Prostate-Specific Antigen (PSA) Rapid Test for Home Use (1 test/box)

The PSA Rapid Test is a self-test that can be performed at home using a fingertip blood sample and is intended to detect elevated levels of prostate-specific antigen (PSA).

PSA is a protein produced mainly by cells of the prostate gland. Elevated PSA levels in the blood may be associated with various conditions affecting the prostate, so PSA testing may help monitor prostate health.

The rapid test can detect PSA at concentrations of 4 ng/ml or higher. The test provides a qualitative result, meaning that it does not determine the exact PSA value but indicates whether the PSA level reaches the detection threshold of the test.

The test may be particularly useful for men who would like a simple, preliminary check of their prostate health that can be performed at home.

Taking the test may be particularly worth considering:

• for men over 50 years of age, or from the age of 45 in those at higher risk,
• if there is a family history of prostate cancer, particularly in a first-degree relative,
• in cases of frequent urination,
• in cases of a weak urine stream,
• if there is difficulty starting or stopping urination,
• in cases of frequent urination at night,
• in cases of painful urination or pelvic pain,
• if blood is present in the urine or semen,
• in cases of newly developed erectile dysfunction without an obvious cause.

It is important to note that these symptoms alone do not indicate prostate cancer, and elevated PSA levels can have several different causes.

Product name: Prostate-Specific Antigen (PSA) Rapid Test

Sample: whole blood/serum/plasma

Pack size: 1 test/box

Format: test cassette

Manufacturer: Hangzhou Alltest Biotech Co., Ltd., Ltd., 550 Yinhai Street, Hangzhou Economic and Technologic Development Area, 310018, Zhejiang, China; Phone: +86-571-56267891; info@alltests.com.cn

EC REP: MedNet GmbH, Hansestraße 91, 48165 Münster, Germany; +49 251 32266-0; info@medneteurope.com

Before starting the test, allow the test kit to reach room temperature (15–30 °C). Wash your hands with soap and warm water, then place the test cassette and the necessary components on a clean, level surface.

1. Remove the protective cap from the sterile lancet.

2. Disinfect the fingertip of the middle or ring finger using the supplied alcohol wipe.

3. Place the lancet against the fingertip and press firmly. After puncturing the fingertip, wipe away the first drop of blood.

4. Hold your hand downwards and gently massage the finger until another drop of blood forms.

5. Touch the open end of the capillary dropper to the blood drop. The blood will automatically be drawn into the dropper. Wait until the blood reaches the marked line. Make sure that no air bubbles form.

6. Using the capillary dropper, transfer the blood sample into the sample well marked S on the test cassette.

7. Once all the blood has been transferred into the sample well, add 1 drop of buffer.

8. Wait for the coloured lines to appear. Read the result after 5 minutes. After 10 minutes, the result can no longer be interpreted reliably.

If two coloured lines appear – one in the C (control) region and one in the T (test) region – the result is positive.

According to the instructions for use, this indicates that the PSA level is 4 ng/ml or higher (≥4 ng/ml). In the event of a positive result, it is recommended to consult a doctor and show them the test result. The doctor may recommend further examinations if necessary.

A positive result alone does not mean that prostate cancer is present. Elevated PSA levels may also occur, for example, in benign prostate enlargement, so the result should always be evaluated together with other clinical information.

If only the C control line appears and no line is visible in the T region, the result is negative.

According to the instructions for use, this indicates a PSA level below 4 ng/ml. However, if prostate-related symptoms or complaints persist, it is recommended to consult a doctor even if the result is negative.

If the C control line does not appear, the test result is invalid. This may be caused, for example, by an insufficient sample volume or incorrect performance of the test procedure. In this case, the test must be repeated using a new test cassette.

According to the comparative study on clinical samples reported by the manufacturer:

Positive agreement: 99.0%

Negative agreement: 99.4%

Overall agreement: 99.2%

Detection limit: 4 ng/ml PSA

The PSA Rapid Test is a screening test that provides a preliminary result and cannot be used on its own to diagnose prostate disease or prostate cancer. In the event of a positive result, further medical evaluation is required, and if symptoms persist, it is recommended to consult a doctor even if the result is negative.

The instructions for use also state that certain treatments, such as hormone therapy or manipulation of the prostate, may affect PSA levels.

The kit must be stored at 2–30 °C, must not be frozen and is intended for single use only.