At enrollment, participants provided written informed consent and underwent HIV/STI testing, including (1) rapid HIV: Advance Quality Anti-HIV 1&2 (InTec Products, Inc); (2) rapid syphilis: Advance Quality Anti-TP (InTec Products, Inc); (3) confirmatory HIV: Architect HIV Ag/Ab Combo, Abbott, Geenius™ HIV ½ Supplemental Assay (Bio-Rad); (4) confirmatory syphilis: BD Macro-Vue™ rapid plasma regain (RPR) (Becton, Dickinson and Company) and Architect Syphilis Treponemal assay (Abbott); and (5) chlamydia and gonorrhea: Aptima Combo 2@ Assay (Hologic). Participants received rapid HIV/STI test results, and then completed the baseline survey, participated in the sexual risk reduction counseling session, and were randomized (1:1) to the intervention or control group. Participants returned within approximately one month to receive their confirmatory HIV/syphilis test and STI test results. All STI-positive participants were offered free treatment, and HIV-positive participants were referred to local clinics for free HIV care. At that visit, participants also completed the Proyecto PrEParado survey. All surveys were interviewer-administered using computer-assisted personal-interviewing. Study procedures were approved by ethics committees at the University of California, San Diego, Xochicalco University in Tijuana, and SADEC-FEMAP in Ciudad Juarez.
Architect hiv ag ab combo
Manufactured by Abbott
Sourced in United States, Germany
The ARCHITECT HIV Ag/Ab Combo is a laboratory diagnostic instrument designed to detect the presence of both HIV antigen and antibodies in human serum or plasma samples. The core function of this product is to provide a qualitative determination of HIV infection status.
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23 protocols using architect hiv ag ab combo
1
HIV/STI Screening and Risk Reduction Counseling
2
Assessing HIV Serological Status
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Serological status was assessed by plasma venous sampling using the fourth-generation Abbott ARCHITECT HIV Ag/Ab Combo assay.
3
Postvaccination HIV Serostatus in Adults
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In this study, the inclusion criteria for participants included (1 ): aged 18–75 years (2 (link)); 2-4 weeks postvaccination with the second dose of Sinovac CoronaVac; and (3 ) being willing to participate in the study activities and signed written informed consent. The HIV infection was preliminarily identified by HIV rapid test kit in all participants. Besides, we re-identified the HIV serostatus for PLWH using Abbott ARCHITECT HIV Ag/Ab Combo assay at the study site. The exclusion criteria were (1 ): a presence of severe hearing loss, impaired vision, or intellectual disability observed by the interviewers (2 (link)); a history of SARS-CoV-2 infection which was defined by searching national medical records and self-reports (3 ). a history of vaccination with another COVID-19 vaccine instead of CoronaVac according to the national medical records; or (4 (link)) major psychiatric illness (schizophrenia or bipolar disorder) or other severe diseases which were not suitable for this study based on clinician’s assessment.
4
Quantifying HIV Antigens and Antibodies
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ARCHITECT HIV Ag/Ab Combo (Abbot) was used to quantify HIV-specific p24 Ag and Ab. The sample relative luciferase unit (RLU) was calculated using multiplying the sample to cut off ratio with cut off RLU. The cut-off RLU was obtained multiplying calibrator 1 mean RLU with 0.40.
5
Evaluation of HIV Diagnostic Assays
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For the retrospective parts of sensitivity and specificity, all samples were tested with the Access HIV combo V2 according to the manufacturer’s recommendations. Tests found negative for the study of sensitivity were planned to be repeated once.
For the prospective part of specificity, all samples were tested in parallel with Access HIV combo V2 and either Architect HIV Ag/Ab Combo at the Pitié-Salpêtrière Hospital or Prism HIV O Plus (Abbott) and Procleix Ultrio (Novartis Diagnostics, Emeryville, CA, USA) at the EFS centers. All gray zone and reactive samples were retested in duplicate, followed, if remaining gray zone or reactive, by a confirmatory assay. Confirmatory assays were conducted using either New LAV Blot I and II at Pitié Salpêtrière Hospital or INNO-LIA HIV I/II Score (Innogenetics, Gent, Belgium) at the EFS centers.
