Evaluation of a new third-generation ARCHITECT rHTLV-I/II assay for blood screening and diagnosis.
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.
Kapprell
Hans-Peter
HP
Abbott GmbH and Co. KG, 65205 Wiesbaden-Delkenheim, Germany. hans-peter.kapprell@abbott.com
Stieler
Myriam
M
Oer
Michael
M
Goller
Andreas
A
Hausmann
Michael
M
Schochetman
Gerald
G
Devare
Sushil G
SG
Qiu
X
X
D001331:Automation / Q000379:methods; D001769:Blood / Q000821:virology*; D015490:HTLV-I Infections / Q000175:diagnosis* / Q000821:virology; D015491:HTLV-II Infections / Q000175:diagnosis* / Q000821:virology; D015368:Human T-lymphotropic virus 1 / Q000302:isolation & purification*; D015367:Human T-lymphotropic virus 2 / Q000302:isolation & purification*; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D010949:Plasma / Q000821:virology; D012680:Sensitivity and Specificity; D044967:Serum / Q000821:virology; D014773:Virology / Q000379:methods*