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

• The price includes 5% VAT.

• The product can be ordered for professional use.

Carcinoembryonic Antigen (CEA) Rapid Test for the Assessment of Tumorous and Inflammatory Conditions

The CEA Rapid Test Kit (Whole Blood/Serum/Plasma) is intended to aid in the diagnosis of various cancers. Carcinoembryonic antigen (CEA) is a protein that can be produced by different types of cancer cells. Measuring the CEA level in the blood can help physicians diagnose certain types of cancer and monitor their treatment. The CEA rapid test is an assay that allows the CEA level in the blood to be measured quickly.

The results of the carcinoembryonic antigen rapid test may indicate the following:

1. Cancers: The CEA level may often be elevated in certain types of cancer, such as colorectal cancer, lung cancer, pancreatic cancer, breast cancer and liver cancer. However, not every type of cancer causes an elevated CEA level, and other factors may also affect the CEA level.
2. Inflammatory conditions: The CEA level may increase in inflammatory conditions such as ulcerative colitis or Crohn’s disease.
3. Liver diseases: Certain liver diseases, such as liver cirrhosis or hepatitis, may also cause an elevated CEA level.
4. Smoking: Smoking may also affect the CEA level, so the CEA level may be higher in smokers.

The CEA level is not specific, so other factors may also cause an elevation. For this reason, the results of the CEA rapid test must always be evaluated by a physician together with the patient’s complete clinical picture and other diagnostic examinations. Monitoring the CEA level can be useful in the diagnosis of cancers and in monitoring the response to treatment, but it does not by itself constitute the basis of a complete diagnosis. The test kit can be ordered for professional use.

CEA Rapid Test Specification

Product name: Carcinoembryonic (CEA) Antigen Rapid Test Kit
Sample: whole blood/serum/plasma
Packaging: 1 pc/box
Format: Cassette test
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
Expiry date: 31/03/2028

CEA Rapid Test Kit Contents

• 1 test cassette
• 1 disposable pipette
• 1 buffer solution
• 1 fingertip lancet
• 1 alcohol wipe
• 1 instructions for use in Hungarian

How to Use the Fingertip Lancet

1. Take the yellow single-use fingertip lancet out of the packaging. Remove the transparent cap.
2. Press it against your fingertip. The needle will be released automatically.
3. After use, dispose of the lancet in the waste bin.

The visual aid is intended exclusively for healthcare professionals. The product is not intended for self-testing.

Test Procedure

Read the Instructions for Use carefully before performing the test! Before testing, allow the test, the sample and/or the controls to reach room temperature (15-30°C).

1. Remove the test from the sealed pouch and use it as soon as possible. For the best results, the assay should be performed within one hour.

2.A Place the test device on a clean, level surface.

Dispense 3 drops of whole blood/serum/plasma into the sample well (S) of the test cassette using the supplied disposable pipette, and start the timer.

Avoid trapping air bubbles in the sample well (S), and do not allow any solution to get onto the result area.

2.B Place the test device on a clean, level surface.

Allow 3 drops of fingertip whole blood to drop into the sample well of the test cassette, then start the timer.

Avoid trapping air bubbles in the sample well (S), and do not allow any solution to get onto the result area.

3. If the migration across the membrane has not started after 1 minute, add 1 drop of buffer solution to the sample well (S).

4. Wait for the colored line(s) to appear. The result must be read after 10 minutes. After 20 minutes the result is invalid.

CEA Rapid Test Performance

• 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

The test may only be used by qualified professionals and healthcare workers! Carbon Web Kft. accepts no liability for use for self-testing purposes.

ATTENTION!
Pursuant to Government Decree No. 45/2014 (II. 26.), for health protection or hygiene reasons the product cannot be returned after delivery; therefore the 14-day right of return does not apply to this product. Section 29 (1) The consumer may not exercise the right under Section 20 (the consumer’s right of withdrawal) e) in respect of a product in sealed packaging which, for health protection or hygiene reasons, cannot be returned once opened after delivery.

Carbon Web Kft. is not responsible for the fulfilment of the legal obligations related to the Buyer’s procurement procedure, as this falls within the Buyer’s competence; its liability is limited exclusively to the information on intended use and to the goods delivered.