Discordant human T‐lymphotropic virus screening with Western blot confirmation: evaluation of the dual‐test algorithm for US blood donations

Discordant human T‐lymphotropic virus screening with Western blot confirmation: evaluation of... ABBREVIATIONSNRnonreactiveRRrepeat reactiveWBWestern blotScreening for human T‐lymphotropic virus (HTLV) antibodies in the United States was mandated by the Food and Drug Administration (FDA) in 1988 (first for HTLV‐1 followed by HTLV‐2 in 1998). In the United States, HTLV prevalence is relatively low at 3.37 per 100,000 donations collected from 2011 to 2012. HTLV screening has used a dual‐testing algorithm beginning with either a chemiluminescent immunoassay or an enzyme‐linked immunosorbent screening assay (ELISA). Before the availability of a licensed supplemental assay, repeat‐reactive (RR) samples on a first assay (Assay 1) were retested with a second screening assay (Assay 2). Donors with RR results by Assay 2 were deferred from blood donation and further tested using an unlicensed supplemental test to confirm reactivity while nonreactive (NR) donors remained eligible for donation until RR on a subsequent donation. This “dual‐test” algorithm was replaced in May 2016 with the FDA requirement (Federal Register 29842; May 22, 2015) that all RRs by Assay 1 be further tested by a licensed HTLV supplemental test (Western blot [WB]). In this study, we have requalified the dual‐test algorithm using the available licensed HTLV WB.MATERIALS AND METHODSStudy protocolThis postmarket, open‐label, single‐center clinical study involved testing 100 randomly selected HTLV http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Transfusion Wiley

Discordant human T‐lymphotropic virus screening with Western blot confirmation: evaluation of the dual‐test algorithm for US blood donations

Loading next page...
 
/lp/wiley/discordant-human-t-lymphotropic-virus-screening-with-western-blot-oSdxM3cj3T
Publisher
Wiley Subscription Services, Inc., A Wiley Company
Copyright
© 2018 AABB
ISSN
0041-1132
eISSN
1537-2995
D.O.I.
10.1111/trf.14471
Publisher site
See Article on Publisher Site

Abstract

ABBREVIATIONSNRnonreactiveRRrepeat reactiveWBWestern blotScreening for human T‐lymphotropic virus (HTLV) antibodies in the United States was mandated by the Food and Drug Administration (FDA) in 1988 (first for HTLV‐1 followed by HTLV‐2 in 1998). In the United States, HTLV prevalence is relatively low at 3.37 per 100,000 donations collected from 2011 to 2012. HTLV screening has used a dual‐testing algorithm beginning with either a chemiluminescent immunoassay or an enzyme‐linked immunosorbent screening assay (ELISA). Before the availability of a licensed supplemental assay, repeat‐reactive (RR) samples on a first assay (Assay 1) were retested with a second screening assay (Assay 2). Donors with RR results by Assay 2 were deferred from blood donation and further tested using an unlicensed supplemental test to confirm reactivity while nonreactive (NR) donors remained eligible for donation until RR on a subsequent donation. This “dual‐test” algorithm was replaced in May 2016 with the FDA requirement (Federal Register 29842; May 22, 2015) that all RRs by Assay 1 be further tested by a licensed HTLV supplemental test (Western blot [WB]). In this study, we have requalified the dual‐test algorithm using the available licensed HTLV WB.MATERIALS AND METHODSStudy protocolThis postmarket, open‐label, single‐center clinical study involved testing 100 randomly selected HTLV

Journal

TransfusionWiley

Published: Jan 1, 2018

References

You’re reading a free preview. Subscribe to read the entire article.


DeepDyve is your
personal research library

It’s your single place to instantly
discover and read the research
that matters to you.

Enjoy affordable access to
over 12 million articles from more than
10,000 peer-reviewed journals.

All for just $49/month

Explore the DeepDyve Library

Unlimited reading

Read as many articles as you need. Full articles with original layout, charts and figures. Read online, from anywhere.

Stay up to date

Keep up with your field with Personalized Recommendations and Follow Journals to get automatic updates.

Organize your research

It’s easy to organize your research with our built-in tools.

Your journals are on DeepDyve

Read from thousands of the leading scholarly journals from SpringerNature, Elsevier, Wiley-Blackwell, Oxford University Press and more.

All the latest content is available, no embargo periods.

See the journals in your area

DeepDyve Freelancer

DeepDyve Pro

Price
FREE
$49/month

$360/year
Save searches from Google Scholar, PubMed
Create lists to organize your research
Export lists, citations
Read DeepDyve articles
Abstract access only
Unlimited access to over
18 million full-text articles
Print
20 pages/month
PDF Discount
20% off