title: Sensitivity and specificity of human T-lymphotropic virus (HTLV) types I and II polymerase chain reaction and several serologic assays in screening a population with a high prevalence of HTLV-II.
abstract: BACKGROUND
  Since 1988, all blood donations in the United States have been screened for antibodies to human T-lymphotropic virus type I (HTLV-I). However, the sensitivity of current serologic tests for the detection of HTLV type II (HTLV-II) antibodies and the diagnostic utility of direct tests for HTLV-I and -II using polymerase chain reaction (PCR) are poorly defined.
  
  
  METHODS
  Five hundred sixty-nine HTLV-I- or -II-seropositive and 687 age- and sex-matched seronegative samples from a high-risk population at an inner-city emergency department were selected. All samples were tested with four HTLV enzyme immunoassays (EIAs), one Western blot assay and one type-specific Western blot assay, one HTLV type-specific EIA, and a research HTLV-I/II PCR kit.
  
  
  RESULTS
  Sensitivity of the various EIAs ranged from 95.1 to 99.5 percent, and specificity ranged from 97.2 to 99.4 percent. PCR performed in duplicate without selective retesting had lower sensitivity (85.1 %) and specificity (88.0%). However, PCR detected 20 (3.2%) HTLV-I-positive and 47 (7.5%) HTLV-II-positive samples among the 627 samples that were negative in all EIAs. The type-specific EIA and PCR assay had the highest rate of concordance in classifying samples as either HTLV-I or II, with the type-specific EIA and type-specific Western blot having the next highest rates of concordance.
  
  
  CONCLUSIONS
  In this sample set from a population at high risk for HTLV-II, screening with HTLV-I/II PCR had lower sensitivity and specificity than that with EIAs. However, 4.1 to 10.8 percent of samples were PCR positive but seronegative for HTLV-I or -II, and their true infection status remains undetermined.
authors.affiliation: Department of Laboratory Medicine, University of California San Francisco, 94143-0884, USA.
authors.forename: H
authors.initials: H
authors.lastname: Liu
authors.forename: M
authors.initials: M
authors.lastname: Shah
authors.forename: S L
authors.initials: SL
authors.lastname: Stramer
authors.forename: W
authors.initials: W
authors.lastname: Chen
authors.forename: B J
authors.initials: BJ
authors.lastname: Weiblen
authors.forename: E L
authors.initials: EL
authors.lastname: Murphy
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D015491:HTLV-II Infections / Q000453:epidemiology*; D015368:Human T-lymphotropic virus 1 / Q000235:genetics* / Q000276:immunology*; D015367:Human T-lymphotropic virus 2 / Q000235:genetics* / Q000276:immunology*; D006801:Humans; D007124:Immunoenzyme Techniques; D008403:Mass Screening; D008875:Middle Aged; D016133:Polymerase Chain Reaction; D015995:Prevalence; D012680:Sensitivity and Specificity
chemical_list: D000914:Antibodies, Viral