INTRODUCTION

Strip-Immunoassay with antigens produced by recombinant techniques for the detection and differentiation of IgG and IgA antibodies against Helicobacter pylori type I and type II

The gram negative, spiral shaped bacterium Helicobacter pylori was described by Warren and Marschall in 1983. The connection between chronic type B gastritis and Helicobacter pylori has been well studied. In fact, there is a causal relation between Helicobacter pylori and almost all duodenal and stomach ulcers. Moreover, Helicobacter pylori is associated with an increased risk of gastric adenocarcinomas. Apart from strains of different virulence, host factors may also be responsible for this phenomenon.

The eradication of Helicobacter pylori cures not only gastritis or peptic ulcer, but also low malignant gastric MALT lymphomas. Although peptic ulcers are also cured without eradication of Helicobacter pylori, there is a recurrence within one year in up to half of all the cases in the absence of permanent acid suppression treatment. The rate of recurrence is less than 5 % per year after successful microbial eradication.

In comparison with other immunological techniques, the recomLine Helicobacter exhibits additional criteria with regard to sensitivity and specificity. Above all, reactivities with individual antigens and virulence factors like CagA and VacA can be safely detected.

PRODUCT ADVANTAGES

• Characterized Helicobacter pylori antigens
  • Safe identification of type I strain infections by CagA and VacA antigens
  • Safe detection of type I and type II strain infections by recombinant antigens GroEL, UreA, HcpC and gGT
• Recombinant antigens
  • High sensitivity and specificity
  • Easy and clear interpretation due to easy to read bands
• Evaluation with clinically defined sera
• Easy manual and automated test procedure
• Easy and objective evaluation and documentation by recomScan software
• Test procedure and reagents identical in all MIKROGEN strip tests - reagents exchangeable
• Safe evaluation due to strip specific controls (cut-off and conjugate control)
• CE label: The recomLine Helicobacter tests meet the high standard of the EC directive 98/79/EC on in vitro diagnostic medical devices

TESTPRINCIPLE AND PROCEDURE

1^st Incubation
A test strip loaded with Bordetella antigens is incubated with diluted serum or plasma in a dish for 1 hour.

wash 3 times

2^nd Incubation
Peroxidase conjugated anti-human antibodies (IgG specific) are added. Incubate for 45 minutes.

wash 3 times

Color reaction
8 minutes after addition of the coloring solution, insoluble colored bands develop at the sites on the test strips occupied by antibodies.

RECOMBINANT HELICOBACTER PYLORI ANTIGENS

EVALUATION

Diagnostic Sensitivity

* borderline was considered positive

Diagnostic Specificity

Analysis of clinically defined patient samples

STORAGE AND SHELF LIVE

At +2°C - +8°C 12 months from the date of production

COMMERCIAL PRODUCT