Onchocerciasis Rapid Test
Onchocerciasis, commonly known as river blindness, affects approximately 26 million people with an estimated 123 million people at risk–mostly in poor, rural communities near streams and rivers in Africa.
For Africa to move from disease control to elimination, better diagnostic tools are needed, especially for monitoring post-control areas for signs of reinfection and for detecting cases in low-prevalence areas.
PATH has recently developed a rapid, affordable, and field-friendly diagnostic test based on the detection of antibodies to the Onchocerca volvulus antigen, Ov16.
Ultimately, the goal of the project is to make the onchocerciasis 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.
River blindness is a parasitic infection transmitted to humans through the bite of the blackfly. It causes itching, skin disfiguration, and with chronic exposure, permanent blindness. It also leads affected communities to abandon productive agricultural fields for fear of infection.
International partnerships have helped reduce the burden of onchocerciasis, paving the way for elimination. These efforts rely on continuous, community-wide testing, which allow control programs to target efforts and monitor recurrence.
Previously, the best available test was an invasive, labor-intensive procedure called a skin snip. Eliminating onchocerciasis will require using improved diagnostic tools like this new test.
The goal of this project was to develop 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.
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 program is funded by the Bill & Melinda Gates Foundation.
- Press Release – Announcing the new onchocerciasis rapid test
- FAQ – Onchocerciasis Rapid Test
- Fact Sheet – Onchocerciasis Rapid Test
- Poster, ASTMH 2014 – Field evaluation of Standard Diagnostics
Onchocerciasis IgG4 rapid diagnostic test prototypes
- Poster, ASTMH 2014 – Application of recombinant human antibody to validation and quality control of serological assays in support of onchocerciasis elimination programs
- Poster, ASTMH, 2013 – Criteria for testing development of rapid diagnostic test to support onchocerciasis control and elimination programs
- PATH 2013 Annual Report – section on diagnostics
- December 2013 article in PATH newsletter “Directions” about onchocerciasis test
- WHO - African Program for Onchocerciasis Control (APOC)
For more information
Contact the Onchocerciasis Team
Tala de los Santos, Project Lead
Contact PATH’s Seattle headquarters