... Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime HIV-1 Calibrator Kit, Abbott RealTime HIV-1 Control Kit. ...
Center for Biologics Evaluation and Research (CBER)
... Device Code: MZF. ... Upgrade the m2000 system software to add a code that will not allow the system to use expired reagents. ...
... For detailed information on application file installation, refer to the ... 1 assay with the Abbott m2000 system and 1.0 ... Sebire K, McGavin K, Land S, et al ...
... Internal Control RNA. The reagent also contains dNTPs, ROX� passive reference dye and an aptamer oligonucleotide. The reagent is formulated in a ...
HIV-1 viral load determination is a crucial step for monitoring the efficacy of highly active antiretroviral therapy (HAART) and predicts disease progression. Real-time PCR based assays are available for monitoring the viral load. They differ in sensitivity, genomic target region and dynamic range. In this study, the performance of the ...
PubMed
... Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert. Page 2. Key to symbols used ...
The need for viral load (VL) monitoring of HIV patients receiving antiretroviral therapy (ART) in resource-limited settings (RLS) has become apparent with studies showing the limitations of immunological monitoring. We compared the Abbott m2000 Real-Time (Abbott) HIV-1 assay with the Roche ...
... Screening; Infectious Disease Tests. -. HIV-1/2. -. Human Immunodeficiency Virus Types 1 & 2 (Anti-HIV-1/2 Assay). Abbott ...
BackgroundHIV-1 is characterized by increased genetic heterogeneity which tends to hinder the reliability of detection and accuracy of HIV-1 RNA quantitation assays.MethodsIn this study, the Abbott RealTime HIV-1 (Abbott RealTime) ...
PubMed Central
HIV-1 viral load testing is essential to the management of HIV-1-infected patients, and proper specimen handling ensures accurate viral load (VL) results. This study was performed to (i) evaluate the effect of freezing plasma in situ in BD Vacutainer plasma preparation tubes (PPT) on the accuracy of HIV-1 viral load results using the ...
BACKGROUND: HIV-1 viral load assays are critical tools to monitor antiretroviral therapy efficacy in HIV-infected patients. Two assays based on real-time PCR are available, the Abbott Real-Time HIV-1 assay (Abbott assay) and the new ...
HIVAB HIV-1/HIV-2 (rDNA) EIA is an in vitro enzyme immunoassay for the qualitative detection of antibodies to human immunodeficiency viruses ...
Abstract Background: Human immunodeficiency virus type-1 (HIV-1) RNA viral load is a surrogate marker that is routinely used to determine indications for, and monitor the effectiveness of HIV-1 treatment. We developed three reagents for potential use in routine quality control of HIV-1 RNA quantitative assays. In this report, we compare the stability of ...
Given the worldwide increasing spread of HIV-1 genetic variants, it is mandatory that assays used for nucleic acid testing for HIV-1 detect all existing groups and subtypes of HIV-1. In this report the development and evaluation of a quantitative real-time HIV-1 RT-PCR assay that targets a conserved region within the pol integrase ...
... REASON: Abbott has seen an increase in customer complaints for calibration failures when PRISM-HIV-1 Group O Positive Assay Control (2) (Symbol: OPC) is out of ...
The Abbott RealTime human immunodeficiency virus type 1 (HIV-1) assay (ART) and the Cobas AmpliPrep/Cobas TaqMan HIV-1 test (CTM) are commercially available assays for quantification of HIV-1 RNA in plasma. We evaluated performance characteristics, workflow, throughput, ...
Abstract Background: Diagnostic laboratories need automation that facilitates efficient processing and workflow management to meet today's challenges for expanding services and reducing cost, yet maintaining the highest levels of quality. Methods: Processing efficiency of two commercially available automated systems for quantifying HIV-1 and HCV RNA, ...
... For the detection of antibodies to HIV-1 (anti-HIV-1) Groups M and O and/or antibodies to HIV-2 (anti-HIV-2) in human serum and plasma ...
