Prostate Specific Antigen WB Test Strip

Main technical information of this PSA test kit is listed in the following table:

Former Cat. No.:	PSA 523
Description:	Prostate Specific Antigen WB Test Strip
Category:	Tumor Marker
Style:	Dipstick
Unit:	PCS
Specimen:	Serum, whole blood, plasma
No. of Step:	One Step
Reading Time:	10-20 Minutes
Cut Off:	4 ng/ml
Specification:	3.0 mm
Quan. or Qual.:	Qualitative
Sensitivity:	98.6%
Specificity:	98.5%
Assay Principle:	Colloidal Gold Chromatographic Immuno Double Antibody Sandwich

The standard kit size of this Prostate Specific Antigen Dipstick test kit is 100 tests per box; 48 boxes per carton.

To save freight cost, sometimes bulk packing is used, meaning test strip, cassette or multi-test panel is packed in single aluminum pouch; 50 or 100 pouches in one plastic bag; and then plastic bags are packed in cartons along with the unfolded boxes for the test kits. In this way, the customers can easily pack the tests into test kits after receiving the bulk packed goods.

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

Materials Provided

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

To carry out the assay with a Prostate Specific Antigen WB Test Strip, Serum, whole blood or plasma should be collected according to the instructions given in the Instruction For Use included in the test kit. After collecting, it is preferable to perform the testing as early as possible; if not viable, the specimen should be stored properly. A general introduction about the collection, and storage of the specimens is given below.

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.

Whole Blood Collection

Whole blood can be collected with blood collection tube with venipuncture into blood collection tube (containing EDTA, citrate or heparin).

Or, by lancet lancing. Clean the area to be lanced with an alcohol swab. Squeeze the end of the fingertip and pierce with a sterile lancet. Wipe away the first drop of blood with sterile gauze or cotton. Take a dropper provided, while gently squeezing the dropper tube, immerse the open end in the blood drop and then gently release the pressure to draw blood into the dropper.

Plasma Collection

Collect blood specimen into a lavender, blue or green top blood collection tube, containing EDTA, citrate or heparin, respectively, by vein puncture.

Separate the plasma by centrifugation.

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

Serum, Whole Blood, Plasma Storage Condition

Test specimens as soon as possible after collecting.

The serum and plasma specimens can be stored up to 3 days at 2-8°C if not tested immediately. These specimens should be frozen at -20°C for longer time storage. Don’t freeze and thaw the specimens for many times.

Whole blood specimens (from venepuncture or fingerstick) should be stored at 2~8°C and must be tested within 24 hours after collection. Do not freeze a whole blood specimen.

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.

Colloidal Gold Chromatographic Immuno Double Antibody Sandwich method is used in this Prostate Specific Antigen WB Test Strip to detect the Prostate Specific Antigen in human Serum, whole blood or plasma specifically. The introduction of this Colloidal Gold Chromatographic Immuno Double Antibody Sandwich testing principle is given blow.

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.