Korean Helicobacter Pylori (Hp-Cla)

Specification
Strength/ Size
Packing Size
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Helicobacter Pylori

(H.pylori) Antibody

Test Cards
50 Card

Test Per

Pack
50
Box Pack


Helicobacter Pylori

(H.pylori) Antigen

Test Cards
50 Card

Test Per

Pack
50
Box Pack

General Information
One-Step H.Pylori Ag Rapid Test is to detect the antigens in stool.
For H.Pylori Ag Rapid tests:
Sensitivity: 98.9 %, Specificity: 98.5%,
Specimen: Stool
Reading Time: 10 min

General Information
One-Step H.Pylori Ab Rapid Test is to detect the antibodies against H. pylori in serum, plasma or whole blood.
For H.Pylori Ab Rapid tests:
Sensitivity: 98.9 %, Specificity: 98.5%,
Specimen: Serum, Plasma or Whole Blood
Reading Time: 10 min

Helicobacter pylori is a parasitic bacterium in the stomach that lives between the gastric mucosa and mucus. According to the WHO, more than half of the world's population has H. pylori and is the third leading cause of cancer-related deaths. In 1994, the WHO's IARC classified H. Pylori as a Class 1 carcinogen. The incidence of H. pylori in developing countries is the highest worldwide, highlighting the need for highly accurate and manageable testing. By 2025, the H. pylori testing market is expected to be worth 6 billion. Accordingly, SML Genetree has developed a reagent that can diagnose Helico-bacter pylori and Clarithromycin-resistant mutants (A2142G, A2143G) through DNA extracted from human hygienic tissue using Real-time Polymerase Chain Reaction. Since it contains multiple gene regions, Helico-bacter pylori and Clarithromycin-resistant mutations can be detected sensitively, and high reproducibility has been demonstrated through repeated tests by serially diluting various positive samples and standards. In addition, as a result of clinical evaluation on human sanitary inspection tissue by commissioning a large domestic consignment inspection institution, high sensitivity and specificity were confirmed, proving its excellent clinical performance.

We are the authorized distributing partner of the South Korean diagnostic manufacturer BioTNS.

Our role is to distribute in South Korea and overseas the Covid-19
RT-PCR PNA kits.

1 kit allows you to test 100 patients.

- CE approved
- US FDA approved

Contact us to receive your quotation.

INTENDED USE

The Helicobacter-Pylori antigen rapid test kit (stool) is a rapid visual immunoassay for the qualitative detection of helicobacter pylori antigen in human stool specimens. This kit is used as an aid in the diagnosis of H. pylori infection.



INTRODUCTION

Helicobacter pylori (also known as Campylobacter pylori) as a spiral-shaped gram negative bacteria which infects the gastric mucosa. H. pylori to causes several gastro-enteric diseases such as non-ulcerous dyspepsia, gastric and duodenal ulcer, active gastritis and can even increase the risk of stomach adenocarcinoma.

The epidemiologic study shows that more than 50% of the world's population is infected by H. pylori strains. Infection is more prevalent in developing countries. The lowest infection rate is 20%, and the highest infection rate can be 90% in developing countries. H. pylori strains is the major reason to cause chronic gastritis and gastric ulcers, 80%-90% chronic gastritis patients and 95%-100% gastric ulcers patients are infected by H. pylori strains. So the detection and treatment of H. pylori strains infection is very important.

At present several invasive and non-invasive approaches are available to detect this infection state. Invasive methodologies require endoscopy of the gastric mucosa with histologic, cultural and urease investigation, which are expensive and require some time for diagnosis. Alternatively, non-invasive methods are available such as breath tests, which are extremely complicated and not highly selective, and classical ELISA and immunoblot assays. This Kit belongs to non-invasive approach.

The H pylori can be utilized as a rapid screening process for large populations of patients and highly indicated in the early diagnosis of H pylori infection as the immune response can often precede clinical manifestations of disease From a diagnostic point of view, a high serum level specific antibodies against H pylori must be interpreted as an indication of type B asymptomatic gastritis

Specification:
Specimen:Serum/plasma/whole blood
Sensitivity:96%
Specificity:90%
Packaging:25 cassettes/box,
Certificate:CE and ISO 13485
Raw materials is imported from US
OEM packaging is available

Factview H. pylori Ag" likely refers to a diagnostic test for detecting Helicobacter pylori antigens in biological samples. Helicobacter pylori is a bacterium that colonizes the stomach lining and is associated with various gastrointestinal conditions, including gastritis, peptic ulcers, and even stomach cancer.

The "H. pylori Ag" test is designed to identify the presence of antigens produced by H. pylori in specimens such as stool, saliva, or gastric tissue. This test is valuable for diagnosing H. pylori infection, as it offers a non-invasive alternative to traditional methods such as endoscopy with biopsy.

The test usually involves collecting a sample from the patient, typically stool, and then processing it to detect H. pylori antigens using immunological methods such as enzyme immunoassay (EIA) or lateral flow immunoassay. These methods rely on the specific binding of antibodies to H. pylori antigens present in the sample, leading to a visible or measurable signal indicating the presence of the bacterium.

The detection of H. pylori antigens in clinical samples can aid in the diagnosis of H. pylori infection and help guide appropriate treatment strategies, such as antibiotic therapy and acid-suppressing medications. It is particularly useful for monitoring treatment effectiveness and detecting H. pylori recurrence after treatment completion.

CTK Biotech's, OnSite H. pylori Ab Combo Rapid Test is a sandwich lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG, IgM and IgA) against Helicobacter pylori (H. pylori) in human serum, plasma or whole blood.