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

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

Regular price €9,29 EUR
Regular price €10,84 EUR Sale price €9,29 EUR
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Quantity
Under the applicable legislation, Carbon Web Kft. may sell IVD self-tests online to private individuals in accordance with EüM Decree 7/2004 (XI. 23.) and may have them delivered to the customer's home by parcel delivery after the order has been placed. Please note that by placing an order you waive your right to receive professional information on the use of the self-test. For correct performance of the test, detailed instructions for use in Hungarian are enclosed; you can find them in the test box and on our website.
The PSA rapid test is a self-test that can be performed at home on a blood sample taken from the fingertip and is intended for the detection of elevated levels of prostate-specific antigen (PSA).
PSA is a protein produced mainly by the cells of the prostate. An increase in the PSA level measurable in the blood may be associated with various changes affecting the prostate, therefore PSA testing can help in monitoring the health of the prostate.
The rapid test is able to detect PSA from a concentration of 4 ng/mL. The test gives a qualitative result, i.e. it does not determine the exact PSA value, but indicates whether the PSA level reaches the detection limit of the test.
Who may consider performing the PSA rapid test?
The test may be useful primarily for men who would like a simple initial check of their prostate health that can be performed at home.
Performing the test is particularly worth considering:
  • in men over 50 years of age, or from the age of 45 in case of higher risk,
  • if prostate cancer has occurred in the family, especially in a first-degree relative,
  • in case of frequent urination,
  • in case of a weak urine stream,
  • if there is difficulty starting or finishing urination,
  • in case of frequent urination at night,
  • in case of painful urination or pelvic pain,
  • if blood appears in the urine or semen,
  • in case of newly developed erectile dysfunction without a clear cause.
It is important to note that these symptoms alone do not indicate prostate cancer, and an elevated PSA level can also have several causes.
Test specifications
Product name: Prostate-specific antigen (PSA) rapid test
Sample: whole blood/serum/plasma
Pack size: 1 pc/box
Format: test cassette
Manufacturer: Hangzhou Alltest Biotech Co., Ltd., Ltd., 550 Yinhai Street, Hangzhou Economic and Technologic Development Area, 310018, Zhejiang, China; Telephone: +86-571-56267891; [info@alltests.com.cn](mailto:info@alltests.com.cn)
EC REP: MedNet GmbH, Hansestraße 91, 48165 Münster, Germany; +49 251 32266-0; [info@medneteurope.com](mailto:info@medneteurope.com)
Test procedure
Before starting the test, allow the test kit to come to room temperature (15–30 °C). Wash your hands with soap and warm water, then place the test cassette and the necessary items on a clean, level surface.
1. Remove the protective cap from the sterile lancet.
2. Disinfect the fingertip of the middle or ring finger with the enclosed alcohol wipe.
3. Place the lancet against the fingertip and press it firmly. After the puncture, wipe away the first drop of blood.
4. Hold your hand downward and gently massage your finger until another drop of blood forms.
5. Touch the open end of the capillary dropper to the drop of blood. The blood is drawn into the dropper by itself. Wait until the blood reaches the indicator line. Make sure that no air bubbles form.
6. Using the capillary dropper, transfer the blood sample into the sample well marked S of the test cassette.
7. Once the blood has completely entered the sample well, add 1 drop of buffer.
8. Wait for the colored lines to appear. Read the result after 5 minutes. After 10 minutes, the result can no longer be reliably interpreted.
Interpretation of the result
POSITIVE – two lines: C + T
If two colored 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 case of a positive result, it is recommended to consult a doctor and show the test result. The doctor may recommend further examinations if necessary.
A positive result alone does not mean that prostate cancer is present. An elevated PSA level may also occur, for example, in benign prostatic enlargement, therefore the result must always be evaluated together with other clinical information.
NEGATIVE – C line only
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 complaints or symptoms persist, it is recommended to consult a doctor even in case of a negative result.
INVALID – no C line
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 by incorrect performance of the test steps. In this case, the test must be repeated with a new test cassette.
Test performance
Based on a comparative study performed on clinical samples, as reported by the manufacturer:
Positive percent agreement: 99.0%
Negative percent agreement: 99.4%
Overall percent agreement: 99.2%
Detection limit: 4 ng/mL PSA
Important information
The PSA rapid test is a screening test that gives a preliminary result and cannot be used on its own to diagnose prostate disease or prostate cancer. In case of a positive result, further medical examination is required, and in case of persistent complaints it is advisable to consult a doctor even with a negative result.
The instructions for use also point out that certain treatments, such as hormone therapy or manipulation of the prostate, may influence the PSA level.
The kit should be stored at 2–30 °C, must not be frozen, and is intended for single use only.