Description

The test is designed to qualitatively determine the prostate exosomal protein (PSEP) content in human urine, as an aid to the clinical diagnosis of chronic prostatitis.
Prostatitis, a major disease that affects men’s lives, has an impact on men’s sexual and reproductive function and early diagnosis and treatment is therefore of great importance. The results of several clinical trials have shown that patients with chronic prostatitis have increased levels of PSEP in their urine, which is a reliable indicator for the diagnosis of chronic prostatitis. The Prostate Exosomal Protein Qualitative Detection Test Kit (Colloidal Gold) can be used in the complementary diagnosis of chronic prostatitis by analysing urine from adult men.

This product is mainly used as an aid in the clinical diagnosis of chronic prostatitis. If a red band appears in the test area (T), this indicates a positive result, indicating that the subject may have chronic prostatitis; if no red band is evident in the test area (T), the result is negative, indicating that the subject does not have chronic prostatitis; A red band in the QC area (C) also serves as an internal control standard for the reagent, which helps to determine whether the urine sample volume is sufficient and whether the chromatographic process is regular.

Sampling requirements
1. This test strip can be used for urine. Subjects should observe good hygiene when collecting urine samples, and should follow a light diet beforehand and avoid excessive alcohol consumption and semen collection.
2. Urine should be collected in a clean and dry container. Intraday urine can also be tested.
3. If urine samples cannot be sent for testing in time, they can be stored stable for 24 hours at 2-8°C or for two months at -20°C.

Test method
Test samples, reagents and other equipment should be at room temperature before use and should be used as soon as possible after opening.
Test card: tear open the aluminium foil pouch, remove the test card and lay it on a flat surface. Using the dropper provided with the kit, aspirate urine, give approx. 3 drops (about 150 microlitres) of urine into the well of the test card and observe the result after 5-10 minutes. Read the result within 30 minutes.
Test pen: tear open the aluminium foil pouch, remove the test pen, dip the test section into approx. for 10 seconds in the urine and place on a flat surface. Observe the result after 5-10 minutes. Read the result within 30 minutes at the latest.
[Kimutatási határ]
This product shows a qualitative result with a minimum detection limit of 1.2 ng/ml.
[A vizsgálati eredmények értelmezése]
Negative 1: Only one coloured stripe (control line – line C) appears in the test area, indicating a negative result.
2. Positive: two coloured stripes (control line – line C and test line – line T) appear in the test area, indicating a positive result.
3. Invalid: the control line does not appear, indicating a test failure or reagent failure. Please perform the test with a new test strip.

Performance indicators
1. Minimum detection limit: The test uses an in-house PSEP standard with a minimum detection limit of 1.2 ng/ml.
2. Accuracy: using a negative factory PSEP reference, all results of 3 replicates are negative; using a positive factory PSEP reference, all results of 3 replicates are positive.
3. reproducibility: taking the same batch of 10 PSEP detection kits and testing with the factory reference concentration of 1.2 ng/ml PSEP. The reaction results should be consistent and the colour rendition should be uniform.