Generic name: Test-Reagent for 5-hydroxyindoleacetic acid
Packing specification: 0.5ml x 1 piece；
【Intended Use】
This reagent is used for qualitative testing of 5-hydroxyindoleacetic acid in urine. Digestive cancers, breast cancers, gastric ulcers and gastritis resulting from Helicobacter pylori (HP) infection, mastitis, carcinoid syndrome, pheochromocytoma, acute appendicitis, and excessive alcohol consumption can induce stress responses in the human body, which may result in abnormalities of amino acid metabolism, thus rendering the 5-hydroxyindoleacetic acid content in the urine much higher than that of a normal individual. By utilizing the characteristic color reaction with 5-hydroxyindoleacetic acid, this reagent can determine whether there are any relevant abnormal metabolisms in the tested individual.
The results of the test conducted using this reagent kit should not be used for the early diagnosis of malignant tumors. If the test result is positive, it should be used for clinical reference only and should not be the sole basis for clinical diagnosis and treatment. For clinical diagnosis, the positive test result should be used in combination with other laboratory test results. Limited by the analytical sensitivity of the kit, if the test result is negative, it should be carefully analyzed. It is recommended that the test results be considered in combination with other highly specific tumor markers. Limited by the methodology and the product's raw materials, the test results of this product are not comparable with the test results of other similar reagents.
【Testing Principle】
This reagent determines whether there are any relevant abnormal metabolisms in the tested individual by the characteristic color reaction between mercuric salt and 5-hydroxyindoleacetic acid, and according to the different colors produced.
【Main Ingredients】
Nitric acid, sulfuric acid, mercurous nitrate, mercuric sulfate, naphthol, and deionized water.
【Storage Condition and Effective Duration】
This reagent should be stored in dry, well ventilated room far away from direct sunlight and heat source within the temperature range 5℃ ~40℃. In such case its effective duration may be three years.
Production date, expiration date and effective duration are detailed in the packaging label.
【Requirements】
The test taker should provide an early morning urine sample; on the day before, the test taker should not drink alcohol, not take any medicine, or take in any high protein/high amino acids food or dietary supplements.
【Test Method】
Take clean urine 3ml and put it into the ampoule with this reagent of 0.5ml, after shaking it well place it statically for 3~5 minutes and compare the color of precipitate with the standard colorimetric plate to judge the result.
【Reference Value (Reference Range)】
Refer to the colorimetric plate.
【Interpretation of Test Result】
A negative result shows a normal metabolism of 5- hydroxyindoleacetic acid; while in case of a positive result, re-examination is needed after all interferences are removed (do not drink alcohol, not take medicine, drink fewer water, eat fewer food and dietary supplements which are high in protein and amino acid). If the re-examination result is still positive, a further examination by specialized hospital is suggested.
【Limitation of Test Method】
This reagent can only be used for qualitative test of 5- hydroxyindoleacetic acid in human urine, and a positive result can only indicate abnormal amino acid metabolism but cannot be as conclusive evidence of malignant diseases.
【Property Index】
The data for patients with digestive cancers (including esophageal cancer, gastric cancer, and bowel cancer) or breast cancer and the data for people in general are based on clinical data.
Item Rate of positive 5-hydroxyindoleacetic acid(5-HIAA)
Digestive cancers include esophageal cancer, gastric cancer and bowel cancer 76%
Breast cancer 66%
People in general 3.6%
【WARNING】
1. This reagent is highly corrosive and thus special care should be taken when using it. In case of splashing on skin or clothes, please wash with soap; once into eyes, flush eyes with clean water; if necessary, go to see a doctor.
2. If the precipitate is green or sage green, it indicates the interference from jaundice. In such case, the test should be done again after the jaundice disappears.
3. It is possible that the patient with gastric ulcer or gastritis and HP infection whose result of test by this reagent is positive may have got early gastric cancer. In the case of failure to find any canceration, the regular test and monitoring with this reagent should be conducted after all HPs are killed, and attention should be paid closely to the development of gastric disease.
4. Cancer patients are not prone to positive results due to loss of stress response ability during various treatments, or in cases of severe nutritional depletion (especially in advanced stages of the disease).
5. The mercuric salt contained in this reagent exists in a stable complex state, so the waste liquid after the test can just be landfilled.
Website: www.haymanhealth.com
Production License No.: ESYJXSCX20100232
Medical Device Registration Certificate No.: GXZZ 20143401815Product standard code: YZB/G 5998-2014
[Date of the approval and revision of the Instructions]
Date of Approval: May 16, 2019
Date of revision: May 16, 2019(The production date and expiry date are shown in the certificate of approval.)
