The core HTA information is only a minor source for our report
Ingrid Wilbacher, Sonja Scheffel, Gottfried Endel
Austria - HVB
CRC screening, stool test, M2PK
Another test for CRC Screening was compared with the results of FIT and gFOBT in Terms of diagnostic accuracy.
Ingrid Wilbacher, Sonja Scheffel, Gottfried Endel. CRC Screening mit M2-PK Stuhltest. http://www.hauptverband.at/portal27/hvbportal/content?contentid=10007.758087&viewmode=content
Colorectal cancer (CRC) is one of the most common cancers worldwide and has a good prognosis regarding early detection which makes it a good candidate for screening programmes. Currently several different stool tests for CRC are available such as faecal occult blood tests (gFOBT, FIT) and the new M2-PK test. In Austria, the decision to use a specific screening test is up to the investigating physician of the screening examination.
The aim of this study is to evaluate the usefulness of the M2-PK (fecal M2-pyruvate kinase isoenzyme) stool test as an instrument for the screening of colorectal cancer and to compare the tests (gFOBT and FIT) which are currently in use.
Rapid assessment based on the CRC Screening-HTA from EUnetHTA and according to the national adaptation of this EUnetHTA report from Austria.
Systematic literature search in Pubmed and Cochrane Library using the EUnetHTA search strategy (with exception of EMBASE search which is fee-based) for studies about M2-PK stool test.
Study selection process by two independent authors, data extraction by one author and checked against by the other author.
Eleven studies were included; three of them are systematic reviews with detailed description of the methods, three primary studies and five narrative reviews.
An overview of the ranges (table 4) of the various tests shows a sensitivity of CRC detection for M2-PK of 68,8-93%, for gFOBT 13-63%, and for FIT 47,5-100%. Specificity ranges for M2-PK between 65-100%, for gFOBT 88-98%, and for FIT 83,3-89%.
Only three of the included studies focus explicitly on measurements of not-selected screening populations (Li 2012, Kim 2014, Leen 2014).
From the included studies, none examined the impact of the tests regarding mortality, and only one study (Kim 2014) describes different cancer stages.
Regarding the appropriateness of the M2-PK test as a screening tool for reducing CRC mortality with the help of early detection in an asymptomatic population, reliable recommendations cannot be derived from the included studies.
The wide variabilities and the information given about test accuracy, and the partially selected population within these included studies about test accuracy somehow even determine these uncertainties.