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AZP Dot Assay Kits

anti-Zona Pellucida IgG and IgM Dot Assay kits are intended to be used as a convenient and rapid aid in the analysis of woman infertility.

Anti-Zona Pellucida IgG DOT Assay Kit

Intended Use

Atlas Link Technology Co., Ltd is supplying two Dot assay kits for the detection of AZP antibodies, namely AZP IgG test kit and AZP IgM test kit, which are intended to be used to respectively detect antibody isotypes of IgG and IgM specific to the Zona Pellucida, and are intended to be used as a convenient and rapid aid in the analysis of woman infertility.

AZP Testing Principle

anti-Zona Pellucida IgG and IgM Dot Assay kits are rapid test based on the Gold Immuno-filtration Assay (GIFA) principle. In these rapid test kits, purified Zona Pellucida antigen is used as marker, and secondary antibodies, i.e. mouse anti-human IgM, or IgG antibody, conjugated with colloidal gold is used as detector. During the assay test, the IgM or IgG antibody specific to Zona Pellucida, if presents in the serum specimen, antigen+AZP+anti-human-colloidal gold complex will develop in the test spot region, and colored spot will appear, indicating a positive result.

How AZP Causes Infertility

Many immunological reasons have been suggested on how AZP causes infertility. For example, when anti-ZP antibodies present, they can bind with the ZP3, one of the four major zona pellucida glycoproteins which allow species-specific sperm binding, thus will prevent the sperm from binding to the zona pellucida. And when AZP binds with the zona pellucida, the antigen-antibody complex may hinder the sperm from entering the zona pellucida even the sperm binding happen, and block the sperm-ovum interaction and ultimately from fertilizing the ovum.

Zona Pellucida

The zona pellucida is a glycoprotein membrane surrounding the plasma membrane of an oocyte. The zona pellucida is essential for oocytes fertilization. In the process of fertilization, spermatozoa fuse with the zona pellucida which surrounds the mature oocyte; the resulting acrosome reaction breaks down the egg's tough coating so that the sperm can fertilize the ovum. In women body, five days after the fertilization, the blastocyst performs zona hatching; the zona pellucida degenerates and decomposes to be replaced by the underlying layer of Zona Pellucida cells.

Anti-Zona Pellucida (AZP) Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
AZP I712 Zona Pellucida IgM Dot Assay serum 25 Bulk: 1200 PCS
Boxed: 36 Boxes
AZP I722 Pellucida IgG Dot Assay serum 25 Bulk: 1200 PCS
Boxed: 36 Boxes
How to Use

Zona Pellucida IgM Dot Assay

General Information

(IVD Kit »-» Immunological Infertility -» Dot Immuno Gold Filtration Assay)

Catalog No.:AZP I712
Description:Zona Pellucida IgM Dot Assay
Category:Immunological Infertility
Style:DOT Card
Unit:PCS
Specimen:serum
No. of Step:Two Step
Reading Time:3 Minutes
Cut Off:
Specification:25T
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Method:DGFIA Capture

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:36 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1200 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):15.0 KG

Materials Provided in the Test Kit

  • Filtration assay device;
  • Washing buffer Gold colloidal Conjugate solution;
  • Disposable dropper for sample transfer;
  • Instruction for use.

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 DGFIA Capture

DGFIA Capture Method Illustration

For the detection of IgM-class antibodies, capture technique has its advantage in that it can reduce the interference from the IgG class, thus increase the specificity of the test kit.

In a capture dot filtration test kit, antibodies directed to human IgM antibody (anti-i chain) are pre-coated in the test region on the millipore filtering membrane. When specimen is added, the IgM, if present, will be captured by this secondary antibody, anti-IgM.

After washing away the specimen, especially the IgG antibody, the antigen conjugated with colloidal gold particle will be added. If the IgM antibody was captured in the prior step, the IgM will bind to the antigen conjugate. When the colloidal gold particles congregate, a red or pink color will develop, indicating a positive result.

If no IgM in the specimen, this complex will not develop, the antigen conjugated colloidal gold particles will not congregate, and no color will develop in the test region, indicating a negative result.

Information | Packing | Specimen | Principle

Pellucida IgG Dot Assay

General Information

(IVD Kit »-» Immunological Infertility -» Dot Immuno Gold Filtration Assay)

Catalog No.:AZP I722
Description:Pellucida IgG Dot Assay
Category:Immunological Infertility
Style:DOT Card
Unit:PCS
Specimen:serum
No. of Step:Two Step
Reading Time:3 Minutes
Cut Off:
Specification:25T
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
Method:DGFIA indirect

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:36 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1200 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):15.0 KG
GW per CTN (Bulk):15.0 KG

Materials Provided in the Test Kit

  • Filtration assay device;
  • Washing buffer Gold colloidal Conjugate solution;
  • Disposable dropper for sample transfer;
  • Instruction for use.

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 DGFIA indirect

DGFIA Indirect Method Illustration

With indirect Dot filtration test kit, the millipore filtering membrane is pre-coated with purified or recombinant viral antigens. The detecting conjugate reagent is stored in a vial, whose main component is rabbit anti human IgG (anti-IgG) antibodies, which is conjugated with colloidal gold particles.

During the first step, sample is added to the sample well in the test cassette. The target IgG antibodies, if present, will be captured by the pre-coated antigens.

The wells are washed to remove unbound serum proteins. Then, the colloidal gold conjugate is added. If the target IgG antibodies have been captured in the first step, the IgG antibody will react with the added secondary antibody, anti-IgG conjugate, and red color will develop, indicating a positive result.

Information | Packing | Specimen | Principle