دورية أكاديمية
Analytical validation of a practical molecular assay prognostic of survival in nonsquamous non-small cell lung cancer.
| العنوان: | Analytical validation of a practical molecular assay prognostic of survival in nonsquamous non-small cell lung cancer. |
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| المؤلفون: | Kratz JR; Thoracic Oncology Program, Department of Surgery, University of California, San Francisco, San Francisco, CA, USA., Tham PT, Mulvihill MS, Ziaei F, Ray MR, Hurst JW, Segal MR, Berryman DM, Chu W, He B, Jablons DM, Mann MJ |
| المصدر: | Diagnostic molecular pathology : the American journal of surgical pathology, part B [Diagn Mol Pathol] 2013 Jun; Vol. 22 (2), pp. 65-9. |
| نوع المنشور: | Journal Article; Research Support, Non-U.S. Gov't; Validation Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Raven Press Country of Publication: United States NLM ID: 9204924 Publication Model: Print Cited Medium: Internet ISSN: 1533-4066 (Electronic) Linking ISSN: 10529551 NLM ISO Abbreviation: Diagn Mol Pathol Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: New York, N.Y. : Raven Press, c1992- |
| مواضيع طبية MeSH: | Polymerase Chain Reaction*, Carcinoma, Non-Small-Cell Lung/*diagnosis, Carcinoma, Non-Small-Cell Lung/genetics ; DNA Primers ; Formaldehyde/metabolism ; Gene Expression Regulation, Neoplastic ; Humans ; Linear Models ; Oligonucleotide Array Sequence Analysis ; Paraffin Embedding/methods ; Prognosis ; RNA, Neoplasm/genetics ; RNA, Neoplasm/isolation & purification ; Reproducibility of Results |
| مستخلص: | A molecular assay prognostic of survival in resected nonsquamous non-small cell lung cancer designed to meet the need for improved risk stratification in early-stage disease has recently been described. This assay measures the expression levels of 14 genes using RNA extracted from formalin-fixed, paraffin-embedded (FFPE) tissues. The assay underwent blinded clinical validation in 2 large international cohorts involving approximately 1500 patients; the analytical precision and reproducibility of this assay, however, have not yet been reported. For each of the 14 TaqMan quantitative polymerase chain reaction (PCR) primer and probe sets used in the molecular prognostic assay, the linear range, PCR efficiency, limits of blank, limits of quantitation, and quantitative bias were determined using serial dilutions of pooled RNA extracted from FFPE samples. The reproducibility of the entire molecular assay was determined by performing repeat testing of FFPE samples over multiple days. The linear range of individual quantitative TaqMan PCR primer and probe sets was between 2(10)- and 2(15)-fold input RNA. The median C(T) of the quantitative PCR primer and probe sets at 10 ng of input RNA was 24.3; the median efficiency was 91.2%. The median quantitative bias across all quantitative PCR primer and probe sets was 0.75% (range, 0.32% to 1.32%). In repeat testing, the mean SD of the risk score (scaled from 1 to 100) was 2.18, with a mean coefficient of variation of 0.08. The molecular prognostic assay presented in this study demonstrates high precision and reproducibility, validating its clinical utility as a reliable prognostic tool that can contribute to the management of patients with early-stage disease. |
| المشرفين على المادة: | 0 (DNA Primers) 0 (RNA, Neoplasm) 1HG84L3525 (Formaldehyde) |
| تواريخ الأحداث: | Date Created: 20130501 Date Completed: 20140102 Latest Revision: 20191210 |
| رمز التحديث: | 20221213 |
| DOI: | 10.1097/PDM.0b013e318273fb61 |
| PMID: | 23628816 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1533-4066 |
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| DOI: | 10.1097/PDM.0b013e318273fb61 |