Document Detail


Comparison of HIV-1 detection in plasma specimens and dried blood spots using the Roche COBAS Ampliscreen HIV-1 test in Kisumu, Kenya.
MedLine Citation:
PMID:  21777620     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
The World Health Organization recommends screening donor blood for HIV in centralized laboratories. This recommendation contributes to quality, but presents specimen transport challenges for resource-limited settings which may be relieved by using dried blood spots (DBS). In sub-Saharan Africa, most countries screen donor blood with serologic assays only. Interest in window period reduction has led blood services to consider adding HIV nucleic acid testing (NAT). The U.S. Food and Drug Administration (FDA) mandates that HIV-1 NAT blood screening assays have a 95% detection limit at or below 100copies/ml and 5000copies/ml for pooled and individual donations, respectively. The Roche COBAS Ampliscreen HIV-1 test, version 1.5, used for screening whole blood or components for transfusion, has not been tested with DBS. We compared COBAS Ampliscreen HIV-1 RNA detection limits in DBS and plasma. An AIDS Clinical Trials Group, Viral Quality Assurance laboratory HIV-1 standard with a known viral load was used to create paired plasma and DBS standard nine member dilution series. Each was tested in 24 replicates with the COBAS Ampliscreen. A probit analysis was conducted to calculate 95% detection limits for plasma and DBS, which were 23.8copies/ml (95% CI 15.1-51.0) for plasma and 106.7 (95% CI 73.8-207.9) for DBS. The COBAS Ampliscreen detection threshold with DBS suggests acceptability for individual donations, but optimization may be required for pooled specimens.
Authors:
Jully A Okonji; Sridhar V Basavaraju; Jane Mwangi; Ray W Shiraishi; Matthew Odera; Kenneth Ouma; John P Pitman; Lawrence H Marum; Chin-Yih Ou; Clement Zeh
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-7-12
Journal Detail:
Title:  Journal of virological methods     Volume:  -     ISSN:  1879-0984     ISO Abbreviation:  -     Publication Date:  2011 Jul 
Date Detail:
Created Date:  2011-7-22     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8005839     Medline TA:  J Virol Methods     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2011. Published by Elsevier B.V.
Affiliation:
Centre for Biomedical Research and Technology, Kenya Medical Research Institute (KEMRI), Off Kisumu-Busia Road, P.O. Box 1578-40100, Kisumu, Kenya.
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