiDx NTDx Assist results showed that none of the 1250 participants samples analyzed had any presence of W. bancrofti microfilariae in their blood. Since no positive samples was detected by the reference test and the AiDx NTDx Assist, it was impossible to estimate the sensitivity of the device. However, based on the negative results obtained, the AiDx NTDx Assist showed a specificity of 100%, an accuracy of 100% and a Negative Predictive Value of 100%.

Despite the baseline report obtained from the National data base of the ministry of health, indicating the prevalence of 10%, 8.2%, 4.2% and 4% in the four local government areas where samples were collected, we were not able to find a participant with detectable microfilaria. Evaluation of the AiDx NTDx Assist device shows direct correlation with the expert manual microscopy. Although samples were taken in remote/rural areas of some of the LGA, e.g., Adodo Ota, result obtained however suggest a deviation from baseline and reality. This may be due to previous MDA undertaken in 2018 as reported by the state NTD officers. Further, thorough reassessment is therefore recommended .

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