ArticlePloS one2018
Field evaluation of near point of care Cepheid GeneXpert HIV-1 Qual for early infant diagnosis.
Article in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04793750 (Ending the HIV Epidemic Through Point-of-Care Technologies), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.
What it found
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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.
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.
Ending the HIV Epidemic Through Point-of-Care Technologies (EHPOC): Performance Evaluation of Novel POC HIV Tests in Baltimore
Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pooled it
- Point-of-care tests detecting HIV nucleic acids for diagnosis of HIV-1 or HIV-2 infection in infants and children aged 18 months or less.The Cochrane database of systematic reviews · 2021Pooled it
- Evaluating the impact of point-of-care HIV viral load assessment on linkage to care in Baltimore, MD: a randomized controlled trial.BMC infectious diseases · 2023Trial
- A Randomized Trial of Point-of-Care Early Infant Human Immunodeficiency Virus (HIV) Diagnosis in Zambia.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Trial
- Operational experiences associated with the implementation of near point-of-care early infant diagnosis of HIV in Myanmar: a qualitative study.BMC health services research · 2021Trial
- Public health implications of diagnosing and treating acute HIV.Current opinion in HIV and AIDS · 2025Review
- Rapid diagnosis of acute HIV-1 infection cases: first real-world performance of point-of-care HIV-1 nucleic acid testing in China.Frontiers in public health · 2025Article
- Nucleic acid amplification testing using dried blood spots to confirm the diagnosis of HIV-1 in adults.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2024Article
- Process Evaluation of Services for HIV-Infected Post-Partum Women and HIV-Exposed Infants in Primary Health Care Blantyre Malawi.Health services insights · 2024Article
- Observational
- Sensitive and Quantitative Point-of-Care HIV Viral Load Quantification from Blood Using a Power-Free Plasma Separation and Portable Magnetofluidic Polymerase Chain Reaction Instrument.Analytical chemistry · 2023Article
- 'If I am on ART, my new-born baby should be put on treatment immediately': Exploring the acceptability, and appropriateness of Cepheid Xpert HIV-1 Qual assay for early infant diagnosis of HIV in Malawi.PLOS global public health · 2023Article
- Validation of the point-of-care (POC) technologies Xpert HIV-1 Qual and m-PIMA HIV 1/2 detect for early diagnosis of HIV-1 and HIV-2 in Senegal.The Pan African medical journal · 2022Article
- Point-of-care HIV maternal viral load and early infant diagnosis testing around time of delivery at tertiary obstetric units in South Africa: a prospective study of coverage, results return and turn-around times.Journal of the International AIDS Society · 2020Article
- Microfluidic Point-of-Care Testing: Commercial Landscape and Future Directions.Frontiers in bioengineering and biotechnology · 2020Review
- Programmatic evaluation of feasibility and efficiency of at birth and 6-week, point of care HIV testing in Kenyan infant.PloS one · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAccess to point-of-care HIV testing shortens turn-around times, time to diagnosis and reduces loss to follow-up hence minimizing barriers to early linkage to care and treatment among HIV infected infants. Currently samples for early infant HIV diagnosis are sent to centralized testing facilities which are few and located only at specific regions in Kenya. However, there are Point of Care (POC) early infant diagnosis [EID] technologies elsewhere such as SAMBA and ALERE-Q that are yet to be evaluated in Kenya despite the urgent need for data to inform policy formulation regarding EID. The Cepheid GeneXpert HIV-1 Qual (GeneXpert) technology for POC EID offers a great opportunity to minimize HIV associated morbidity, mortality and loss to follow-up through decentralization of early infant HIV testing to the clinics. This technology also allows for same-day results thus facilitating prompt linkage to care.
methodsWe evaluated the GeneXpert HIV Qual EID POC in Homabay County against the standard of care platform, Roche CAP/CTM HIV-1 qualitative PCR, using dried blood spots (DBS). Between February-July 2016, DBS samples were collected from HIV exposed children <18 months of age enrolled in a cross-sectional study. Samples were collected by qualified nurse counselors, and were tested by trained technicians using field based GeneXpert and conventional laboratory based Roche CAP/CTM HIV-1 qualitative PCR. Sensitivity and specificity were determined.
resultsOverall, 3,814 mother/infant pairs were included in the study, out of which 921 infants were HIV exposed as per the mothers' HIV status and based on the infant's HIV rapid test. A total of 969 PCR tests were performed, out of which 30 (3.3%) infants were concordantly positive using both platforms. GeneXpert HIV-1 Qual yielded a sensitivity of 94.1% and specificity of 99.8% with an overall error rate of 0.7%.
conclusionOur findings show that GeneXpert HIV-1 Qual performs well compared to CAP/CTM using DBS samples, suggesting that this technology may be adopted in decentralized laboratories as a near POC device. It may contribute to prompt diagnosis of HIV exposed infants hence enabling early linkage to care, thus advancing further gains in EID.
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