H. Pylori Antibody Test Kits (box of 25 kits)

H. Pylori Antibody Test Kits (pouch of 1 kit)

H. Pylori Antigen Test Kits (box of 25 kits)

H. Pylori Antigen Test Kits (pouch of 1 kit)

*Packaging color may differ according to distribution region.

H. Pylori Test Kits

AccuQuik™ Diagnostic Detection

H. Pylori Test Kits are a point-of-care diagnostic tool used to detect the presence or absence of the bacteria Helicobacter pylori. This product is manufactured by AdvaCare Pharma, a pharmaceutical company certified by CE and ISO standards.

Type

Specimen

Form

Packaging

What are H. Pylori Test Kits?

Product Category:

Rapid Test Kits

Indicated Use:

Sub-Category:

Infectious Disease

H. Pylori Test Kits are medical diagnostic tools used to detect the presence of Helicobacter pylori (H. pylori) bacteria within a patient's stomach and upper digestive tract. This bacteria can cause a number of gastrointestinal conditions, such as gastritis, peptic ulcer disease, and stomach cancer.

Rapid testing can increase the likelihood of early detection and treatment of H. pylori infections, which can help to prevent serious complications for some patients. Helicobacter pylori diagnostic tests are available in two forms: H. pylori antibody test kits or H. pylori antigen test kits.

Both the antigen and antibody test kits feature immunochromatographic assays. These tests offer rapid results, usually within 10-15 minutes.

AdvaCare Pharma is a reputable manufacturer of H. Pylori Test Kits, which are produced in ISO and CE-certified facilities in India, China, and the USA. Every facility is regularly inspected to ensure they are compliant with healthcare standards for quality and safety.

Product Specifications

Type

Specimen

Form

Helicobacter Pylori Antibody Test Kit

Helicobacter Pylori Antibody Test Kit is a rapid qualitative assessment used to detect the presence of H. pylori antibodies within a whole blood or serum/plasma sample. Antibodies are produced in response to an infection.

The Helicobacter pylori antibody test kit is available as a strip or a cassette, which contains a strip inside of a plastic box. The test strip is coated with antigens that are specific to the bacteria H. pylori. Any antibodies in the blood will bind to the antigens on the strip and cause a visible sign, which indicates a positive result.

Helicobacter Pylori Antigen Test Kit

Helicobacter Pylori Antigen Test Kit is a qualitative assessment that is used to detect the presence of H. pylori antigens, which are proteins produced by the bacteria.

The rapid test is available as a strip or a cassette with a strip inside of it. The test strip is coated with antibodies specific to H. pylori antigens. When a stool sample is administered to the strip, the antigens in the fecal specimen will bind to the antibodies, causing a visible line to appear on the strip.

Whole Blood

Whole Blood specimen is required for this style of test. Collect blood using the standard venipuncture (2 drops) or fingerstick (50 μL) techniques. This specimen is transferred with a capillary tube or dropper to the assigned area of the cassette, where a drop of the corresponding buffer dilution will be added immediately afterward to proceed with the test.

Serum/Plasma

Serum/Plasma specimen is required for this style of test. The specimen of serum or plasma is transferred after centrifugation with a capillary tube or dropper to the assigned area of the cassette. Then, a drop of the corresponding buffer dilution will be added immediately afterward to proceed with the test. The test result will appear as positive, negative, or invalid.

Fecal Swab

Fecal Swab is used to take a sample of cells from the stool sample. The long, thin part of the swab is made of plastic. There is a tip at the end of the swab that is inserted into the stool sample and rotated to ensure that the entire tip area of the swab is in contact with the sample. The swab comes in a sterile blister pack. After collecting the sample, the swab is placed in a buffer dilution to proceed with the test.

Cassette

Cassette consists of a plastic box that contains a test strip inside. Each cassette has an area for sample placement and a window to view the results, which will appear as positive, negative, or invalid.

The test strip inside contains reagents that will produce a visible line as the test result.

Strip

Strip is a thin piece of plastic containing reactive agents. Each strip features an area specific for sample application and an area in which the test results appear.

The strip features an immunochromatographic assay-based test, or a lateral flow assay, that is used for the qualitative detection of Helicobacter pylori in a sample.

Why are we a top H. Pylori Test Kits manufacturer?

AdvaCare Pharma is a reliable manufacturer of H. Pylori Test Kits, a product within the AccuQuik™ brand of diagnostic detection devices. Our production facilities are held to stringent CE and ISO standards. As a manufacturer of rapid test kits, AdvaCare Pharma partners with an extensive global network of institutions, including hospitals, pharmacies, distributors, and more.

For 20 years, AdvaCare Pharma has been dedicated to providing premium and affordable pharmaceutical products for an ever-changing global community. We prioritize our partners and pride ourselves on building lasting and mutually beneficial relationships.

Uses

How should H. Pylori Test Kits be used?

