Diagnostic Technologies

Onchocerciasis Rapid Test

PATH onchocerciasis point-of-care diagnostic test

The SD BIOLINE Onchocerciasis IgG4 rapid test pre-production prototype.
Photo: PATH/Dunia Faulx


partner focus: Thomas B. Nutman, MD, and the NIAID in DxNEWS»

news: PATH 2014 Annual Report features new river blindness tool »

on our blog: The flies have it – river blindness and the communities it affects. »

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Project goal

Learn about the disease onchocerciasis.

The goal of the onchocerciasis rapid test project was to make a rapid test commercially available for purchase by the onchocerciasis community to help elimination efforts. PATH announced the availability of the test, the SD BIOLINE Onchocerciasis IgG4, manufactured and distributed by Standard Diagnostics, Inc. (SD), in November 2014.

The test was developed to be an affordable rapid test that is easy to use, requires less-invasive sampling methods, and provides faster results. It has significant advantages over methods currently in use. Its design features make the test practical and convenient for use in the field.

In combination with other strategies, this simple, field-friendly, and affordable rapid test could be a powerful tool for use in Africa as onchocerciasis programs move from control to elimination.


PATH has collaborated with scientists at the National Institutes of Health, a South Korean manufacturer, and others to bring the new SD BIOLINE Onchocerciasis IgG4 rapid test for river blindness to market.

The new point-of-care test developed by PATH and partners is based on the detection of antibodies to a parasite antigen called Ov16, which was identified by scientists at the National Institute of Allergy and Infectious Diseases (NIAID). The test detects exposure to Onchocerca volvulus, the parasite that causes onchocerciasis, by checking for these antibodies in a single drop of blood from a finger prick. It is fast, accurate, easy to use, and less painful for patients than the skin-snip test.

Development History

In 2012, NIAID scientists evaluated test prototypes and found excellent performance. In addition, PATH studied how users interact with the test and used their feedback to refine the test’s design.

PATH partnered with two organizations in the endemic country of Togo to conduct field-based evaluations in early 2013. The goal of this work was to evaluate the performance of the test in field conditions. We compared the Ov16 rapid test to the two proven methods of diagnosis, the skin snip and the ELISA tests, evaluating dried blood spots in the lab collected during our field work. Using the valuable data provided by the field study, PATH further refined the test.

To bring the test to market, PATH sought a manufacturing partner that could meet regulatory and process requirements to create and effectively distribute the product at an affordable price. After onsite assessments of several candidates, we selected SD, a firm based in South Korea.

In early 2013, PATH transferred the technology for the test to SD. PATH is supporting these efforts and helping facilitate introduction of the commercial test, SD BIOLINE Onchocerciasis IgG4, in local markets. PATH also ran follow-up laboratory- and field-based evaluations of the test and used the results to further refine the prototype.


PATH launched the SD BIOLINE Onchocerciasis IgG4 rapid test in late 2014 with SD as manufacturer and distributor.

The new test, together with mass drug treatment, has the potential to help vulnerable communities finally end the suffering caused by onchocerciasis.


This project includes significant scientific contributions from the NIAID, part of the NIH. This project is funded with a grant from the Bill & Melinda Gates Foundation.


Quality Assurance Program

Guidelines designed for policymakers and program planners wishing to implement a quality assurance program for serological tests detecting IgG4 antibodies specific to the Ov16 antigen from Onchocerca volvulus are below.

  • “Guidelines for Organizing a Quality Assurance Program for Ov16 Serological Rapid Tests”

Training Materials

Training Materials for the SD BIOLINE Onchocerciasis IgG4 rapid test: 


For more information

phone email more info

Contact the Onchocerciasis team

Tala de los Santos, Global Program Leader, Diagnostics


Contact PATH’s Seattle headquarters
Tel: 206.285.3500
Fax: 206.285.6619


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