Main study results and methods for AHI screening are described elsewhere.5 (link),14 (link) Briefly, between June 2012-January 2014, persons ≥18 years who tested HIV-seronegative or serodiscordant at two HIV testing and counseling clinics and two sexually transmitted infections (STI) clinics, were screened for the presence of plasma HIV RNA. HIV serostatus testing was done according to Malawian standard of care with two serial rapid tests, Alere Determine HIV-1/2 (Alere) and Unigold Recombigen HIV-1/2 (Trinity Biotech), with a third test for resolution of discordant results (if positive, persons were considered HIV-seropositive). AHI screening was conducted using Abbott RealTime HIV-1 Assay (Abbott Laboratories, Chicago, IL, reportable range of 40–10,000,000 copies/mL) or COBAS AMPLICOR HIV-1 MONITOR test (Roche, Pleasanton, CA, reportable range of 400–750,000 copies/mL). AHI was defined as the presence of HIV RNA in a person with seronegative or serodiscordant antibody results. Participants were randomized to standard of care (SC), sexual behavioral intervention (BI), or sexual behavioral intervention and ART (BIA) (1:2:2 ratio) and were followed for 52 weeks.
Cobas amplicor hiv 1 monitor test
Manufactured by Roche
Sourced in United States
The Cobas Amplicor HIV-1 Monitor Test is a laboratory diagnostic tool used to quantify the amount of HIV-1 RNA in a patient's blood sample. It is designed to aid in the clinical management of individuals infected with HIV-1.
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17 protocols using cobas amplicor hiv 1 monitor test
1
AHI Screening and Intervention Study
2
Quantitative HIV-1 Viral Load and DNA Detection
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The HIV-1 viral load in the plasma of patients infected with HIV-1 was quantitatively detected using a standardized RT-qPCR (Cobas Amplicor HIV-1 Monitor Test; version 1.5; Ultra-sensitive specimen preparation; Roche Diagnostic Systems Inc) as previously described (17 (link)). The detection limit in the plasma was defined as 50 HIV-1 RNA copies/ml.
The total HIV-1 DNA, including the integrated HIV-1 DNA and episomal two long terminal repeat (2LTR) circles, in the peripheral blood was detected using a HIV-1 DNA Detection kit (PCR-Fluorescent Probing; SUPBIO; Guangzhou Hailite Biotechnology Co., Ltd.). Briefly, the total DNA was isolated from the blood using a QIAamp DNA Blood Mini Kit (Qiagen GmbH). The 50 µl reaction system contained 5 µl DNA and 45 µl PCR master mix. The test was performed using a Light Cycler 1.2 (Roche Diagnostics GmbH). The amplification conditions were set as follows: i) five cycles of 37°C for 5 min, 95°C for 10 min; ii) 95°C for 15 sec, 65°C for 15 sec and 72°C for 20 sec; iii) 40 cycles of 95°C for 15 sec, 62°C for 15 sec and 72°C for 20 sec; and iv) 10 cycles of 95°C for 15 sec, 52°C for 15 sec and 72°C for 32 sec. Two standard curves were calculated according to the volume of blood or PBMC counts. The results were expressed as copies/ml and copies/106 PBMCs.
The total HIV-1 DNA, including the integrated HIV-1 DNA and episomal two long terminal repeat (2LTR) circles, in the peripheral blood was detected using a HIV-1 DNA Detection kit (PCR-Fluorescent Probing; SUPBIO; Guangzhou Hailite Biotechnology Co., Ltd.). Briefly, the total DNA was isolated from the blood using a QIAamp DNA Blood Mini Kit (Qiagen GmbH). The 50 µl reaction system contained 5 µl DNA and 45 µl PCR master mix. The test was performed using a Light Cycler 1.2 (Roche Diagnostics GmbH). The amplification conditions were set as follows: i) five cycles of 37°C for 5 min, 95°C for 10 min; ii) 95°C for 15 sec, 65°C for 15 sec and 72°C for 20 sec; iii) 40 cycles of 95°C for 15 sec, 62°C for 15 sec and 72°C for 20 sec; and iv) 10 cycles of 95°C for 15 sec, 52°C for 15 sec and 72°C for 32 sec. Two standard curves were calculated according to the volume of blood or PBMC counts. The results were expressed as copies/ml and copies/106 PBMCs.
3
Evaluation of Metabolic and HIV Parameters
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Total cholesterol, triglyceride, glucose, HbA1C, high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein-cholesterol (LDL-C) levels were determined after at least an 8-hour fast. The data of most recent plasma HIV RNA load, CD4 lymphocyte count, blood urea nitrogen, serum creatinine, estimated glomerular filtration rate (eGFR) that was calculated with the use of the abbreviated Modification of Diet in Renal Disease (MDRD) equation [24] (link), hemoglobin, and rapid plasma reagin (RPR) (within 6 months of survey) were collected using a standardized case record form. Plasma HIV RNA load was quantified using the Cobas Amplicor HIV-1 Monitor test (Cobas Amplicor version 1.5, Roche Diagnostics Corporation, IN, USA) with a lower detection limit of 20 copies/mL, and CD4 count was determined using FACFlow (BD FACS Calibur, Becton Dickinson, CA, USA). Bone mineral density (BMD) was measured with the use of dual-energy X-ray absorptiometry scan (Lunar Prodigy; GE Healthcare, Belgium) [17] (link).
