On March 17th,IColocomf, a combined detection kit for SDC2 and TFPI2 gene methylation (fluorescence PCR method) independently developed by Emerson, was approved by the National Class III Medical Device Registration Certificate (National Instrument Approval 20223400373), information After the announcement, the IColocomf kit has attracted much attention from the industry. In order to allow partners who pay attention to and support IColocomf to understand the product faster, better and more conveniently, we focus on the basic information of the product, performance advantages, applicable departments, and testing steps. We have summarized and briefly described common problems, and released 'IColocomf Ten Questions and Ten Answers', so that your expectations will not be delayed!
IColocomf Ten Questions and Ten Answers
01.
About detecting target genes?
IColocomf Gene Methylation Reagent can detect 2 target genes, namely SDC2 and TFPI2;
02.
About product composition, expiration date and specifications?
IColocomf products are composed of four parts: sample collection device, nucleic acid extraction reagent, nucleic acid purification reagent, and PCR reagent, and the validity period is 12 months;
The specification of sample collection kit is 1 person/box; the specifications of nucleic acid extraction kit and nucleic acid purification kit are 48T and 96T; the specifications of PCR kit are 24T, 48T and 96T;
03.
How many types of medical devices are there?
IColocomf product sample collection kits, nucleic acid extraction kits, and nucleic acid purification kits are all Class 1 medical devices, and PCR kits are Class 3;
04.
About product performance?
IColocomf detection sensitivity: 95.3%; specificity: 93.5%; advanced adenoma sensitivity: 63.4%;
05.
About core strengths?
Dual target complementation improves the sensitivity of left and right colon detection;
06.
About the applicable department?
Medical technology department: laboratory department, pathology department, molecular diagnosis center, central laboratory;
Clinical departments: Gastroenterology, gastrointestinal surgery, anorectal, oncology, geriatrics, endocrinology;
Medical center;
07.
About the sample size?
08.
About detection steps and time?
The detection process includes four steps: sample processing, nucleic acid extraction, transformation and purification, and qPCR, and the required time is 0.1h, 1.34h, 1.9h, and 1.16h, respectively;
09.
About results quality control standards and interpretation standards?
Quality control standard:
Sample validity: ACTB≤36, positive control: 26≤Ct≤30, negative control: Unde or Ct≥40;
Detection and interpretation standards:
Both genes were interpreted according to the following standards
Ct value ≤38 is positive
Ct>38 or Unde is interpreted as negative
Sample Interpretation Criteria:
SDC2 or TFPI2 is positive, that is, the judgment result is positive
Both SDC2 and TFPI2 are negative, that is, the judgment result is negative
10.
About sample test results?
If the sample test result is positive, it means that the subject has a high risk of colorectal cancer or precancerous lesions at the time of sampling, and other tests such as colonoscopy are recommended to confirm the diagnosis;
If the test result of the sample is negative, it means that the risk of colorectal cancer or precancerous lesions of the subject is low at the time of sampling, but the risk of the disease cannot be completely ruled out. It is recommended to retest every 1-3 years. The actual situation of the tester recommends colonoscopy;
About Emerson Life TechnologyWuhan Amisen Life Technology Co., Ltd. was established in January 2015. It is a high-tech enterprise focusing on the research and development, registration, production and sales of early non-invasive detection products for high-incidence malignant tumors in the world. The company is committed to the global promotion of cancer early diagnosis technology products. , Combining epigenetics, bioinformatics, clinical big data and artificial intelligence analysis, adhering to the product concept of 'early, accurate, convenient, inclusive', it has created a new generation of tumor screening and detection technology platform and product system, leading the way It has launched a series of early non-invasive detection products covering digestive system tumors, gynecological tumors, urinary system tumors and pan-cancer types, etc., which truly realizes early, non-invasive and accurate detection of tumors, and fundamentally reduces the incidence and death of tumors. rate, nip cancer in the bud, and escort human life and health.
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