A first evaluation of the Septin 9 test in the Czech Republic

Czech version

Authors: Pavel Sychra ¹; V. Procházka ¹; L. Roubalová ²; J. Zapletalová ³; M. Konečný ¹
Authors‘ workplace: II. interní klinika – gatroenterologická a hepatologická LF UP a FN Olomouc ¹; Oddělení klinické biochemie, FN Olomouc ²; Ústav lékařské biofyziky, LF UP Olomouc ³
Published in: Gastroent Hepatol 2016; 70(4): 300-304
Category: Clinical and Experimental Gastroenterology: Original Article
doi: https://doi.org/10.14735/amgh2016300

Overview

Colorectal cancer still persists despite advances in diagnosis and therapy. The unfulfilled expectations of screening programs has led to the development of new tests based on molecular biology for early diagnosis. Reports over the past 15 years concerning the possibility of using epigenetic markers of colon cancer for colon cancer diagnosis led us to study the feasibility of using the Septin 9 test comprised in the Epi proColon Plasma Quick Kit on a group of 108 patients undergoing colonoscopy, the reference method. We were interested in the sensitivity and specificity of the test under our clinical conditions. Among the 108 patients, colonoscopy detected adenomas in 41, carcinomas in 21, and no findings in 46 persons. In the patients with negative colonoscopic findings, the Septin 9 test was negative for 34 and positive for two, with 10 people were classified as “not detected” (ND) because the DNA concentration in the isobath was below the required level. In patients with a confirmed adenoma, the Septin 9 test was negative in 26 and positive in one, and 14 people were classified as ND. In patients with cancer, the Septin 9 test was negative in seven and positive in seven, and seven were classified as ND. The sensitivity of the Septin 9 assay was 19.5% and the specificity was 94.4%. Septin 9 test positivity was found significantly more often in people with cancer than in those with an adenoma or with negative findings on colonoscopy (p = 0.003). The Septin 9 test showed a high degree of specificity (94.4%). It was disappointing that the test showed very low sensitivity in patients with adenoma (only 3.7%). The overall results of the study were affected by the high proportion of tests in which the concentration of DNA in the isolate was insufficient, necessitating that these patients be classified as ND.

Key words:
septins – Septin 9 – sensitivity – specificity – colorectal neoplasms

The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study.

The Editorial Board declares that the manuscript met the ICMJE „uniform requirements“ for biomedical papers.

Submitted:
7. 7. 2016

Accepted:
8. 8. 2016

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