Performance evaluation of the new fully automated human immunodeficiency virus antigen‐antibody combination assay designed for blood screening

Sickinger, Eva; Jonas, Gesa; Yem, Alex W.; Goller, Andreas; Stieler, Myriam; Brennan, Catherine A.; Hausmann, Michael; Schochetman, Gerald; Devare, Sushil G.; Hunt, Jeffery C.; Kapprell, Hans-Peter; Bryant, Jane

doi:10.1111/j.1537-2995.2007.01583.x

Cited by 25 publications

(14 citation statements)

References 26 publications

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“…Second, the two panels provided by manufacturers, which accounted for 48% of all samples, might have overestimated the performance of Abbott and Roche assays, as suspected in other studies. 30,31 However, the overall performance of assays did not change when these panels were excluded from the analysis (data not shown). Third, p24Ag levels of supernatant samples used to evaluate LODs might be considered as not accurate since they were determined using only one p24Ag assay, which may have an intrinsic variability in its capacity to detect p24Ag of different genotypes, and because the reference standard used to establish p24Ag level is probably a subtype B.…”

Section: Discussionmentioning

confidence: 79%

The variable sensitivity of HIV Ag/Ab combination assays in the detection of p24Ag according to genotype could compromise the diagnosis of early HIV infection

Ly¹,

Plantier²,

Leballais³

et al. 2012

Journal of Clinical Virology

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Section: Discussionmentioning

confidence: 79%

The variable sensitivity of HIV Ag/Ab combination assays in the detection of p24Ag according to genotype could compromise the diagnosis of early HIV infection

Ly¹,

Plantier²,

Leballais³

et al. 2012

Journal of Clinical Virology

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“…5 More sensitive, fourth-generation tests, which detect both antigens and antibodies, shrink the virus-positive–antibody-negative window by about 5 days. 12 Testing for viral RNA in plasma closes this gap by an additional 7 days.…”

Section: The Hiv-1 Transmission Eventmentioning

confidence: 99%

Acute HIV-1 Infection

et al. 2011

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In 2009, the United Nations Estimated that 33.2 Million People worldwide were living with human immunodeficiency virus type 1 (HIV-1) infection and that 2.6 million people had been newly infected.1 The need for effective HIV-1 prevention has never been greater. In this review, we address recent critical advances in our understanding of HIV-1 transmission and acute HIV-1 infection. Fourth-generation HIV-1 testing, now available worldwide,2,3 will allow the diagnosis of infection in many patients and may lead to new treatments and opportunities for prevention.

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“…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

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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.

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Performance evaluation of the new fully automated human immunodeficiency virus antigen‐antibody combination assay designed for blood screening

Cited by 25 publications

References 26 publications

The variable sensitivity of HIV Ag/Ab combination assays in the detection of p24Ag according to genotype could compromise the diagnosis of early HIV infection

The variable sensitivity of HIV Ag/Ab combination assays in the detection of p24Ag according to genotype could compromise the diagnosis of early HIV infection

Acute HIV-1 Infection

Challenges for Rapid Molecular HIV Diagnostics

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