Color: | Blue | Format: | Cassette |
---|---|---|---|
Specimen: | Feces | Storage: | 2-30°C |
Shelf Time: | 24months | Certificate: | CE |
Highlight: | rapid diagnostic test kits,One Step Rapid Test |
Aaccurate PSA Rapid Test Cassette Whole Blood / Serum / Plasma
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.1 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).2
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 3 to 10ng/ml is considered to be in the “gray-zone” and levels above
10ng/ml are highly indicative of cancer.3 Patients with PSA values between 3-10ng/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).4
The PSA 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.
PRINCIPLE
The 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 (T) intensity weaker than the
reference line (R) indicates that the PSA level in the specimen is between 3-10ng/ml. A test line (T) intensity
equal or close to the reference line (R) indicates that the PSA level in the specimen is approximately 10ng/ml.
A test line (T) intensity stronger than the reference line (R) 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.
How to use?
REAGENTS
The cassette contains PSA monoclonal antibody particles and PSA monoclonal antibody coated on the membrane.
Applications:
The PSA Prostate Specific Antigen Semi-Quantitative Rapid Test Cassette (Whole Blood /Serum /Plasma) is a
rapid chromatographic immunoassay for semi-quantitative detection of Prostate Specific Antigen in whole blood,
serum or plasma.
Specifications
Model |
A rapid test for the qualitative detection of Prostate Specific Antigen (PSA) in whole blood, serum |
Format |
Strip, Cassette |
Accuracy |
99.2% |
Shelf life |
24months |
Component |
Test cassettes, Droppers, Package insert, Sample dilution tube |
Specimen |
Serum/Plasma/Blood |
Storage |
2-30°C |
Read time |
20 mins |
Others |
The kits can be made according to the customers' artwork or design |
STORAGE AND STABILITY
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.