Evaluation of a new third-generation ARCHITECT rHTLV-I/II assay for blood screening and diagnosis
| Autor: | Michael Oer, Sushil G. Devare, Gerald Schochetman, Michael Hausmann, Andreas Goller, Myriam Stieler, Xiaoxing Qiu, Hans-Peter Kapprell |
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| Rok vydání: | 2010 |
| Předmět: |
Serum
Microbiology (medical) Blood transfusion Hospitalized patients viruses Coefficient of variation medicine.medical_treatment Evaluation data Sensitivity and Specificity Automation Plasma Virology Humans Mass Screening Medicine Human T-lymphotropic virus 1 medicine.diagnostic_test business.industry Human T-lymphotropic virus 2 Blood Screening General Medicine HTLV-I Infections Third generation Blood Infectious Diseases Virus type Immunoassay HTLV-II Infections business |
| Zdroj: | Diagnostic Microbiology and Infectious Disease. 67:61-69 |
| ISSN: | 0732-8893 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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