HIV clinics in Canada provide care to an increasing number of patients born outside of Canada with HIV-1 non-B subtype infections. Because the Easy Q HIV-1 v1.2 assay (EQ; bioM�rieux) failed to detect some non-B subtype infections, a multiassay HIV-1 viral load (VL) study was conducted with patients with diverse ...
The plasma human immunodeficiency virus (HIV) RNA load is used in the clinical routine for the monitoring of HIV infection and the patient's response to antiretroviral therapy. Other body fluids or dried blood spots (DBS) can be used, however, to assess the level of viremia. The use of DBS may be especially helpful for the monitoring of HIV-infected patients in resource-poor settings, where access ...
Mar 1, 2011 ... Using a real-time quantitative polymerase chain reaction assay, we demonstrated that significantly more HIV-1-infected patients receiving ...
NASA Website
Heterologous viruses may transactivate or suppress human immunodeficiency virus (HIV)�1 replication. An adenovirus type 5 gene transfer vector (Ad5) HIV-1 vaccine was recently evaluated in a clinical trial, without efficacy. In this context, it is relevant to ask what effect Ad vectors have on HIV-1 replication, ...
... Abbott and Garcia-Molina [Abb88] described a group of lock-based real-time concurrency control schemes for scheduling soft real-time transactions ...
DTIC Science & Technology
... Abbott, R. and H. Garcia-Molina, �Scheduling Real-Time Transactions: A Performance Evaluation,� Proceedings of the 14th VLDB Conference, Aug. ...
The new Abbott RealTime hepatitis B virus (HBV) assay was compared to the Cobas AmpliPrep/Cobas TaqMan assay with 128 serum samples from patients with chronic hepatitis B. There was an excellent correlation (r = 0.961) between the two assays, with the Abbott RealTime test showing at least equivalent sensitivity and ...
... R.Abbott, and H.Garcia-Molina, �Scheduling Real-time Transactions: a Performance Eval- uation,'' ACM Trans. on Database Systems, vol. 17, no. ...
BACKGROUND: Automated HIV-1 RNA extraction and its quantification by real-time PCR assays provide improved sample processing and better analytical performances. The new Artus HIV-1 RealTime assay can be performed after automated extraction with the Qiagen Qiasymphony robot. ...
BackgroundIn resource-limited settings, most perinatally HIV-1-infected infants do not receive timely antiretroviral therapy because early HIV-1 diagnosis is not available or affordable.ObjectiveTo assess the performance of a low cost in-house real-time PCR assay to detect ...
BackgroundIn the Zurich Primary HIV infection study (ZPHI), minority drug-resistant HIV-1 variants were detected in some acutely HIV-1-infected patients prior to initiation of early antiretroviral therapy (ART). Here, we investigated the reappearance of minority K103N and M184V ...
There is an urgent need for low-cost, simple, and accurate human immunodeficiency virus type 1 (HIV-1) viral load monitoring technologies in resource-limited settings, particularly at the time of the scaling-up of first and second-line highly active antiretroviral therapies. This review describes the main characteristics and advantages/ disadvantages of ...
BackgroundXenotropic murine leukaemia virus-related virus (XMRV) is a recently discovered human gammaretrovirus with yet unknown prevalence and transmission route(s). Its presence in prostate stromal fibroblasts and prostatic secretions suggests that XMRV might be sexually transmitted. We chose to study a compartment closely connected to the prostate, a location where XMRV was detected in ...
Cellular APOBEC3G (A3G) protein is packaged into human immunodeficiency virus type 1 (HIV-1) virions in producer cells yet restricts viral replication in target cells. To characterize this restriction in target cells, the effect of A3G on generating various HIV-1 cDNA products was measured by quantitative ...
