Prostate Specific Antigen (PSA) Rapid Test

CE APPROVED

 

Intended Use:

Biocan Tell Me Fast Prostate Specific Antigen (PSA) Rapid Test is for the rapid detection of human PSA in serum or plasma at or above the cutoff level of 4 ng/mL to help in the diagnosis of prostate cancer. This assay provides only a preliminary test and not a confirmatory test. All results should be verified with other qualified assays.

Summary and Principle of the assay:

Prostate specific antigen (PSA) is a signal chain glycoprotein containing two hundred forty amino acid residues and four carbohydrate side chains. The complete gene encoding PSA has been sequenced and localized to chromosome 19. PSA functions as a kallikrein-like serine protease and is produced exclusively by the epithelial cells lining the acini and ducts of the prostate gland. It is secreted into the prostatic ducts and at ejaculation it serves to liquefy the seminal coagulum. Many studies confirm that PSA is the most useful and meaningful tumor marker known for prostate cancer. Quantitative PSA detection by enzyme linked immunosorbent assay (ELISA) indicates the range of normal human serum PSA concentration is between 0.1 and 2.6 ng/ml, and the half-life of serum PSA is between 2.2 and 3.2 days. The principle of the PSA Test Kit is double antibody sandwich format. The antibody specific to PSA are conjugated to colloidal gold and incorporated into the strip pad. When the sample is added, PSA in the sample can be captured by specific antibodies conjugated to colloidal gold. Through capillary action, the antigen-antibody-gold complexes migrate along the nitrocellulose membrane and then are captured by the marker-specific antibodies immobilized on the membrane and red color lines will appear on the test zone (T) zone if PSA protein presents in the specimen. Antibody-gold complexes will be captured in the control zone (C) where goat anti-mouse IgG is immobilized. To serve as an internal process control, a control band was designed to indicate that the test is performed properly, and should always be seen after test is completed. Absence of a colored control line in the control region is an indication of an invalid result.    

Prostate Specific Antigen (PSA)

Semi-Quantitative Rapid Test

CE APPROVED

 
  • For early screening and detection of PSA or monitoring patients in remission.

  • Can also be used to monitor patients with a history of prostate cancer.

  • The test has a cut-off value of 3ng/ml and a reference value of 10ng/ml.

  • Easy to use, fast result within minutes, cost effective and requires no special equipment.

  • Completely non-invasive test for screening of prostate cancer.

Intended Use:

Biocan Tell Me Fast Prostate Specific Antigen (PSA) rapid chromatographic immunoassay Rapid Test is for Semi-Quantitative detection of Prostate Specific Antigen in whole blood, serum or plasma to help in the diagnosis of prostate cancer. This assay provides only a preliminary test and not a confirmatory test. All results should be verified with other qualified assays. The test has a cut-off value of 3ng/ml and a reference value of 10ng/ml.

Summary and Principle of the assay:

Prostate specific antigen (PSA) is a signal chain glycoprotein containing two hundred forty amino acid residues and four carbohydrate side chains. The complete gene encoding PSA has been sequenced and localized to chromosome 19. PSA functions as a kallikrein-like serine protease and is produced exclusively by the epithelial cells lining the acini and ducts of the prostate gland. It is secreted into the prostatic ducts and at ejaculation it serves to liquefy the seminal coagulum. Many studies confirm that PSA is the most useful and meaningful tumor marker known for prostate cancer. Quantitative PSA detection by enzyme linked immunosorbent assay (ELISA) indicates the range of normal human serum PSA concentration is between 0.1 and 2.6 ng/ml, and the half-life of serum PSA is between 2.2 and 3.2 days. The prostate specific antigen test is the most valuable tool available for the diagnosis of early prostate cancer. Many studies have confirmed that the presence of PSA is the most useful and meaningful tumor marker known for prostate cancer and prostate infection of Benign Prostatic Hyperplasia (BPH). Biocan Tell Me Fast Prostate Specific Antigen Semi-Quantitative Rapid Test Device (Whole blood /Serum/Plasma) utilizes a combination of colloidal gold conjugate and anti-PSA antibodies to selectively detect total PSA in whole blood, serum or plasma. The test has a cut-off value of 3ng/ml and a reference value of 10ng/ml. Biocan PSA Rapid Test Cassette (Whole Blood /Serum /Plasma) is a semi-quantitative, membrane-based immunoassay for the detection of PSA in whole blood, serum or plasma. The membrane is pre-coated with PSA antibodies on the test line region. During testing, the specimen reacts with the particle coated with anti-PSA antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-PSA antibodies on the membrane and generate a colored line. A test line (1) intensity weaker than the reference line (R) indicates that the PSA level in the specimen is between 3-10ng/ml. A test line (1) intensity equal or close to the reference line (2) indicates that the PSA level in the specimen is approximately 10ng/ml. A test line (1) intensity stronger than the reference line (2) indicates that the PSA level in the specimen is above 10ng/ml. To serve as a procedural control, a colored line will always appear in the control line region (C) indicating that proper volume of specimen has been added and membrane wicking has occurred.

About PSA:

Cancer is a disease in which cells in the body grow out of control. When cancer starts in the prostate, it is called prostate cancer. Not including skin cancer, prostate cancer is the most common cancer in American men. The prostate is a part of the male reproductive system, which includes the penis, prostate, and testicles. The prostate is located just below the bladder and in front of the rectum. It is about the size of a walnut and surrounds the urethra (the tube that empties urine from the bladder). It produces fluid that makes up a part of semen. As a man ages, the prostate tends to increase in size. This can cause the urethra to narrow and decrease urine flow. This is called benign prostatic hyperplasia, and it is not the same as prostate cancer. Men may also have other prostate changes that are not cancer. (Source US CDC) Most prostate cancers grow slowly and don’t cause any health problems in men who have them. Most prostate cancers found by screening are small and slow growing and may not be fatal. Some men may have a faster growing prostate cancer and will benefit from early treatment. Prostate cancer is the most common type of non-skin cancer in men. Studies have suggested that serum prostate-specific antigen (PSA), a protein produced only by prostate tissue and often elevated in patients with prostate cancer, is one of the most useful tumor markers in oncology.

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