Can We Improve the Management of Blood Donors With Nonspecific Reactivity in Viral Screening and Confirmatory Assays?

Kiely, Philip; Wood, Erica M.

doi:10.1016/j.tmrv.2004.09.004

Cited by 16 publications

(26 citation statements)

References 44 publications

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“…Finally, the test for HIV showed the highest specificity when compared with NAT assays. These results are consistent with those obtained in previous studies [32,33,40]. …”

Section: Discussionsupporting

confidence: 94%

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Prevalence and trends of markers of hepatitis B virus, hepatitis C virus and human Immunodeficiency virus in Argentine blood donors

et al. 2014

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BackgroundTransfusion-transmitted infections are a major problem associated with blood transfusion. The aim of this study was to determine prevalence and trends of HBV, HCV and HIV in blood donors in Argentina.MethodsA retrospective study was carried out in blood donors of 27 transfusion centers covering the whole country over a period of eight years (2004-2011). Serologic screening assays for HBsAg, anti-HBc, anti-HCV, and anti-HIV were performed in all centers and nucleic acid amplification testing (NAT) was performed in 2 out of the 27 centers.ResultsThe 2,595,852 samples tested nationwide from 2004 to 2011 showed that the prevalence of HBsAg decreased from 0.336% to 0.198% (p < 0.0001), that of anti-HBc from 2.391% to 2.007% (p < 0.0001), that of anti-HCV from 0.721% to 0.460%, (p < 0.0001) and that of anti-HIV from 0.208% to 0.200 (p = 0.075). The prevalence of HBV, HCV and HIV was unevenly distributed among the different regions of the country. Two out of 74,838 screening- negative samples were positive in NAT assays (1 HIV-RNA and 1 HCV-RNA); moreover, HBV-DNA, HCV-RNA and HIV-RNA were detected in 60.29, 24.54 and 66.67% of screening-positive samples of the corresponding assays. As regards donors age, positive HBV-DNA and HCV-RNA donors were significantly older than healthy donors (46.6, 50.5 and 39.5 y respectively, p < 0.001).ConclusionsArgentina has a low prevalence of HBsAg, anti-HCV and anti-HIV in blood donors, with a decreasing trend for HBsAg, anti-HBc and anti-HCV but not for anti-HIV over the last 8 years. The uneven distribution of transfusion-transmitted infections prevalence among the different regions of the country highlights the need to implement regional awareness campaigns and prevention. The discrepancy between samples testing positive for screening assays and negative for NAT assays highlights the problem of blood donors who test repeatedly reactive in screening assays but are not confirmed as positive upon further testing. The uneven distribution of age between healthy donors and NAT-positive donors could be related to changes in risks of these pathogens in the general population and might be attributed to a longer exposure to transmission risk factors in elderly people.

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“…Finally, the test for HIV showed the highest specificity when compared with NAT assays. These results are consistent with those obtained in previous studies [32,33,40]. …”

Section: Discussionsupporting

confidence: 94%

“…As regards HBV, many authors have observed low specificity for total anti-HBc tests when using enzyme immunoassays [32,35,36]. However, the use of this immunoassay as additional marker significantly increased the positive predictive value of the identification of truly HBV-infected individuals.…”

Section: Discussionmentioning

confidence: 99%

Prevalence and trends of markers of hepatitis B virus, hepatitis C virus and human Immunodeficiency virus in Argentine blood donors

et al. 2014

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“…For some time it has been recognized that most anti‐HIV and anti‐HTLV IB indeterminate results in voluntary blood donors without detectable viral RNA/DNA represent non‐specific reactivity . However, as approximately 25% of HCV‐infected individuals spontaneously clear the virus , anti‐HCV IB indeterminate results in the absence of detectable HCV RNA may therefore represent either past exposure to HCV with partial seroreversion or non‐specific reactivity.…”

Section: False Positive Serological Resultsmentioning

confidence: 99%

“…Just over 10 years ago, we reviewed the management of donors with FP serological screening test results . Taking into account diagnostic and therapeutic developments since that time, the purpose of this review is, firstly, to review the potential causes of serological FP results and strategies that can help to distinguish between false and ‘true’ positive serological results; secondly, to discuss some of the interpretative difficulties associated with nucleic acid testing (NAT); and thirdly, to describe the unintended consequences of FP results for both blood services and blood donors for whom being informed of FP results can have adverse psychological effects.…”

Section: Introductionmentioning

confidence: 99%

False positive viral marker results in blood donors and their unintended consequences

2018

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False positive (FP) viral marker results in blood donors continue to pose many challenges. Informing donors of FP results and subsequent deferral can result in stress and anxiety for donors and additional complexity and workload for blood services. Donor management strategies need to balance the requirement to minimise donor anxiety and inconvenience while maintaining sufficiency of supply. Decisions about how and when to inform donors of FP results and determine deferral periods can be difficult as FP results, while often transitory, can take up to several years to resolve. Additional complexities include the interpretation of indeterminate serological confirmatory testing without detectable viral RNA or non-discriminated NAT results with concomitant anti-HBc reactivity - both may be due to FP results, but the former may also represent past infection and the later may represent occult hepatitis B infection. In this review we discuss strategies to minimise indeterminate serological confirmatory results, possible donor deferral policies and the impact on donors when notified of FP results. We also provide some new data from Australia that address the challenge of interpreting non-discriminated NAT results with concomitant anti-HBc reactivity. Ultimately, the challenge is for each blood service to develop appropriate strategies for donor management, taking into account local information and requirements.

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“…Therefore, most repeatedly reactive (RR) results on screening IAs in blood donor populations do not confirm as positive and usually represent biologic false‐reactive (BFR) results that are not indicative of past or current infection with the virus in question. Although the number of BFR results is usually a very low proportion of the total number of donations tested, they nevertheless present a challenge for blood services in terms of donor and product management 10‐16 . Owing to regulatory requirements, in most jurisdictions donations that test RR on screening IAs must be discarded, regardless of confirmatory testing results.…”

mentioning

confidence: 99%

Long‐term serologic follow‐up of blood donors with biologic false reactivity on an anti‐human T‐cell lymphotropic virus Types I and II chemiluminescent immunoassay and implications for donor management

Kiely¹,

THOMAS²,

Kebede³

2008

Transfusion

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Can We Improve the Management of Blood Donors With Nonspecific Reactivity in Viral Screening and Confirmatory Assays?

Cited by 16 publications

References 44 publications

Prevalence and trends of markers of hepatitis B virus, hepatitis C virus and human Immunodeficiency virus in Argentine blood donors

Prevalence and trends of markers of hepatitis B virus, hepatitis C virus and human Immunodeficiency virus in Argentine blood donors

False positive viral marker results in blood donors and their unintended consequences

Long‐term serologic follow‐up of blood donors with biologic false reactivity on an anti‐human T‐cell lymphotropic virus Types I and II chemiluminescent immunoassay and implications for donor management

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