Evidence map›Paper›PMID 27769309›Full record

ArticleVirology journal2016

Analytical characteristics and comparative evaluation of Aptima HIV-1 Quant Dx assay with Ampliprep/COBAS TaqMan HIV-1 test v2.0.

Angelos Hatzakis, Helen Papachristou, Sangeetha J Nair, Jacqueline Fortunko, Tracy Foote, HeeCheol Kim, Tashi L Peling, Andrew J Worlock

Open access · goldAbstract readComparative StudyEvaluation Study
In one paragraph

Article in Virology journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.3field-weighted citation impact, top 19% 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

11 citing papers in PubMed, 23 citations in OpenAlex.

  1. Article
  2. Enfermedades infecciosas y microbiologia clinica · 2022
    Article
  3. Article
  4. Article
  5. High-Throughput Transcription-mediated amplification on the Hologic Panther is a highly sensitive method of detection for SARS-CoV-2.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2020
    Article
  6. Performance evaluation of the Aptima HIV-1 RNA Quant assay on the Panther system using the standard and dilution protocols.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2020
    Article
  7. Article
  8. Article
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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

8 authors at 2 institutions in 2 countries.

Angelos HatzakisDepartment of Hygiene, Epidemiology and Medical Statistics, Medical School, National and Kapodistrian University of Athens, Mikras Asias 75, GR-11527, Athens, Greece. ahatzak@med.uoa.gr.
Helen PapachristouDepartment of Hygiene, Epidemiology and Medical Statistics, Medical School, National and Kapodistrian University of Athens, Mikras Asias 75, GR-11527, Athens, Greece.
Sangeetha J NairHologic Inc., 10210 Genetic Center Drive, San Diego, CA, 92121, USA.
Jacqueline FortunkoHologic Inc., 10210 Genetic Center Drive, San Diego, CA, 92121, USA.
Tracy FooteHologic Inc., 10210 Genetic Center Drive, San Diego, CA, 92121, USA.
HeeCheol KimHologic Inc., 10210 Genetic Center Drive, San Diego, CA, 92121, USA.
Tashi L PelingHologic Inc., 10210 Genetic Center Drive, San Diego, CA, 92121, USA.
Andrew J WorlockHologic Inc., 10210 Genetic Center Drive, San Diego, CA, 92121, USA.
Hologic (United States) · USNational and Kapodistrian University of Athens · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundQuantitation of HIV-RNA is critically important for diagnosis, prognosis, treatment, monitoring and assessment of infectivity in HIV-1 infection. The objective of this study was to assess performance characteristics of the Aptima HIV-1 Quant Dx assay (Aptima), a new transcription mediated amplification (TMA), fully integrated and automated assay from Hologic Inc., San Diego, CA, USA. The analytical sensitivity, analytical specificity, precision and detection of HIV-1 subtypes were tested based on commercially available international standards or panels. A selected group of 244 anti-HIV-1 (+) plasma samples was used for comparison with Roche COBAS Ampliprep/COBAS TaqMan HIV- 1 test v2.0 (Roche CAP/CTM), (Roche Molecular Systems, Pleasanton, CA).

resultsThe 50 and 95 % limit of detection were estimated at 4.9 (95 % CI 3.9-5.7) and 17.6 (15.2-21.2) IU/mL respectively. The specificity was found 99.83 (99.06-99.97) %. The standard deviations and coefficient of variations for panels with 50 and 100 copies/mL (1.7 and 2 log copies/mL) were 0.14 log copies/mL (8.67 %CV) and 0.18 log copies/mL (9.91 %CV) respectively. The detection rate for Aptima and Roche assays was 220/244 (90.2 %) and 217/244 (88.9 %) respectively.

conclusionThe Aptima assay is a sensitive, specific, precise and accurate test for measuring HIV-1 viral loads and for the detection of HIV-1 infections.

Indexed as

HIV-1HIV InfectionsHumansMolecular Diagnostic TechniquesRNA, ViralSensitivity and SpecificityViral LoadRNA, Viral

Identifiers

PMID27769309
PMCPMC5073876
OpenAlexW2535822160

What OpenQuestion holds

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Registered trials

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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.