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

Fiscus, Susan A.; McMillion, Takesha; Nelson, Julie A.; Miller, William C.

doi:10.1128/jcm.01525-13

Cited by 8 publications

(4 citation statements)

References 23 publications

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“…2021; 9(2):e105098. infection, and HIV-1 RNA in plasma samples is detectable earlier and is more reliable than HIV-1 proviral DNA in PBMC specimens of neonates with perinatal infection (19,30). Testing for HIV-1 RNA is more sensitive than the detection of HIV-1 proviral DNA for neonates younger than two months old, receiving prophylaxis with zidovudine syrup (8,9).…”

Section: Discussionmentioning

confidence: 99%

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Non Detection of HIV-1 Proviral DNA in PBMCs of the Neonates Born to Iranian HIV-Infected Mothers in PMTCT Program

Habib

Bokharaei‐Salim

Kiani

et al. 2021

Arch Pediatr Infect Dis

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Background: Early diagnosis of immunodeficiency virus-1 infection in children and access to treatment for this infection is critical in decreasing infant mortality. Objectives: The aim of the current survey was to determine the presence of HIV-1 genomic RNA in plasma and proviral DNA in peripheral blood mononuclear cell (PBMC) specimens of neonates born to HIV-infected mothers. Methods: leprevention of mother-to-child transmission (PMTCT) program were enrolled in this study to compare two different diagnostic methods. After the extraction of viral RNA of plasma and genomic DNA of PBMC specimens, HIV-1 RNA and proviral DNA was tested by amplification of the long terminal repeat (LTR) region of HIV-1 using real-time PCR. Results: Out of 73 evaluated infants, 41 infants (56.2%) were male. The average age of the mothers with HIV-1 infection was 30.7 ± 5.2 (range: 19–47) years. The results revealed that none of the infants were infected with HIV-1, and also all were negative for HIV-1 genomic RNA in plasma specimen and proviral DNA of HIV-1 in PMBC samples. During the present study, 20 infants born to HIV-1 positive mothers who were not included in the PMTCT project were accidentally identified. Four infants (20%) out of these 20 infants were infected with HIV, all were infected with CRF35-AD of HIV, and none carried variants with surveillance drug-resistant mutations. Conclusions: The results of the present study showed that two molecular methods of detecting HIV infection (presence of genomic RNA of HIV-1 in plasma and proviral DNA of HIV-1 in PBMC specimens) are completely in agreement with each other, and the PMTCT program is possibly an effective program.

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Section: Discussionmentioning

confidence: 99%

“…Studies have indicated that HIV DNA PCR is significantly more sensitive than co-culture in the detection of HIV-1 in infected infants, and this method is recommended as the gold standard for virologic diagnosis of HIV infection in infants (1,19).…”

Section: Introductionmentioning

confidence: 99%

Non Detection of HIV-1 Proviral DNA in PBMCs of the Neonates Born to Iranian HIV-Infected Mothers in PMTCT Program

Habib

Bokharaei‐Salim

Kiani

et al. 2021

Arch Pediatr Infect Dis

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“…The qualitative Roche HIV-1 DNA Amplicor assay has been extensively used for EID and has been considered as the gold standard assay (8), although it has been phased out when new assays have been tested for EID of HIV-1 (9,10).…”

Section: Assays Evaluation For Hiv-eid Using Dbsmentioning

confidence: 99%

Evaluation of four commercial virological assays for early infant HIV-1 diagnosis using dried blood specimens

et al. 2016

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“…The Aptima HIV-1 RNA qualitative test (Hologic, Inc., San Diego, CA), a U.S. FDA-approved assay for molecular diagnosis of acute and primary HIV-1 infection, was selected for use in this study because of its claims of extreme sensitivity (14 copies/ml) and ability to detect the very earliest times of infection, with reported detection 12 days prior to that of enzyme immunoassay (EIA) repeat-reactive (RR) tests or 6 days prior to that of p24 antigen detection ( 24 , 25 ). This study evaluated the performance characteristics of the Aptima HIV-1 RNA assay and its ability to detect AHI by twice-weekly testing of small blood volumes (SBVs) from uninfected participants at high risk for HIV-1 infection.…”

Section: Introductionmentioning

confidence: 99%

Identification of Acute HIV-1 Infection by Hologic Aptima HIV-1 RNA Qualitative Assay

et al. 2017

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The Hologic Aptima HIV-1 Qualitative RNA assay was used in a rigorous screening approach designed to identify individuals at the earliest stage of HIV-1 infection for enrollment into subsequent studies of cellular and viral events in early infection (RV 217/Early Capture HIV Cohort [ECHO] study). Volunteers at high risk for HIV-1 infection were recruited from study sites in Thailand, Tanzania, Uganda, and Kenya with high HIV-1 prevalence rates among the populations examined. Small-volume blood samples were collected by finger stick at twice-weekly intervals and tested with the Aptima assay. Participants with reactive Aptima test results were contacted immediately for entry into a more comprehensive follow-up schedule with frequent blood draws. Evaluation of the Aptima test prior to use in this study showed a detection sensitivity of 5.5 copies/ml (50%), with all major HIV-1 subtypes detected. A total of 54,306 specimens from 1,112 volunteers were examined during the initial study period (August 2009 to November 2010); 27 individuals were identified as converting from uninfected to infected status. A sporadic reactive Aptima signal was observed in HIV-1-infected individuals under antiretroviral therapy. Occasional false-reactive Aptima results in uninfected individuals, or nonreactive results in HIV-1-infected individuals not on therapy, were observed and used to calculate assay sensitivity and specificity. The sensitivity and specificity of the Aptima assay were 99.03% and 99.23%, respectively; positive and negative predictive values were 92.01% and 99.91%, respectively. Conversion from HIV-1-uninfected to -infected status was rapid, with no evidence of a prolonged period of intermittent low-level viremia.

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

Cited by 8 publications

References 23 publications

Non Detection of HIV-1 Proviral DNA in PBMCs of the Neonates Born to Iranian HIV-Infected Mothers in PMTCT Program

Non Detection of HIV-1 Proviral DNA in PBMCs of the Neonates Born to Iranian HIV-Infected Mothers in PMTCT Program

Evaluation of four commercial virological assays for early infant HIV-1 diagnosis using dried blood specimens

Identification of Acute HIV-1 Infection by Hologic Aptima HIV-1 RNA Qualitative Assay

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