Evidence map›Paper›PMID 29803089›Full record

ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2018

Performance of the Alere Determine™ HIV-1/2 Ag/Ab Combo Rapid Test with algorithm-defined acute HIV-1 infection specimens.

Monica M Parker, S Berry Bennett, Timothy J Sullivan, Sally Fordan, Laura G Wesolowski, Kelly Wroblewski, Anne M Gaynor

Open access · hybridAbstract readEvaluation Study
In one paragraph

Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.5field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 28 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Self-Testing as a Hope to Reduce HIV in Transgender Women-Literature Review.International journal of environmental research and public health · 2022
    Review
  6. Article
  7. Article
  8. Performance evaluation of four point-of-care HIV tests using unprocessed specimens.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2020
    Article
  9. Article
  10. Article
  11. Article
  12. Point of care testing for infectious diseases.Clinica chimica acta; international journal of clinical chemistry · 2019
    Review
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 1 country.

Monica M ParkerWadsworth Center, New York State Department of Health, 120 New Scotland Avenue, Albany, NY, 12208, United States. Electronic address: monica.parker@health.ny.gov.
S Berry BennettFlorida Bureau of Public Health Laboratories, 1217 Pearl St., Jacksonville, FL, 32202, United States. Electronic address: Berry.Bennett@FLHealth.gov.
Timothy J SullivanWadsworth Center, New York State Department of Health, 120 New Scotland Avenue, Albany, NY, 12208, United States. Electronic address: timothy.sullivan@health.ny.gov.
Sally FordanFlorida Bureau of Public Health Laboratories, 1217 Pearl St., Jacksonville, FL, 32202, United States. Electronic address: Sally.Fordan@FLHealth.gov.
Laura G WesolowskiCenters for Disease Control and Prevention, United States.
Kelly WroblewskiAssociation of Public Health Laboratories, 8515 Georgia Ave., Suite 700, Silver Spring, MD, 20910, United States. Electronic address: Kelly.wroblewski@aphl.org.
Anne M GaynorAssociation of Public Health Laboratories, 8515 Georgia Ave., Suite 700, Silver Spring, MD, 20910, United States. Electronic address: anne.gaynor@aphl.org.
Association of Public Health Laboratories · USFlorida Department of Health · USNew York State Department of Health · USCenters for Disease Control and Prevention · US

Funding

Intramural CDC HHS CC999999OSELS CDC HHS U60 OE000103
6 · The paper itself

Abstract

backgroundThe capacity of HIV Antigen/Antibody (Ag/Ab) immunoassays (IA) to detect HIV-1 p24 antigen has resulted in improved detection of HIV-1 infections in comparison to Ab-only screening assays. Since its introduction in the US, studies have shown that the Determine HIV-1/2 Ag/Ab Combo assay (Determine Ag/Ab) detects HIV infection earlier than laboratory-based IgM/IgG-sensitive IAs, but its sensitivity for HIV-1 p24 Ag detection is reduced compared to laboratory-based Ag/Ab assays. However, further evaluation is needed to assess its capacity to detect acute HIV-1 infection.

objectiveTo assess the performance of Determine Ag/Ab in serum from acute HIV-1 infections. STUDY

designSelect serum specimens that screened reactive on a laboratory-based Ag/Ab IA or IgM/IgG Ab-only IA, with a negative or indeterminate supplemental antibody test and detectable HIV-1 RNA were retrospectively tested with Determine Ag/Ab. Results were compared with those of the primary screening immunoassay to evaluate concordance within this set of algorithm-defined acute infections.

resultsOf 159 algorithm-defined acute HIV-1 specimens, Determine Ag/Ab was reactive for 105 resulting in 66.0% concordance. Of 125 that were initially detected by a laboratory-based Ag/Ab IA, 81 (64.8%) were reactive by Determine Ag/Ab. A total of 34 acute specimens were initially detected by a laboratory-based IgM/IgG Ab-only IA and 24 (70.6%) of those were reactive by Determine Ag/Ab.

conclusionsDue to their enhanced sensitivity, laboratory-based Ag/Ab IAs continue to be preferred over the Determine Ag/Ab as the screening method used by laboratories conducting HIV diagnostic testing on serum and plasma specimens.

Indexed as

AlgorithmsHIV-1HIV-2HIV AntibodiesHIV AntigensHIV InfectionsHumansImmunoassayRetrospective StudiesSensitivity and SpecificityTime FactorsHIV AntibodiesHIV AntigensAcute infectionAlgorithmDetermineHIVPerformance

Identifiers

PMID29803089
PMCPMC11013022
OpenAlexW2803665049

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.