Performance Evaluation of the Multi-gene Methylation Detection Kit for Colorectal Cancer.

Early detection of colorectal cancer (CRC) can lead to earlier diagnosis and intervention, thereby improving patient survival. Existing techniques fall short of clinical needs. Thus, early detection of CRC still needs a cost-effective, efficient, and widely accepted screening tool.This study aimed to evaluate the performance of a Multi-gene Methylation Detection Kit for Human Colorectal Cancer in a series of standards and clinical samples.A series of DNA standards and 88 patients were included. According to the kit's instructions, a simplified multiplex quantitative polymerase chain reaction method was used to detect the methylation level of the samples. The accuracy, limit of detection, interference factors, sensitivity, and other performance parameters of the kit were studied.Statistical analysis of the test results of all standards in the verification experiment showed that the positive and negative coincidence rates were 100%. The results for the kit's minimum detection limit and minimum nucleic acid input met the expected standards. The kit's sensitivity, specificity and accuracy were 89.36%, 97.56% and 93.18%, respectively for clinical samples.The Multi-gene Methylation Detection kit for Colorectal Cancer has a high detection performance for CRC, and this non-invasive, convenient and high-performance method for early detection of CRC may address current limitations in CRC screening and meet the clinical expectations.