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Good Specificity
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Extensive Range of Applications
A CLIA test kit for the quantitative determination of Gastrin Releasing Peptide Precursor (ProGRP) in human serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
【INTENDED USE】
The Gastrin Releasing Peptide Precursor (ProGRP) Test Kit (CLIA) is intended for quantitative determination of Gastrin Releasing Peptide Precursor (ProGRP) in human serum and plasma, as an aid in diagnosis of Lung cancer in clinical practice.
For professional in vitro diagnostic use only.
【SUMMARY】
Progastrin releasing peptide (Progastrin releasing peptide, ProGRP) is the precursor structure of gastrin releasing peptide (GRP) and the initial product encoded by the GRP gene, commonly found in nerve fibers, non-gastric antrum tissue, brain and lungs. On neuroendocrine cells, ProGRP can be alternatively spliced to produce three isomers, which have a common C-terminal sequence,1 which can be stably expressed in plasma.
At present, as a tumor marker, ProGRP has high sensitivity and specificity for small cell lung cancer (SCLC).2 It is an important indicator for early diagnosis, efficacy judgment and prognosis analysis of SCLC. ProGRP does not produce or produces very little in benign and other non-small cell lung cancer lesions, and has a high diagnostic value for small cell lung cancer. Studies have shown that ProGRP has a specificity of 88.89% for the diagnosis of SCLC and a sensitivity of 63.16% for early SCLC.3 The combined detection of ProGRP with NSE and CYFRA21-1 and other indicators will help to further improve the accuracy of the diagnosis of small cell lung cancer.
【PRINCIPLE】
This product uses the double antibody sandwich method. In the first step, the sample, the ProGRP antibody labeled with alkaline phosphatase, and the magnetic particles coated with the ProGRP antibody are mixed. After incubation, the ProGRP in the sample forms an immune complex with the corresponding antibody. In the second step, magnetic separation and cleaning are performed to remove free enzyme-labeled antibodies.
The third step is to add the chemiluminescent substrate solution to the immune complex. Luminescence signal generated by the enzyme reaction is detected by the Automatic Chemiluminescence Immunoassay Analyzer and the detected luminescence intensity is related to the concentration of ProGRP in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of ProGRP in the sample.
【REAGENTS】
The reagent strip includes ProGRP antibody coated with magnetic particles, alkaline phosphatase labeled ProGRP antibody, wash buffer and substrate solution.
【INTERPRETATION OF RESULTS】
The ProGRP test result should be calculated by Automatic Chemiluminescence Immunoassay Analyzer and displayed on the screen. For additional information, please refer to the user manual of Automatic Chemiluminescence Immunoassay Analyzer.
【LIMITATIONS】
1. For professional in vitro diagnostic use only.
2. Unreasonable sample collection, storage and processing procedures may lead to erroneous test results.
3. Test results beyond the detection range of the kit are not credible.
4. Severe hemolysis, incomplete agglutination or microbial contamination may cause errors in the results.
【EXPECTED RESULTS】
According to the non-parametric method, this reagent performs a 90% median analysis on the ProGRP test results of 218 normal population samples with a 95% confidence level, and the 95% percentile concentration value is less than 80 pg/mL.
Due to differences in geography, race, gender, and age, it is recommended that each laboratory establish its own reference value (range).
