These guidelines are 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. They describe some important basic principles and the main practical aspects of a quality assurance program. The objectives of a quality assurance program are discussed in this document. It is now widely accepted that quality assurance, quality control, and quality assessment constitute an essential part of testing programs and of diagnostic testing in general.

The availability of Ov16 rapid tests does not automatically guarantee high-quality results. Many steps are involved between selecting a test, how and when testing will occur, conducting the test, reporting results, and how the results are used to inform control and elimination programs. At each step in the process, there is the potential that something can go wrong. Therefore, onchocerciasis control and elimination programs should ensure that sufficient support is made available to provide a suitable program to monitor and, if necessary, improve the quality of testing. A well-functioning program is an important step toward achieving highquality testing results and eventual elimination of onchocerciasis.

As of the publication date of this document, only one rapid test serology for detection of IgG4 antibodies specific to Ov16 antigen exists: Alere SD BIOLINE Onchocerciasis IgG4 Rapid Test.