Interpretation of low reactivity in the Abbott architect rHTLV I/II assay
File(s)
Published version
Author(s)
Tosswill, JHC
Taylor, GP
Type
Journal Article
Abstract
Objective
The objective of this study is to reduce donor tissue wastage.
Aim
The aim of this study is to determine, in the case of the Abbott Architect rHTLV I/II assay, whether a signal/cut‐off (S/CO) ratio higher than the manufacturer's recommendation of 1·0 could be applied to diagnose significant HTLV‐1 seroreactivity.
Background
The detection of human T cell leukaemia virus type 1 (HTLV‐1) infection is primarily based on serology often utilising random access platforms. Although current assays have high sensitivity and specificity, in low‐prevalence regions, significant numbers of false‐positive reactions occur. A comprehensive follow‐up is difficult within the time frame of organ donation. This can lead to donor tissue wastage.
Methods
A retrospective analysis of 12 250 samples previously tested on the Abbott Architect rHTLV I/II platform and further tested by confirmatory serology/molecular detection to determine the sensitivity and positive predictive value in the S/CO ratio range was conducted.
Results
Where the sample S/CO ratio was >20 (n = 498), HTLV infection was confirmed in all but eight subjects. All of these eight had indeterminate confirmatory results, and none were found to be uninfected. Conversely, in the samples within the S/CO ratio range 1–4 (n = 271), no subject was subsequently found to be HTLV‐infected although HTLV infection could not be excluded in all cases, primarily due to lack of follow‐up samples (n = 60/271).
Conclusions
Samples with an S/CO ratio of <4·0 on the Abbott Architect rHTLV I/II platform represent a low risk of HTLV infection in the UK, and organs from such donors might reasonably be considered for transplantation, within the context of appropriate risk–benefit assessment.
The objective of this study is to reduce donor tissue wastage.
Aim
The aim of this study is to determine, in the case of the Abbott Architect rHTLV I/II assay, whether a signal/cut‐off (S/CO) ratio higher than the manufacturer's recommendation of 1·0 could be applied to diagnose significant HTLV‐1 seroreactivity.
Background
The detection of human T cell leukaemia virus type 1 (HTLV‐1) infection is primarily based on serology often utilising random access platforms. Although current assays have high sensitivity and specificity, in low‐prevalence regions, significant numbers of false‐positive reactions occur. A comprehensive follow‐up is difficult within the time frame of organ donation. This can lead to donor tissue wastage.
Methods
A retrospective analysis of 12 250 samples previously tested on the Abbott Architect rHTLV I/II platform and further tested by confirmatory serology/molecular detection to determine the sensitivity and positive predictive value in the S/CO ratio range was conducted.
Results
Where the sample S/CO ratio was >20 (n = 498), HTLV infection was confirmed in all but eight subjects. All of these eight had indeterminate confirmatory results, and none were found to be uninfected. Conversely, in the samples within the S/CO ratio range 1–4 (n = 271), no subject was subsequently found to be HTLV‐infected although HTLV infection could not be excluded in all cases, primarily due to lack of follow‐up samples (n = 60/271).
Conclusions
Samples with an S/CO ratio of <4·0 on the Abbott Architect rHTLV I/II platform represent a low risk of HTLV infection in the UK, and organs from such donors might reasonably be considered for transplantation, within the context of appropriate risk–benefit assessment.
Date Issued
2018-08-01
Date Acceptance
2017-09-26
Citation
Transfusion Medicine, 2018, 28 (4), pp.326-330
ISSN
1365-3148
Publisher
Wiley
Start Page
326
End Page
330
Journal / Book Title
Transfusion Medicine
Volume
28
Issue
4
Copyright Statement
© 2017 The Authors. Transfusion Medicine published by John Wiley & Sons Ltd on behalf of British Blood Transfusion Society. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction
in any medium, provided the original work is properly cited (https://creativecommons.org/licenses/by/4.0/)
in any medium, provided the original work is properly cited (https://creativecommons.org/licenses/by/4.0/)
Subjects
Science & Technology
Life Sciences & Biomedicine
Hematology
confirmation
HTLV-1
screening
serology
transplantation
T-CELL LEUKEMIA
INFECTED BLOOD-DONORS
VIRUS TYPE-I
HTLV-I
PROVIRAL DNA
MYELOPATHY
PREVALENCE
RETROVIRUS
ANTIBODIES
LYMPHOMA
1103 Clinical Sciences
Cardiovascular System & Hematology
Publication Status
Published
Date Publish Online
2017-10-24