Alpha-Fetoprotein (AFP) Rapid Test (1 pc/box)

Alpha-Fetoprotein (AFP) Rapid Test for Liver, Testicular, or Ovarian Cancer Detection

The Alpha-Fetoprotein (AFP) Rapid Test is intended for the qualitative detection of AFP levels in whole blood, serum, or plasma. Elevated AFP levels may be associated with various pathological conditions. It is important to note that a high AFP level is not specific to a single condition and may result from multiple causes. This rapid test can aid in the diagnosis of liver, testicular, and ovarian cancers, among other diseases.

Potential causes of elevated AFP levels include:

• Pregnancy: Naturally elevated AFP levels during pregnancy.

• Genetic disorders: Increased AFP can occur with conditions like Down syndrome or neural tube defects.

• Liver diseases: Such as hepatitis or liver cirrhosis.

• Liver cancer (Hepatocellular carcinoma): AFP is a key tumor marker in liver cancer diagnostics.

• Teratomas: Tumors containing multiple tissue types can also elevate AFP levels.

• Pancreatic cancer: Occasionally linked to increased AFP.

Important: A high AFP level is only a possible indicator. Further diagnostics and medical evaluation are required for confirmation.

Specifications

Product name: Alpha-Fetoprotein (AFP) Rapid Test Kit

Sample type: Whole blood / Serum / Plasma

Format: Cassette

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: 2026.09.

Alpha-Fetoprotein (AFP) Rapid Test Kit Contents

• 1 test cassette
• 1 disposable pipette
• 1 buffer solution
• 1 lancet
• 1 alcohol swab
  
• 1 instruction 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’s or control ID. For best results, perform the test within one hour after opening.

2.A Using the provided disposable pipette, add 3 drops of whole blood/serum/plasma into the sample well (S) of the test cassette, then start the timer.

Avoid trapping air bubbles in the sample well (S), and do not allow any liquid into the result window.

2.B Alternatively, allow 3 drops of fingertip whole blood to drip directly into the sample well (S) of the test cassette, then start the timer.

Avoid trapping air bubbles in the sample well (S), and do not allow any liquid into the result window.

3. If migration across the membrane does not start within 1 minute, add 1 drop of buffer solution into the sample well (S).

4. Wait for the colored line(s) to appear. Read the result at 10 minutes. Do not interpret the result after 20 minutes.

AFP Test Performance

• Relative Sensitivity: 99.2% (97.9%–99.7%)*

• Relative Specificity: 98.8% (97.5%–99.4%)*

• Overall Accuracy: 99.0% (98.1%–99.4%)*
  *95% Confidence Intervals

Legal Notices

Professional Use

This product is an in vitro diagnostic (IVD) and intended exclusively for professional use by medical personnel. Use for self-testing is not permitted. The manufacturer/distributor accepts no liability for damages resulting from improper or unauthorized use.

Right of Withdrawal

In accordance with § 312g (2) No. 3 of the German Civil Code (BGB), there is no right of withdrawal for sealed goods which, for reasons of health protection or hygiene, are not suitable for return if their seal has been removed after delivery.

Disclaimer

The seller assumes no responsibility for compliance with legal regulations within the buyer’s procurement process. The seller’s responsibility is limited solely to the delivery of the ordered goods and the provision of information regarding their proper use.