Prostate PSA Rapid Test (1 pc/box)

• The product is available for professional use only.

Prostate PSA Rapid Test

Prostate cancer is the most common type of cancer in men and the second leading cause of death among cancer-related diseases. The incidence of prostate cancer increases dramatically in men over 40, and it affects 50% of men over the age of 70. Compared with other types of cancer, prostate cancer can be treated more successfully when diagnosed early.

Prostate-specific antigen, or PSA for short, is a protein produced by the prostate gland. Its main function is to maintain the liquid state of seminal fluid. It is also present in the bloodstream, and changes in PSA levels provide important information about the condition of the prostate.

An elevated PSA level generally indicates that the prostate is enlarged (hypertrophic). This may be caused by a benign condition, such as prostatitis, but it may also indicate prostate cancer. Therefore, it is important for every man over the age of 50 to have a PSA test regularly. Detecting the problem at an early stage significantly increases the chances of recovery. The test is available for professional use only.

Prostate Rapid Test Specifications

Product name: Prostate PSA rapid test
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,
EC REP: Lotus NL B.V. Koningin Julianaplein 10, le Verd, 2595AA,The Hague,Netherlands
Expiry date: 30/09/2027

Contents of the Prostate PSA Rapid Test Kit

• 1 test cassette
• 1 disposable pipette
• 1 buffer solution
• 1 lancet
• 1 alcohol wipe
• 1 Hungarian-language instruction manual

Test Procedure

Read the Instructions for Use carefully before performing the test!

Before use, allow the devices, reagents and samples and/or controls to reach room temperature (15°C–30°C).

1. Remove the test from the sealed pouch and place it on a clean, horizontal surface. Label the device with the patient or control identification. For best results, the test should be performed within one hour.
2. Add 1 drop of serum/plasma to the specimen well (S) of the device using the supplied disposable pipette, then add 1 drop of buffer and start the timer. OR Add 2 drops of whole blood to the specimen well (S) of the device using the supplied disposable pipette, then add 1 drop of buffer and start the timer. OR Allow 2 drops of whole blood collected from the fingertip to fall into the center of the specimen well (S) of the test device, then add 1 drop of buffer and start the timer. Avoid trapping air bubbles in the specimen well (S), and do not add solution to the result area.
3. As the test begins to work, the color migrates across the membrane. Wait for the colored band(s) to appear. The result must be read after 5 minutes. The result is invalid after 10 minutes.

Performance of the Prostate PSA Rapid Test

• Relative sensitivity: >98,8%
• Relative specificity: >98,6%
• Overall agreement: >98,6%

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

ATTENTION!
According to Government Decree 45/2014 (II. 26.), for health protection or hygiene reasons, the product cannot be returned after delivery; therefore, the 14-day right of withdrawal does not apply to this product. § 29 (1) The consumer may not exercise the right under § 20 (the consumer's right of withdrawal) in the case of a sealed product which, for health protection or hygiene reasons, cannot be returned after being opened following delivery.

Carbon Web Kft. is not responsible for compliance with legal obligations related to the Buyer's procurement procedure, as this falls within the Buyer's responsibility; its responsibility is limited exclusively to providing information regarding proper use and to the goods delivered.