PSA Rapid Test Cassette (Whole Blood/Serum/Plasma) (Qualitative)

Sample

Human whole blood, serum or plasma

Intended Use

The PSA Qualitative Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for qualitative detection of Prostate Specific Antigen in whole blood, serum or plasma.

Storage

Store as packaged at room temperature or refrigerated (2-30 °C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

Precision

Intra-Assay
Assays were carried out to determine assay reproducibility using replicates of 10 tests in three different runs for each of four lots using PSA specimen levels at 0 ng/mL, 4 ng/mL, 10 ng/mL and 20 ng/mL. The specimens were correctly identified >99% of the time.
Inter-Assay
Between-run precision has been determined by using the four PSA specimen levels at 0 ng/mL, 4 ng/mL, 10 ng/mL and 20 ng/mL of PSA in 3 independent assays. Three different lots of the PSA Qualitative Rapid Test Cassette (Whole Blood/Serum/Plasma) have been tested using these specimens. The specimens were correctly identified >99% of the time.

Sensitivity

Sensitivity and Specificity
The PSA Qualitative Rapid Test Cassette (Whole Blood/Serum/Plasma) has been tested with leading commercial PSA ELISA Test using clinical samples.

General Description

Prostate specific antigen (PSA) is produced by prostate glandular and endothelial cells. It is a single chain glycoprotein with a molecular weight of approximate 34 kDa. PSA exists in three major forms circulating in the serum. These forms are free PSA, PSA bound to α1-Antichymotrypsin (PSA-ACT) and PSA complexed with α2-macroglobulin (PSA-MG).
PSA has been detected in various tissues of the male urogenital system but only prostate glandular and endothelial cells secrete it. The PSA level in serum of healthy men is between 0.1 ng/mL and 2.6 ng/mL. It can be elevated in malignant conditions such as prostate cancer, and in benign condition such as benign prostatic hyperplasia and prostatitis. A PSA level of 4 to 10 ng/mL is considered to be in the "gray-zone" and levels above 10 ng/mL are highly indicative of cancer.
Patients with PSA values between 4-10 ng/mL should undergo further analysis of the prostate by biopsy. 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).
The PSA Qualitative Rapid Test Cassette (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 4 ng/mL.