Prostate Specific Antigen Rapid Test Device

Intended Use

Prostate Specific Antigen Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of prostate specific antigens in human whole blood, serum, or plasma specimens. Prostate Specific Antigen Rapid Test Device is intended for use as an aid in the diagnosis of prostate cancer.

Introduction

Prostate cancer is the most frequent type of cancer found in the man and the second cause of death due to the cancer in man. Prostate cancer incidences increase dramatically in males with an age over 40 years, occurring in 50% of those over 70 years.

Specimen Collection and Storage

● The PSA Rapid Test Device (Whole Blood/Serum/Plasma) is intended for use with human whole blood, serum, or plasma specimens only.

● Intake of Finasteride (5-reductaseinhibitor) will reduce the PSA concentration by max. 50%. This should be considered by the interpretation of the results.

● Different factors could increase the PSA level in blood serum and should be avoided before collection of the blood sample and/or should be desisted from by the patient before sample taking.

■ Ride on a bicycle: 24 hours before taking of blood sample

■ Sexual activities (Ejaculation): 24-48 hours before taking of blood sample

■ Every manipulation of the prostate by medical examinations. The following intervals are recommended until taking of blood sample:

● Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.

● Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.

● Containers containing anticoagulants such as EDTA, citrate, or heparin should be used for whole blood storage.

● Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.

● If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.

● Icteric, lipemic, hemolysed, heat treated and contaminated specimens may cause erroneous results.

Test Procedure

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