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Realtime hiv 1 test

Manufactured by Abbott
Sourced in United States, Canada

The Abbott RealTime HIV-1 test is a quantitative real-time PCR assay designed for the detection and quantification of HIV-1 RNA in human plasma samples.

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9 protocols using realtime hiv 1 test

1

Successful Aging Among HIV-Infected Adults

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Participants were 120 PLWH and 94 persons without HIV, aged 36 to 65, from the five-year Multi-Dimensional Successful Aging among HIV-Infected Adults study. Baseline data were examined in this study. The University’s Institutional Review Board approved this study, and all participants provided written, informed consent. In order to enroll a representative cohort of participants, exclusion criteria were minimal: 1) diagnosis of a psychotic disorder or mood disorder with psychotic features (asked at screening visit); 2) presence of a neurological condition (beyond HIV infection) known to impact cognitive functioning (e.g., Alzheimer’s disease, stroke, traumatic brain injury); 3) positive urine toxicology on the day of testing. An HIV/HCV finger stick point of care test (Abbott RealTime HIV-1 test, Abbott Laboratories, Illinois, USA) was used to test all participants for HIV infection. Of the participants who reported they were HIV- at screening, none tested positive for HIV nor HCV.
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2

Cross-Sectional Study of Frailty in PLWH

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Data were collected as part of the NIMH-funded Multi-Dimensional
Successful Aging among HIV Infected Adults Study at University of California,
San Diego (UCSD), which is described in an earlier publication.33 Briefly, the study recruited
community-dwelling PLWH and HIV-uninfected adults 35 to 65 years old. The
exclusion criteria were: 1) history of psychotic disorder or a mood disorder
with psychotic features; 2) the presence of a neurological condition not related
to HIV infection and known to affect cognitive functioning, such as
Alzheimer’s disease, stroke or traumatic brain injury; and 3) having a
positive urine toxicology test for drugs of abuse during the baseline visit.
During the screening, participants with unknown HIV status were tested with the
HIV/HCV finger stick point of care test (Abbott Real-time HIV-1 test, Abbott
Laboratories, Illinois, USA). Participants were compensated for participation.
The UCSD Institutional Review Board approved the study and participants provided
written informed consent to participate. The sample for the present
cross-sectional analyses is based on biomedical and psychosocial data from the
baseline visit and includes 65 PLWH and 62 HIV-uninfected participants who were
administered frailty assessment.1
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3

Successful Aging Among HIV-Infected Adults

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Participants were 90 HIV-positive and 94 HIV-negative persons, with balanced recruiting in each age decade (36–45, 46–55, 56–65), from the five-year Multi-Dimensional Successful Aging among HIV-Infected Adults study conducted at the University of California, San Diego (UCSD).16 (link) Only baseline data were included in this analysis. The study received approval from the UCSD Institutional Review Board. Participants provided written, informed consent. Exclusion criteria for the parent study were diagnosis of a psychotic disorder and presence of a neurological condition known to impact cognitive functioning (e.g., stroke). Additional exclusion criteria for current analyses included being off ART, having detectable HIV viral load (>50 copies/ml), and meeting criteria for a current substance use disorder. HIV infection was screened via a fingerstick test (Medmira, Nova Scotia, Canada) and confirmed with an Abbott RealTime HIV-1 test (Abbott Laboratories, Illinois, USA) or by submitting specimens to a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory (ARUP Laboratories, Utah, USA) for HIV-1 viral load quantitation.
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4

Comprehensive HIV Diagnostic Assessment

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Modules of the WHO Composite International Diagnostic Interview (CIDI, v2.1) were administered to assess for current and past (occurring >12 months ago) mood and substance use disorders based on the DSM-IV-TR. All participants were tested for HIV using a fingerstick test (Medmira, Nova Scotia, Canada) and confirmed with an Abbott RealTime HIV-1 test (Abbott Laboratories, Illinois, USA) or by submitting specimens to a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory (ARUP Laboratories, Utah, USA) for HIV-1 viral load quantitation. At each visit, additional HIV characterization included AIDS status, plasma viral load, CD4+ T-cell counts (nadir and current), estimated duration of HIV disease, and current antiretroviral therapy (ART) regimen.
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5

