title: Sensitivity and specificity of a DNA polymerase chain reaction nonisotopic-based detection method for the confirmation of infection with human T-lymphotropic virus types I and II.
abstract: BACKGROUND
  A convenient, standard format for the detection of polymerase chain reaction (PCR) amplicons would increase the use of PCR for the confirmation of infection with human T-lymphotropic virus types I and II (HTLV-I and HTLV-II).
  
  
  OBJECTIVE
  To determine the sensitivity and specificity of an enzyme oligonucleotide assay (EOA) for the confirmation of infection with HTLV-I or HTLV-II.
  
  
  METHODS
  The sensitivity of the EOA was determined by examining 88 specimens representing diverse geographic-associated genotypes and clinical manifestations. The specificity was determined by testing 40 HTLV-seroindeterminate (PCR-negative) specimens.
  
  
  RESULTS
  Of the 52 HTLV-I-positive specimens tested, 46 (88%) were confirmed positive for HTLV-I by the EOA; these included 25 of 30 (83%) specimens from asymptomatic carriers, 14 of 15 (93%) specimens from patients with HTLV-I-associated myelopathy, and all 7 specimens from patients with adult T-cell leukemia. Similarly, 33 of 36 (92%) HTLV-II-positive specimens were confirmed positive for HTLV-II. None of the specimens were wrongly classified. All specimens tested with distinct geographic-associated genotypes for HTLV-I and -II were detected by EOA. Analysis of seroindeterminate specimens, all of which were previously shown to be negative by nested PCR, showed that none of 40 were detected by either the HTLV-I or HTLV-II EOA.
  
  
  CONCLUSIONS
  The overall sensitivity of the EOA detection for confirmation of HTLV-I and HTLV-II was 79 of 88 (90%) and the overall specificity was 100%. These findings demonstrate that the EOA provides a simple, standardized assay system for reliable confirmation and typing of HTLV infection.
authors.affiliation: Retrovirus Diseases Branch, Division of Viral and Rickettsial Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Mail Stop G19, 1600 Clifton Road, Atlanta, GA 30333, USA.
authors.forename: C S
authors.initials: CS
authors.lastname: Dezzutti
authors.forename: P P
authors.initials: PP
authors.lastname: Patel
authors.forename: S M
authors.initials: SM
authors.lastname: Owen
authors.forename: W M
authors.initials: WM
authors.lastname: Switzer
authors.forename: J
authors.initials: J
authors.lastname: Meshulam
authors.forename: R B
authors.initials: RB
authors.lastname: Lal