PHIA data from Cameroon, Côte d’Ivoire, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Namibia, Rwanda, Tanzania, Uganda, Zambia, and Zimbabwe were used in our analysis. The PHIA survey methods were previously described (Patel/Duong, manuscript in current JAIDS supplement, Radin/Sachathep, manuscript in current JAIDS supplement). The analysis was limited to adult participants aged 15–59 years. Eligible consenting adult participants were asked the month, year, and result of their most recent HIV test. Those who reported an HIV-positive result were asked the month and year of ARV initiation. Participants received home-based HIV testing and counseling using two or three rapid tests according to the national HIV diagnostic rapid test algorithm for each country. HIV-positive field test results were confirmed using Geenius HIV 1/2 Supplemental Assay (BioRad, Marnes-la-Coquette, France) in a satellite laboratory.
Geenius hiv 1 2 supplemental assay
Manufactured by Bio-Rad
Sourced in France, United States
The Geenius HIV 1/2 Supplemental Assay is a rapid test designed to differentiate between HIV-1 and HIV-2 antibodies in human serum or plasma samples. The assay utilizes recombinant HIV-1 and HIV-2 antigens to detect the presence of specific antibodies.
Automatically generated - may contain errors
7 protocols using geenius hiv 1 2 supplemental assay
1
HIV Prevalence and ART Initiation Across Africa
2
Characterization of HIV-1/2 Reference Specimens
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The HIV 85-member subpanel consisted of well-characterized HIV-1 (n = 35)-, HIV-2 (n = 3)-, and HIV-1/2 (n = 2)-positive specimens and negative specimens (n = 45). These were characterized by the 3rd-generation Genetic Systems HIV-1/2 Plus O enzyme immunoassay (EIA) (Bio-Rad Laboratories, Hercules, CA) and the Cambridge Biotech HIV Western blot assay (Maxim Biomedical, Rockville, MD) using a standard algorithm. Serotyping was achieved with the Multispot HIV-1/2 assay and the Geenius HIV-1/2 supplemental assay, which detects and differentiates HIV-1 and HIV-2 antibodies (Bio-Rad). These specimens serve as reference specimens in the HIV serology reference laboratory at the CDC and were acquired from Boca Biolistics Inc. (Pompano Beach, FL). The same mode of characterization was used for panel 1 specimens.
3
National HIV Continuum of Care Survey
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Survey staff administered the household and the adult questionnaires during a face-to-face interview with participants using Google Nexus 9 tablets. The household questionnaire collected data on household assets and access to food. The adult questionnaire included questions on lifetime and recent sexual behaviors, as well as questions on the HIV continuum of care for those who reported being HIV positive. Only one female participant aged 15 years or older in each household was randomly selected to answer questions about experiences with sexual violence, to mask the nature of the questions to other members of the household. Any female younger than 18 who reported being sexually exploited was referred to support services for counseling and further management.
Rapid HIV testing was conducted using point-of-care (POC) tests—Determine HIV-1/2 Rapid Test (Alere)—and confirmed with a Uni-Gold HIV Test (Trinity Biotech), as per the national algorithm. Laboratory verification of all HIV-positive results was done using the Geenius HIV-1/2 Supplemental Assay (Bio-Rad). Viral load testing was done preferentially on plasma, or on dried blood spots (DBSs) if necessary, at a central lab on an automated platform.
Rapid HIV testing was conducted using point-of-care (POC) tests—Determine HIV-1/2 Rapid Test (Alere)—and confirmed with a Uni-Gold HIV Test (Trinity Biotech), as per the national algorithm. Laboratory verification of all HIV-positive results was done using the Geenius HIV-1/2 Supplemental Assay (Bio-Rad). Viral load testing was done preferentially on plasma, or on dried blood spots (DBSs) if necessary, at a central lab on an automated platform.
