Fifteen commercial syphilis kits were assessed against the same moderately sized specimen panel that included 114 serum and plasma specimens from syphilis cases and 249 specimens from unselected blood donors. The 114 specimens from syphilis cases comprised 40 from cases of primary syphilis, 43 from cases of secondary syphilis, 19 from cases of early latent syphilis, and 12 from cases of late latent syphilis. Of the 15 kits, ten were enzyme immunoassays, four were Treponema pallidum haemagglutination assays, and one was a T. pallidum particle agglutination assay. Thirteen of the 15 kits gave final specificities of 100%; the other two kits were repeatedly reactive with one to two specimens. Initial sensitivities ranged from 93.9 to 99.1%. Most variation between kits was observed in results for the groups with untreated primary and treated late latent disease, although the differences were not statistically significant. The comparative data on kit performance derived from this study is useful for examining syphilis testing guidelines and for making informed purchasing decisions.
|Number of pages||9|
|Journal||European Journal of Clinical Microbiology and Infectious Diseases|
|Publication status||Published - Oct 2007|
Bibliographical noteFunding Information:
Acknowledgements This work was funded by the Device Evaluation Service (DES) of the Medicines and Healthcare products Regulatory Agency (MHRA). The DES has since transferred to the National Health Service Purchasing and Supply Agency (NHS-PASA) and is now known as the Centre for Evidence-based Purchasing (CEP). We would like to acknowledge the assistance from the manufacturers and thank them for supplying kits. We would like to thank Brian Dow (Scottish National Blood Transfusion Service), David Wenham, Anant Patel, Ruth Bradshaw, and Colette Cullen (North London Blood Centre) for providing specimens. We thank David Gelb (HPA Statistics, Modelling and Bioinformatics Department) for his assistance with the statistical analysis, Jude Pendrey and Ingrid Hamilton (HPA Virus Reference Department) for confirmatory testing of some specimens, and Laura Dean, Rachel White, Li Fu, and Ajay Patel (HPA Evaluations and Standards Laboratory) for their assistance in the laboratory and with the preparation of this report. We would also like to thank Ian Simms (HPA HIV and STI Department), who conducted the national syphilis study from which many of the positive specimens were drawn.