Evaluation of COBAS AmpliPrep/COBAS TaqMan CMV Test for use in hematopoietic stem cell transplant recipients.

Abstract:

INTRODUCTION:Cytomegalovirus (CMV) is a common opportunistic infection that contributes to poor outcomes in hematopoietic stem cell transplant (HSCT) recipients. Prevention of CMV end-organ disease in allogeneic HSCT recipients is commonly achieved by preemptive antiviral therapy of asymptomatic CMV reactivation that is detected by serial nucleic acid testing (NAT). However, there was no standardized CMV NAT until the development of the World Health Organization (WHO) International Standard. Areas covered: This article provides a comprehensive review on COBAS AmpliPrep/TaqMan (CAP/CTM) CMV assay (Roche) and emphasizes the limitations in the clinical use of CMV NAT in HSCT recipients. Expert commentary: The CAP/CTM CMV Test is the first US FDA approved commercial quantitative NAT for CMV viral load monitoring of plasma samples in solid organ transplant and HSCT recipients. The CAP/CTM assay has wide linear range of DNA quantification and demonstrates colinearity to the WHO International Standard. Studies of CAP/CTM CMV assay in HSCT recipients are still limited, but are now being reported to define viral thresholds for diagnosis, surveillance and monitoring. Results from these early studies in HSCT recipients suggest that, while the WHO IS has improved the inter-laboratory result variances, there are still important factors that continue to contribute to assay variability. This lack of harmony among NAT highlights the need for further standardization.

journal_name

Expert Rev Mol Diagn

authors

Ramanan P,Razonable RR

doi

10.1080/14737159.2017.1325737

subject

Has Abstract

pub_date

2017-07-01 00:00:00

pages

633-639

issue

7

eissn

1473-7159

issn

1744-8352

journal_volume

17

pub_type

杂志文章,评审
  • Bioinformatic approaches for modeling the substrate specificity of HIV-1 protease: an overview.

    abstract::HIV-1 protease has a broad and complex substrate specificity, which hitherto has escaped a simple comprehensive definition. This, and the relatively high mutation rate of the retroviral protease, makes it challenging to design effective protease inhibitors. Several attempts have been made during the last two decades t...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/14737159.7.4.435

    authors: Rögnvaldsson T,You L,Garwicz D

    更新日期:2007-07-01 00:00:00

  • Fluorescence in situ hybridization: a multitarget approach in diagnosis and management of urothelial cancer.

    abstract::Noninvasive tests for detecting genetic or molecular alterations in urine indicative of urothelial cancer are increasingly becoming the focus of urological cancer research. Since its approval by the US FDA in 2001, the fluorescence in situ hybridization test (Vysis UroVysion) has been widely evaluated. In general, pub...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/14737159.7.1.11

    authors: Arentsen HC,de la Rosette JJ,de Reijke TM,Langbein S

    更新日期:2007-01-01 00:00:00

  • Statistical tools for linkage analysis and genetic association studies.

    abstract::Genetic mapping by linkage analysis has been an invaluable tool in the positional strategy to identify the molecular basis of many rare Mendelian disorders. With the attention of the scientific and medical community shifting towards the analysis of more common, complex traits, it has become necessary to develop new ap...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/14737159.5.5.781

    authors: Forabosco P,Falchi M,Devoto M

    更新日期:2005-09-01 00:00:00

  • Laser capture microdissection technology.

    abstract::Deciphering the cellular and molecular interactions that drive disease within the tissue microenvironment holds promise for discovering drug targets of the future. In order to recapitulate the in vivo interactions through molecular analysis, one must be able to analyze specific cell populations within the context of t...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/14737159.7.5.647

    authors: Espina V,Heiby M,Pierobon M,Liotta LA

    更新日期:2007-09-01 00:00:00

  • A review of novel technologies and techniques associated with identification of bloodstream infection etiologies and rapid antimicrobial genotypic and quantitative phenotypic determination.

    abstract:INTRODUCTION:The antimicrobial aspect of management of patients with blood stream infections (BSI) and sepsis is time critical. In an era of increasing antimicrobial resistance, rapid detection and identification of bacteria with antimicrobial susceptibility is crucial to direct therapy early in the course of illness. ...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1080/14737159.2018.1480369

    authors: Poole S,Kidd SP,Saeed K

    更新日期:2018-06-01 00:00:00

  • High-resolution DNA melting analysis in clinical research and diagnostics.

    abstract::Among nucleic acid analytical methods, high-resolution melting analysis is gaining more and more attention. High-resolution melting provides simple, homogeneous solutions for variant scanning and genotyping, addressing the needs of today's overburdened laboratories with rapid turnaround times and minimal cost. The fle...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/erm.09.84

    authors: Montgomery JL,Sanford LN,Wittwer CT

    更新日期:2010-03-01 00:00:00

  • A profile of the cobas® CT/NG assay on the cobas® 6800/8800 system for detection of Chlamydia trachomatis and Neisseria gonorrhoeae.

    abstract::Introduction: Chlamydia trachomatis and Neisseria gonorrhoeae infection rates continue to rise worldwide. Increasing screening of the largely asymptomatic infections is critical for timely and effective disease control. Laboratory solutions that can handle increasing volumes and generate highly accurate test results a...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章

    doi:10.1080/14737159.2020.1724093

    authors: Van Der Pol B

    更新日期:2020-04-01 00:00:00

  • Bioinformatics approach to predicting HIV drug resistance.

    abstract::The emergence of drug resistance remains one of the most challenging issues in the treatment of HIV-1 infection. The extreme replication dynamics of HIV facilitates its escape from the selective pressure exerted by the human immune system and by the applied combination drug therapy. This article reviews computational ...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/14737159.6.2.207

    authors: Cordes F,Kaiser R,Selbig J

    更新日期:2006-03-01 00:00:00

  • Investigating lubricin and known cartilage-based biomarkers of osteoarthritis.

    abstract::Introduction: Osteoarthritis (OA) is a degenerative disease which primarily affects hyaline cartilage, leading to pain, stiffness and loss of mobility of the entire articulation. Diagnosis is commonly based on symptoms and radiographs, but there is a growing interest in detecting novel biomarkers, in serum, urine and ...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章

    doi:10.1080/14737159.2020.1733978

    authors: Ravalli S,Szychlinska MA,Lauretta G,Di Rosa M,Musumeci G

    更新日期:2020-04-01 00:00:00

  • Molecular markers related to immunosurveillance as predictive and monitoring tools in non-small cell lung cancer: recent accomplishments and future promises.

    abstract::Introduction: The landscape of systemic treatment options for lung cancer has rapidly evolved with the emergence of immunomodulatory agents such as neutralizing antibodies targeting the programmed cell death protein 1 (PD-1) and its ligand (PD-L1). Another major breakthrough was the introduction of biomarkers, such as...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章

    doi:10.1080/14737159.2020.1724785

    authors: Michaelidou K,Agelaki S,Mavridis K

    更新日期:2020-03-01 00:00:00

  • Molecular evaluation of renal biopsies: a search for predictive and prognostic markers in lupus nephritis.

    abstract::The therapeutic management of patients with lupus nephritis (LN) remains a major challenge. The availability of biomarkers that accurately predict renal flares, response to immunosuppressive treatment and risk of progression to end-stage renal disease would allow the more effective use of currently available immunosup...

    journal_title:Expert review of molecular diagnostics

    pub_type: 评论,杂志文章

    doi:10.1586/erm.11.39

    authors: Edelbauer M,Ho J

    更新日期:2011-07-01 00:00:00

  • RT-PCR/electrospray ionization mass spectrometry approach in detection and characterization of influenza viruses.

    abstract::Reverse-transcription PCR (RT-PCR) coupled with electrospray ionization mass spectrometry (ESI-MS) is a high-throughput nucleic acid-based technology that relies on the accurate measurement of the molecular weight of PCR amplicons that can be used to deduce the base counts (number of As, Gs, Cs and Ts) of DNA. These a...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/erm.10.107

    authors: Deyde VM,Sampath R,Gubareva LV

    更新日期:2011-01-01 00:00:00

  • Recent advances in the development and evaluation of molecular diagnostics for Ebola virus disease.

    abstract:INTRODUCTION:The 2014-16 outbreak of ebola virus disease (EVD) in West Africa resulted in 11,308 deaths. During the outbreak only 60% of patients were laboratory confirmed and global health authorities have identified the need for accurate and readily deployable molecular diagnostics as an important component of the id...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1080/14737159.2019.1595592

    authors: Tembo J,Simulundu E,Changula K,Handley D,Gilbert M,Chilufya M,Asogun D,Ansumana R,Kapata N,Ntoumi F,Ippolito G,Zumla A,Bates M

