For in vitro diagnostic use. The NovaLisa® Trichinella spiralis IgG-ELISA is intended for the qualitative determination of IgG class antibodies against Trichinella spiralis in human serum or plasma (citrate).
Trichinosis is an infection caused by the nematode Trichinella spiralis. It is acquired by ingestion of raw or undercooked meats. Although the nematode may be found in a wide variety of animals worldwide, the domestic and the wild pig are the primary sources of infection in developed nations. Symptoms of infection are usually non-specific but may involve the following: fever, myalgias, periorbital edema and conjunctivitis, nausea, vomiting or diarrhea, and elevated eosinophil counts. Serology is an important tool in the diagnosis of trichinosis. ELISA has been shown as being a very sensitive and specific method. As highly specific for Trichinella spiralis and good suited for the use in ELISA is an excretory-secretory (ES) antigen, that has been purified from the larvae of infected pigs.
Purified antigens are coated to a microwell plate. Antibodies in the patient samples bind to the antigens and are determined during the second step by using enzyme-labelled Protein A (the conjugate). The enzyme converts the colourless substrate (H2O2/TMB) to a blue end product. The enzyme reaction is stopped by adding sulphuric acid and the colour of the mixture switches from blue to yellow at the same time. The final measurement is carried out at 450 nm on a photometer using a reference wavelength ≥ 620 nm.
|Test format||Microtiter plate with 96 wells (12 strips with 8 wells each; strips can be divided into single wells)|
|Incubation time||60 min at 37°C, 30 min at room temperature, 15 min at room temperature|
we have started to provide the documents for our products in an electronic format. These are the Instructions for Use (IFU), the Safety Data Sheets (SDS) and the Certificate of Analysis (CoA). For batches placed on the market after 01 January 2023, you can find our documents on the eIFU portal eifu.r-biopharm.com.