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H.Pylori Test Kits

HP IgM and IgG Dot Assay kits, HP antibody and antigen rapid test kits are available.

H.pylori Antigen and antibody Rapid Test Cassettes

H.Pylori Test Kits

H.Pylori Test cassette with specimen collecting tube

H.Pylori antibody rapid test Kit is a rapid medical testing device based on the principle of lateral flow chromatographic immunoassay principle, for the qualitative detection of antibodies of all isotypes (IgG, IgM, IgA, etc.) specific to Helicobacter pylori in human serum, plasma or whole blood specimen. H.pylori antigen feces test kit is an immunoassay for the detection of H.pylori antigen in human feces specimen. And H.pylori IgG and IgM dot filtration test kits are rapid test kits based on the principle of dot filtration immunoassay, used to detect IgG and IgM antibody to Helicobacter pylori in human serum or plasma.

All these rapid H.pylori test kits are intended to be used as an aid in the diagnosis of H.pylori infections in patients with gastrointestinal symptoms; and are recommended for professional use.

CE marked H.Pylori Antigen Test

For H.Pylori Antigen Rapid Test kit, we have undergone the notification process with EU notified party TUV through our EU Representative, and thus got permission to print CE mark on this product. Documents and Certificates related with our this H.Pylori Antigen test kit can be downloaded as shown below:

Stomach Ulcers

Helicobacter pylori is a bacterium that lives on the lining of the stomach, which is the main cause of stomach ulcers. Studies shows that 90% stomach ulcers are caused by H. pylori.

Stomach ulcers can be cured with the right antibiotics. Before this treatment, the doctor must make certain whether it is caused by H.pylori bacterium. Several techniques, both invasive and non-invasive are utilized to diagnose H.pylori infection. In the in-vitro test realm, both H.pylori antibody test and antigen test are available. H.pylori serum test kits are used to detect anti-H.pylori specific antibody, mostly IgG antibodies in a patient's blood. This Serological approach detects the host's immune response to the infection, but does not distinguish a current active infection from a past infection. In addition, the antibody titer does not change during the treatment, and make the serum test not suitable for the prognosis use.

Helicobacter Pylori Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
HP 921 H.Pylori AB Test Cassette serum/WB/plasma 25 Bulk: 1600 PCS
Boxed: 40 Boxes
HP 922 H.Pylori AG Feces Test Card human faeces 25 Bulk: 1200 PCS
Boxed: 35 Boxes
HP 9212 H.Pylori IgM Dot Assay serum 25 Bulk: 1200 PCS
Boxed: 36 Boxes
HP 9222 H.Pylori IgG Dot Assay serum 25 Bulk: 1200 PCS
Boxed: 36 Boxes
How to Use

H.Pylori AB Test Cassette

General Information

(IVD Kit »-» Digestive Track Disease -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:HP 921
Description:H.Pylori AB Test Cassette
Category:Digestive Track Disease
Style:Card
Unit:PCS
Specimen:serum/WB/plasma
No. of Step:One Step
Reading Time:10 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:95.9%
Specificity:89.6%
Method:Lateral Flow Double Antigen 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.

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/WB/plasma Storage Condition

Test specimens as soon as possible after collecting.

The specimens can be stored up to 3 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 Antigen Sandwich

GICA Double Antigen Sandwich Method Illustration

Double antigen sandwich technology is commonly used to detect total antibody, which include IgM, IgG and IgA antibodies, which all can react and bound to specific antigen. In the lateral flow double antigen sandwich chromatographic rapid test, recombinant or purified antigens are used to capture and detect the total antibodies specifically.

In the test band region, purified or recombinant antigens or proteins are immobilized. In the end of the membrane strip where the samples are supposed to be added, another antigen 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 antigen conjugate particles resolve into the specimen, where the antigen conjugate will react and bound to the target antibodies, if present.

This antibody-antigen conjugate complex then moves along the strip to the testing band region, under capillary effect. Where the immobilized antigen captures the complex, and the antigen-antibody-antigen-colloidal gold 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 antibody in the specimen, the colloidal gold particles will not congregate on the test band region, and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

H.Pylori AG Feces Test Card

General Information

(IVD Kit »-» Digestive Track Disease -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:HP 922
Description:H.Pylori AG Feces Test Card
Category:Digestive Track Disease
Style:Card
Unit:PCS
Specimen:human faeces
No. of Step:One Step
Reading Time:15 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:
Specificity:
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:35 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1200 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):13.6 KG
GW per CTN (Bulk):13.6 KG

Materials Provided in the Test Kit

  • Rapid test cassette in individual pouch;
  • Single Sample Collection Tube with 2ml of 0.9% NaCl and 0.02% sodium azide;
  • Instruction Insert.

Specimen

Faeces Preparation

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 faeces 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.

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

H.Pylori IgM Dot Assay

General Information

(IVD Kit »-» Digestive Track Disease -» Dot Immuno Gold Filtration Assay)

Catalog No.:HP 9212
Description:H.Pylori IgM Dot Assay
Category:Digestive Track Disease
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

H.Pylori IgG Dot Assay

General Information

(IVD Kit »-» Digestive Track Disease -» Dot Immuno Gold Filtration Assay)

Catalog No.:HP 9222
Description:H.Pylori IgG Dot Assay
Category:Digestive Track Disease
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