    更新日期:2019-04-01 00:00:00

  • Dominant spinocerebellar ataxias: a molecular approach to classification, diagnosis, pathogenesis and the future.

    abstract::The capacity to use molecular techniques to establish the genetic diagnoses of the autosomal dominant ataxias has revolutionized the field. It is now possible to systematically classify these disorders according to the nature of the causative mutation, with implications for diagnostic testing, analysis of pathogenesis...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/14737159.3.6.715

    authors: Margolis RL

    更新日期:2003-11-01 00:00:00

  • TRAC in high-content gene expression analysis: applications in microbial population studies, process biotechnology and biomedical research.

    abstract::More than a decade of intensive use of microarray technology has flooded the scientific community with genome-wide expression data of diverse biological states. As a result, connection of the expression signatures of a relatively small number of genes related to, for example, disease states, patient responses or toxic...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/14737159.8.4.379

    authors: Rautio JJ,Satokari R,Vehmaan-Kreula P,Serkkola E,Söderlund H

    更新日期:2008-07-01 00:00:00

  • Antinuclear antibodies as ancillary markers in primary biliary cirrhosis.

    abstract::Antimitochondrial antibodies are the serological hallmark of primary biliary cirrhosis (PBC). Besides antimitochondrial antibodies, the autoantibody profile of PBC includes antinuclear antibodies (ANA) which are detectable by indirect immunofluorescence in up to 50% of PBC patients. Two immunofluorescence patterns are...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/erm.11.82

    authors: Granito A,Muratori P,Quarneti C,Pappas G,Cicola R,Muratori L

    更新日期:2012-01-01 00:00:00

  • Information management driven by diagnostic patient data: right information for the right patient.

    abstract::Existing and future diagnostic technologies are providing a huge amount of data about the patient, which are to be sensibly managed by the treating physician. More than that, the sheer complexity of the interrelation between these data are calling for a radically new approach in the handling of medical data and inform...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/14737159.2.4.355

    authors: Fierz W

    更新日期:2002-07-01 00:00:00

  • Accuracy of early diagnosis and its impact on the management and course of Alzheimer's disease.

    abstract::Alzheimer's disease is the most common form of dementia in the elderly and its prevalence is rapidly rising. Although there is no cure for Alzheimer's disease, treatment can be administered to slow progression or delay the onset of symptoms. A major challenge is the early identification of patients who will develop Al...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/14737159.4.1.63

    authors: Chang CY,Silverman DH

    更新日期:2004-01-01 00:00:00

  • KRAS mutation testing in clinical practice.

    abstract::Activating mutation of KRAS plays a significant role in the pathogenesis of common human malignancies and molecular testing of KRAS mutation has emerged as an essential biomarker in the current practice of clinical oncology. The presence of KRAS mutation is generally associated with clinical aggressiveness of the canc...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/14737159.2015.986102

    authors: Perincheri S,Hui P

    更新日期:2015-03-01 00:00:00

  • Epigenetics as a basis for diagnosis of neurodevelopmental disorders: challenges and opportunities.

    abstract::Neurodevelopmental disorders, such as autism, are complex entities that can be caused by biological and social factors. In a subset of patients with congenital neurodevelopmental disorders, clear diagnosis can be achieved using DNA sequence-based analysis to identify changes in the DNA sequence (genetic variation). Ho...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/14737159.2014.925805

    authors: Kubota T,Miyake K,Hariya N,Mochizuki K

    更新日期:2014-07-01 00:00:00

  • Using bacterial biomarkers to identify early indicators of cystic fibrosis pulmonary exacerbation onset.

    abstract::Acute periods of pulmonary exacerbation are the single most important cause of morbidity in cystic fibrosis patients, and may be associated with a loss of lung function. Intervening prior to the onset of a substantially increased inflammatory response may limit the associated damage to the airways. While a number of b...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/erm.10.117

    authors: Rogers GB,Hoffman LR,Johnson MW,Mayer-Hamblett N,Schwarze J,Carroll MP,Bruce KD

    更新日期:2011-03-01 00:00:00

  • Emerging techniques employed in aptamer-based diagnostic tests.

    abstract::Since aptamers were reported in 1990, research into the applications of aptamers, particularly diagnostic applications, has been growing. Aptamers can act as recognition elements instead of antibodies. In this regard, aptamers have unique characteristics because they are composed of nucleic acids. Intra- and intermole...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/14737159.2014.868307

    authors: Yoshida W,Abe K,Ikebukuro K

    更新日期:2014-03-01 00:00:00

  • Natural history of high-grade cervical intraepithelial neoplasia: a review of prognostic biomarkers.

