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In addition to designing an assay, collecting specimens for validation, and completing the validation, they must also design and implement a quality system to ensure continued performance of the assay.
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The use of the macroscopic surgical specimen for validation of PET image segmentation techniques is one of the most promising approaches reported so far for clinical studies [ 7, 8] provided deformation related to the shrinkage of the specimen after surgical excision are taken into account [ 9].
Total RNA for the panel of six cervical specimens used for validation of genes was isolated using Trizol (Invitrogen) and cDNA was generated using the High Capacity TaqMan Reverse Transcription Reagents, according to the manufacturer's instructions (Applied Biosystems, Foster City, CA).
Nine patients underwent nephrectomy and 4 patients underwent additional targeted biopsy to provide specimens for histopathological validation.
Although it is not unique to predictive biomarker assays, obtaining clinical specimens for assay validation and the determination of interpatient variability of the study population is critical to the success of the assay.
A total number of 100 clinical specimens were tested for validation of the molecular assay.
Real-time PCR techniques are now commonly used for the detection of viral genomes in various human specimens and require for validation both external and internal controls (ECs and ICs).
A larger cohort of fresh-frozen breast tumour (n = 95) and tumour-associated normal breast tissue (n = 17) specimens was used for validation and further analysis of selected miRNAs.
Third, a three-point-bending epoxy/glass graded beam specimen is investigated for validation purposes.
Even when all of the above limitations are met there has been a considerable shortage of quality specimens for discovery and validation studies that overcome the biases inherent in retrospective samples [ 5].
For validation, several specimens were produced and tested.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com