HIV-1 testing was performed at each study visit using two rapid antibody test kits (Determine, Abbott Laboratories; Unigold, Trinity Biotech) in parallel. Discordant rapid HIV-1 test results were resolved using an enzyme-linked immunosorbent assay (ELISA) (Genetic System HIV-1/2 plus O EIA, Bio-Rad Laboratories). All HIV-1 negative samples were tested for p24 antigen (Vironostika HIV-1 p24 ELISA, Biomérieux) through 2015, or for HIV-1 RNA (Xpert® HIV-1 Qual, Cepheid) since 2016. Pre- and post-seroconversion samples were tested for HIV-1 RNA level (Amplicor Monitor 1.5, Roche). Gonococcal infection among participants who reported urethral or rectal symptoms was defined as the detection of gram-negative, intracellular diplococci consistent with Neisseria gonorrhoeae in urethral or rectal secretions.[7 (link)] Prevalent syphilis infection was diagnosed using a positive rapid plasma reagin (RPR, tested annually) titre confirmed by Treponema pallidum hemagglutination assay (TPHA). Incident syphilis was defined as a 4-fold increase in RPR titre confirmed by TPHA.[7 (link)]
Xpert hiv 1 qual
Manufactured by Cepheid
Sourced in Italy
The Xpert HIV-1 Qual is a qualitative in vitro diagnostic test for the detection of HIV-1 RNA in human plasma and whole blood specimens. The test is designed to run on the GeneXpert Instrument System.
Automatically generated - may contain errors
5 protocols using xpert hiv 1 qual
1
HIV-1 Testing and STI Diagnosis Protocol
2
Scaling Up POC EID for HIV-Positive Infants
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The UNITAID/Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) POC EID project (2015-2019)
is a multicountry project in 9 African countries. It aims to reduce HIV-related mortality by
increasing the number of HIV-positive infants whose HIV status is known, facilitating early
return of results and ART initiation through introduction and scale-up of POC EID. Two WHO
prequalified POC EID assays, the m-PIMA HIV-1/2 Detect (Abbott Laboratories, Lake Forest,
Illinois) and Xpert HIV-1 Qual (Cepheid, Sunnyvale, California) were considered for
implementation based on throughput. Implementation of POC EID relies on a hub-and-spoke
model, where a hub is a facility with a POC EID platform and a spoke is a facility that
refers samples for testing at the hub facility. In Kenya, EGPAF and the Ministry of Health
implemented POC EID in 42 hubs and over 700 spoke sites in 12 counties. Implementation began
in August 2017 in 3 pilot hub and 36 spoke facilities in 2 counties, namely, Homa Bay and
Turkana. The former is the region with the one of the highest HIV prevalence in Kenya, while
the latter is a remote region in northern Kenya.
is a multicountry project in 9 African countries. It aims to reduce HIV-related mortality by
increasing the number of HIV-positive infants whose HIV status is known, facilitating early
return of results and ART initiation through introduction and scale-up of POC EID. Two WHO
prequalified POC EID assays, the m-PIMA HIV-1/2 Detect (Abbott Laboratories, Lake Forest,
Illinois) and Xpert HIV-1 Qual (Cepheid, Sunnyvale, California) were considered for
implementation based on throughput. Implementation of POC EID relies on a hub-and-spoke
model, where a hub is a facility with a POC EID platform and a spoke is a facility that
refers samples for testing at the hub facility. In Kenya, EGPAF and the Ministry of Health
implemented POC EID in 42 hubs and over 700 spoke sites in 12 counties. Implementation began
in August 2017 in 3 pilot hub and 36 spoke facilities in 2 counties, namely, Homa Bay and
Turkana. The former is the region with the one of the highest HIV prevalence in Kenya, while
the latter is a remote region in northern Kenya.
3
POC HIV Testing in High-Burden Africa
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Zimbabwe and Kenya are high-HIV burden countries in sub-Saharan Africa and are among the 21 priority countries in the “Global Plan toward the elimination of new HIV infections among children and keeping their mothers alive.”19 Zimbabwe and Kenya have 3 and 8 centralized referral laboratories for EID, respectively, and both have implemented laboratory strengthening activities in recent years. Zimbabwe supports transport of samples from most health facilities to centralized laboratories once weekly. Results are returned through SMS printers; however, approximately 15% of EGPAF-supported facilities included in the POC EID project did not have functioning SMS printers. Significant investment has been made in Kenya's centralized laboratory system, with daily sample transport from requesting facilities to centralized laboratories, and results made available immediately to requesting facilities on an electronic health record system (the EID dashboard).
