Evidence map›Paper›PMID 22832059›Full record

ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2012

Validation for clinical use of a novel HIV-2 plasma RNA viral load assay using the Abbott m2000 platform.

Ming Chang, Geoffrey S Gottlieb, Joan A Dragavon, Stephen L Cherne, Donna L Kenney, Stephen E Hawes, Robert A Smith, Nancy B Kiviat, Papa Salif Sow, Robert W Coombs

Abstract readValidation Study
In one paragraph

Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 13% 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

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Long-term Experience and Outcomes of Programmatic Antiretroviral Therapy for Human Immunodeficiency Virus Type 2 Infection in Senegal, West Africa.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Observational
  7. HIV-2 Drug Resistance Genotyping from Dried Blood Spots.Journal of clinical microbiology · 2020
    Article
  8. Article
  9. Article
  10. Diagnosis of Human Immunodeficiency Virus Infection.Clinical microbiology reviews · 2019
    Review
  11. Article
  12. Detection and differentiation of HIV-2 using the point-of-care Alere q HIV-1/2 Detect nucleic acid test.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2017
    Article
  13. Article
  14. Article
  15. Human Immunodeficiency Virus (HIV).Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2016
    Article
  16. A Pan-HIV Strategy for Complete Genome Sequencing.Journal of clinical microbiology · 2016
    Article
  17. Article
  18. Article
  19. Article
  20. 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

10 authors at 3 institutions in 2 countries.

Ming ChangDepartment of Laboratory Medicine, Division of Virology, University of Washington, Seattle, United States.
Geoffrey S Gottlieb
Joan A Dragavon
Stephen L Cherne
Donna L Kenney
Stephen E Hawes
Robert A Smith
Nancy B Kiviat
Papa Salif Sow
Robert W Coombs
University of Washington · USSeattle University · USCheikh Anta Diop University · SN

Funding

WOMEN'S HEALTH AGENDAU01AI038858 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI BENSON, CONSTANCE ANN · 1996 to 2008
$157.5M
University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI Kenneth Sherr · 1988 to 2026
$104.9M
Antiretroviral Therapy for HIV-2 Infection in SenegalR01AI060466 · NIAID · UNIVERSITY OF WASHINGTON · PI GOTTLIEB, GEOFFREY SCOTT · 2005 to 2014
$6.5M
NIAID NIH HHS 2R01-AI060466NIAID NIH HHS AI-38858NIAID NIH HHS P30 AI027757NIAID NIH HHS R01 AI060466NIAID NIH HHS U01 AI038858
6 · The paper itself

Abstract

backgroundOptimal care of persons infected with human immunodeficiency virus type 2 (HIV-2) requires an accurate assessment of HIV-2 plasma viral load (VL), but no clinically approved quantitative HIV-2 RNA VL assay exists.

objectivesTo validate a novel quantitative HIV-2 RNA assay for clinical and research use. STUDY

designThe Abbott m2000sp/rt platform was adapted for quantification of HIV-2 RNA in plasma. Amplification targeted a region of the long terminal repeat conserved in Group A and B HIV-2. Electron microscopy-counted-HIV-2 standards, the WHO/NIBSC HIV-2 International Standard and clinical specimens (N=162) were used to determine the precision, sensitivity, specificity, linear range, accuracy, and clinical performance of the assay.

resultsThe quantitative linear range of the HIV-2 RNA assay was 10-1,000,000 copies/mL (R(2)>0.99), with a limit of detection of 8 copies/mL (95% CI, 5-18 copies/mL). The assay did not cross-react with HIV-1, and quantification of HIV-2 RNA was not affected by the presence of >5 log(10)HIV-1 RNA copies/mL. The total standard deviation (SD) and intra- and inter-run SD were 0.095, 0.093 and 0.162, respectively, at nominal inputs of 3.7, 1.7 and 1.0 log(10)HIV-2 RNA copies/mL. The HIV-2 WHO/NIBSC International Standard (1000 IU) was shown to contain 152 RNA copies/mL (95% CI 141-163). Overall, HIV-2 RNA was quantified at ≥10 copies/mL from 86 (53%) clinical specimens (median, 2.24 log(10) copies/mL; range 10-16,870), and nine specimens (6%) had HIV-2 RNA detected at <10 copies/mL.

conclusionsWe developed and validated a highly sensitive HIV-2 VL assay that is suitable for clinical and research use.

Indexed as

HIV-2HIV InfectionsHumansPlasmaRNA, ViralSensitivity and SpecificityViral LoadRNA, Viral

Identifiers

PMID22832059
PMCPMC3444162
OpenAlexW2142345643

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.