Testsealabs PSA Prostate Specific Antigen Test
Short Description:
Fast & Accurate：Achieve reliable results in minutes.
Simple Operation：No complex equipment required.
High Accuracy：Lab-grade precision you can trust.
Clear Visual Readout：Results are easy to read and interpret.
Certified Quality Systems：Compliant with ISO 13485 and MDSAP.
Room-Temperature Stability：No cold chain needed—easy to transport and store.
Product Specification
| Principle | Chromatographic Immunoassay | Specimen | Serum/Plasma |
| Reading Time | 15 minutes | QMS Certification | ISO 13485 and MDSAP |
| Storage Temperature | 4-30°C | Shelf life | 2 years |
| Format | Cassette | Specification | 25T/40T |
Intended Use
The PSA Prostate Specific Antigen Test is a rapid chromatographic immunoassay for the qualitative detection of PSA in whole blood/serum/plasma.
Summary
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 4 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 10ng/ml is considered to be in the “gray-zone” and levels above 10ng/ml are highly indicative of cancer.
Patients with PSA values between 4-10ng/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 Prostate Specific Antigen Test utilizes a combination of colloidal gold conjugate and PSA antibody to selectively detect total PSA in serum or plasma. The test has a cut-off value of 4 ng/ml and a reference value of 10ng/ml
