title: Evaluation of a new screening assay for HTLV-1 and -2 antibodies for large-scale use.
abstract: Laboratory testing for Human T-lymphotropic Virus type 1 and 2 (HTLV-1 and -2) infections has become routine in blood transfusion, tissue transplantation and clinical diagnoses in many countries worldwide. Screening is usually based on the detection of antibodies to HTLV-1 and/ or -2. The number of commercially available assays is limited, and among them, ELISA tests based on microtiter format are most commonly used. Recently, the new rHTLV-I/II assay (Abbott Laboratories, Abbott Park, IL) was released; this assay was developed for an automatic large-scale screening platform. This assay was evaluated using pre-characterized serum panels and routine samples from the clinical laboratory. The sensitivity was 100% for HTLV-1 and -2 (99/99 and 42/42, respectively, including one sample that was dually reactive, HTLV-1 + 2). To test assay specificity, panels of blood donor sera, specimens from patients with autoimmune diseases and some viral infections were used. False-reactive samples from previous HTLV diagnoses were also included. With these panels, the specificity was 99.4% (619/623). However, the four false-reactive samples all belonged to the group of samples that were previously considered as false-reactive for HTLV-antibodies. All other samples were negative by the rHTLV-I/II assay, and thus 100% specificity was obtained. The 1,412 samples tested in the clinic by this assay in routine use were all negative (100% specificity). Taken together, the overall specificity was 99.8%. The assay was sensitive, specific and appropriate for the large-scale screening of samples for HTLV-1/2 antibodies.
authors.affiliation: Department of Laboratory Medicine, Microbiology, Orebro University Hospital, 70185 Orebro, Sweden. Kerstin.malm@orebroll.se
authors.forename: Kerstin
authors.initials: K
authors.lastname: Malm
authors.forename: Torbjörn
authors.initials: T
authors.lastname: Kjerstadius
authors.forename: Sören
authors.initials: S
authors.lastname: Andersson
mesh_terms: D005189:False Positive Reactions; D015481:HTLV-I Antibodies / Q000097:blood*; D015490:HTLV-I Infections / Q000097:blood / Q000175:diagnosis*; D015482:HTLV-II Antibodies / Q000097:blood*; D015491:HTLV-II Infections / Q000097:blood / Q000175:diagnosis*; D015368:Human T-lymphotropic virus 1 / Q000276:immunology / Q000302:isolation & purification*; D015367:Human T-lymphotropic virus 2 / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation*; D008163:Luminescent Measurements / Q000295:instrumentation*; D008403:Mass Screening; D012680:Sensitivity and Specificity
chemical_list: D015481:HTLV-I Antibodies; D015482:HTLV-II Antibodies