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Axsym hiv 1 2 go

Manufactured by Abbott
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The AxSYM HIV-1/2 gO is a laboratory diagnostic instrument developed by Abbott. It is designed to detect the presence of antibodies to the human immunodeficiency virus (HIV) types 1 and 2 in human serum or plasma samples. The instrument utilizes a microparticle enzyme immunoassay (MEIA) technology to provide qualitative results.

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11 protocols using axsym hiv 1 2 go

1

Assessing HIV Prevalence and Behaviors

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A computer-assisted interview, administered by trained personnel, was employed using a structured questionnaire with sections on socio-demographic characteristics, injection and sexual behaviours, access to prevention and treatment(16 ). Blood samples were also collected, and HIV tests were performed with a microparticle EIA anti-HIV-1/2 (AxSYM HIV-1/2 gO, Abbott). HIV-1 and HIV-2 infection was confirmed by Western Blot (MP Diagnostics).
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2

HIV Recency Testing Protocol

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HIV testing programs, mainly ARISTOTLE27 (link), referred HIV seropositive clients to TRIP. Blood samples were tested by AxSYM HIV-1/2 gO (Abbott) and confirmed by Western Blot (MP Diagnostics). All HIV+ participants of TRIP were also tested by the Limiting Antigen Avidity (LAg) assay (SediaTM Biosciences Corporation)28 (link). LAg is based on antibody maturation and categorizes HIV infection as recent versus (vs.) long-standing. The standardized Optical Density (ODn) score of 1.5 is used as cut-off for recency (130 days)28 (link). HIV-RNA was quantified in all HIV positive samples in TRIP using Artus HI Virus-1 RG RT-PCR (Qiagen).
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3

HIV Infection Surveillance Protocol for PWID

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Research methods have previously been described (Nikolopoulos et al., 2016 (link), 2017 (link)), so we do so only briefly here.
Setting: The study took place (6/2013–7/2015) in Athens, Greece, where an HIV outbreak among people who inject drugs (PWID) began in 2011 (Paraskevis et al., 2011 (link), 2013 (link), 2015 (link); Nikolopoulos et al., 2015b (link)).
Laboratory Methods: HIV testing used a microparticle anti-HIV-1/2 EIA (AxSYM HIV-1/2 gO, Abbott) confirmed by Western Blot (MP Diagnostics). All HIV+ participants were tested by Limiting Antigen Avidity Assay (LAg; SediaTM Biosciences Corporation) (Duong et al., 2012 (link), 2015 (link); Nikolopoulos et al., 2017 (link)). This test is based on antibody maturation to categorize HIV infection as “recent” or “long-standing.” An Optical Density (ODn) score of 1.5 was used as a cut-off for recent infection, with a median of three ODn values ≤1.5 indicating recent infection. This corresponds to a window period of 130 days (Duong et al., 2015 (link)). HIV RNA was quantified for all HIV-positive samples with Artus HI Virus-1 RG RT-PCR (Qiagen). Antibody-negative samples in social networks were tested for viremia (and thus acute infection) in pools of 10.
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4

HIV-1/2 Detection Using Microparticle EIA and Western Blot

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Microparticle EIA anti-HIV-1/2 (AxSYM HIV-1/2 gO, Abbott) was confirmed with Western Blot (MP Diagnostics).
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5

HIV Antibody Detection and Viral Load Quantification

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Blood samples were tested for HIV antibodies by AxSYM HIV-1/2 gO (Abbott) and confirmed by Western Blot (MP Diagnostics). Recent HIV infection was detected by the LAg assay (Sedia™ Biosciences Corporation) (Duong et al., 2015 (link)). HIV-RNA was quantified in HIV positive samples in TRIP using Artus HI Virus-1 RG RT–PCR (Qiagen). HIV-RNA at HIV clinics was measured using Cobas Taqman HIV, PCR RNA, branched DNA 3.0, and Versant HIV-1 RNA 1.0 kPCR.
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6