4
Household-Based HIV Testing Protocol
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EPHIA staff used a questionnaire prepared for the survey to collect data about
household and individual characteristics. Initial household-based HIV testing
was performed with the national HIV-testing algorithm using three HIV rapid
tests. Individuals with a reactive screening test underwent confirmatory testing
using the Uni-Gold HIV-1/2 (Trinity Biotech, Bray, Ireland). Individuals with
discordant results were administered a tiebreaker test (Vikia HIV-1/2,
bioMérieux, Marcy-l’Étoile, France). All HIV-positive individuals identified in
the field received confirmatory testing in a satellite laboratory using the
Geenius HIV 1/2 Supplemental Assay (Bio-Rad, Hercules, CA USA) [4 ]. Both the questionnaire
and field laboratory data were collected on mobile tablet devices using the
application Open Data Kit, an open-source mobile data collection application.
The Global Positioning System was used to identify and record the geographical
coordinates of each EPHIA sample location. Cluster geolocation data were loaded
onto encrypted and passcode-protected tablet computers in keyhole markup
language format using the MAPS.ME mobile app (https://maps.me ), which includes OpenStreetMap (https://www.openstreetmap.org ) data
[25 ] .
household and individual characteristics. Initial household-based HIV testing
was performed with the national HIV-testing algorithm using three HIV rapid
tests. Individuals with a reactive screening test underwent confirmatory testing
using the Uni-Gold HIV-1/2 (Trinity Biotech, Bray, Ireland). Individuals with
discordant results were administered a tiebreaker test (Vikia HIV-1/2,
bioMérieux, Marcy-l’Étoile, France). All HIV-positive individuals identified in
the field received confirmatory testing in a satellite laboratory using the
Geenius HIV 1/2 Supplemental Assay (Bio-Rad, Hercules, CA USA) [4 ]. Both the questionnaire
and field laboratory data were collected on mobile tablet devices using the
application Open Data Kit, an open-source mobile data collection application.
The Global Positioning System was used to identify and record the geographical
coordinates of each EPHIA sample location. Cluster geolocation data were loaded
onto encrypted and passcode-protected tablet computers in keyhole markup
language format using the MAPS.ME mobile app (
[25 ]
5
Multiplatform SARS-CoV-2 and HIV Diagnostics
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The Roche Elecsys HIV Duo assay is a fourth-generation automated combination immunoassay that uses separate, simultaneous reactions to detect HIV Ag (p24) and HIV-1/2 Abs. The COIs are converted to qualitative results and reported as nonreactive (COI < 1.0) or reactive (COI ≥ 1.0) by the system.
Bio-Rad Geenius HIV 1/2 Supplemental Assay was used for the detection and differentiation of individual antibodies to HIV-1 and HIV-2. The Aptima HIV-1 Quant Dx assay (Hologic Panther system), through transcription-mediated amplification, uses multiple, long primers that target several regions of the HIV-1 genome (pol and long terminal repeat [LTR]) independently to provide a quantitative result.
Presence or absence of SARS-CoV-2 infection was determined by real-time PCR testing for SARS-CoV-2 viral RNA from nasopharyngeal swabs tested at the Henry Ford Hospital microbiology laboratory with commercial PCR systems validated for clinical use under emergency use authorization. To provide redundancy during reagent supply interruptions, we routinely use multiple commercial real-time PCR systems (NeuMoDx 288, NeuMoDx Medical, Ann Arbor, MI; Cepheid GeneXpert and Infinity, Sunnyvale, CA; Hologic Panther, Marlborough, MA; and Diasorin Liaison MDX, Diasorin Molecular LLC, Cypress, CA).
Bio-Rad Geenius HIV 1/2 Supplemental Assay was used for the detection and differentiation of individual antibodies to HIV-1 and HIV-2. The Aptima HIV-1 Quant Dx assay (Hologic Panther system), through transcription-mediated amplification, uses multiple, long primers that target several regions of the HIV-1 genome (pol and long terminal repeat [LTR]) independently to provide a quantitative result.