Energy Citations Database
BackgroundIntegration is an intermediate step in the HIV life cycle and is defined as the insertion of HIV-1 proviral DNA into the host chromosome. If integration does not occur when HIV-1 cDNA enters the nucleus, it circularizes upon itself and forms a 2-LTR circle. Monitoring the level of integrated HIV-1 cDNA in ...
BackgroundHIV-1 genotypic drug resistance is an important threat to the success of antiretroviral therapy and transmitted resistance has reached 9% prevalence in Europe. Studies have demonstrated that HIV-1 DNA load in peripheral blood mononuclear cells (PBMC) have a predictive value for disease progression, independently of CD4 counts and plasma viral ...
A multi-test sequential algorithm based on Rapid/Simple (R/S) assays was applied for the diagnosis of HIV infection among participants in a phase 3 microbicide effectiveness trial. HIV testing was performed on finger-prick blood samples from patients after their enrollment in the trial. The specimens were tested in a serial procedure using three different rapid tests (Determine ...
We used proteomic analyses to assess how drug abuse modulates immunologic responses to infections with the human immunodeficiency virus type 1 (HIV-1). Two dimensional (2D) difference gel electrophoresis was utilized to determine changes in the proteome of peripheral blood mononuclear cells (PBMC) isolated from ...
The development of multidrug-resistant viruses compromises the efficacy of anti-human immunodeficiency virus (HIV) therapy and limits treatment options. Therefore, new targets that can be used to develop novel antiviral agents need to be identified. One such target is the interaction between Vpr, one of the accessory gene products of HIV-1 and Importin {alpha}, which is crucial, not only for the ...
ObjectivesSuppressive HSV therapy can decrease plasma, cervical, and rectal HIV-1 levels in HSV-2/HIV-1 co-infected persons. We evaluated the effect of HSV-2 suppression on seminal HIV-1 levels.DesignTwenty antiretroviral therapy (ART)�naive HIV-1/HSV-2�MSM in Lima, ...
The quantitation of human hepatitis B virus (HBV) in the serum of infected patients is recommended to characterize the course of chronic HBV infection. The aim of this prospective study was to evaluate the performance of the Abbott RealTime PCR assay for HBV DNA quantitation by comparison with the standard Versant HBV DNA 3.0 assay. The better sensitivity ...
Topical microbicides (cellulose acetate 1,2 benzene dicarboxylate [CAP], PRO 2000, SPL7013, and UC781) are being investigated to reduce the sexual transmission of human immunodeficiency virus type 1 (HIV-1). These products were shown to prevent the transfer of infectious HIV-1 from urogenital and colorectal ...
The level of human immunodeficiency virus type 1 (HIV-1) proviral DNA is likely to be an important marker of the long-term effectiveness of highly active antiretroviral therapy. A new method was developed for quantifying HIV-1 group M proviral DNA using TaqMan real-time PCR, in which degenerate ...
Rapid human immunodeficiency virus (HIV) antibody tests have been adopted into national guidelines for HIV testing in many countries in sub-Saharan Africa. One goal of HIV rapid testing is to minimize the occurrence of indeterminate results. From January 2005 to December 2007, plasma (or serum) samples from pregnant women in Bobo-Dioulasso (Burkina Faso, West Africa) were screened for HIV by using ...
BackgroundTransmission of human immunodeficiency virus type 1 (HIV-1) through breast-feeding may involve both cell-free and cell-associated virus. This latter viral reservoir remains, however, to be fully explored. CD4+ T cell-associated virus production in breast milk was therefore investigated.MethodsThe ex vivo spontaneous ...
BackgroundRapid and cost-effective methods for HIV-1 diagnosis and viral load monitoring would greatly enhance the clinical management of HIV-1 infected adults and children in limited-resource settings. Recent recommendations to treat perinatally infected infants within the first year of life are feasible only if early diagnosis is routinely available. Dried blood spots (DBS) on filter paper are ...
Virological monitoring of hepatitis B virus (HBV) DNA is critical to the management of HBV infection. With several HBV DNA quantification assays available, it is important to use the most efficient testing system for virological monitoring. In this study we evaluated the performance characteristics and comparability of three HBV DNA quantification systems: Abbott HBV ...
