Prolonged Second Diagnostic Window for Human Immunodeficiency Virus Type 1 in a Fourth-Generation Immunoassay: Are Alternative Testing Strategies Required?

George, C R Robert; Robertson, Peter; Lusk, M Josephine; Whybin, Ross; Rawlinson, William D.

doi:10.1128/jcm.01573-14

Cited by 13 publications

(6 citation statements)

References 24 publications

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“…We found that the Abbott i2000 performed significantly better than the ELISA on HBV and HCV screening; however, for anti‐TP and anti‐HIV, the ELISA remained the preferred method. The presence of a second diagnostic window for fourth‐generation HIV assays has been reported . During this period, the reduction in the p24 antigen and antigen/antibody complexes may affect the sensitivity of these assays, and many acute HIV infections have been missed using fourth‐generation assays.…”

Section: Discussionmentioning

confidence: 99%

The Performance of the Abbott i2000 for Measuring Serum Markers of Infectious Diseases

Wang

Chen

2016

Clinical Laboratory Analysis

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Background: To date, there is a trend that the chemiluminescent microparticle immunoassays (CMIA) and electrochemiluminescence immunoassays (ECIA) technology gradually replacing the enzymelinked immunosorbent assay (ELISA). But the performance such as the limit of quantitation (LOQ), precision, linear range of CMIA, or ECIA for serum markers of infectious diseases has rarely been reported. Methods: Using proficiency testing samples and standard materials, we confirmed the LOQ of the ELISA and the precision, linear range, LOQ, and instrument biases of the Abbott i2000 for eight serum markers. We used the Abbott i2000 and ELISAs to assess five HIV samples; the researchers were blinded to the true status of the samples. Results: For the Abbott i2000, the coefficients of variation (CV) for the low, medium, and high concentration samples ranged from 1.06 to 12.74%, which were less than the allowable error; the linear ranges of HBsAg and HBsAb were 0.66-304.11 IU/ ml and 8.16-1205.9 mIU/ml, respectively. For the Abbott i2000, the LOQs of HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, anti-HCV, anti-TP, and anti-HIV were 0.026 IU/ ml, 4 mIU/ml, 0.14 NCU/ml, 0.56 NCU/ml, 0.99 NCU/ml, 0.5 NCU/ml, 8.8 mIU/ml, and 1.92 NCU/ml, respectively, and these values were 0.16 IU/ml, 6.97 mIU/ml, 1.16 NCU/ml, 1.63 NCU/ml, 1.79 NCU/ml, 1.03 NCU/ml, 8.33 mIU/ml, and 1.3 NCU/ ml, respectively, for the ELISA. When five HIV samples were blindly assessed, two cases were missed by the Abbott i2000 and the ELISA results were consistent with the expected results. Conclusions: The Abbott i2000 performed significantly better than the ELISA on HBV and HCV screening; however, for anti-TP and anti-HIV, the ELISA remained the preferred method.

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Section: Discussionmentioning

confidence: 99%

The Performance of the Abbott i2000 for Measuring Serum Markers of Infectious Diseases

Wang

Chen

2016

Clinical Laboratory Analysis

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“…(This situation may occur either very soon after the eclipse period has ended or in a rare, second window period after p24 has cleared but before IgM has become detectable. 30 )…”

Section: Summary and Recommendations For Specific Situationsmentioning

confidence: 99%

Selecting an HIV Test: A Narrative Review for Clinicians and Researchers

Hurt¹,

Nelson²,

Hightow-Weidman³

et al. 2017

Sexual Trans Dis

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Given the many options available, selecting an HIV test for a particular clinical or research setting can be daunting. Making an informed decision requires an assessment of the likelihood of acute infection in the test population and an understanding of key aspects of the tests themselves. The ability of individual tests to reliably detect HIV infection depends on the target(s) being detected, when they can be expected to be present following infection, and the concentration of stable target in test specimens – all of which are explained by the virological and serological events following infection. The purpose of this paper is to: review the timeline of HIV infection, nomenclature and characteristics of different tests; compare point-of-care and laboratory-based tests; discuss the impact of different specimens on test performance; and provide practical advice to help clinicians and researchers new to the field select a test that best suits their needs.

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“…33 Immunoassays for HIV-1 and HIV-2 antibodies are integral components of the current generations of HIV diagnostic assays. 33 Immunoassays for HIV-1 and HIV-2 antibodies are integral components of the current generations of HIV diagnostic assays.…”

Section: Selection Of Hiv Gp41 As a Model Systemmentioning

confidence: 99%

“…Selection of HIV gp41 as a model system Indirect immunoassays are useful in the diagnosis of infections from HIV because the production of HIV-specic antibodies is an important biomarker of seroconversion. 33 Immunoassays for HIV-1 and HIV-2 antibodies are integral components of the current generations of HIV diagnostic assays. 34 Assays for antibodies to gp41, a subunit of the HIV envelope protein, 35 are of particular interest in diagnostic assays because they: (i) can be used broadly for subclasses of HIV-1, 36 (ii) persist indenitely aer seroconversion, 33 and (iii) are passively transmitted to newborns from infected mothers as mechanism for protection.…”

Section: Materials and Regentsmentioning

confidence: 99%

Comparison of three indirect immunoassay formats on a common paper-based microfluidic device architecture

et al. 2016

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The ability to detect antibodies that are generated during an immune response is integral to the diagnosis and monitoring of infections. Assays that have been applied to the detection of antibodies are classically referred to as indirect immunoassays, which include three different formats: indirect, double-antigen sandwich, and total IgG capture. Each of these three approaches relies on a unique pair of reagents to capture the target antibody and transduce a detectable signal, which permits assays to be tuned for ideal performance based on the availability and quality of reagents, the resources available to the operator, and the complexity of

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Prolonged Second Diagnostic Window for Human Immunodeficiency Virus Type 1 in a Fourth-Generation Immunoassay: Are Alternative Testing Strategies Required?

Cited by 13 publications

References 24 publications

The Performance of the Abbott i2000 for Measuring Serum Markers of Infectious Diseases

The Performance of the Abbott i2000 for Measuring Serum Markers of Infectious Diseases

Selecting an HIV Test: A Narrative Review for Clinicians and Researchers

Comparison of three indirect immunoassay formats on a common paper-based microfluidic device architecture

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