Reply to “Commutability of the World Health Organization International Standard for Human Cytomegalovirus: Standard or Assay”

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Commutability of Cytomegalovirus WHO International Standard in Different Matrices

Commutability of quantitative standards allows patient results to be compared across molecular diagnostic methods and laboratories. This is critical to establishing quantitative thresholds for use in clinical decision-making. A matrix effect associated with the 1st cytomegalovirus (CMV) WHO international standard (IS) was identified using the Abbott RealTime CMV assay. A commutability study was...

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Establishment of the World Health Organization First International Standard for Factor XII, Plasma, Human

Until recently, the role of factor XII (FXII) in hemostasis was not considered to be important since patients with FXII deficiency do not present with bleeding. The activation of FXII by agents including mast cells and platelet polyphosphates suggests that it may have a role in thrombogenesis. The inhibition of FXII therefore presents an option for antithrombotic therapy, and antibodies and inh...

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Establishment of the World Health Organization 2nd International Standard for Factor XI, Plasma, Human

The 1st International Standard (IS) for blood coagulation factor XI (FXI), plasma, has been successfully used for potency labeling of FXI therapeutics and for diagnosis of FXI deficiency in patients. With stocks of the 1st IS near depletion, a replacement is required. In addition to the functional activity value, assignment of an antigen value to the 2nd IS would allow harmonization of antigen ...

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World Health Organization International Standard to Harmonize Assays for Detection of Hepatitis E Virus RNA

Nucleic acid amplification technique-based assays are a primary method for the detection of acute hepatitis E virus (HEV) infection, but assay sensitivity can vary widely. To improve interlaboratory results for the detection and quantification of HEV RNA, a candidate World Health Organization (WHO) International Standard (IS) strain was evaluated in a collaborative study involving 23 laboratori...

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Virologic suppression measured by a cytomegalovirus (CMV) DNA test calibrated to the World Health Organization international standard is predictive of CMV disease resolution in transplant recipients.

BACKGROUND Cytomegalovirus (CMV) load measurement is used to assess the efficacy of treatment of CMV disease, but lacks standardization. Using the World Health Organization (WHO) international standard for reporting, we correlated viral load with CMV disease resolution. METHODS CMV load was quantified in plasma using a test calibrated to the WHO standard. Three predictive rules were predefine...

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ژورنال

عنوان ژورنال: Journal of Clinical Microbiology

سال: 2016

ISSN: 0095-1137,1098-660X

DOI: 10.1128/jcm.01725-16