The utilization of H. Pylori Test Kits is integral to diagnosing the presence of Helicobacter pylori (H. pylori) bacteria in patients. These kits come in two main types: H. pylori antibody test kits and H. pylori antigen test kits.

The process for using these kits involves several steps to obtain accurate and reliable results:

The appropriate sample must be collected from the patient. For antibody tests, this involves obtaining whole blood or serum/plasma samples, while antigen tests require a fecal swab sample.
Carefully administer the sample to the designated area on the test kit. For antibody tests, the blood sample is applied to the test strip or cassette, while for antigen tests, the fecal swab is utilized.
Add the corresponding buffer solution to the test area immediately. This buffer solution aids the reaction between the sample and the testing components, allowing for the detection of H. pylori antibodies or antigens.

It takes 10-15 minutes for results to appear. During this waiting period, follow the instructions included with the test kit closely. Results should be interpreted based on the appearance of visible lines or indicators on the test strip or cassette. A positive result indicates the presence of H. pylori antibodies or antigens in the sample, while a negative result suggests their absence.

How should H. Pylori Test Kits be disposed of?

Once H. Pylori Test Kits have been used for diagnostic purposes, adequate disposal minimizes the risk of contamination and encourages compliance with safety regulations. Given that these kits involve handling biological specimens, they fall under the category of biohazardous waste.

To dispose of used H. Pylori Test Kits, follow local regulations governing medical waste management. This involves sealing all components of the used kits, including test cassettes or strips, in a secure manner to prevent any potential leakage or contamination.

Biohazard bags or containers specifically designated for infectious waste should be utilized for disposal. Healthcare facilities or laboratories may have specific protocols or procedures in place for the disposal of medical waste, including used diagnostic test kits. Become familiar with these guidelines and adhere to them accordingly to guarantee safe and appropriate disposal practices.

How should H. Pylori Test Kits be stored?

These kits contain sensitive components that can be affected by environmental factors such as temperature, humidity, and light exposure. Unused H. Pylori Test Kits should be stored in a controlled environment that meets the following criteria:

Temperature: Exposure to extreme temperatures, both cold and heat, should be avoided to prevent damage to the test components.
Moisture: The storage area must be dry, as exposure to moisture can compromise the integrity of the test kits. Humid environments can lead to the degradation of test materials and potential contamination, rendering the kits unusable.
Light: Minimize direct exposure to sunlight or artificial light sources, as ultraviolet (UV) radiation can degrade the sensitive reagents and components of the test kits. Therefore, storage in opaque containers or cabinets is recommended to protect the kits from light exposure.

FAQs

How does an H. Pylori Test Kit work?

Both the antibody and antigen testing kits utilize immunochromatographic assays.

What is H. Pylori?

Helicobacter pylori is a type of bacteria that may cause an infection in the stomach and upper small intestines. Though many individuals do not develop symptoms, it is a common infection throughout the world.

Who should be tested with an H. Pylori Test Kit?

Rapid gastrointestinal disorder test kits are recommended for patients with symptoms of certain gastrointestinal conditions, such as peptic ulcer disease, gastritis, dyspepsia, or persistent stomach pain. Testing is also a recommended tool for those with a past infection of H. pylori or those patients who have been previously treated for the infection.

H. pylori tests are also used as a screening tool for patients with a high risk of developing stomach cancer or other complications due to infection with the bacteria.

Should an H. Pylori Antibody Test Kit or H. Pylori Antigen Test Kit be used?

It is dependent on the patient's specific situation and the purpose of administering the test. An antibody test is able to detect the presence of an immune system response to a previous or current infection. #However, it is more effective at detecting a past infection as it takes time for the body to start producing antibodies.

An antigen test is recommended for diagnosing a current infection, particularly in patients with symptoms of peptic ulcer disease or gastritis.

How long before results display on an H. Pylori Test Kit?

It typically takes 10-15 minutes for results to appear for rapid H. pylori test kits.

Can you provide details regarding the shelf life and expiration dates of your H. Pylori Test Kit?

The shelf life and expiration dates of our medical devices are subject to variation based on the product type and storage environment. Typically, Class I and Class II medical devices maintain shelf lives ranging from 3 to 5 years. Comprehensive information regarding shelf life and expiration dates is furnished with each product.

Do your H. Pylori Test Kits adhere to international regulatory protocols?

Our medical devices are specifically developed to align with worldwide regulatory requirements, including CE, ISO, and USFDA certifications, delivering unparalleled safety and efficacy across the globe.

References

Point-of-care testing for Helicobacter pylori infection

This report focused on the accuracy and utility of point-of-care testing for detecting H. pylori infection in adults with upper gastrointestinal symptoms. It highlighted the high prevalence of H. pylori in various populations and the importance of accurate diagnostic methods, especially in primary care settings.

*Regulatory compliance may vary according to production standard, import requirements and/or manufacturing origin.