GENERAL INFORMATION

What is this test kit used for?
This test kit is designed for qualitative detection of 5-hydroxyindoleacetic acid (5-HIAA) in human morning urine. By producing a characteristic color reaction with 5-HIAA, this reagent can determine whether the tester has related metabolic abnormalities. Clinically, it is mainly used for the auxiliary diagnosis of stress responses caused by abnormal cellular activity and various inflammatory diseases.
Is this test kit a diagnostic tool for tumors and/or cancers?
No. This product is not a diagnostic tool for cancer. By detecting abnormal cellular activity, it is sensitive to some cancers (such as Colorectal Cancer, Gastric Cancer, Breast cancer, Esophageal Cancer, Liver Cancer, Gynecological and other Tumors). A positive test result is for clinical reference only and should not be used as the sole basis for clinical diagnosis and treatment. It should be considered in conjunction with other laboratory tests.
It is recommended that test results be considered in conjunction with other clinical diagnostics. Due to limitations in methodology and raw materials, the test results of this product are not comparable with those of other similar reagents.
Can this test kit be used more than once?
No. This is a single-use kit.
Who is the manufacturer of this test kit?
WUHAN CHENKANG SCIENCE TECHNOLOGY CO. LTD.
Who is the overseas sole agent for Hong Kong?
ANCO RESOURCES PTE LIMITED。
Where to find the details of this test kit?
Please refer to the instruction manual, our official website or test procedure video.
What groups of people are not advised to use this test kit?
Individuals with hematuria, jaundice, and cancer patients undergoing treatment.
How should the reagent be stored?
Store in a dry, well-ventilated area (5°C–40°C), away from direct sunlight and heat sources.
What is the shelf life of this test kit?
Three (3) years from the production date (Please check the expiry date on the packing box).
What color is the reagent before use?
Colorless or pale yellow.
What should I do if the reagent changes color before use?
Do not use it. Contact the local agent for a replacement. Please refer to the Return Policy for details.
What type of urine sample is required?
To ensure accurate results, you need to collect your first urine sample in the morning.
When should the gloves be worn?
Recommend wearing gloves from the start of test procedure.
How do I open the reagent?
Use the opener to break the ampoule (press to open), and it serves to protect yourself from cuts.
What amount of morning urine is required as a sample for the test?
Use a dropper to extract 3mL of clean urine and add it into the ampoule bottle until it reaches the 3.5mL mark. Total 3 ml of morning urine is needed to mix with the reagent.
Why should the ampoule be placed on the base before testing?
The base is used to prevent the ampoule from tipping over and to facilitate easy comparison of the test result with the standard colorimetric plate.
How long do I need to wait to obtain the test results after mixing the morning urine with the reagent?
Upon mixing the first morning urine with the reagent, shake gently and thoroughly, allow three (3) to five (5) minutes for sedimentation and color development. Interpretation should occur only after the sediment exhibits the final color reaction.
How should I save the test result records?
It is recommended to take a photo of the test result alongside the standard colorimetric plate for record to facilitate comparison with subsequent test(s) and submit it to the doctor for reference.
What do the color changes of the sediment mean?
Compare the result to the standard colorimetric plate shown in the instruction manual:
  • Negative
    :
    Normal 5-hydroxyindoleacetic acid metabolism in the individual.
  • Weak Positive
    :
    Slight Abnormal 5-hydroxyindoleacetic acid metabolism in the individual.
  • Positive
    :
    Abnormal 5-hydroxyindoleacetic acid metabolism in the individual.
  • Interference color
    :
    Sediment appears greenish may indicate jaundice interference. Retest after jaundice resolves.
For abnormal 5-hydroxyindoleacetic acid metabolism, it may be possibly due to:
  • Body stress responses; or
  • Patients with gastritis or gastric ulcers accompanied by Helicobacter pylori infection; or
  • Inflammatory conditions; or
  • Tumors and/or cancers but subject to further medical diagnosis.
If abnormal 5-hydroxyindoleacetic acid metabolism is detected in the body, based on clinical data, the following cancer risks may exist (see table below). However, it is recommended that specific circumstances be considered in conjunction with other clinical diagnoses.
5-Hydroxyindoleacetic Acid Reagent Kit (Chemical Colorimetric Method) Clinical Data
Clinical Evaluation
Result
Colorectal Cancer
89%
Gastric Cancer
87.5%
Breast Cancer
66%
Esophageal Cancer
63%
Liver Cancer
62%
Gynecological and Other Tumors
63%
Healthy population (11,144 people)
Specificity (negative rate) 96.2%
Data source explanation: The above information is derived from a comprehensive statistical analysis of Phase III clinical data and literature published by relevant hospitals and testing institutions after using this product.
What should I do if the result is positive?
Recommend conducting a retest after three (3) days (During these three (3) days, no alcohol consumption, refrain from taking any medications (non-essential medications), and minimize intake of high-protein, high-amino-acid foods and supplements).
If the result of the retest is still positive, please consult a doctor for further evaluation.
Why do patients with serious illness test negative?
Patients with serious illness may have a reduced stress response during various treatments or when their nutrition is severely depleted (especially in advanced patients), leading to negative results.
Can this test replace pathological examination for determining tumors and/or cancers?
No. It is a preliminary screening tool and further detailed examination is required at a relevant specialist hospital.
How often should I conduct this test regularly?
For negative result, recommend every six (6) months;
For weak positive result, recommend every three (3) months; and
For positive result, recommend once (1) a month.
Is the reagent safe to handle?
No. It is highly corrosive. Always wear gloves and avoid skin/eye contact.
What should I do if the reagent touches my skin?
Wash immediately with soap and water for at least five (5) minutes.
What if it gets into my eyes?
Rinse with plenty of water for fifteen (15) minutes and seek medical attention.
How should I dispose of used items?
It is recommended to place the used items back into the enclosed sealed disposal bag and dispose of them as regular household waste.
Is this test kit registered with United States Food and Drug Administration (FDA or US FDA)?
Yes. This test kit is registered under Class 1 medical devices with Registration/FEI No.: 3009514517。
Is this test kit CE marking registered by the European Commission?？
Yes. This test kit is registered as an in vitro diagnostic by the European Commission under CE No.: NL-CA002-2022-69027。
Is this test kit registered with the Medical Device Registration Certificate (In Vitro Diagnostic Reagents) from the National Medical Product Administration of People's Republic of China?
Yes. This test kit is registered with the Medical Device Registration Certificate (In Vitro Diagnostic Reagents) from the National Medical Product Administration of People's Republic of China, under Registration Certificate Number 鄂械注準20242404942。
Is this test kit certified with Medical Device Quality Management System Certification (ISO13485) for manufacturing?
Yes. This test kit is certified with Medical Device Quality Management System Certification (ISO 13485) for manufacturing under registration number: ZGC23YLG00148R0S。
Who should I contact for technical issues?
If you have any questions, please email cs@ancobiotech.com or press leaving your inquiries and contact information, and we will have a dedicated person reach out to you.