H.Pylori Antigen Feces Test Cassette
H.Pylori Antigen Feces Test Cassette (幽门氏菌抗原粪便测试卡) is a one-step qualitative lateral flow rapid diagnostic test kit, based on the Colloidal Gold Chromatographic Immuno Double Antibody Sandwich principle, which is used to detect Helicobacter Pylori Antigen in human Human Feces specimen.
IFU, CE and ISO
Please refer to the Instruction for Use (IFU), related CE and ISO13485 certificates for H.Pylori Antigen Feces Test Cassette as follow:
- IFU of H.Pylori Antigen Feces Test Cassette
- Notification Form
- CE Self-Declaration of Conformity (DOC)
- Clinical Report
- Materials Safety Data Sheet (MSDS)
- ISO13485:2006 Certificate
All the documents and certificates provided here on the website are subjected to changes without prewarning. Please check with your sales manager for the latest version for practical uses, such as product registration; before carrying out an assay, reading the Instruction for Use included in the test kit is always a good practice.
Detailed information of H.Pylori Antigen Feces Test Cassette
- General and Technical information of this HP test kit;
- Packing specification of this HP Card style test kit (gross weight in full kit package and in bulk packing);
- Specimen used to carry out the assay, and the requirements on specimen collection, storage and processing; and,
- Specific immuno assay principle used in this Helicobacter Pylori Test Kit.
Main technical information of this H.Pylori test kit is listed in the following table:
|Catalog No.:||HP 922|
|Description:||H.Pylori Antigen Feces Test Cassette|
|Category:||Digestive Track Disease|
|No. of Step:||One Step|
|Reading Time:||15 Minutes|
|Quan. or Qual.:||Qualitative|
|Assay Principle:||Colloidal Gold Chromatographic Immuno Double Antibody Sandwich|
The standard kit size of this Helicobacter Pylori Card test kit is 25 tests per box; 35 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:||25 Tests|
|Dimension of Kit Box:||21.0 * 12.5 * 6.5 CM|
|Boxes per Carton:||35 Kits|
|Tests per Carton (BULK):||1200 Tests|
|G.W. per Carton (Boxed):||13.6 KG|
|G.W. per Carton (Bulk):||13.6 KG|
|Carton Dimension:||53 * 45 * 36 CM|
|Carton Volume:||0.085 CBM|
- Rapid test cassette in individual pouch;
- Single Sample Collection Tube with 2ml of 0.9% NaCl and 0.02% sodium azide;
- Instruction Insert.
To carry out the assay with a H.Pylori Antigen Feces Test Cassette, Human Feces 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.
Collect feces into a clean, dry specimen collection container.
Unscrew the cap of the specimen collection tube, and randomly poke the specimen collection stick fixed in the cap into the fecal specimen on at least 3 different sites. Do not scoop the fecal specimen.
Tighten the cap of the specimen collection tube, and shake the tube vigorously to mix the specimen and the extraction buffer.
The mixed liquid is the specimen that can be tested immediately.
Human Feces Storage Condition
Best results will be obtained if the assay is performed within 6 hours after collection.
Specimen prepared in the specimen collection tube may be stored for 6 months at -20°C.
Let the specimen come to room temperature naturally before testing the refrigerated specimens.
Colloidal Gold Chromatographic Immuno Double Antibody Sandwich method is used in this H.Pylori Antigen Feces Test Cassette to detect the Helicobacter Pylori Antigen in human Human Feces 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.