title: Screening for antibodies against Treponema pallidum with chemiluminescent microparticle immunoassay: analysis of discordant serology results and clinical characterization.
abstract: BACKGROUND
  Traditionally, testing for syphilis has consisted of initial screening with a non-treponemal test, then retesting reactive specimens with a treponemal test. Recent availability of a chemiluminescent microparticle immunoassay for detecting antibodies against Treponema pallidum has led several laboratories in China to adopt chemiluminescent microparticle immunoassay for screening of syphilis, with subsequent testing of reactive serum samples with non-treponemal tests. We evaluated the utility of chemiluminescent microparticle immunoassay for routine screening of syphilis.
  
  
  METHODS
  Antibodies against Treponema pallidum were screened in 20,550 serum samples using chemiluminescent microparticle immunoassay. Chemiluminescent microparticle immunoassay-positive samples were reflexively tested with rapid plasma reagin tests and Treponema pallidum particle agglutination assays. Dot-immunoblot assays were used to confirm results of chemiluminescent microparticle immunoassay-positive and Treponema pallidum particle agglutination-negative serum samples.
  
  
  RESULTS
  Overall, 267 samples (1.3%) were chemiluminescent microparticle immunoassay-positive, and 185 (69.3%) of those chemiluminescent microparticle immunoassay-positive serum samples were also Treponema pallidum particle agglutination-positive. Samples' signal to cut-off ratio for chemiluminescent microparticle immunoassay correlated with diagnostic reliability, as greater samples' signal to cut-off ratio corresponded with greater concordance between chemiluminescent microparticle immunoassay and Treponema pallidum particle agglutination results. Dot-immunoblot testing of 82 chemiluminescent microparticle immunoassay-positive and Treponema pallidum particle agglutination-negative serum samples showed that 16 samples (19.5%) were Dot-immunoblot-positive, 28 (34.2%) were indeterminate and 38 (46.3%) were negative.
  
  
  CONCLUSIONS
  Because there is a certain percentage of false-positive results using chemiluminescent microparticle immunoassay for routine screening of syphilis, further analysis by Treponema pallidum particle agglutination is recommended to confirm diagnostic results. While in screening populations discrepancies between chemiluminescent microparticle immunoassay and Treponema pallidum particle agglutination results are quite prevalent, confirmation by immunoblot assay may be useful.
authors.affiliation: Department of Clinical Laboratory, Peking University First Hospital, Beijing, China zyli_1979@163.com.
authors.forename: Zhiyan
authors.initials: Z
authors.lastname: Li
authors.affiliation: Department of Clinical Laboratory, Peking University First Hospital, Beijing, China.
authors.forename: Zhenru
authors.initials: Z
authors.lastname: Feng
authors.affiliation: Department of Clinical Laboratory, Peking University First Hospital, Beijing, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Liu
authors.affiliation: Department of Clinical Laboratory, Peking University First Hospital, Beijing, China.
authors.forename: Cunling
authors.initials: C
authors.lastname: Yan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000907:Antibodies, Bacterial / Q000097:blood*; D002648:Child; D005260:Female; D006801:Humans; D007118:Immunoassay; D008163:Luminescent Measurements; D008297:Male; D008403:Mass Screening; D008875:Middle Aged; D013587:Syphilis / Q000097:blood / Q000175:diagnosis* / Q000276:immunology; D013588:Syphilis Serodiagnosis; D014210:Treponema pallidum / Q000276:immunology*; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial
keywords: Screening; Treponema pallidum; serological test; syphilis