Evidence map›Paper›PMID 28732472›Full record

ArticleBMC infectious diseases2017

GeneXpert HIV-1 quant assay, a new tool for scale up of viral load monitoring in the success of ART programme in India.

Smita Kulkarni, Sushama Jadhav, Priyanka Khopkar, Suvarna Sane, Rajkumar Londhe, Vaishali Chimanpure, Veronica Dhilpe, Manisha Ghate, Rajendra Yelagate, Narayan Panchal and 5 more

Abstract readEvaluation Study
In one paragraph

Article in BMC infectious diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 3 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, 3 syntheses or guidelines pooled it.

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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

15 authors.

Smita KulkarniDepartment of Virology, National AIDS Research Institute, Plot No 73, G-block, M I D C, Bhosari, Pune, Maharashtra, 411026, India. skulkarni@nariindia.org.ORCID 0000-0002-3271-2403
Sushama JadhavDepartment of Virology, National AIDS Research Institute, Plot No 73, G-block, M I D C, Bhosari, Pune, Maharashtra, 411026, India.
Priyanka KhopkarDepartment of Virology, National AIDS Research Institute, Plot No 73, G-block, M I D C, Bhosari, Pune, Maharashtra, 411026, India.
Suvarna SaneDepartment of Virology, National AIDS Research Institute, Plot No 73, G-block, M I D C, Bhosari, Pune, Maharashtra, 411026, India.
Rajkumar LondheDepartment of Virology, National AIDS Research Institute, Plot No 73, G-block, M I D C, Bhosari, Pune, Maharashtra, 411026, India.
Vaishali ChimanpureDepartment of Virology, National AIDS Research Institute, Plot No 73, G-block, M I D C, Bhosari, Pune, Maharashtra, 411026, India.
Veronica DhilpeDepartment of Virology, National AIDS Research Institute, Plot No 73, G-block, M I D C, Bhosari, Pune, Maharashtra, 411026, India.
Manisha GhateDepartment of Virology, National AIDS Research Institute, Plot No 73, G-block, M I D C, Bhosari, Pune, Maharashtra, 411026, India.
Rajendra YelagateDepartment of Virology, National AIDS Research Institute, Plot No 73, G-block, M I D C, Bhosari, Pune, Maharashtra, 411026, India.
Narayan PanchalDepartment of Virology, National AIDS Research Institute, Plot No 73, G-block, M I D C, Bhosari, Pune, Maharashtra, 411026, India.
Girish RahaneDepartment of Virology, National AIDS Research Institute, Plot No 73, G-block, M I D C, Bhosari, Pune, Maharashtra, 411026, India.
Dilip KadamByramjee Jeejeebhoy Medical College (BJMC), Sassoon General Hospital, Jai Prakash Narayan Road, Near Pune Railway Station, Pune, Maharashtra, 411001, India.
Nitin GaikwadYashwantrao Chavan Memorial Hospital (YCM), No.476/2692, Sant Tukaram Nagar, Pimpri, Pimpri-Chinchwad, Pune, Maharashtra, 411018, India.
Bharat RewariWorld Health Organization (WHO) Country office for India, World Health House, Indraprastha Estate, Mahatma Gandhi Marg, New Delhi, Delhi, 110002, India.
Raman GangakhedkarDepartment of Virology, National AIDS Research Institute, Plot No 73, G-block, M I D C, Bhosari, Pune, Maharashtra, 411026, India.

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundRecent WHO guidelines identify virologic monitoring for diagnosing and confirming ART failure. In view of this, validation and scale up of point of care viral load technologies is essential in resource limited settings.

methodsA systematic validation of the GeneXpert® HIV-1 Quant assay (a point-of-care technology) in view of scaling up HIV-1 viral load in India to monitor the success of national ART programme was carried out. Two hundred nineteen plasma specimens falling in nine viral load ranges (<40 to >5 L copies/ml) were tested by the Abbott m2000rt Real Time and GeneXpert HIV-1 Quant assays. Additionally, 20 seronegative; 16 stored specimens and 10 spiked controls were also tested. Statistical analysis was done using Stata/IC and sensitivity, specificity, PPV, NPV and %misclassification rates were calculated as per DHSs/AISs, WHO, NACO cut-offs for virological failure.

resultsThe GeneXpert assay compared well with the Abbott assay with a higher sensitivity (97%), specificity (97-100%) and concordance (91.32%). The correlation between two assays (r = 0.886) was statistically significant (p < 0.01), the linear regression showed a moderate fit (R

conclusionThe viral load results of GeneXpert HIV-1 Quant assay compared well with Abbott HIV-1 m2000 Real Time PCR; suggesting its use as a Point of care assay for viral load estimation in resource limited settings. Its ease of performance and rapidity will aid in timely diagnosis of ART failures, integrated HIV-TB management and will facilitate the UNAIDS 90-90-90 target.

Indexed as

HIV-1Antiretroviral Therapy, Highly ActiveCase-Control StudiesHIV InfectionsHumansIndiaPoint-of-Care SystemsReal-Time Polymerase Chain ReactionReproducibility of ResultsSensitivity and SpecificityViral LoadAbbott RealTime PCRARTGeneXpert HIV-1 quantHIV-1Point of care technologiesViral load

Identifiers

PMID28732472
PMCPMC5521114

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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.