INTRODUCTION

Enzyme immunoassay with antigens produced by recombinant techniques for the de­tec­tion of IgG and IgM antibodies against Toxoplasma gondii

Toxoplasma gondii shows the highest incidence of any human pathogenic parasite in central Europe. As a rule, the course of infection is asymptomatic or mild and confers lifelong immunity on immunocompetent persons. Initial contact with the pathogen during pregnancy can result in transmission of the pathogen to the foetus, leading to severe damage.

The main task of routine diagnosis is thus within the framework of preventive examinations during pregnancy. Due to the asymptomatic genesis of a toxoplasmosis in most cases, detection of Toxoplasmosis is in most cases serological. Enzyme immunoassays or immunofluorescent tests are mainly used for screening.

The recomWell Toxoplasma IgG assay can be initially also used as screening assay because of the high sensitivity and specifity. After a positive screening result a quantitative determination of  IgM and IgG antibodies is recommended. Using the recomWell Toxoplasma IgG already for screening only the quantitative determination of IgM antibodies is necessary. Positive IgM and IgG results can be idealy confirmed by using the recomLine Toxoplasma, which also can give information about the time point of infection.

Genetically engineered immunodominant antigens of tachyzoites and bradyzoites are used in the recomWell Toxoplasma assay. In contrast to other ELISA systems using a total lysate antigen of Toxoplasma gondii different recombinant antigens - depending on the characteristics - can be utilised for the IgM and IgG assay. This results in an optimal discrimation between early and  late immmune response.

PRODUCT ADVANTAGES

• Recombinant antigens, therefore
  • High sensitivity and specificity
  • Excellent discrimination between negative and positive results
  • Immunodominant antigens of tachyzoites and bradyzoites
• Separate detection of IgG and IgM antibodies possible
• Quantitative results in International Units for IgG
• Identical procedure for IgG and IgM determination
• No RF absorbance necessary in the case of IgM determination
• Easy to quantify
• Easy test procedure; automation possible
• Test procedure and reagents identical in all MIKROGEN ELISA - reagents exchangeable
• Break-a-parts: single simple examination possible
• CE label: The recomWell Toxoplasma tests meet the high standard of the EC directive 98/79/EC on in vitro diagnostic medical devices.

TESTPRINCIPLE AND PROCEDURE

Indirect sandwich test.
Recombinant antigens are bound to the solid phase.

1^st Incubation
Add patient samples diluted 1:101 (sample: 10 µl of serum or plasma), incubate for 1 h at 37 °C.

Wash 4 times

2^nd Incubation
Add peroxidase conjugated anti-human IgG or IgM antibodies (conjugate), incubate for 30 min at 37 °C.

Wash 4 times

Color reaction
Add ready-to-use TMB solution and incubate for 30 min at room temperature. Stop the substrate reaction with H₃PO₄ and measure the extinction at 450 nm.

APPLIED RECOMBINANT TOXOPLASMA ANTIGENS

EVALUATION

STORAGE AND SHELF LIVE

At +2°C - +8°C 18 months from the time of production

COMMERCIAL PRODUCT