CE 100% Specificity Early Detection Helicobacter Pylori Rapid Test Kit

Product Specification

H. Pylori Antigen Detection Test Kit

For the qualitative detection of Antigens to H. pylori in feces

Main Features

☀ High Sensitivity: 100%

☀ Specificity: 100%

☀ Reliable: Accuracy higher than 97.5%, early detection of the presence of H.Pylori Antigens

☀ Simple: No Instrument Required

☀ Convenient: Room Temperature Storage, Built-In Control Line

☀ Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes

☀ Certified by Authoritative Certification System and Standards

☀ Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"

Summary and Explanation of The Test

The infection of Helicobacter pylori (H. pylori) is associated with a variety of gastro-intestinal diseases, such as stomach ulcer, chronic active gastritis and gastric, duodenal and gastric adenocarcinoma. Antibodies to H.Pylori are developed in individuals infected with H. pylori as a serological response. Detecting these specific antibodies to H. pylori can be used as a qualitative assay in the diagnosis of H. pylori infection. It may be used either as an adjunction to endoscopy or as an alternative measure in symptomatic patients.

The H. pylori Antigen Detection Test kit is a chromatographic immunoassay (CIA) for the rapid determination of antigens to H. pylori in feces specimens. The test is to be used as an aid in the diagnosis of infection due to H. pylori.

Principle

The H. pylori Rapid Test is a lateral flow, immune chromatographic - screening test. H. pylori antigens are precoated onto membrane as a capture reagent on the test band region. During the assay the specimen feces is allowed to react with H.pylori antibodies-gold conjugate. The mixture then moves laterally on the membrane chromatographically to the test region with immobilized antibodies of H. pylori. If H. pylori antibodies are present in the specimen, two red bands are formed on the test cassette. One red band in the control region indicates a negative result.

Reagents and Materials Provided

1. Test Device: A pouch contains a single test for HPAg and a desiccant.

2. Sample collection (with diluent).

3. Instruction for use.

Materials Required But Not Provided

Clock or Timer

Warning and Precautions

1. For in vitro diagnostic use only.

2. All patient samples should be treated as if capable of transmitting diseases.

3. Do not interchange reagents from different lots or use test kit beyond expiration date.

4. Interference substance in the samples or failed operation may cause false result. Please retest with a new one or use other way to confirm.

5. Patient specimens may contain infectious agents and should be handled as capable of transmitting disease. Wear disposable gloves throughout the specimen collection and assay procedures.

Storage

The H. pylori Rapid Test should be stored at temperature 4-30°C the sealed pouch for the duration of the shelf life (24months).

Do the test in 1 hour when you open the pouch

Sample Collection and Preparation

1. Collect stool sample by using the sample collection device provided.

2. Unscrew the top of the sample collection device, take out the sample collection stick, and collect the sample by dipping the stick into 3 different places of the stool sample.

3. Put the sample collection stick back in the sample collection device and screw together tightly.

4. If the sample cannot be tested on the day of collection, store the stool sample at 4℃ for up to 7 days. Bring the specimen to room temperature before test.

Assay Procedure

1. Remove the test device from foil pouch by tearing along the notch.

2. Specimen collection. Please see Specimen Collection and Preparation.

3. Shake the sample collection device several times.

4. Holding the sample collection device upright, carefully screw off the cap of collection device.

5. Squeeze 2-3 drops (80-100ul) of the sample solution on the test cassette.

6. Observe the result in15 minutes.

Interpretation of Results

Negative: Only one pink band appears. This indicates that no H. pylori antibodies have been detected.

Positive: Two pink bands appear. This indicates that the specimen contains H. pylori antibodies.

Invalid: If no band appears, this indicates a possible error in performing the test. The test should be repeated using a new device.