Early Diagnosis of HIV Infection in the Breastfed Infant

Ou, Chin Yih; Fiscus, Susan A.; Ellenberger, Dennis; Parekh, Bharat; Korhonen, Christine; Nkengasong, John N.; Bulterys, Marc

doi:10.1007/978-1-4614-2251-8_4

Cited by 3 publications

(3 citation statements)

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“…Our previous data (10) and those of others (11,12) demonstrate that DBS yield extremely sensitive and specific results and have been recommended for use in low-resource countries with other HIV-1 nucleic acid assays as a means to provide greater accessibility to testing (7,8,25). The Aptima assay is currently being used in New York State to identify HIV infection in infants (26) and should be considered an alternative to the Roche Amplicor HIV-1 DNA assay for infant diagnosis.…”

Section: Discussionmentioning

confidence: 90%

“…However, Roche plans to discontinue this assay in the next few years, so alternative assays must be found (8). Although there are several alternatives, including the Roche TaqMan and Abbott RealTime quantitative HIV-1 RNA and qualitative HIV-1 total nucleic acid assays, the Gen-Probe Aptima HIV-1 RNA qualitative assay is the only nucleic acid assay currently approved by the FDA for HIV diagnosis using serum or plasma (9).…”

Section: T He Joint United Nations Program On Hiv/aids (Unaids)mentioning

confidence: 99%

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Validation of the Gen-Probe Aptima Qualitative HIV-1 RNA Assay for Diagnosis of Human Immunodeficiency Virus Infection in Infants

Fiscus¹,

McMillion²,

Nelson³

et al. 2013

J Clin Microbiol

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The qualitative Roche HIV-1 DNA Amplicor assay has been used for the past 20 years to diagnose HIV infection in infants and young children but is being phased out; hence, alternative assays must be found. The Gen-Probe Aptima qualitative HIV-1 RNA assay is currently the only FDA-cleared HIV-1 nucleic acid assay approved for diagnosis, but data on the use of this assay with infant plasma are limited. We assessed Aptima's performance using control material for reproducibility and limit of detection and 394 plasma samples (0.2 to 0.5 ml) from HIV-exposed infected and uninfected infants and children for analytical sensitivity and specificity. Assays to assess within-run repeatability and between-run reproducibility indicated that the controls with 10,000 (

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Section: Discussionmentioning

confidence: 90%

Section: T He Joint United Nations Program On Hiv/aids (Unaids)mentioning

confidence: 99%

Validation of the Gen-Probe Aptima Qualitative HIV-1 RNA Assay for Diagnosis of Human Immunodeficiency Virus Infection in Infants

Fiscus¹,

McMillion²,

Nelson³

et al. 2013

J Clin Microbiol

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“…Definitive diagnosis requires testing viral nucleic acid or antigen, which is technically complex. 7–10 Fourth generation antigen-detecting HIV rapid assays are available but their performance is poor. 11 Polymerase chain reaction (PCR) to detect viral nucleic acid is commercially available and has been adopted in resource-poor settings and is recommended by the World Health Organization (WHO) to diagnose HIV-infected infants.…”

Section: Introductionmentioning

confidence: 99%

Development and Implementation Challenges of a Quality Assured HIV Infant Diagnosis Program in Nigeria Using Dried Blood Spots and DNA Polymerase Chain Reaction

Audu

Onwuamah

Salu

et al. 2015

AIDS Research and Human Retroviruses

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Nigeria has one of the highest HIV burdens as well as mother-to-infant transmission rates in the world. A pilot program using polymerase chain reaction (PCR)-based testing of dried blood spot (DBS) specimens was implemented to enable early identification of HIV-infected infants and timely referral and linkage to care. From February 2007 to October 2008, whole blood was collected by finger prick to prepare DBS from infants < 18 months presenting in six public mother-and-child health facilities in Lagos, Nigeria. The DBS were tested using the Roche Amplicor HIV-1 DNA Test, v1.5. To monitor laboratory testing quality, all of the PCR-positive and 10% of the PCR-negative DBS were retested by the same method at another reference laboratory. Three hundred and sixty-five randomly selected infants were screened using HIV rapid tests (RT) according to the national algorithm and RT-negative and PCR-positive specimens were also tested using Genscreen enzyme-linked immunosorbent assay (EIA) (Bio-Rad, France). The turnaround time (TAT) from sample collection, testing, and dispatching of results from each health facility was monitored. A total of 1,273 infants with a median age of 12.6 weeks (1 day to 71.6 weeks) participated in the program and 280 (22.0%) were PCR positive. HIV transmission levels varied greatly in the different health facilities ranging from 7.1% to 38.4%. Infants aged 48 to 72 weeks had the highest level of PCR positivity (41.1%). All PCR-positive specimens were confirmed by retesting. The mean turnaround time from DBS collection to returning of the laboratory result to the health facilities was 25 days. Three infants were found to be HIV antibody negative by rapid tests but were positive by both PCR and the fourth generation EIA. The DBS-based PCR program accurately identified all of the HIV-infected infants. However, many programmatic challenges related to the laboratory and TAT were identified.

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