RESUMO
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.
Assuntos
Kit de Reagentes para Diagnóstico , Sorodiagnóstico da Sífilis/métodos , Sífilis/sangue , Testes de Hemaglutinação/métodos , Humanos , Técnicas Imunoenzimáticas/métodos , Kit de Reagentes para Diagnóstico/economia , Kit de Reagentes para Diagnóstico/normas , Sensibilidade e Especificidade , Sífilis/imunologia , Sorodiagnóstico da Sífilis/economia , Sorodiagnóstico da Sífilis/normas , Treponema pallidum/isolamento & purificaçãoRESUMO
The ability of hepatitis A virus (HAV) to agglutinate human erythrocytes was used to develop IgM and IgG antibody capture haemadherence tests (MACHAT and GACHAT). Haemadherence was dependent on the pH of the red cell suspension and was best in the pH range 5.4 to 5.8. The tests were applied to serum, urine, and saliva specimens from individuals susceptible to, or with recent or past infection with HAV. Haemadherence test reactivities were compared with results obtained with IgM and IgG antibody capture radioimmunoassay (MACRIA and GACRIA) and competitive radioimmunoassay (COMPRIA). For 339 serum specimens examined, the sensitivity and specificity of MACHAT were 98.2% and 99.6%, respectively, and of GACHAT 99.1% and 100.0%. For 303 urine specimens, the sensitivity and specificity of MACHAT were 99.1% and 100.0%, and of GACHAT 100% for both. On initial testing, accuracy on saliva specimens was considerably less. For 2,819 saliva specimens, the sensitivity and specificity of MACHAT were 85.7% and 97.2% and of GACHAT 90.4% and 94.7%. The haemadherence test is a simple, inexpensive method which is satisfactory for use on serum and urine specimens. MACHAT and GACHAT can be used for epidemiological investigations, e.g., hepatitis A outbreaks and, in conjunction with a confirmatory test, for clinical diagnostic testing.