Evaluation of a New HTLV-I/II Polymerase Chain Reaction

Abstract

Aim: Evaluation of a qualitative HTLV-I/Il DNA polymerase chain reaction (PCR) test for the detection of HTLV-I/II DNA (Roche Diagnostic Systems, Branchburg, N.J., USA) in various panels. Methods: The panels consisted of fresh EDTA blood samples from blood donors who were anti-HTLV-I/II ELISA repeatably reactive: 53 were Western blot (WB) positive, 228 were WB indeterminate and 15 were WB negative. Elevent ELISA-negative blood donors were used as negative controls. Furthermore, specimens from 1 HTLV-II-infected intravenous drug user and from 1 HTLV-II-infected blood donor were included in the panel. Peripheral blood lymphocytes were prepared by red blood cell lysis with the Roche washing solution and stored at <-23 °C until processing. Amplification products were analyzed with the HTLV-I/II detection kit. Results: All 53 anti-HTLV-I/II ELISA- and WB-positive samples and both HTLV-II-positive samples tested positively by PCR. All 228 anti-HTLV-I/II ELISA-positive and WB-indeterminate, all 15 ELISA-positive and WB-negative and all 11 ELISAnegative control samples tested negative by PCR. Conclusion: The Roche Amplicor HTLV-I/II test is a simple test, suitable for the confirmation of HTLV-I and -II infection in individuals with indeterminate or positive WB patterns.