- All > Quality and Safety: Medicines > Blood Products and Related Biologicals
- All > Quality and Safety: Medicines > Quality Assurance
- All > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Keywords > good quality in vitro diagnostics (IVDs)
- Keywords > guidelines and standards
- Keywords > prequalification - In Vitro Diagnostics assessment
- Keywords > prequalification – diagnostic assessment
- Keywords > rapid diagnostic test (RDT)
- Keywords > syphilis infection
- Keywords > in vitro Diagnostic (IVD)
- Keywords > in vitro diagnostic medical devices
(2018; 26 pages)
The purpose of this document is to provide technical guidance to in vitro diagnostic (IVD) medical device manufacturers that intend to seek WHO prequalification of rapid diagnostic tests (RDTs) used to detect syphilis infection. For the purpose of this document, RDTs are lateral-flow or flow-through immunochromatographic antigen or antibody detection tests, which rely on the capture of dye-labelled antibodies or antigens to produce a visible band or dot on a strip of nitrocellulose, often encased in plastic housing, referred to as cassettes.
The document is relevant to qualitative RDTs that detect antibodies to T. pallidum alone or in combination with antibody detection to non-treponemal antigens which are used as part of a testing algorithm.
• A T. pallidum antibody RDT submitted for WHO prequalification is expected to detect all disease stages with the exception of congenital syphilis or neurosyphilis, unless claimed;
• A non-treponemal antibody RDT is expected to detect syphilis related reagin antibodies.
The requirements outlined in this document do not include those necessary to demonstrate that the IVD could be used for confirmatory testing, nor the requirements for any accompanying quality control material. However, if quality control material is provided with the assay, it should demonstrate that the IVD is functional and performs as claimed. (ISO 15198) The requirements are not intended for self-testing.
Minimum performance requirements for WHO prequalification are summarized in this document and apply equally to RDTs intended solely for the detection of syphilis and to those tests manufactured where syphilis detection comprises one component of a multidetection system (e.g. a HIV/syphilis dual-detection RDT).