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PSA and PSA Test Strip & Cassette

The PSA Rapid Test Kits supplied by Atlas Link Technology Co., Ltd are used as an aid in the diagnosis of prostate cancer.

One Step PSA serum Test Kit

Intended Use

PSA rapid test kits, also known as one-step PSA tests, are a rapid direct binding PSA immunoassay for the qualitative detection of Prostate Specific Antigen (PSA) in human serum specimen. These in-vitro diagnostic (IVD) rapid PSA Test Kits are used as an aid in the diagnosis of prostate cancer, and also to be used to screen other men under higher risk of prostate cancer.

Atlas Link Technology Co., Ltd would like to offer quality PSA rapid test Strips and PSA test cassette at competitive prices.

Who should take the PSA test

Based on the lateral flow chromatography principle, monoclonal and polyclonal antibodies are employed to identify the PSA tumor marker specifically. When PSA concentration is higher than 4 ng/mL, two lines will develop indicating a positive result; when it lower, one line on control region and a negative result.

A blood test to measure Prostate-specific antigen (PSA) is considered the most effective test currently available for the early detection of prostate cancer. The rapid test kits are used to screening men faced with high risk of prostate cancer, especially over 50 years old.

PSA as a Tumor Marker

PSA refers to a protein produced by the cells of the prostate gland. PSA is normally present in low concentration in the blood of all adult men. In human blood, the normal concentration range of this biomarker is 0.0 to 4.0 ng/ml, and PSA levels between 4 and 10 ng/mL are considered to be suspicious of prostate cancer or other prostate disorders such as prostatitis, benign prostatic hyperplasia (BPH).

Prostate Specific Antigen (PSA) Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
PSA 521 PSA Rapid Test Strip serum 100 Bulk: 6000 PCS
Boxed: 48 Boxes
PSA 522 PSA Rapid Test Cassette serum 25 Bulk: 1600 PCS
Boxed: 40 Boxes
How to Use

PSA Rapid Test Strip

General Information

(IVD Kit »-» Tumor Marker -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:PSA 521
Description:PSA Rapid Test Strip
Category:Tumor Marker
Style:Dipstick
Unit:PCS
Specimen:serum
No. of Step:One Step
Reading Time:10-20 Minutes
Cut Off:4 ng/ml
Specification:3.0 mm
Quan. or Qual.:Qualitative
Sensitivity:100%
Specificity:99.5%
Method:Lateral Flow Double Antibody Sandwich

Packing Specification

Tests per Kit:100 Tests
Box Dimension:21.0 * 12.5 * 5.5 CM
Kits per CTN:48 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):6000 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):16.0 KG

Materials Provided in the Test Kit

  • Lateral Flow immunochromatographic assay (GICA) Strip;
  • Instruction leaflet;
  • Disposable urine cup (optional).

Specimen

Serum Collection

Collect blood specimen into a red top blood collection tube by vein puncture, which contains no anticoagulants.

Allow the blood to clot, or separate the serum by centrifugation.

Carefully withdraw the serum into a new pre-labeled tube.

serum Storage Condition

Test specimens as soon as possible after collecting. The specimens can be stored up to 5 days at 2-8°C if not tested immediately. The specimens should be frozen at -20°C for longer time storage. Don’t freeze and thaw the specimens for many times. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing. Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.

Testing Principle of Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

In the double antibody sandwich lateral flow chromatographic rapid test, two antibodies are used to detect viral protein or antigen.

In the test band region, antibody specific to the target antigen or protein is immobilized. In the end of the membrane strip where the samples are added, another antibody conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antibody conjugate particles will resolve into the specimen, where the antibody conjugate will react and bound to the target protein or viral antigen, if present.

This antigen-antibody conjugate complex then moves along the strip to the testing band region, under capillary effect. The immobilized antibody in the test line region then bound to another binding site on the antigen complex, and the antibody-antigen-antibody complex is fixed on test band region.

When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target protein or antigen in the specimen, the colloidal gold particles will not congregate and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

PSA Rapid Test Cassette

General Information

(IVD Kit »-» Tumor Marker -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:PSA 522
Description:PSA Rapid Test Cassette
Category:Tumor Marker
Style:Card
Unit:PCS
Specimen:serum
No. of Step:One Step
Reading Time:10-20 Minutes
Cut Off:4 ng/ml
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:100%
Specificity:99.5%
Method:Lateral Flow Double Antibody Sandwich

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:40 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1600 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):14.0 KG
GW per CTN (Bulk):16.5 KG

Materials Provided in the Test Kit

  • Test cassette in single foil pouch with desiccant;
  • Disposable sample dropper;
  • Instruction leaflet.

Specimen

Serum Collection

Collect blood specimen into a red top blood collection tube by vein puncture, which contains no anticoagulants.

Allow the blood to clot, or separate the serum by centrifugation.

Carefully withdraw the serum into a new pre-labeled tube.

serum Storage Condition

Test specimens as soon as possible after collecting. The specimens can be stored up to 5 days at 2-8°C if not tested immediately. The specimens should be frozen at -20°C for longer time storage. Don’t freeze and thaw the specimens for many times. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing. Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.

Testing Principle of Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

In the double antibody sandwich lateral flow chromatographic rapid test, two antibodies are used to detect viral protein or antigen.

In the test band region, antibody specific to the target antigen or protein is immobilized. In the end of the membrane strip where the samples are added, another antibody conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antibody conjugate particles will resolve into the specimen, where the antibody conjugate will react and bound to the target protein or viral antigen, if present.

This antigen-antibody conjugate complex then moves along the strip to the testing band region, under capillary effect. The immobilized antibody in the test line region then bound to another binding site on the antigen complex, and the antibody-antigen-antibody complex is fixed on test band region.

When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target protein or antigen in the specimen, the colloidal gold particles will not congregate and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle