CEA Antigen Test Cassette
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GoldHealth Medical – One Step CEA Whole Blood Rapid Screen Test
Introduction
The One Step CEA Whole Blood Test by GoldHealth Medical is a cutting-edge chromatographic immunoassay designed for the qualitative detection of Carcino-Embryonic Antigen (CEA) in human whole blood specimens. This test leverages the principle of sandwich immunology, employing two monoclonal antibodies to specifically identify CEA. As one of the most commonly tested tumor markers, elevated CEA levels can signal the presence of cancer or other health concerns. This rapid, highly sensitive test delivers results in just 15 minutes, with no need for additional instruments. The sensitivity threshold is an impressive 5 ng/mL.
Test Procedure
– Open the sealed pouch and remove the cassette.
– Using the provided plastic pipettor, draw one drop of whole blood and apply it to the sample well.
– Add one drop of dilution buffer to the same sample well.
– Wait for colored bands to appear. Read results within 15 minutes; do not interpret after 30 minutes.
Interpretation of Results
– Negative: A single colored band appears in the control region, indicating no detectable CEA in the sample.
– Positive: Distinct colored bands appear in both the control and test regions, confirming the presence of detectable CEA.
– Invalid: No visible bands or only one band appears in the test region, suggesting a possible error. Repeat the test with a new device.
Limitations
– For in-vitro diagnostic use only.
– Qualitative detection only; not suitable as a final test for blood donors.
Storage and Stability
The test kit is stable at room temperature (2°C to 30°C) until the expiration date when stored in the sealed pouch. Avoid direct sunlight, moisture, and heat to maintain optimal performance.
Product Highlights
– Rapid Results: Delivers accurate results in just 15 minutes.
– High Sensitivity: Detects CEA levels as low as 5 ng/mL.
– Ease of Use: Simple, visually interpreted test requiring no specialized equipment.
– Reliable Performance: Backed by GoldHealth Medical’s commitment to quality and innovation.
Applications
Ideal for hospitals, clinics, research institutions, and home users seeking a reliable, rapid diagnostic tool for early detection of elevated CEA levels.
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About GoldHealth Medical
GoldHealth Medical is a leader in the development and production of in-vitro diagnostic reagents. With over two decades of experience, we deliver high-quality, innovative solutions for fertility, infectious disease, tumor marker detection, and more. Our state-of-the-art GMP-certified facilities and dedicated R&D team ensure products that meet the highest standards of accuracy and reliability.
Why Choose GoldHealth Medical?
– Proven Expertise: Over 20 years of experience in diagnostic product development.
– Advanced Manufacturing: High-standard GMP production environment.
– Custom Solutions: Tailored products through professional OEM and ODM services.
– Uncompromising Quality: A robust quality control system ensures consistent excellence.
GoldHealth Medical is committed to advancing healthcare through precision diagnostics. Explore our range of products and experience the difference today.




Common Shipping and Delivery Considerations
- Packaging:
Medical devices need secure packaging to avoid damage during transit, including shock-absorbing materials or custom foam inserts. - Compliance with Regulations:
Ensure compliance with local and international standards (e.g., FDA, CE) and shipping regulations like Good Distribution Practice (GDP). - Temperature Control:
Some devices require temperature-controlled shipping (e.g., refrigerated trucks or special packaging) to maintain product integrity. - Tracking and Documentation:
Shipments should be tracked with necessary documents like invoices, certificates, and import/export paperwork. - Lead Time:
Plan ahead for lead times, which can vary depending on the equipment size and delivery location. - Insurance: Due to the high value of medical equipment, consider insurance to protect against loss or damage during transit.
- Customs and Import Regulations: Account for customs procedures and tariffs when shipping internationally, ensuring proper documentation.
- Special Handling:
Fragile or hazardous medical devices may require special handling, with clear labeling to ensure proper care. - Delivery Method:
Choose the appropriate shipping method (air, sea, or ground) depending on the equipment’s size, value, and urgency. - Returns and Reverse Logistics:
Have a clear process in place for returns, repairs, and warranty claims if necessary.
Frequently Asked Questions
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Our mission and vision
At Gold Health Medical, our vision is to revolutionize healthcare by providing high-quality medical equipment that enhances patient care and improves healthcare efficiency. We are committed to being a trusted partner for medical professionals and institutions, ensuring they have access to the latest and most reliable medical technology.
Our goal is to bridge the gap between innovation and accessibility, making advanced healthcare solutions available to providers worldwide. Through excellence in service, integrity, and continuous improvement, we strive to empower healthcare professionals with the tools they need to deliver superior patient outcomes.
Together, we are shaping the future of medical care—one innovation at a time.


What Our Customers Say
At Gold Health Medical, we take pride in delivering high-quality medical equipment and exceptional customer service. Here’s what our satisfied clients have to say about their experience with us:

Product Overview
GoldHealth Medical proudly presents the CEA Test Cassette, a cutting-edge solution in pathological analysis. Designed for precision and reliability, this high-accuracy diagnostic tool is ideal for hospitals, clinics, research labs, and home healthcare settings. With its advanced engineering and user-friendly design, the CEA Test Cassette delivers exceptional performance for detecting Carcinoembryonic Antigen (CEA) levels, supporting early diagnosis and effective monitoring of various health conditions.
Key Features
- Unmatched Accuracy: Engineered for high-precision results, ensuring reliable diagnostic outcomes.
- Efficient Design: Compact strip format for ease of use and seamless integration into workflows.
- Durable Construction: Crafted from high-quality plastic, ensuring longevity and consistent performance.
- Certified Quality: Compliant with CE and ISO13485 standards, guaranteeing safety and efficacy.
Technical Specifications
- Instrument Classification: Class II medical device
- Power Source: Machinery-driven operation
- Shelf Life: 2 years from the date of manufacture
- Packaging Details:
- 50 pcs per box
- Single package dimensions: 12 x 6 x 1 cm
- Single package weight: 0.050 kg
Warranty and Support
- Comprehensive Warranty: 3-year coverage for peace of mind
- Dedicated After-Sales Service: Access to online technical support for seamless assistance
Applications
The CEA Test Cassette is a versatile tool for:
- Early detection and monitoring of cancer-related conditions
- Supporting clinical research and laboratory diagnostics
- Enhancing patient care in rehabilitation centers and home settings
GoldHealth Medical is committed to delivering innovative, high-quality medical solutions that empower healthcare professionals and improve patient outcomes. The CEA Test Cassette exemplifies our dedication to precision, reliability, and excellence in medical diagnostics.