Strategies for diagnosis of HTLV-I and -II

• Published in: Transfusion (Philadelphia, Pa.) Vol. 42; no. 6; pp. 780 - 791
• Main Authors: Thorstensson, Rigmor, Albert, Jon, Andersson, Sören
• Format: Journal Article
• Language: English
• Published: Boston, MA, USA Blackwell Science Inc 01.06.2002; Blackwell Publishing
• Subjects: Algorithms; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis; Blotting, Western - economics; Cost Control; DNA, Viral - blood; Enzyme-Linked Immunosorbent Assay - economics; HTLV-I Antibodies - blood; HTLV-I Infections - blood; HTLV-I Infections - diagnosis; HTLV-I Infections - epidemiology; HTLV-II Antibodies - blood; HTLV-II Infections - blood; HTLV-II Infections - diagnosis; HTLV-II Infections - epidemiology; Human T-lymphotropic virus 1 - genetics; Human T-lymphotropic virus 1 - immunology; Human T-lymphotropic virus 1 - isolation & purification; Human T-lymphotropic virus 2 - genetics; Human T-lymphotropic virus 2 - immunology; Human T-lymphotropic virus 2 - isolation & purification; Humans; Immunoassay - economics; Leukocytes, Mononuclear - virology; Mass Screening - economics; Mass Screening - methods; Medical sciences; Polymerase Chain Reaction - economics; Prospective Studies; Proviruses - isolation & purification; RNA, Viral - blood; Sensitivity and Specificity; Sweden - epidemiology; Transfusions. Complications. Transfusion reactions. Cell and gene therapy; Viremia - diagnosis; Viremia - epidemiology; Sweden; Costs; Biochemical analysis; Transfusion; Retroviridae; Medical screening; Contamination; Blood; Virus; Polymerase chain reaction; HTLV-II virus; Sensitivity; Decision aid; HTLV-I virus; ELISA assay; Comparative study
• ISSN: 0041-1132; 1537-2995
• DOI: 10.1046/j.1537-2995.2002.00114.x

BACKGROUND : No gold standard exists for diagnosis of HTLV infection. The aim of thus study was to compare the accuracy of a combination of two sensitive ELISAs with Western blot (WB), a line immunoassay, and PCR for diagnosis of HTLV infection. STUDY DESIGN AND METHODS : Nine hundred eighty‐five specimens were tested for the presence of HTLV antibodies by HTLV‐I and/or HTLV‐II EIAs (Murex and Ortho), WB (Diagnostic Biotechnology), line immunoassay (INNO‐LIA, Innogenetics), and/or presence of HTLV DNA by PCR. The results were compared with the probable HTLV infection status of each subject, as determined by detailed review of all available laboratory, clinical, and epidemiologic data. RESULTS : The sensitivity for diagnosis of HTLV‐I infection was high for all assays evaluated, but both PCR and WB had a lower sensitivity rate (approx., 80%) for confirmation of HTLV‐II. INNO‐LIA detected 94 percent of the HTLV‐II‐positive samples. However, Murex EIA in combination with Ortho EIA was 100‐percent sensitive for the detection of both HTLV‐I and HTLV‐II antibodies. Furthermore, the number of samples giving indeterminate results in the ELISA combination was much lower as compared with WB (2.5% vs. 50%). CONCLUSION : Based on these findings, a new, more sensitive and specific test strategy for HTLV diagnosis than the current algorithm, which includes WB, is proposed. Thereby, both the direct and indirect costs can be substantially reduced.