Developed by Human Metabolomics Institute, Inc. and based on data from 6,000 clinical samples, the Liver Fibrosis and Cirrhosis Screening Kit features a groundbreaking non-invasive in-vitro diagnostic technology that assesses the levels of liver fibrosis and the early risk of liver cirrhosis through the detection and analysis of serological indicators repeatedly screened via metabolomics. The kit meets the high clinical standards and requirements for the sensitivity and specificity of test results, and can be used for repeated test with good stability of results.
The kit offers highly diagnostic accuracy for liver fibrosis, especially for early liver fibrosis, which is more convenient for dynamic monitoring of the disease progression and evaluation of efficacy.
The kit has been passed the application for approval of innovative medical device by Guangdong Medical Products Administration and registered in U.S. Food and Drug Administration, with four invention patents, one international patent, and two software copyrights.
Testing Procedure
01
Sample collection
02
IVD kit processing
03
Mass spectrometry detection
04
Analysis by AI-enabled diagnostic software
05
Issuance of a test report
Sample Requirements
Recommended sample volume
Serum30µL
Sample Preservation
Please repack the samples collected in time and then store them in a - 80℃ refrigerator as soon as possible 15 minutes after the quenching of liquid nitrogen. Repeated freeze-thawing should be avoided.
Technical Advantages
- Wide application: It can be used to test serum, plasma, or dry blood spots.
- High compatibility: It applies to many liquid chromatography-tandem mass spectrometry systems from different Chinese manufacturers.
- Superior quality: Comprehensive and strict quality control measures lead to the reliability of test results.
High throughput: It can automatically test multiple samples and analyze results, hence reducing human errors.
High accuracy: With liver biopsy as the prime standard, both its sensitivity and specificity are above 90%.