Test-Reagent for 5-Hydroxyindoleacetic Acid (Qualitative Colorimetric Method)

Product Overview

This product is Test-Reagent for 5-Hydroxyindoleacetic Acid (Qualitative Colorimetric Method) designed for the qualitative detection of 5-Hydroxyindoleacetic Acid (“5-HIAA”) in morning urine. 5-HIAA is a biomarker of abnormal amino acid metabolism caused by cellular irregularities (such as inflammation or stress responses). Through a characteristic color reaction, it enables rapid preliminary screening of metabolic abnormalities, aiding in the identification of potential health risks. Clinical studies demonstrate detection sensitivity for certain tumors and cancers* (including Colorectal Cancer, Gastric Cancer, Breast Cancer, Esophageal Cancer, and Liver Cancer, as well as Gynecological and Other Tumors).

【Key Features】
  • Rapid color result within #3-5 minutes , simple operation;
  • Suitable for at-home self-testing or clinical preliminary screening;
  • Clinically validated efficacy; and
  • Complies with international standards (U.S. FDA, EU CE, ISO13485).
    • Note: Test results must be comprehensively evaluated alongside clinical examinations and should not be used as a basis for cancer diagnosis. For details regarding the product's sensitivity in detecting certain tumors and cancers, please refer to Section 1 of the "Special Attention and Disclaimer" on this website.
    • The "3 minutes" mentioned above refers solely to the minimum duration required to achieve a visible color result.
【Clinical Data Summary】
Clinical Evaluation
Results
Colorectal Cancer
89%
Gastric Cancer
87.5%
Breast Cancer
66%
Esophageal Cancer
63%
Liver Cancer
62%
Other Tumors
63%
Health Population (n=11,144)
Specificity（Negative）96.2%
  • Clinical Data of the Test-Reagent for 5-Hydroxyindoleacetic Acid (Qualitative Colorimetric Method)

5-羥吲哚乙酸測定試劑盒

【Each Test-Reagent Kit Contains】
  • 5-Hydroxyindoleacetic Acid 0.5ml x 1;
  • Bottle Opener x 1;
  • Transparent Plastic Cup x 1;
  • Examination Gloves x 1;
  • Dropper x 1;
  • Base x 1;
  • Instruction Manual x 1；and
  • Sealed Disposal Bag x 1.

Intended Use

This product is intended for qualitative detection of 5-hydroxyindoleacetic acid (“5-HIAA”) in human morning urine to assess amino acid metabolism abnormalities caused by Helicobacter pylori infection, inflammation, or stress responses. Abnormal results may indicate:

Body Stress Response and Inflammation Assessment
Monitors metabolic changes caused by body stress responses; and
Aids in evaluating inflammatory conditions such as H. pylori-associated gastric ulcers and gastritis.
Tumor and Cancer Risk Indication*
Clinical studies demonstrate detection sensitivity for certain tumors and cancers* (including Colorectal Cancer, Gastric Cancer, Breast Cancer, Esophageal Cancer, and Liver Cancer, as well as Gynecological and Other Tumors).
  • Note: Test results must be comprehensively evaluated alongside clinical examinations and should not be used as a basis for cancer diagnosis. For details regarding the product's sensitivity in detecting certain tumors and cancers, please refer to Section 1 of the "Special Attention and Disclaimer" on this website.

Test Principle

5-Hydroxyindoleacetic acid (“5-HIAA”) is a key metabolic marker in the human body, with concentration changes closely linked to abnormal cellular proliferation. When abnormal cell growth triggers body stress responses, it disrupts the metabolism of amino acids such as tryptophan and tyrosine, leading to significantly elevated levels of 5-HIAA and its metabolites in urine.

This product utilizes a colorimetric method to detect 5-HIAA concentration changes in morning urine. The urine sample reacts specifically with the reagent, producing a characteristic color change. By comparing the result with the standard colorimetric plate, test outcomes (Negative / Weak Positive / Positive) can be determined within #3-5 minutes.

  • The "3 minutes" mentioned above refers solely to the minimum duration required to achieve a visible color result.

