| Autor: |
Robert W. Cook, Brooke Middlebrook, Jeff Wilkinson, Kyle R. Covington, Kristen Oelschlager, Federico A. Monzon, John F. Stone |
| Jazyk: |
angličtina |
| Rok vydání: |
2018 |
| Předmět: |
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| Zdroj: |
Diagnostic Pathology, Vol 13, Iss 1, Pp 1-8 (2018) |
| Druh dokumentu: |
article |
| ISSN: |
1746-1596 |
| DOI: |
10.1186/s13000-018-0690-3 |
| Popis: |
Abstract Background The DecisionDx-Melanoma test provides prognostic information for patients with cutaneous melanoma (CM). Using formalin-fixed paraffin-embedded primary tumor tissue, the RT-PCR-based test classifies patients into a low- (Class 1) or high-risk (Class 2) category for recurrence based on expression of 31 genes. The current study was designed to assess the analytical validity of this test. Methods Inter-assay, inter-instrument, and inter-operator studies were performed to evaluate reliability of the 31-gene expression test results, sample stability and reagent stability. From March 2013 through June 2016, the gene expression test was performed on 8244 CM tumors. De-identified data from Pathology Reports were used to assess technical success. Results Robust sample and reagent stability was observed. Inter-assay concordance on 168 specimens run on 2 consecutive days was 99% and matched probability scores were significantly correlated (R2 = 0.96). Inter-instrument concordance was 95%, and probability scores had a correlation R2 of 0.99 (p |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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