Development of candidate reference reagent for HIV-1 RNA and comparison analysis for different HIV-1 RNA quantitative assay
-
Borae G. Park
, Jee-Hye Choi
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 these re-agents in storage and compare their performance in three different HIV-1 RNA quantitative assays.
Methods: The candidate reagents were derived from readily available pre-existing reagents and examined for stability at different storage temperatures. They were compared in three commercially available HIV-1 RNA quantitative assays: the Cobas TaqMan HIV-1 Test (Cobas TaqMan), the RealTime HIV-1 Assay (Abbott RealTime), and the NucliSens EasyQ HIV-1 Assay v1.1 (NucliSens EasyQ).
Results: The candidate reagent derived from an HIV culture supernatant (candidate CS) was the most stable of the three candidates and showed good reproducibility. Candidate CS yielded the highest HIV-1 titer of the three candidates in the Cobas TaqMan assay and the lowest HIV-1 titer and stability of the three candidates in the NucliSens EasyQ system.
Conclusions: The candidate CS is the most appropriate of the three candidate reagents for quantitative testing of HIV-1 RNA. This working reagent should be useful for use in routine calibration for quality control in centers with limited financial resources. The Cobas TaqMan assay tended to yield higher viral load results than the other assays when used with our three candidate reagents.
©2011 by Walter de Gruyter Berlin Boston
Articles in the same Issue
- Editorial
- Athlete's biological passport: to test or not to test?
- Review
- Prognostic value of cystatin C in acute coronary syndromes: enhancer of atherosclerosis and promising therapeutic target
- Opinion Papers
- The function of oxalic acid in the human metabolism
- Current limitations of the Athlete's Biological Passport use in sports
- Limits and pitfalls of Athlete's Biological Passport
- The Athlete Biological Passport from the perspective of an anti-doping organization
- Perspectives
- Genetics of infectious diseases: hidden etiologies and common pathways
- Guidelines and Recommendations
- IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 °C. Part 9: Reference procedure for the measurement of catalytic concentration of alkaline phosphatase
- Genetics and Molecular Diagnostics
- A template for mutational data analysis of the CFTR gene
- High resolution melting analysis to genotype the most common variants in the HFE gene
- General Clinical Chemistry and Laboratory Medicine
- Bayesian analysis of an international ELISA comparability study
- Inflammatory markers in preeclamptic patients
- Pre-analytical effects of different lithium heparin plasma separation tubes in the routine clinical chemistry laboratory
- Pre-acquisition system assessment of the Sysmex® Coagulation System CS-2100i and comparison with end-user verification; a model for the regional introduction of new analysers and methods
- Evaluation of a commercially available rapid urinary porphobilinogen test
- Reference Values and Biological Variations
- Reference intervals and age and gender dependency for arterial blood gases and electrolytes in adults
- Within-subject biological variation of glucose and HbA1c in healthy persons and in type 1 diabetes patients
- Determinants of oxidative stress related to gender: relevance of age and smoking habit
- Soluble ST2 is not independently associated with androgen and estrogen status in healthy males and females
- Infectious Diseases
- Development of candidate reference reagent for HIV-1 RNA and comparison analysis for different HIV-1 RNA quantitative assay
- Prognostic value of serum angiotensin-converting enzyme activity for outcome of community-acquired pneumonia
- The evaluation of colloidal gold immunochromatographic assay (GICA) for rapid diagnosis of influenza A disease
- Cardiovascular Disease
- N-terminal pro-B-type natriuretic peptide in early and advanced phases of obesity
- Vaspin plasma concentrations and mRNA expressions in patients with stable and unstable angina pectoris
- Prospective study of first stroke in relation to plasma homocysteine and MTHFR 677C>T and 1298A>C genotypes and haplotypes – evidence for an association with hemorrhagic stroke
- Letters to the Editor
- Evaluation of the analytical performance of the Beckman Coulter AU680 automated analytical system based on quality specifications for allowable performance derived from biological variation
- Collagen peptides, interstitial remodelling and sudden cardiac death in hypertrophic cardiomyopathy
- Erratum
- Modified phosphatidylserine-dependent antiprothrombin ELISA enables identification of patients negative for other antiphospholipid antibodies and also detects low avidity antibodies
Articles in the same Issue
- Editorial
- Athlete's biological passport: to test or not to test?
- Review
- Prognostic value of cystatin C in acute coronary syndromes: enhancer of atherosclerosis and promising therapeutic target
- Opinion Papers
- The function of oxalic acid in the human metabolism
- Current limitations of the Athlete's Biological Passport use in sports
- Limits and pitfalls of Athlete's Biological Passport
- The Athlete Biological Passport from the perspective of an anti-doping organization
- Perspectives
- Genetics of infectious diseases: hidden etiologies and common pathways
- Guidelines and Recommendations
- IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 °C. Part 9: Reference procedure for the measurement of catalytic concentration of alkaline phosphatase
- Genetics and Molecular Diagnostics
- A template for mutational data analysis of the CFTR gene
- High resolution melting analysis to genotype the most common variants in the HFE gene
- General Clinical Chemistry and Laboratory Medicine
- Bayesian analysis of an international ELISA comparability study
- Inflammatory markers in preeclamptic patients
- Pre-analytical effects of different lithium heparin plasma separation tubes in the routine clinical chemistry laboratory
- Pre-acquisition system assessment of the Sysmex® Coagulation System CS-2100i and comparison with end-user verification; a model for the regional introduction of new analysers and methods
- Evaluation of a commercially available rapid urinary porphobilinogen test
- Reference Values and Biological Variations
- Reference intervals and age and gender dependency for arterial blood gases and electrolytes in adults
- Within-subject biological variation of glucose and HbA1c in healthy persons and in type 1 diabetes patients
- Determinants of oxidative stress related to gender: relevance of age and smoking habit
- Soluble ST2 is not independently associated with androgen and estrogen status in healthy males and females
- Infectious Diseases
- Development of candidate reference reagent for HIV-1 RNA and comparison analysis for different HIV-1 RNA quantitative assay
- Prognostic value of serum angiotensin-converting enzyme activity for outcome of community-acquired pneumonia
- The evaluation of colloidal gold immunochromatographic assay (GICA) for rapid diagnosis of influenza A disease
- Cardiovascular Disease
- N-terminal pro-B-type natriuretic peptide in early and advanced phases of obesity
- Vaspin plasma concentrations and mRNA expressions in patients with stable and unstable angina pectoris
- Prospective study of first stroke in relation to plasma homocysteine and MTHFR 677C>T and 1298A>C genotypes and haplotypes – evidence for an association with hemorrhagic stroke
- Letters to the Editor
- Evaluation of the analytical performance of the Beckman Coulter AU680 automated analytical system based on quality specifications for allowable performance derived from biological variation
- Collagen peptides, interstitial remodelling and sudden cardiac death in hypertrophic cardiomyopathy
- Erratum
- Modified phosphatidylserine-dependent antiprothrombin ELISA enables identification of patients negative for other antiphospholipid antibodies and also detects low avidity antibodies