Carcinoembryonic Antigen (CEA) Rapid Test (1 pc/box)

Rapid Test for the Detection of Carcinoembryonic Antigen (CEA) - For Assessment of Cancerous and Inflammatory Conditions

The CEA Rapid Test Kit (whole blood/serum/plasma) is designed to assist in the diagnosis of various cancerous conditions. Carcinoembryonic antigen (CEA) is a protein that can be produced by certain types of cancer cells. Measuring the CEA level in the blood can help physicians diagnose certain types of cancer and monitor treatment progress. The CEA rapid test enables quick detection of CEA levels in the bloodstream.

CEA Rapid Test Results May Indicate:

• Cancerous Conditions: Elevated CEA levels are often observed in cases such as colorectal, lung, pancreatic, breast, and liver cancers. However, not all cancers cause an increase in CEA levels, and other factors may influence the results.

• Inflammatory Conditions: Diseases such as ulcerative colitis and Crohn's disease may also cause elevated CEA levels.

• Liver Diseases: Conditions such as cirrhosis or hepatitis may contribute to higher CEA levels.

• Smoking: CEA levels may be elevated in smokers, even in the absence of illness.

Note: CEA is not a cancer-specific marker. Therefore, test results must always be interpreted by a medical professional in the context of the patient's complete clinical profile and other diagnostic findings. While CEA testing is useful for monitoring cancer treatment and recurrence, it should not be used as a standalone diagnostic tool. 

Product name: Carcinoembryonic Antigen (CEA) Rapid Test Kit

Sample type: Whole blood / Serum / Plasma

Packaging: 1 test/box

Format: Cassette

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3RD FLOOR, BUILDING 4, NO. 1418 - MOGANSHAN ROAD, HANGZHOU, ZHEJIANG, 50 CHINA, imd.assuretech@diareagent.com

EC REP: Lotus NL B.V., Koningin Julianaplein 10, le Verd, 2595AA, The Hague, Netherlands, peter@lotusnl.com

Expiration date: 2026.05.

• 1 Test cassette

• 1 Disposable pipette

• 1 Buffer solution

• 1 Lancet for finger prick

• 1 Alcohol wipe

• 1 User manual in English

Instructions for Using the Lancet

1. Remove the yellow single-use lancet from its packaging.

2. Remove the transparent cap.

3. Press it firmly against the fingertip. The lancet will automatically release.

4. After use, dispose of the lancet in a sharps container or trash.

Test Procedure

Please read the user manual carefully before performing the test. Collect the sample according to the instructions. Before use, ensure that all devices, reagents, samples, and/or controls have reached room temperature (15°C-30°C).

After sample collection:

1. Remove the test from the sealed pouch and place it on a clean, flat surface. Label the test with the patient or control identifier. For best results, conduct the test within one hour of opening the pouch.

2.A For serum or plasma samples:

Hold the pipette vertically and dispense 2 drops of serum or plasma (approx. 50μL) into the sample well (S) on the test cassette, then start the timer.

2.B For whole blood samples:

Hold the pipette vertically and dispense 3 drops of blood into the sample well (S), then add 1 drop of buffer solution (approx. 40μL) and start the timer.

Avoid air bubbles entering the sample well (S), and do not apply any solution onto the result area. During the process, color will migrate along the membrane.

3. Wait for the colored lines to appear. Read the result after 10 minutes. Results read after 20 minutes are invalid.

• Relative Sensitivity: 98.8% (96.5%–99.6%)*

• Relative Specificity: 99.3% (98.1%–99.8%)*

• Overall Agreement: 99.2% (98.2%–99.6%)*
  *95% Confidence Interval