PSA4 Prostate Cancer Screening Test
 

confidential, quantitative diagnostic test performed at home for determining elevated Prostate Specific Antigen (PSA) levels. High blood serum PSA readings have been confirmed and validated as a significant marker for abnormal prostate function including malignant cancerous tumors. A PSA level blood screen plus a digital palpitation examination is recommended for all men aged fifty and older as part of the routine physical examination.

INTENDED USE:

The PSA4 (Prostate Specific Antigen) Screening test is a quantitative screening test to identify PSA system levels in whole blood. System PSA levels of 3 ng/ml or greater are generally accepted to be an indication that further evaluation and consultation with a healthcare professional is warranted. The  PSA4 Prostate Cancer Screening Test provides the same clinical results that can be obtained from a local medical laboratory without the high expense and inconvenience of physician appointments, laboratory fees, and often painful and unnecessary procedure of direct venous or arterial blood draws. The test is performed at home, takes less than 10 minutes and results are obtained in approximately the same time as those routinely ordered through a physician. 

PRINCIPLES OF THE TEST

Prostate Specific Antigen (PSA) is secreted by the epithelial cells of the acini and ducts in the prostate gland. Normal total PSA concentration in whole blood is 0.1-2.6 ng/ml PSA. Laboratory and medical research studies have determined that elevated levels of PSA is a most useful tumor marker in the preliminary diagnosis of prostate cancers. Normal levels are generally agreed to range up to 3 ng/ml PSA, elevated levels up to 9 ng/ml and levels over 9 ng/ml as extremely abnormal. High PSA levels are not definitive in themselves as a diagnosis of prostate cancer. Other procedures are necessary to confirm a diagnosis including ultrasound and biopsy. Benign Prostatic Hyperplasia (BPH) or enlargement of the prostate is very common in men over fifty and typical symptoms mimic more serious prostatic complications thus necessitating further examination. However, as with most cancers, early detection can greatly improve the successful treatment of the disease and the PSA4 Screening Test can provide valuable information in that regard.

TEST COMPONENTS PROVIDED

 FDA approved PSA Sample Collection Kit: Pre-treated sample card, finger lancet, gauze, alcohol swab, band-aid, test form and instruction manual (English/Spanish)
 Prepaid laboratory mailer
 Prepaid quantitative PSA analysis by CLIA Certified Laboratory
•  Laboratory notification, andd explanation of test results within 5 days

TEST PROCEDURE

The PSA4 test is very easy to perform in the privacy, confidentiality and convenience of the home. The Five basic steps:  The carbonless sample identification form is filled out, A blood sample is obtained through a simple finger prick using the virtually painless, spring loaded lancet, the sample blood is applied to special predefined areas on a sample collection card, a copy of the completed form, the collection card are then placed in the pre-addressed, postage paid mailer and sent to the laboratory. Test results are then returned within five days.

 

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The PSA4 Prostate Cancer Screening Test is FDA approved and available for home or professional use


    
Item :   PROST-1000           Prostate Cancer Screening test

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