For the prospective part of specificity, all samples were tested in parallel with Access HIV combo V2 and either Architect HIV Ag/Ab Combo at the Pitié-Salpêtrière Hospital or Prism HIV O Plus (Abbott) and Procleix Ultrio (Novartis Diagnostics, Emeryville, CA, USA) at the EFS centers. All gray zone and reactive samples were retested in duplicate, followed, if remaining gray zone or reactive, by a confirmatory assay. Confirmatory assays were conducted using either New LAV Blot I and II at Pitié Salpêtrière Hospital or INNO-LIA HIV I/II Score (Innogenetics, Gent, Belgium) at the EFS centers.
6
Vaccine-Induced Seropositivity Monitoring
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VISR was assessed 2 weeks after the third and fourth vaccinations and at 9 and 12 months after enrollment using a diagnostic algorithm that includes 4 different enzyme immunoassays (EIAs): Abbott Architect HIV Ag/Ab Combo, Abbot Prism, Bio-Rad Genetic Systems HIV Combo Ag/Ab EIA, and Bio-Rad Multispot HIV-1/HIV-2 Rapid Test. For participants with a positive result in any of these assays, RNA PCR (Abbott m2000 HIV-1 Real-Time PCR) was performed to distinguish vaccine-induced responses from actual infection.
7
COVID-19 Booster Vaccination Study
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In this study, the inclusion criteria for participants included: (1) aged between 18 and 65 years, (2) no history of SARS-CoV-2 infection, (3) having received full immunization (two doses of COVID-19 inactivated vaccine) and the first COVID-19 inactivated booster dose, (4) the second COVID-19 booster dose has not been vaccinated yet, and (5) willingness to participate in the study activities and having signed written informed consent. The HIV infection status was preliminarily self-reported by participants before attending this site study. We re-identified the HIV serostatus for PLWH using the Abbott ARCHITECT HIV Ag/Ab Combo assay, which has high sensitivity and specificity (S/CO ≥ 1.0, Reactive) at the study site. The exclusion criteria were: (1) interviewees with severe hearing loss, visual impairment, or intellectual disability and (2) major mental illness (schizophrenia or bipolar disorder) or neurocognitive impairment as assessed by the clinician.
8
HIV Exposure Assessment and Management
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Upon presentation at the clinic, information regarding the sexual exposure, consultation delay, the source and the patient’s history of at-risk behavior was evaluated by a triage nurse. Patients were also explained the follow-up procedure and provided counseling on antiretroviral (ARV) therapy. HIV rapid testing (INSTI), MEIA screening for HIV antibodies and antigen p24 tests (Abbott ARCHITECT ® HIV Ag/Ab Combo) were offered to patients and their partners, if present at the consultation. Patients were then examined by a physician, attributed an exposure risk (negligible, moderate or high) and indicated a treatment accordingly. Advice on ARV use and STD counseling was also provided to patients at this time.
9
Molecular testing for STIs
10
Rapid Screening for HIV, Syphilis, and STIs
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Participants underwent rapid antibody testing for HIV (Advance Quality Anti-HIV 1&2; InTec Products, Inc) and syphilis (Advance Quality Anti-TP; InTec Products, Inc). Rapid test results were delivered to participants within ~ 20 min, and those whose rapid test results were positive underwent confirmatory HIV (Architect HIV Ag/Ab Combo; Abbott; Geenius™ HIV ½ Supplemental Assay; Bio-Rad;) and/or syphilis (rapid plasma reagin (RPR) test: BD Macro-Vue™ RPR; Becton, Dickinson and Company; Treponemal (TP) assay: Architect Syphilis TP assay; Abbott) testing. RPR and TP positive participants with titers ≥1:8 were considered active syphilis cases. Urine samples were collected to detect Chlamydia trachomatis and Neisseria gonorrhoeae infections via nucleic acid amplification testing (Aptima Combo 2® Assay; Hologic). The San Diego County Public Health Laboratory conducted all nucleic acid amplification and confirmatory testing, the results of which were delivered to participants within approximately 1 month. STI-positive participants were offered free treatment according to Mexican STI treatment guidelines and HIV-positive participants were referred to municipal health clinics in Tijuana and Ciudad Juarez for free care and treatment.
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