The project used both WHO prequalified POC assays, Abbott's m-Pima HIV-1/2 Detect and the Cepheid's Xpert HIV-1 Qual. The Ministry of Health and country teams were able to choose whichever mix of platforms best fit the laboratory network and site specifications with no influence of the study team and our analysis does not differentiate between the 2 types of platforms.
The project used both WHO prequalified POC assays, Abbott's m-Pima HIV-1/2 Detect and the Cepheid's Xpert HIV-1 Qual. The Ministry of Health and country teams were able to choose whichever mix of platforms best fit the laboratory network and site specifications with no influence of the study team and our analysis does not differentiate between the 2 types of platforms.
4
Comprehensive HIV Screening and Diagnosis
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Alere™ HIV Combo (rebranded to Determine™ HIV Ultra, from Abbott) was used for the screening of HIV infection. It is a fourth-generation rapid test that detects IgM and IgG Abs to HIV-1/HIV-2. Moreover, it detects p24 Ag to HIV-1. This is what sets it apart from third-generation testing, as it allows detecting both HIV Abs and p24 Ag with the same test [24 ].
Rapid, qualitative HIV RNA testing (Xpert® HIV-1 Qual, Cepheid) was performed to confirm reactive p24 Ag and/or HIV Ab test. If result detected HIV, a positive HIV diagnosis was confirmed. In case of divergent results, a second quantitative HIV RNA test (Xpert® HIV-1 Viral Load, Cepheid) was performed. If the second quantitative HIV RNA test result was positive, the final HIV diagnostic result was considered positive, whereas if the second test was negative, the final HIV diagnosis was negative. In parallel a blood sample was send to an external laboratory to perform a Western Blot assay (WB). Tests that produced false-positive results for the “p24 Ag only” were investigated by the manufacturer.
A rapid testing of T-lymphocyte counts (PIMATM CD4, Abbott) was also performed to assess baseline immunity.
Rapid, qualitative HIV RNA testing (Xpert® HIV-1 Qual, Cepheid) was performed to confirm reactive p24 Ag and/or HIV Ab test. If result detected HIV, a positive HIV diagnosis was confirmed. In case of divergent results, a second quantitative HIV RNA test (Xpert® HIV-1 Viral Load, Cepheid) was performed. If the second quantitative HIV RNA test result was positive, the final HIV diagnostic result was considered positive, whereas if the second test was negative, the final HIV diagnosis was negative. In parallel a blood sample was send to an external laboratory to perform a Western Blot assay (WB). Tests that produced false-positive results for the “p24 Ag only” were investigated by the manufacturer.
A rapid testing of T-lymphocyte counts (PIMATM CD4, Abbott) was also performed to assess baseline immunity.
5
Quantification of HIV RNA and Proviral DNA
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Intracellular and supernatant HIV RNAs were quantitated using Cobas AmpliPrep and Cobas-6800 (Roche, Milan, Italy), respectively. Both platforms and tests are routinely used at the Virology Unit, Pisa University Hospital; are certified for in vitro diagnostics; and detect up to 20 HIV RNA copies/ml. HIV msRNA was detected and quantitated using a TILDA (20 (link)). Briefly, total RNA extracted as described above was reverse transcribed at 50°C for 15 min, denatured at 95°C for 2 min, and amplified for 24 cycles (95°C for 15 s and 60°C for 4 min) on a T100 PCR instrument (Bio-Rad, Hercules, CA, USA). At the end of this process, samples were diluted to 50 μl with Tris-EDTA buffer, and 1 μl of the sample was used as the template for a second tat/rev real-time PCR. Primer sequences and details to calculate means and standard deviations of ΔCT (threshold cycle) values were described previously (21 (link)). Proviral DNA in 293T cells was assayed with Xpert HIV-1 Qual, manufactured by Cepheid (Milan, Italy) and certified for in vitro diagnostics. This assay has a sensitivity of 278 copies/ml in whole blood (55 (link), 56 (link)). Before Xpert HIV-1 Qual analysis, genomic DNA extracted from 293T cells was RNase treated to eliminate contaminating cellular RNA.
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