Evidence map›Paper›PMID 31274537›Full record

SynthesisAIDS (London, England)2019

Performance of Cepheid Xpert HIV-1 viral load plasma assay to accurately detect treatment failure.

Jilian A Sacks, Youyi Fong, Mercedes Perez Gonzalez, Mauro Andreotti, Shrikala Baliga, Nigel Garrett, Jeanne Jordan, Etienne Karita, Smita Kulkarni, Orna Mor and 8 more

Abstract readEvaluation StudyMeta-Analysis
In one paragraph

Synthesis in AIDS (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

17 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Observational
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. 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

18 authors.

Jilian A SacksClinton Health Access Initiative, Boston, Massachusetts.
Youyi FongFred Hutchinson Cancer Research Center, Seattle, Washington.
Mercedes Perez GonzalezWorld Health Organization, Geneva, Switzerland.
Mauro AndreottiNational Center for Global Health, Istituto Superiore di Sanita, Viale Regina Elena, Rome, Italy.
Shrikala BaligaKasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka, India.
Nigel GarrettCentre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa.
Jeanne JordanGeorge Washington University, Washington, District of Columbia, USA.
Etienne KaritaProject San Francisco/Rwanda-Zambia HIV Research Group, Kigali, Rwanda.
Smita KulkarniICMR-National AIDS Research Institute, Pune, Maharashtra, India.
Orna MorCentral Virology Laboratory, Public Health Services, Israel Ministry of Health, Tel - Hashomer, Israel.
Fausta MoshaNational Health Laboratory Quality Assurance and Training Centre, Dar es Salaam, Tanzania.
Zibusiso NdlovuMedecins Sans Frontieres, Southern Medical Unit, Cape Town, South Africa.
Jean-Christophe PlantierNormandie University, Unirouen, Rouen University Hospital, Laboratory of Virology, Rouen, France.
Shanmugam SaravananY. R. Gaitonde Centre for AIDS Research and Education, Taramani, Chennai, Tamil Nadu, India.
Lesley ScottDepartment of Molecular Medicine and Haemotology, School of Pathology, Faculty of Health Science, University of Witwatersrand, Johannesburg, South Africa.
Trevor PeterClinton Health Access Initiative, Boston, Massachusetts.
Meg DohertyWorld Health Organization, Geneva, Switzerland.
Lara VojnovWorld Health Organization, Geneva, Switzerland.

Funding

Statistical methods for HIV-1 immune correlates studiesR01AI122991 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI FONG, YOUYI · 2016 to 2020
$1.6M
NIAID NIH HHS R01 AI122991World Health Organization 001
6 · The paper itself

Abstract

backgroundCoverage of viral load testing remains low with only half of the patients in need having adequate access. Alternative technologies to high throughput centralized machines can be used to support viral load scale-up; however, clinical performance data are lacking. We conducted a meta-analysis comparing the Cepheid Xpert HIV-1 viral load plasma assay to traditional laboratory-based technologies.

methodsCepheid Xpert HIV-1 and comparator laboratory technology plasma viral load results were provided from 13 of the 19 eligible studies, which accounted for a total of 3790 paired data points. We used random effects models to determine the accuracy and misclassification at various treatment failure thresholds (detectable, 200, 400, 500, 600, 800 and 1000 copies/ml).

resultsThirty percent of viral load test results were undetectable, while 45% were between detectable and 10 000 copies/ml and the remaining 25% were above 10 000 copies/ml. The median Xpert viral load was 119 copies/ml and the median comparator viral load was 157 copies/ml, while the log10 bias was 0.04 (0.02-0.07). The sensitivity and specificity to detect treatment failure were above 95% at all treatment failure thresholds, except for detectable, at which the sensitivity was 93.33% (95% confidence interval: 88.2-96.3) and specificity was 80.56% (95% CI: 64.6-90.4).

conclusionThe Cepheid Xpert HIV-1 viral load plasma assay results were highly comparable to laboratory-based technologies with limited bias and high sensitivity and specificity to detect treatment failure. Alternative specimen types and technologies that enable decentralized testing services can be considered to expand access to viral load.

Indexed as

Treatment FailureAnti-HIV AgentsDrug MonitoringHIV-1HIV InfectionsHumansMolecular Diagnostic TechniquesPlasmaSensitivity and SpecificityViral LoadAnti-HIV Agents

Identifiers

PMID31274537
PMCPMC7024604

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.