HIV Diagnosis and Monitoring Protocol

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Until 1996, HIV diagnosis was established by enzyme immunoassay with confirmation by immunoblot assay. After 1997, HIV polymerase chain reaction (PCR) was used to confirm the diagnosis in patients with reactive serologic tests.
Initial serologic testing for HIV 1 and 2 was performed using a micro-particle enzyme immunoassay (MEIA; AxSYM HIV 1/2 gO, Abbott Laboratories, Abbott Park, USA). If serology was reactive, specimens were confirmed using the Chiron RIBA HIV-1/HIV-2 strip immunoblot assay.
For the purpose of this report, we used the CDC definition of AIDS [16 ]. Opportunistic infections are defined by microbiological confirmation (by stain for Pneumocystis jirovecii, culture for M. tuberculosis, atypical mycobacteria, and fungi).
Molecular testing included HIV PCR, which uses three sets of four primers from envelope, polymerase, reverse transcriptase, and core protein genes. Viral load was measured with the branched DNA method (VER SANT HIV-1 RNA 3.0 Assay, [bDNA], Bayer Diagnostics, Berkeley, CA, USA). Results were reported in a range from 50 to >500,000 copies/ml. CD4+ count and percentage was obtained by standard flow cytometric methods.
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7

HIV Diagnosis and Monitoring Protocol

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Until 1996, HIV diagnosis was established by enzyme immunoassay with confirmation by immunoblot assay. After 1997, HIV polymerase chain reaction (PCR) was used to confirm the diagnosis in patients with reactive serologic tests.
Initial serologic testing for HIV 1 and 2 was performed using a micro-particle enzyme immunoassay (MEIA; AxSYM HIV 1/2 gO, Abbott Laboratories, Abbott Park, USA). If serology was reactive, specimens were confirmed using the Chiron RIBA HIV-1/HIV-2 strip immunoblot assay.
For the purpose of this report, we used the CDC definition of AIDS [16 ]. Opportunistic infections are defined by microbiological confirmation (by stain for Pneumocystis jirovecii, culture for M. tuberculosis, atypical mycobacteria, and fungi).
Molecular testing included HIV PCR, which uses three sets of four primers from envelope, polymerase, reverse transcriptase, and core protein genes. Viral load was measured with the branched DNA method (VER SANT HIV-1 RNA 3.0 Assay, [bDNA], Bayer Diagnostics, Berkeley, CA, USA). Results were reported in a range from 50 to >500,000 copies/ml. CD4+ count and percentage was obtained by standard flow cytometric methods.
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8

HIV Status Determination Protocol

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The HIV status of study participants who reported being HIV+ from testing elsewhere were classified as such only if they provided written medical documentation of their status. Participants with undocumented, unknown, or prior HIV- status were provided with counseling and HIV testing, if consenting, to HIV testing; those declining HIV testing were classified as HIV-unknown (HIVunk).
HIV infection was determined by rapid test with the Alere Determine HIV 1/2 (Alere Medical Co, Ltd., Chiba, Japan), with confirmation of positives by enzyme-linked immunosorbent assay with the AxSYM HIV 1/2 gO (ABBOTT, Wiesbaden, Germany). For discordant results on these two tests, gelatin particle agglutination assay with the SERODIA—HIV (Fujirebio Inc., Tokyo, Japan) was used for final determination.
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9

HIV-1/2 Serological Screening Protocol

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Blood samples were tested by a microparticle anti-HIV-1/2 EIA (AxSYM HIV-1/2 gO, Abbott) and confirmed by Western Blot (WB) (MP Diagnostics). Specimens that were initially reactive (S/CO, ≥1.0) or initially gray zone reactive (0.9 ≤ S/CO < 1.0) in AxSYM HIV-1/2 gO were retested in duplicate. Results on WB p31 band reactivity were recorded. P31 can be detected approximately 100 days after infection and could be used as an indicator of recency among individuals with positive WB (Fiebig stage V: WB+/p31−) [19 (link),20 (link)].
WB-confirmed samples were further tested by LAg (Figure 1). Samples with ODn less than two during the screening mode were subjected to confirmatory evaluation and tested in triplicate. If the median of the three ODn values was then ≤ 1.5, the seroconversion was classified as recent (LAg+). The ODn cutoff of 1.5 corresponds to a mean duration of recent infection of 130 days [14 (link)].
HIV RNA was quantified in positive specimens obtained from participants of the first round of ARISTOTLE using Artus HI Virus-1 RG RT-PCR (Qiagen).
Available data on HIV-1 subtypes and circulating recombinant forms (CRF) were retrieved from an existing database as described in [21 (link)].
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10

HIV Antibody Detection and Viral Load Quantification

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Blood samples were tested for HIV antibodies by AxSYM HIV-1/2 gO (Abbott) and confirmed by Western Blot (MP Diagnostics). Recent HIV-1 infection was determined using the Limiting Antigen Avidity assay [55 (link)]. HIV-RNA in plasma was quantified using Artus HI Virus-1 RT-PCR (Qiagen), according to the manufacturer’s recommendations.
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