Quantification of HIV-1 in Humanized Mice

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Blood samples (30 µL) were collected from humanized DRAG mice pre- and post-infection in tubes containing 18 mM EDTA solution. Following centrifugation at 3,300 rpm for 10 min at 4°C, plasma and the cell pellet were separately stored frozen at −20°C. The viral load in the plasma was determined using the Abbott RealTime HIV-1 Test (Abbott Molecular, Inc.) as previously described (10 (link)). The cell pellet was thawed, lysed, and HIV-1 RNA or DNA was extracted and quantified by quantitative real-time (qRT)-PCR. Student’s t-test was used to determine if the decrease in viral load on day 42 was significant or not.
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6

Viral Load Monitoring in Humanized DRAG Mice

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Blood samples were collected from humanized DRAG mice pre- and post-infection every 3 days for two weeks and then at weekly intervals for a total of 16 weeks. Viral load in the whole blood was determined using the Abbott RealTime HIV-1 Test (Abbott Molecular, Inc.) with minor modifications. Whole blood specimens were collected in tubes containing EDTA solution and then frozen. To determine viral load, frozen blood samples were thawed and lysed. HIV-1 RNA was extracted following the FDA cleared test method and quantified. Although whole blood was used, no inhibition of the assay was observed based upon the performance of the internal extraction control. As the blood volumes collected were slightly variable, the values obtained were adjusted by 1 log to account for an average dilution factor of 10.
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7

Successful Aging in HIV-Infected Adults

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Participants included 215 adults (117 PLWH, 98 HIV-uninfected) enrolled in the baseline visit of the Multi-Dimensional Successful Aging among HIV-Infected Adults study conducted at the University of California San Diego (UCSD) HIV Neurobehavioral Research Program and the UCSD Sam and Rose Stein Institute for Research on Aging from 2013–2015 (Moore et al, 2018 (link); Moore et al, 2017c (link); Rooney et al, 2019 (link)). Inclusion criteria included being between the ages of 36–65 years old, being fluent in English, and having the ability to provide informed consent. Exclusion criteria included the presence of a neurologic condition other than HIV known to impact cognitive functioning (e.g., Alzheimer’s Disease), diagnosis of a psychotic condition that could impact neurocognitive test performance (e.g., schizophrenia), and having a positive urine toxicology screen on day of testing for an illicit substance other than cannabis. Confirmation testing for HIV serostatus was completed during the testing visit (Abbott RealTime HIV-1 Test ). In order to be included in present analyses, participants had to have data available on the main variables of interest, i.e. MetS and neurobehavioral disturbances.
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8

HIV Confirmation Testing and Diagnostics

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All participants had confirmation testing for HIV status at the time of the visit (Abbott RealTime HIV-1 Test; HIV-1 and HIV-2 Antibody Antigen Evaluation). Lor PLWH CD4+ count and plasma HIV viral load were determined from blood specimens taken at the time of the study visit. Plasma HIV viral loads were deemed “undetectable” at 50 copies/mL or less. Nadir CD4+ count was self-reported unless the study lab value was determined to be lower than the self-report. AIDS diagnosis was made using the CDC classification of 3 or C (Centers for Disease Control and Prevention, 1993 (link)). Estimated duration of HIV infection and antiretroviral medication (ART) use were self-reported by the participant at the time of the visit.
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9

Monitoring HIV-1 Viral Load Suppression

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Follow up HIV-1 VLs for treatment monitoring were done after at least 6 months of treatment using Abbott Real Time HIV-1 test (Abbott laboratories, Illinois, USA) with a detection limit of 40 RNA copies/ml. Suppression was defined as a VL < 50 RNA copies/ml. Virological failure was defined as a VL ≥ 1000 RNA copies/ml after at least 6 months of HAART.
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