Prostate PSA Rapid Test (1 pc/box)

Prostate PSA Rapid Test

Prostate cancer is the most common cancer type among men and ranks as the second leading cause of cancer-related death. The incidence dramatically increases in men over 40 years old, affecting up to 50% of men over 70. Compared to other cancers, prostate cancer has a better prognosis when detected early.

Prostate-Specific Antigen (PSA) is a protein produced by prostate gland cells, primarily responsible for maintaining the fluidity of seminal plasma. PSA is also present in the bloodstream, and changes in PSA levels provide important diagnostic information about prostate health.

An elevated PSA level generally indicates prostate enlargement (hyperplasia), which can be caused by benign conditions such as prostatitis or potentially by prostate cancer. Regular PSA testing is highly recommended for men over 50 to facilitate early detection, significantly improving treatment outcomes. This PSA rapid test is intended exclusively for professional use.

Specifications

Product Name: Prostate PSA Rapid Test

Sample Type: Whole blood / Serum / Plasma

Packaging: 1 test/box

Test 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: 2026-02

Kit Contents

• 1 x Test cassette

• 1 x Disposable pipette

• 1 x Buffer solution

• 1 x Lancet (finger prick device)

• 1 x Alcohol swab

• 1 x Instruction leaflet in English

Testing Procedure

Please read the instruction leaflet carefully before performing the test.

1. Allow all reagents, samples, and controls to reach room temperature (15°C–30°C) before testing.

2. Remove the test cassette from the sealed pouch and place it on a clean, flat surface. Label the cassette with patient or control ID. For optimal results, perform the test within one hour of opening.

3. Using the disposable pipette, add:

   • 1 drop of serum or plasma into the sample well (S), then add 1 drop of buffer solution and start the timer,
     OR

   • 2 drops of whole blood into the sample well (S), then add 1 drop of buffer and start the timer,
     OR

   • Allow 2 drops of capillary whole blood (finger prick) to drop into the sample well (S), then add 1 drop of buffer and start the timer.

4. Avoid trapping air bubbles in the sample well, and do not add buffer to the result window.

5. After application, the colored reagent will migrate along the membrane.

6. Read results after 5 minutes. Results after 10 minutes are invalid.

Performance Characteristics

• Relative Sensitivity: >98.8%

• Relative Specificity: >98.6%

• Overall Agreement: >98.6%

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.

Instructions