Sensitive and accurate quantification of hepatitis B virus (HBV) DNA is necessary for monitoring patients with chronic hepatitis receiving antiviral therapy in order to determine treatment response and to adapt therapy in case of inadequate virologic control. The development of quantitative PCR assays has been crucial in meeting these needs. The objective of this study was to compare the ...
Randomized trials have produced sound evidence about the efficacy of screening with human papillomavirus (HPV) DNA tests in reducing cervical cancer incidence and mortality. We evaluated the clinical performance and reproducibility of the Abbott RealTime High Risk (HR) HPV test compared with that of the HR hybrid capture 2 (HC2) assay as assessed by a ...
The ability to detect HIV-2 and to discriminate between HIV-1 and HIV-2 infections was evaluated in 46 serum samples from Guinea-Bissau (GB) and Guinea-Conakry (GC) using serological tests and commercial (HIV-1) and in-house (HIV-2) real-time PCR assays. Samples were first identified as HIV-2 ...
Sodium heparin, an anticoagulant used widely for blood collection, has been known to inhibit DNA polymerase activity in polymerase chain reaction (PCR) assays. However, all cryopreserved plasma samples collected in the 1980s and early 1990s at the Multicenter AIDS Cohort Study were from heparin-treated blood, which poses a problem in quantifying the target nucleic acids contained in those samples ...
BackgroundRecently there has been an increasing interest and appreciation for the gut as both a viral reservoir as well as an important host-pathogen interface in human immunodefiency virus type 1 (HIV-1) infection. The gut associated lymphoid tissue (GALT) is the largest lymphoid organ infected by HIV-1. In this study we examined if different ...
Culture for detection of Neisseria gonorrhoeae (NG) is being replaced by molecular assays, but difficulties are observed with false positive and negatives results, especially for extragenital samples. This study evaluates the Abbott CT/NG Real-Time assay and a real-time porA pseudogene assay. Samples (n = 600) from a mixed prevalence ...
Several commercial methods exist for the molecular detection of Chlamydia trachomatis and Neisseria gonorrhoeae in clinical samples. Here we evaluated the performance characteristics of the newly FDA-cleared Abbott RealTime CT/NG assay (where "CT" stands for Chlamydia trachomatis and "NG" stands for Neisseria gonorrhoeae) that uses the automated m2000 ...
Page 1. Use of Fluorognost HIV-1 Immunofluorescent Assay (IFA) (4/23/92) ... SUBJECT: Use of Fluorognost HIV-1 Immunofluorescent Assay (IFA) ...
... Roche Amplicor HIV-1 Monitor Test. ... Product Information. Label - Roche Amplicor HIV-1 Monitor Test (PDF - 3536KB). -. -. Supporting Documents. ...
... Premarket Approvals with Supporting Documents. -. Home Access HIV-1 Test System. ... Product Information. Label - Home Access HIV-1 Test System (PDF - 2243KB). -. -. ...
... Science & Research (Biologics); News & Events (Biologics); Resources for You (Biologics). -. HIV-1 (Western Blot). ... HIV-1 (Western Blot). ...
... APTIMA HIV-1 RNA Qualitative Assay. ... Product Information. APTIMA HIV-1 RNA Qualitative Assay Package Insert (PDF - 608KB). -. -. Supporting Documents. ...
ObjectivesTo assess whether the commercial ViroSeq HIV-1 Genotyping System (Abbott Molecular, Des Plains, IL, USA) can be used in conjunction with dried blood spots (DBS) for clinical monitoring of drug resistance in patients who fail antiretroviral treatment (ART) in rural Tanzania.Patients and methodsPatients at Haydom Lutheran ...
'95-'96 Roger Gordon Industrial Advisory Board Abbott Laboratories Dr. Jonathan Miller Principal Scientist Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064...
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