Ac-anti H pylori rapid diagnostic test (RDT) kit with control serum. Demonstration using negative patient serum

Helicobacter pylori is a gram negative bacterium discovered in 1982 that is present in the gastrointestinal mucosa. It is commonly transmitted person-to-person or through water and contaminated food. Although about 50% of the population may have this bacterium in the GI tract, only some of the infected people may develop symptoms and signs. The contribution of H. pylori infection to the development of digestive pathologies such as: ulcer, gastritis, malignant pathology is demonstrated. The most common symptoms are heartburn, pain, loss of appetite or weight loss. Currently, treatment for H. pylori infection is done with antibiotics.
Rapid diagnostic tests for Ac anti-HP use side-flow immunochromatographic technology. This implies the existence of a support that has the ability to carry the sample through capillarity to the reaction zone. Once the patient’s sample is deposited in the sample well it migrates to the areas with the bioactive particles and react with them. After about 5 minutes, control lines (C) and test (T) are observed by visual analysis.

Rapid Diagnostic Test Kit for Anti-HP Antibody with Control Serum can be used both in screening and in diagnosing H. pylori infection. The advantage of using control serum is to obtain a semi-quantitative result quickly and at low cost without the need for complex laboratory equipment. Typically, the level of Anti-H Ac. pylori is not used to monitor treatment because IgG remains for a long time in the blood, but recent studies suggest that monitoring of serum IgG levels after treatment can provide an early indication of the efficacy of therapy in eradicating H. pylori infection. In addition, serum IgG levels can provide evidence of infection in patients with chronic gastritis even when biopsy samples are negative by microbiological and / or histological testing. H. pylori is a pathogen that stays in the gastric mucosa and causes changes (cornice gastritis): atrophy, metaplasia and dysplasia. Serum IgG is a good indicator for evaluating and monitoring these changes. Thus, a serum IgG antibody concentration in the serum (according to Sedgwick, 1991) from 10μg / mL to 90μg / mL is considered a positive value, after 90μg / mL no distinction can be made between the concentration and the intensity of the immune reaction .
A positive result indicates either a current infection or a past infection; therefore the serological test does not present diagnostic accuracy in people who have already had an infection, but the development of kits that achieve a semi-quantitative detection of the IgG anti-H. pylori antibody level in the serum make the method (lateral flow immunochromatography ) to reach a higher specificity and a better sensitivity than the qualitative method.
These tests are used around the world, being accessible to both large-flow hospitals and limited resource offices. Testing the patient sample is done quickly and the result is obtained in about 15 minutes, without the need for other equipment, being more economical and reliable than the ELISA method. Although the ELISA method provides more precise (quantitative) results, the introduction of control serum makes testing by rapid tests a fast, cheap, and easy-to-use semi-quantitative method that allows the doctor to quickly make the best decisions for patients. Of the kit components, only the controls have to stay at low temperature (refrigerator), the test boxes can be stored at room temperature for extended periods of time.
* Currently our team is working on a clinical trial for this product.