    abstract::The natural history of high-grade cervical intraepithelial neoplasia (CIN) is largely unpredictable and current histopathological examination is unable to differentiate between lesions that will regress and those that will not. Therefore, most high-grade lesions are currently treated by surgical excision, leading to o...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/14737159.2015.1012068

    authors: Koeneman MM,Kruitwagen RF,Nijman HW,Slangen BF,Van Gorp T,Kruse AJ

    更新日期:2015-04-01 00:00:00

  • Basic principles of real-time quantitative PCR.

    abstract::Real-time quantitative PCR allows the sensitive, specific and reproducible quantitation of nucleic acids. Since its introduction, real-time quantitative PCR has revolutionized the field of molecular diagnostics and the technique is being used in a rapidly expanding number of applications. This exciting technology has ...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/14737159.5.2.209

    authors: Arya M,Shergill IS,Williamson M,Gommersall L,Arya N,Patel HR

    更新日期:2005-03-01 00:00:00

  • Predictive biomarkers for the treatment of resectable esophageal and esophago-gastric junction adenocarcinoma: from hypothesis generation to clinical validation.

    abstract:INTRODUCTION:Esophageal and esophago-gastric junction (EGJ) adenocarcinomas remain a major health problem worldwide with a worryingly increasing incidence. Recent trials indicate survivals benefit for preoperative or perioperative chemoradiotherapy compared to surgery alone. Beside standard chemoradiotherapy regimens, ...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1080/14737159.2018.1454312

    authors: Piro G,Carbone C,Santoro R,Tortora G,Melisi D

    更新日期:2018-04-01 00:00:00

  • Advances in quantitative immunohistochemistry and their contribution to breast cancer.

    abstract::Introduction: Automated image analysis provides an objective, quantitative, and reproducible method of measurement of biomarkers. Image quantification is particularly well suited for the analysis of tissue microarrays which has played a major pivotal role in the rapid assessment of molecular biomarkers. Data acquired ...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章

    doi:10.1080/14737159.2020.1743178

    authors: Yaghoobi V,Martinez-Morilla S,Liu Y,Charette L,Rimm DL,Harigopal M

    更新日期:2020-05-01 00:00:00

  • Recent progress in protein profiling of clinical tissues for next-generation molecular diagnostics.

    abstract::Differences in protein levels and the activation of signaling pathways have been extensively studied in tumor tissues, but the implementation of protein profiling methods in routine hospital workflows lags far behind that of nucleic acid-based approaches. In this review, major technologies that are currently used for ...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/14737159.2015.1070098

    authors: Boellner S,Becker KF

    更新日期:2015-01-01 00:00:00

  • Near instrument-free, simple molecular device for rapid detection of herpes simplex viruses.

    abstract::The first near instrument-free, inexpensive and simple molecular diagnostic device (IsoAmp HSV, BioHelix Corp., MA, USA) recently received US FDA clearance for use in the detection of herpes simplex viruses (HSV) in genital and oral lesion specimens. The IsoAmp HSV assay uses isothermal helicase-dependent amplificatio...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/erm.12.34

    authors: Lemieux B,Li Y,Kong H,Tang YW

    更新日期:2012-06-01 00:00:00

  • Current molecular diagnostics of breast cancer and the potential incorporation of microRNA.

    abstract::Although comprehensive molecular diagnostics and personalized medicine have sparked excitement among researchers and clinicians, they have yet to be fully incorporated into today's standard of care. This is despite the discovery of disease-related oncogenes, tumor-suppressor genes and protein biomarkers, as well as ot...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1586/erm.09.25

    authors: Zoon CK,Starker EQ,Wilson AM,Emmert-Buck MR,Libutti SK,Tangrea MA

    更新日期:2009-07-01 00:00:00

  • Molecular diagnostics for hereditary hearing loss in children.

    abstract:INTRODUCTION:Hearing loss (HL) is the most common birth defect in industrialized countries with far-reaching social, psychological and cognitive implications. It is an extremely heterogeneous disease, complicating molecular testing. The introduction of next-generation sequencing (NGS) has resulted in great progress in ...

    journal_title:Expert review of molecular diagnostics

    pub_type: 杂志文章,评审

    doi:10.1080/14737159.2017.1340834

    authors: Sommen M,Wuyts W,Van Camp G

    更新日期:2017-08-01 00:00:00