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Evaluation of the Aptima HIV-1 Quant Dx Assay for HIV-1 RNA Quantitation in Different Biological Specimen Types.

ABSTRACT: The search for a cure for HIV infection has highlighted the need for increasingly sensitive and precise assays to measure viral burden in various tissues and body fluids. We describe the application of a standardized assay for HIV-1 RNA in multiple specimen types. The fully automated Aptima HIV-1 Quant Dx assay (Aptima assay) is FDA cleared for blood plasma HIV-1 RNA quantitation. In this study, the Aptima assay was applied for the quantitation of HIV RNA in peripheral blood mononuclear cells (PBMCs; n = 72), seminal plasma (n = 20), cerebrospinal fluid (CSF; n = 36), dried blood spots (DBS; n = 104), and dried plasma spots (DPS; n = 104). The Aptima assay was equivalent to or better than commercial assays or validated in-house assays for the quantitation of HIV RNA in CSF and seminal plasma. For PBMC specimens, the sensitivity of the Aptima assay in the detection of HIV RNA decayed as background uninfected PBMC counts increased; proteinase K treatment demonstrated some benefit in restoring signal at higher levels of background PBMCs. Finally, the Aptima assay yielded 100% detection rates of DBS in participants with plasma HIV RNA levels of ?35 copies/ml and 100% detection rates of DPS in participants with plasma HIV RNA levels of ?394 copies/ml. The Aptima assay can be applied to a variety of specimens from HIV-infected subjects to measure HIV RNA for studies of viral persistence and cure strategies. It can also detect HIV in dried blood and plasma specimens, which may be of benefit in resource-limited settings.

SUBMITTER: Yek C

PROVIDER: S-EPMC5527433 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Evaluation of the Aptima HIV-1 Quant Dx Assay for HIV-1 RNA Quantitation in Different Biological Specimen Types.

Yek Christina C Massanella Marta M Peling Tashi T Lednovich Kristen K Nair Sangeetha V SV Worlock Andrew A Vargas Milenka M Gianella Sara S Ellis Ronald J RJ Strain Matthew C MC Busch Michael P MP Nugent C Thomas CT Richman Douglas D DD

Journal of clinical microbiology 20170607 8

The search for a cure for HIV infection has highlighted the need for increasingly sensitive and precise assays to measure viral burden in various tissues and body fluids. We describe the application of a standardized assay for HIV-1 RNA in multiple specimen types. The fully automated Aptima HIV-1 Quant Dx assay (Aptima assay) is FDA cleared for blood plasma HIV-1 RNA quantitation. In this study, the Aptima assay was applied for the quantitation of HIV RNA in peripheral blood mononuclear cells (P ...[more]

PMID: 28592548

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Project description:BackgroundThe diagnosis of pulmonary tuberculosis presents challenges in children because symptoms are non-specific, specimens are difficult to obtain, and cultures and smears of Mycobacterium tuberculosis are often negative. We assessed new diagnostic approaches for tuberculosis in children in a resource-poor country.MethodsChildren with symptoms suggestive of pulmonary tuberculosis (cases) were enrolled from August, 2002, to January, 2007, at two hospitals in Lima, Peru. Age-matched and sex-matched healthy controls were enrolled from a low-income shanty town community in south Lima. Cases were grouped into moderate-risk and high-risk categories by Stegen-Toledo score. Two specimens of each type (gastric-aspirate, nasopharyngeal-aspirate, and stool specimens) taken from each case were examined for M tuberculosis by auramine smear microscopy, broth culture by microscopic-observation drug-susceptibility (MODS) technique, standard culture on Lowenstein-Jensen medium, and heminested IS6110 PCR. Specimens from controls consisted of one nasopharyngeal-aspirate and two stool samples, examined with the same techniques. This study is registered with ClinicalTrials.gov, number NCT00054769.Findings218 cases and 238 controls were enrolled. 22 (10%) cases had at least one positive M tuberculosis culture (from gastric aspirate in 22 cases, nasopharyngeal aspirate in 12 cases, and stool in four cases). Laboratory confirmation of tuberculosis was more frequent in cases at high risk for tuberculosis (21 [14.1%] of 149 cases with complete specimen collection were culture positive) than in cases at moderate risk for tuberculosis (one [1.6%] of 61). MODS was more sensitive than Lowenstein-Jensen culture, diagnosing 20 (90.9%) of 22 patients compared with 13 (59.1%) of 22 patients (p=0.015), and M tuberculosis isolation by MODS was faster than by Lowenstein-Jensen culture (mean 10 days, IQR 8-11, vs 25 days, 20-30; p=0.0001). All 22 culture-confirmed cases had at least one culture-positive gastric-aspirate specimen. M tuberculosis was isolated from the first gastric-aspirate specimen obtained in 16 (72.7%) of 22 cases, whereas in six (27.3%), only the second gastric-aspirate specimen was culture positive (37% greater yield by adding a second specimen). In cases at high risk for tuberculosis, positive results from one or both gastric-aspirate PCRs identified a subgroup with a 50% chance of having a positive culture (13 of 26 cases).InterpretationCollection of duplicate gastric-aspirate specimens from high-risk children for MODS culture was the best available diagnostic test for pulmonary tuberculosis. PCR was insufficiently sensitive or specific for routine diagnostic use, but in high-risk children, duplicate gastric-aspirate PCR provided same-day identification of half of all culture-positive cases.

Dataset Information

Evaluation of the Aptima HIV-1 Quant Dx Assay for HIV-1 RNA Quantitation in Different Biological Specimen Types.

Publications

Evaluation of the Aptima HIV-1 Quant Dx Assay for HIV-1 RNA Quantitation in Different Biological Specimen Types.

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