Onchocerciasis Rapid Test
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.
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 test is commercially available to the entire NTD community. Interested programs can order directly from SD.
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.
- Press Release – Announcing the new onchocerciasis rapid test
- FAQ – Onchocerciasis Rapid Test
- Fact Sheet – Onchocerciasis Rapid Test
- Technical Brochure – Onchocerciasis Rapid Test
- Poster, ASTMH 2015 – An implementable and sustainable quality assurance program for Ov16 serology-based rapid tests
- 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
- PATH 2014 Annual Report – feature on test
- 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 Programme for Onchocerciasis Control (APOC)
- Alere/SD Product Page
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 for the SD BIOLINE Onchocerciasis IgG4 rapid test:
- Field use instructions
- Training panel instructions
- Quality Assurance (QA) panel instructions
- A Recombinant Positive Control for Serology Diagnostic Tests Supporting Elimination of Onchocerca volvulus. PLOS Neglected Tropical Diseases, January 2016.
- A Rapid Point of Contact Tool for Mapping and Integrated Surveillance of Wuchereria bancrofti and Onchocerca volvulus infection. Clinical and Vaccine Immunology, May 2015.
- Extended Result Reading Window in Lateral Flow Tests Detecting Exposure to Onchocerca volvulus: A New Technology to Improve Epidemiological Surveillance Tools. PLOS ONE, July 2013.
For more information
Contact the Onchocerciasis team
Tala de los Santos, Global Program Leader, Diagnostics
Contact PATH’s Seattle headquarters