PMID- 20227221 OWN - NLM STAT- MEDLINE DCOM- 20100621 LR - 20191210 IS - 1879-0070 (Electronic) IS - 0732-8893 (Linking) VI - 67 IP - 1 DP - 2010 May TI - Evaluation of a new third-generation ARCHITECT rHTLV-I/II assay for blood screening and diagnosis. PG - 61-9 LID - 10.1016/j.diagmicrobio.2009.12.021 [doi] AB - In comparison to current on-market assays, the ARCHITECT rHTLV-I/II assay is the first fully automated assay that simultaneously detects human T-cell lymphotropic virus type I (HTLV-I) and type II (HTLV-II) in human serum and plasma. Specificity was assessed on 5646 blood donors and 692 clinical specimens. For sensitivity determination, 301 HTLV-I-positive and 105 HTLV-II-positive specimens were tested. Precision was between 3.98% and 4.31% coefficient of variation (CV) for specimens with 1 to 6 sample to cutoff. Specificity was 99.95% and 99.86% on specimens from blood donors and hospitalized patients, respectively. Sensitivity evaluation showed 100% detection on 301 HTLV-I and 105 HTLV-II specimens. HTLV-I and HTLV-II viruses are still circulating among general populations even in the low prevalence areas. To control the further spread of these retroviruses, we need to know that it is important to continue screening of blood. The performance evaluation data from this study demonstrate that the high throughput and fully automated ARCHITECT rHTLV-I/II chemiluminescence immunoassay effectively serves this purpose. CI - (c) 2010 Elsevier Inc. All rights reserved. FAU - Kapprell, Hans-Peter AU - Kapprell HP AD - Abbott GmbH and Co. KG, 65205 Wiesbaden-Delkenheim, Germany. hans-peter.kapprell@abbott.com FAU - Stieler, Myriam AU - Stieler M FAU - Oer, Michael AU - Oer M FAU - Goller, Andreas AU - Goller A FAU - Hausmann, Michael AU - Hausmann M FAU - Schochetman, Gerald AU - Schochetman G FAU - Devare, Sushil G AU - Devare SG FAU - Qiu, X AU - Qiu X LA - eng PT - Comparative Study PT - Evaluation Study PT - Journal Article DEP - 20100312 PL - United States TA - Diagn Microbiol Infect Dis JT - Diagnostic microbiology and infectious disease JID - 8305899 SB - IM MH - Automation/methods MH - Blood/*virology MH - HTLV-I Infections/*diagnosis/virology MH - HTLV-II Infections/*diagnosis/virology MH - Human T-lymphotropic virus 1/*isolation & purification MH - Human T-lymphotropic virus 2/*isolation & purification MH - Humans MH - Mass Screening/*methods MH - Plasma/virology MH - Sensitivity and Specificity MH - Serum/virology MH - Virology/*methods EDAT- 2010/03/17 06:00 MHDA- 2010/06/22 06:00 CRDT- 2010/03/16 06:00 PHST- 2009/10/30 00:00 [received] PHST- 2009/12/14 00:00 [revised] PHST- 2009/12/22 00:00 [accepted] PHST- 2010/03/16 06:00 [entrez] PHST- 2010/03/17 06:00 [pubmed] PHST- 2010/06/22 06:00 [medline] AID - S0732-8893(09)00512-4 [pii] AID - 10.1016/j.diagmicrobio.2009.12.021 [doi] PST - ppublish SO - Diagn Microbiol Infect Dis. 2010 May;67(1):61-9. doi: 10.1016/j.diagmicrobio.2009.12.021. Epub 2010 Mar 12.