Performance evaluation of the FDA-approved Determine™ HIV-1/2 Ag/Ab Combo assay using plasma and whole blood specimens

Masciotra, Silvina; Luo, Wei; Westheimer, Emily; Cohen, Stéphanie; Hall, Laura; Pan, Yi; Peters, Philip J.; Owen, S. Michele

doi:10.1016/j.jcv.2017.03.019

Cited by 22 publications

(12 citation statements)

References 27 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…First, we only tested on serum samples, which may lend to more enriched concentrations of antibodies compared with capillary whole blood (as performed during self-testing). Test sensitivity reported in our study could have been inflated; however, this bias is more pertinent to small volume, lateral flow tests than for flow-through tests 9. Second, tests were performed by trained virologists.…”

Section: Discussionmentioning

confidence: 86%

Sensitivity of the STAT-VIEW rapid self-test and implications for use during acute HIV infection

Boukli¹,

Boyd

Wendremaire³

et al. 2017

Sex Transm Infect

View full text Add to dashboard Cite

Over half of AHI patients had reactive serology using the STAT-VIEW rapid self-test when performed on serum samples. Considering that detection sensitivity increased substantially over infection time, individuals should not rely on a negative result to accurately exclude HIV infection within at least 5 weeks of potential HIV exposure. Notwithstanding strong recommendations against rapid test use during AHI, some utility in detecting HIV is observed 5-12 weeks after transmission.

show abstract

Section: Discussionmentioning

confidence: 86%

Sensitivity of the STAT-VIEW rapid self-test and implications for use during acute HIV infection

Boukli¹,

Boyd

Wendremaire³

et al. 2017

Sex Transm Infect

View full text Add to dashboard Cite

show abstract

“…POC tests are attractive alternatives for many applications, but performance differs substantially depending on the specimen type; tests using oral transudate are significantly less sensitive than those using whole blood, and tests using whole blood are less sensitive than those using serum or plasma. 11–14 This hierarchy is at least partially explained by the relative concentration of detectable target(s) per volume of specimen tested. Forty-five percent of whole blood is made up of cells, so additional processing to yield plasma or serum further concentrates antigens and antibodies per unit volume.…”

Section: What Influence Does Specimen Type Have On Testing?mentioning

confidence: 99%

“…17 Studies of a newer version of this same test suggest interim improvements, with antigen sensitivity as high as 88%. 14,18 Using plasma instead of whole blood enhances test performance, suggesting a role for this test in situations when laboratory support is available but an automated platform is not. 14 …”

Section: What Advantages Do Poc Tests Have Over Laboratory-based Assays?mentioning

confidence: 99%

“…14,18 Using plasma instead of whole blood enhances test performance, suggesting a role for this test in situations when laboratory support is available but an automated platform is not. 14 …”

Section: What Advantages Do Poc Tests Have Over Laboratory-based Assays?mentioning

confidence: 99%

“…To accomplish this, laboratory-based p24/IgM/IgG sensitive assays on serum or plasma should be used whenever possible. In settings with support for specimen processing but without an automated test platform, using serum or plasma with a p24/IgM/IgG sensitive POC test will improve its sensitivity (compared to whole blood) 11,13,14 and offers the potential for earlier diagnosis than with IgM/IgG sensitive tests. Although most people with symptomatic HIV-1 acute retroviral syndrome (e.g., fever, pharyngitis, and lymphadenopathy) will have detectable p24 antigenemia, adding a nucleic acid test to the diagnostic workup (where available) may help capture the small proportion of those with recent infections who are RNA-positive but antigen-negative.…”

Section: Summary and Recommendations For Specific Situationsmentioning

confidence: 99%

See 2 more Smart Citations

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

Hurt¹,

Nelson²,

Hightow-Weidman³

et al. 2017

Sexual Trans Dis

View full text Add to dashboard Cite

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.

show abstract

A simple algorithm for selecting cases to investigate acute and early HIV infections in low‐ and middle‐income countries

Matsuda¹,

Ahagon

Coelho

et al. 2021

Journal of Medical Virology

View full text Add to dashboard Cite

We documented the outcome of an over 10-year effort to diagnose acute and early HIV infections (AEHI) in an Infectious Diseases Outpatient Clinic with limited resources. Of a total of 132 cases, 119 HIV-RNA tests were performed from 2017-2020, 12 cases were identi ed, using a simple algorithm: risk exposure of six weeks or less before the visit and/or symptoms compatible with acute retroviral syndrome 7-30 days after exposure and/or undetermined 3rd generation rapid diagnostic test or serology. AEHI diagnoses varied from 2.4% among asymptomatic to 25% for undetermined serology cases using a simple screening applicable to different settings.

show abstract

Performance evaluation of the FDA-approved Determine™ HIV-1/2 Ag/Ab Combo assay using plasma and whole blood specimens

Cited by 22 publications

References 27 publications

Sensitivity of the STAT-VIEW rapid self-test and implications for use during acute HIV infection

Sensitivity of the STAT-VIEW rapid self-test and implications for use during acute HIV infection

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

A simple algorithm for selecting cases to investigate acute and early HIV infections in low‐ and middle‐income countries

Contact Info

Product

Resources

About