Antigen‐antibody combination assays for blood donor screening: weighing the advantages and costs

Laperche, Syria

doi:10.1111/j.1537-2995.2008.01676.x

Cited by 24 publications

(22 citation statements)

References 28 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…These so-called 4th generation enzyme or chemiluminescent immunoassays (EIAs; ChIAs) are engineered for dual detection of p24 antigen and immunodominant HIV antibodies. These antigen-antibody tests are widely available in Europe, Australia, and recently in Latin America[10-12] and can detect a subset of acute infections without the need for specimen pooling, which is normally done to increase efficiency and reduce costs of (Nucleic Acid Amplification Tests) NAATs[13]. While somewhat more expensive than antibody tests, these new 4 th generation assays have the advantage of a single test that can be performed on a wide array of available equipment, making them adaptable to most ‘1st tier’ laboratory settings in the developing world.…”

Section: Current State Of the Art In Hiv Detectionmentioning

confidence: 99%

Challenges for Rapid Molecular HIV Diagnostics

Schito¹,

D’Souza²,

Owen³

et al. 2010

J INFECT DIS

View full text Add to dashboard Cite

The introduction of serological point-of-care (POC) assays 10 years ago dramatically changed the way HIV infections were identified and diagnosed. Testing at the POC has lead to a dramatic increase in the number of individuals who are screened and, most importantly, receive their HIV test result. As the AIDS epidemic continues to mature and scientific advances in prevention and treatment are evaluated and implemented, there is a need to identify acute (viremic pre-seroconversion) infections and to discriminate “window phase” infections from those that are serologically positive, especially in resource limited settings (RLS), where the majority of the world’s vulnerable populations reside and where the HIV incidence is highest. Rapid testing methods are now at a crossroad. There is opportunity to implement and evaluate the incremental diagnostic utility of new test modalities that are based on sophisticated molecular diagnostic technologies and which can be performed in settings where laboratory infrastructure is minimal. The way forward requires sound scientific judgment, as well as an ability to further develop and implement these tests despite a variety of technical, social and operational hurdles to declare success.

show abstract

Section: Current State Of the Art In Hiv Detectionmentioning

confidence: 99%

Challenges for Rapid Molecular HIV Diagnostics

Schito¹,

D’Souza²,

Owen³

et al. 2010

J INFECT DIS

View full text Add to dashboard Cite

show abstract

“…Multiple strategies reduce human immunodeficiency virus (HIV) transmission through blood transfusion . The primary measure is screening blood for HIV antibodies . However, antibody testing leaves a residual risk due to the time after infection before antibodies are detectable (i.e., “window period”) .…”

mentioning

confidence: 99%

Does offering human immunodeficiency virus testing at the time of blood donation reduce transfusion transmission risk and increase disclosure counseling? Results of a randomized controlled trial, São Paulo, Brazil

et al. 2015

View full text Add to dashboard Cite

Background In a randomized controlled trial (RCT) in a blood bank in São Paulo, we tested the hypotheses that offering client-centered HIV counseling and testing to blood donors would: 1) reduce the risk of HIV contamination in the blood supply by diverting higher risk, test-seeking donors away from donation, and 2) increase return for results and referrals to care. Study Design and Methods We randomly selected weeks between August, 2012 and May, 2013 when donors were offered HIV counseling and testing (N=6,298), leaving usual procedure weeks as control (N=5,569). Results Few candidate donors chose HIV testing (N=81, 1.3%). There was no significant difference in HSV-2 prevalence (a marker of sexual risk) among donors during intervention weeks compared to control (10.4% vs 11.1%, p=0.245). No donor choosing testing was HIV-infected, and there was no difference in HSV-2 prevalence between testers and donors (9.9% vs. 10.4%, p=0.887). Returning for positive results did not differ between testers and donors (3 of 3 vs. 58 of 80, p=0.386). A higher proportion of donors acknowledged that HIV testing was a strong motivation to donate during intervention weeks compared to control (2.6% vs. 2.0%, p=0.032). Conclusion The evidence of our RCT is that offering HIV counseling and testing at the time of donation would not change the risk of contamination in the blood supply, nor improve results disclosure and referral to care.

show abstract

“…Figure 3 presents our recommendation for an algorithm for screening and confirmation of HIV at blood banks in Brazil based on our analysis. We recommend that screening be performed with one fourth‐generation IA due to published results showing that these tests are more sensitive during the window phase 14‐16 . Repeat‐reactive donors would be asked to return to give a follow‐up sample that would be tested by the original screening IAs and, if reactive, submitted to a second IA.…”

Section: Discussionmentioning

confidence: 99%

Performance of parallel screening of Brazilian blood donors with two human immunodeficiency virus immunoassays: implications for sequential immunoassay testing algorithms in other countries

Sabino¹,

Salles²,

Almeida‐Neto³

et al. 2011

Transfusion

View full text Add to dashboard Cite

Background In Brazil it is mandatory to screen donors for HIV antibodies using two immunoassays (IAs) in parallel. Confirmatory testing is performed only on reactive donors who return for counseling. The goal of this analysis was to determine if concordant IA reactivity accurately predicts infection and can be used for HIV incidence/prevalence analyses. Methods We reviewed HIV screening and confirmatory results obtained for 307,407 donations in the first year of the REDS-II study in Brazil (2007), and for 2,304,755 donations collected from 1996 to 2006 in one of the REDS-II sites (Sao Paulo). Results In the Sao Paulo site, 11,410 (0.50%) HIV-IA-reactive donations were discarded, but only 2,095 (0.09%) were reactive to both IAs. Western blot was positive on 1,002 (48%) dual-IA-reactive donors who returned for counseling. Only 4 HIV-infected donors were detected who had been missed at screening by one of the IAs; all occurred prior to 2002. The positive predictive value (PPVs) of dual-IA-reactivity varied from 45.8 to 100%, with 80–90% PPVs when using IAs from different manufacturers. If both assays yielded signal-to-cutoff (S/C) values ≥3.0, PPVs ranged from 91–99%, with ~99% sensitivity for true HIV seropositivity. Conclusion Parallel testing of all donations has limited efficacy when highly sensitive IAs are used. Reactivity by two sequential IAs is useful for prevalence studies if the assays are from different manufacturers and especially if high S/C values are considered.

show abstract

Antigen‐antibody combination assays for blood donor screening: weighing the advantages and costs

Abstract: immune complexes: an alternative to molecular biology in the diagnosis of early HCV infection. Transfusion 2003;43: 958-62. 8. Tobler LH,

Cited by 24 publications

References 28 publications

Challenges for Rapid Molecular HIV Diagnostics

Challenges for Rapid Molecular HIV Diagnostics

Does offering human immunodeficiency virus testing at the time of blood donation reduce transfusion transmission risk and increase disclosure counseling? Results of a randomized controlled trial, São Paulo, Brazil

Performance of parallel screening of Brazilian blood donors with two human immunodeficiency virus immunoassays: implications for sequential immunoassay testing algorithms in other countries

Contact Info

Product

Resources

About