EVALUATION OF A NEW HTLV-I II POLYMERASE CHAIN-REACTION/

Aim: Evaluation of a qualitative HTLV-I/II DNA polymerase chain reacti on (PCR) test for the detection of HTLV-I/II DNA (Roche Diagnostic Sys tems, Branchburg, N.J., USA) in various panels. Methods: The panels co nsisted of fresh EDTA blood samples from blood donors who were anti-HT LV-I/II ELISA repeatably reactive: 53 were Western blot (WB) positive, 228 were WB indeterminate and 15 were WB negative. Elevent ELISA-nega tive blood donors were used as negative controls. Furthermore, specime ns from 1 HTLV-II-infected intravenous drug user and from 1 HTLV-II-in fected blood donor were included in the panel. Peripheral blood lympho cytes were prepared by red blood cell lysis with the Roche washing sol ution and stored at < -23 degrees C until processing. Amplification pr oducts 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-positi ve samples tested positively by PCR. All 228 anti-HTLV-I/II ELISA-posi tive and WB-indeterminate, all 15 ELISA-positive and WB-negative and a ll 11 ELISA-negative control samples tested negative by PCR. Conclusio n: The Roche Amplicor HTLV-I/II test is a simple test, suitable for th e confirmation of HTLV-I and -II infection in individuals with indeter minate or positive WB patterns.