Presence or absence of SARS-CoV-2 infection was determined by real-time PCR testing for SARS-CoV-2 viral RNA from nasopharyngeal swabs tested at the Henry Ford Hospital microbiology laboratory with commercial PCR systems validated for clinical use under emergency use authorization. To provide redundancy during reagent supply interruptions, we routinely use multiple commercial real-time PCR systems (NeuMoDx 288, NeuMoDx Medical, Ann Arbor, MI; Cepheid GeneXpert and Infinity, Sunnyvale, CA; Hologic Panther, Marlborough, MA; and Diasorin Liaison MDX, Diasorin Molecular LLC, Cypress, CA).
6
Evaluating HIV-1/2 Dual EIA Test Accuracy
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The test results were all entered independently in Microsoft Excel (Microsoft Corporations, Redmond, USA) by two laboratory personnel. All entries were double-checked for errors, duplications, and later merged before performing any data analysis. Analysis was completed using laboratory spreadsheets as the data source. The Pearson chi-square (χ2) test was used to determine the relationship with categorical variables while Wilcoxon rank sum test was used for continuous variables. Percentage overall agreement was calculated to show the relationship between the dual EIA test results and Geenius final HIV-1/2 classification. In addition, Positive Predictive Value (PPV), with the corresponding 95% Confidence Interval (CI), was calculated to confirm dual EIA HIV positive, using Bio-Rad Geenius™ HIV-1/2 Supplemental Assay as the gold standard. The confidence bounds were calculated using exact binomial bounds.
The tests were two-tailed and P value of ≤ 0.05 was considered as statistical significance. Data analysis was performed using IBM SPSS Statistics version 21.0 (IBM Corporation, Armonk, NY, USA).
The tests were two-tailed and P value of ≤ 0.05 was considered as statistical significance. Data analysis was performed using IBM SPSS Statistics version 21.0 (IBM Corporation, Armonk, NY, USA).
7
KSHV Seroprevalence Among MSM and TGW with HIV
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This is a cross-sectional study of KSHV seroprevalence among MSM and TGW with HIV in Dallas, Texas. Participants were recruited from an HIV clinic at Parkland Health, a large safety-net hospital system in Dallas, through referrals from medical providers, by word of mouth, and through self-referral by recruitment flyers. This study was approved by the University of Texas Southwestern Institutional Review Board (STU 2019-1204).
Potential participants were considered eligible to enroll if they were (1) aged ≥18 years; (2) a cisgender man or transgender woman; (3) HIV positive, as confirmed by either a combination of a positive third- or fourth-generation HIV Ag/Ab test with positive Geenius HIV 1/2 supplemental assay (Bio-Rad Laboratories) or enzyme-linked immunosorbent assay (ELISA)/Western blot, and/or detectable serum HIV RNA nucleic acid amplification test; (4) reported sex with men (current or prior); and (5) spoke Spanish or English. Exclusion criteria included (1) known KSHV disease or (2) cognitive impairment interfering with ability to consent. Participants who received medical care outside of the Parkland system for their HIV were asked to complete a release of information request so their medical records could be obtained.
Potential participants were considered eligible to enroll if they were (1) aged ≥18 years; (2) a cisgender man or transgender woman; (3) HIV positive, as confirmed by either a combination of a positive third- or fourth-generation HIV Ag/Ab test with positive Geenius HIV 1/2 supplemental assay (Bio-Rad Laboratories) or enzyme-linked immunosorbent assay (ELISA)/Western blot, and/or detectable serum HIV RNA nucleic acid amplification test; (4) reported sex with men (current or prior); and (5) spoke Spanish or English. Exclusion criteria included (1) known KSHV disease or (2) cognitive impairment interfering with ability to consent. Participants who received medical care outside of the Parkland system for their HIV were asked to complete a release of information request so their medical records could be obtained.
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