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Realtime hiv 1 rna pcr

Manufactured by Abbott

The RealTime HIV-1 RNA PCR is a laboratory equipment product that uses real-time polymerase chain reaction (PCR) technology to detect and quantify the presence of HIV-1 ribonucleic acid (RNA) in patient samples.

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4 protocols using realtime hiv 1 rna pcr

1

Multiple Sources for Viral Load Data

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There were three different sources for VL data. First, during the computer-assisted self-interview prevalent HIV-positive participants were asked, “What was the result of your most recent viral load test (undetectable, detectable, I don’t know)?” (referred to as self-report). Next, each HIV positive participant provided a blood sample which was treated with EDTA-anticoagulation agent and from which plasma VL testing was performed with the Abbott RealTime HIV-1 RNA PCR (sensitivity of 40 copies/mL; referred to as “study-specific”). Lastly, all participants were requested to sign an authorization for release of medical records from their primary healthcare provider as well as the Chicago Department of Public Health (CDPH). Medical records (service date and VL) retrieved via primary healthcare providers were separately extracted by two trained research staff members and resulting data was reviewed by a third staff member for quality assurance. Medical records retrieved from CDPH were electronically accessed via their Enhanced HIV/AIDS Reporting System (eHARS). An undetectable VL was defined as fewer than 200 copies/mL for both study-initiated laboratory testing and data extracted from medical records. “Blips,” or transient small increases in VL during prolonged viral suppression, were defined as >1000 copies/mL [31 (link)].
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2

HIV and STI Screening Protocol

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Fingerstick blood samples were collected as part of each participant’s visit every six months. Each participant’s HIV infection status was determined using the Alere Determine HIV1/2 Ab/Ag Combo 4th generation point-of-care (POC) test. Those who tested positive on the POC HIV tests received confirmatory HIV antigen and antibody immunoassay testing following current CDC HIV testing guidelines35 . Viral load testing was performed with the Abbott RealTime HIV-1 RNA PCR (sensitivity of 40 copies/mL). PLWH were categorized as having undetectable viral load if their laboratory results were < 50 copies/mL, detectable viral load was defined as ≥ 50 copies/mL36 (link), 37 . Regardless of participant’s self-reported STI history, we tested for both rectal gonorrhea and chlamydia via collection of rectal swabs.
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3

Post-Mortem HIV Analysis of Subject 123

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Post-mortem tissues from subject 123, a 43-year-old Caucasian male, were provided by the National Disease Research Interchange (NDRI), without patient identifying information. The University of Massachusetts Medical School IRB considered that this research was not human subjects research as defined by DHHS and FDA regulations (IRB ID: H00014098). Subject 123 was on drug therapy (Tenofovir, Ritonavir, Abacavir, Tipranavir, Raltegravir, Etravirine) and had a well-controlled plasma viral load (<75 copies/ml3) at the last test, 7 months before death. The cause of death was cardio-pulmonary arrest and was diagnosed with HAD. Post-mortem plasma and serum samples were found to have undetectable viral copy number by the Infectious Disease Laboratory at the Children’s Hospital of Chicago using Abbott RealTime HIV-1 RNA PCR. Tissues collected at autopsy included frontal lobe, occipital lobe, parietal lobe, lymph node, lung, colon and blood cells.
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4

Evaluating HIV Viral Suppression Outcomes

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The primary outcome of this analysis was viral suppression as reflected in HIV RNA viral load (VL). VL testing was done by the Rakai Health Sciences Program at each of the study’s time points: baseline/pre-intervention initiation (time 0), 12-months post intervention initiation (time 1), and 24-months post intervention initiation (time 2). Plasma VL measurements were quantified in blood samples collected in EDTA tubes using Abbott RealTime HIV-1 RNA PCR, version 5.00. In accordance with the Abbott platform, VL was dichotomized between undetectable (< 40 copies/ml) and detectable (≥ 40 copies/ml) levels. Binary measures of VL have greater clinical relevance as health care practitioners aim to for all patients to achieve viral suppression. However, continuous measures of VL offer greater granularity for patient monitoring and data analysis. As such, in addition to our primary endpoint, we have included an exploratory analysis of the intervention’s effect on the continuous measure of VL, normalized using log10 transformation, reducing both skew and kurtosis (SK = 10.7 v. 1.1; KR = 159.4 v. 2.9).
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