4
Comprehensive Diagnostic Testing for HIV, STIs
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HIV infection was diagnosed with two different rapid blood tests for the detection of HIV antibodies (Oraquick HIV 1/2, manufactured in Thailand for Orasure Technologies, Bethlehem, PA, USA; Determine, Abbott Laboratories, Wiesbaden, Germany; and UniGold Recombogen, Trinity Biotech, Wicklow, Ireland), which were done concurrently. Positive or discordant HIV rapid were confirmed by HIV PCR RNA (COBAS AmpliPrep, COBAS AMPLICOR HIV-1 MONITOR Test, version 1.5, Roche Diagnostics, Indianapolis, IN, USA). Pregnancy testing for the Human chorionic gonadotropin (hCG) hormone was conducted on urine samples using the QuickVue One-Step hCG Urine Test, Quidel Corporation, San Diego, CA, USA). Neisseria gonorrhoeae and Chlamydia trachomatis were detected in endocervical swab samples using the PCR Roche COBAS Amplicor (Roche Diagnostics, Indianapolis, IN, USA). Trichomonas vaginalis was detected in a vaginal swab using the In Pouch assay (BioMed Diagnostics, Santa Clara).
5
Quantitative HIV-1 Viral Load Assay
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Human immunodeficiency virus-1 viral load in the plasma of the AIDS patients was quantitatively detected using a standardized reverse transcriptase-polymerase chain reaction assay (Cobas Amplicor HIV-1 Monitor Test, version 1.5, Ultra Sensitive Specimen Preparation, Roche Diagnostic Systems Inc., Branchburg, NJ, USA). Low detection limit in plasma was defined as 50 HIV-1 RNA copies/ml.
6
HIV RNA Viral Load Testing
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Specimens underwent HIV RNA polymerase chain reaction (PCR) testing using the COBAS AMPLICOR HIV-1 MONITOR Test (Roche, Pleasanton, CA) (reportable range of 50–750,000 copies/mL) or Abbott RealTime HIV-1 m2000 Assay (Abbott Laboratories, Chicago, IL) (reportable range of 40–10,000,000 copies/mL). Microtubes containing whole blood were processed and plasma specimens were pooled in a 9:1 pooling algorithm. Positive pools were deconstructed and individual specimens tested to identify which contained detectable HIV RNA.28 (link)–31 (link)
7
HIV Diagnostic Testing Protocol
8
Monitoring cART Response in HIV
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PVL was quantified using the Cobas Amplicor HIV-1 Monitor test (Cobas Amplicor version 1.5, Roche Diagnostics, Indianapolis, IN, USA) with a lower detection limit of 20 copies/mL, and CD4 count was determined using FACFlow (BD FACS Calibur, Becton Dickinson, San Jose, CA, USA). The CD4 counts and PVL were monitored one month after initiation of cART in antiretroviral-naïve participants or after a change of regimen due to virological failure and every three to six months thereafter according to the local HIV treatment guidelines.
9
Comprehensive Viral and Endocrine Biomarker Assessment
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CD4 cell count was measured by flow cytometry (FACSCantoII, Becton Dickinson, Franklin Lakes, NJ, USA), and plasma HIV load (HIV RNA) was determined using a standardized reverse transcriptase-polymerase chain reaction assay (Cobas Amplicor HIV-1 Monitor Test, version 1.5, Ultrasensitive specimen preparation, Roche Diagnostic Systems Inc., Branchburg, NJ, USA). The lower limit of detection in plasma was 50 HIV-1 RNA copies/mL. HCV infection was detected by measuring antibodies to HCV in serum samples by using ELISA (Ortho HCV 3.0 ELISA test, Ortho Clinical Diagnostic, Amersham, Buckinghamshire, UK) and an immunoblot assay (SIA, Chiron RIBA, Chiron Corporation, Emeryville, CA, USA). HBV infection was detected by measuring the hepatitis B surface antigen level using an enzyme-linked fluorescent assay (Biomerieux, Lyon, France). Serum TSH level was measured by a one-step radioimmunometric assay (IRMA-mat, Byk-Sangtec Diagnostica, Dietzenbach, Germany), and serum FT3 and FT4 levels were measured using radioimmunological assays (Amerlex MAB, Ortho Clinical Diagnostics, Milan, Italy).
10
Monitoring HIV Treatment Response
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Plasma HIV RNA load was quantified using the Cobas Amplicor HIV-1 Monitor test (Cobas Amplicor version 1.5, Roche Diagnostics Corporation, IN) with a lower detection limit of 40 copies/mL, and CD4 lymphocyte count was determined using FACFlow (BD FACS Calibur, Becton Dickinson, CA). The CD4 counts and plasma HIV RNA loads were monitored one month after initiation of combination antiretroviral therapy in antiretroviral-naive patients, or change of regimens in the presence of virological failure; and every three to six months thereafter according to the national HIV treatment guidelines.
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