Product Certification Information

fda_registered
Food and Drug Administration（FDA or U.S. FDA）Registration

Device Class: Class I Medical Device

Registration/FEI No.: 3009514517

CE_registered
European Union CE Marking Registration

Product Type: In Vitro Diagnostic Device

CE No.: NL-CA002-2022-69027

National Medical Product Administration of People's Republic of China Registration

Registration Type: Class II Medical Device (In Vitro Diagnostic Reagent)

Registration No.: 鄂械注准20242404942

iso_certified
Quality Management System Certification

Standard: ISO 13485

Certificate No.: ZGC23YLG00148R0S

Instructions for Use

Detailed Instructions：Click here to download
【Test Procedure】
  1. Collect morning urine in a plastic cup.
  2. Put on gloves and use the opener to open the ampoule (press to open), placing it on the base.
  3. Use a dropper to extract total 3 mL of urine and add it to the ampoule containing 0.5 mL reagent.
  4. Mix thoroughly by shaking and let it stand for 5 minutes.
  5. Compare the precipitate color with the standard colorimetric plate for result interpretation (refer to Reference Values/ Range on the plate).
  6. Put all used materials into the sealed disposal bag, then dispose it according to local environmental regulations.
測試流程
【Video for Test Procedure】

Cancer Sentinel*: Early Detection · Proactive Prevention · Timely Intervention

3-5 Minute Rapid Color Test Morning Urine Home Test:
  • Convenient for users to self-test at home.
  • Non-invasive, Instrument-Free: Easy to use, no specialized equipment required.
  • 3-Minute Cancer Risk: Quick results provided to help users understand their health status.
Advantages and Features
  • Early Warning of Malignant Tumor Risk*: Detect potential health issues early.
  • Over 90% sensitivity in detecting digestive system cancer risk: Highly effective detection capabilities.
  • Clinical studies have confirmed: Screening accuracy in healthy individuals reaches 96.2%*, effectively eliminating cancer risks.
  • High Sensitivity: Detection rates for colorectal and gastric cancer approach 90%*.
  • Multiple Cancer Coverage: Detects colorectal, gastric, esophageal, breast, liver, gynecological, and other cancers.
  • Note: Test results must be comprehensively evaluated alongside clinical examinations and should not be used as a basis for cancer diagnosis. For details regarding the product's sensitivity in detecting certain tumors and cancers, please refer to Section 1 of the "Special Attention and Disclaimer" on this website.
  • The "3 minutes" mentioned above refers solely to the minimum duration required to achieve a visible color result.

Product Application Value

Personal & Family Health Protection: Affordable Early Cancer Screening Solution

This cost-effective home testing kit enables convenient early cancer detection through morning urine sampling, quickly assessing risk for multiple common cancers. It’s simple operation makes regular health monitoring accessible to everyone at an affordable price, embodying the healthcare principle of "early detection, early prevention, early intervention".

Easy to use
:
Non-invasive, no instrument required.
Accurate & Reliable
:
Clinically validated for effective detection of common cancers* such as Colorectal Cancer, Gastric Cancer, Breast Cancer, Esophageal Cancer, Liver Cancer, Gynecological and Other Tumors.
Clear Results & Actionable Guidance
:
Negative results indicate low risk for reassurance; positive results recommend further medical consultation.
Cost-Effective and Convenient
:
Low cost and user friendly, ideal for regular individual and family health monitoring.
A Win-Win Solution for Insurers and Enterprises: Innovative Health Risk Management

This product uses innovative " #3-minute Cancer Risk Detection”* technology to offer a new health management strategy. It provides early cancer risk alerts with over 96.2% accuracy* in screening healthy populations, effectively helping exclude cancer risks.

Value for Insurance Institutions:
  • Optimize Product Design
:
Improve insurance products and control long-term costs through early risk evaluation.
  • Expand Services Model
:
Introduce "Prevention + Protection" one-stop services to expand into health management.
Value for Enterprises:
  • Enhance Staff Well-being
:
By providing convenient testing, showing corporate caring culture and increasing reassurance.
  • Reduce Risk and Optimize Benefits:
:
Reduce productivity loss and medical costs through early risk detection, improving both staff health and efficiency.
Smart Early Screening: Enhancing Local Healthcare Efficiency and Reduce System Burden

This product provides medical institutions with a cost-effective and convenient tool for early cancer screening, significantly improving early detection rates and helping to reduce the burden on local healthcare systems.

Accurate Triage, Optimized Resources
  • High sensitivity to common cancers* such as colorectal (89%) and gastric cancer (87.5%), suitable for large-scale screening by governments and institutions.
  • Early detection of high-risk groups allows timely intervention, significantly reducing healthcare costs and specialist referrals.
  • Filtering out low-risk individuals to ease pressure on public hospital outpatient services.
Expanded Services, Improved Risk Management
  • Ideal for clinics and at-home self-testing, can be incorporated into routine screenings to flexibly meet diverse needs.
  • Specificity of 96.2%: negative results reliably exclude cancer risk*, positive results recommend further medical consultation, facilitating early health risk intervention.
  • Note: Test results must be comprehensively evaluated alongside clinical examinations and should not be used as a basis for cancer diagnosis. For details regarding the product's sensitivity in detecting certain tumors and cancers, please refer to Section 1 of the "Special Attention and Disclaimer" on this website.
  • The "3 minutes" mentioned above refers solely to the minimum duration required to achieve a visible color result.