For in vitro diagnostic use. The RIDASCREEN® Hantavirus Puumala virus tests are enzyme immunoassays for the quantitative detection of IgG or IgM antibodies to the Hantavirus Puumala in human serum.
The tests are intended for use only in cases of a suspected hantavirus infection.
Taxonomically, the hantavirus belongs to the bunyaviruses. It is an enclosed RNA virus. The RNA is present as an single strand in three ring-shaped segments. Hantaviruses are found throughout the world. However, there are geographic distributions for the individual hanta species given the serotype-specific host reservoirs. The species Puumala and Dobrava-Belgrade as well as Hantaan are resident in Eurasia. The pathogen reservoir is persistently and asymptomatically infected rodents such as mice that excrete large quantities of the pathogen through the urine, feces and saliva. The pathogens are transmitted to humans through contact infection, or by inhaling them in a feces-or urine-containing aerosol. In addition to harmless flu-like symptoms, an infection with hantavirus can cause hemorrhagic fever with renal syndrome (Nephropathia epidemica, HFRS) or pulmonary involvement (hantavirus pulmonary syndrome (HPS)). The lethality depends strongly on the virus strain and the severity of the infection. The humoral immune response is primarily directed against the nucleocapsid antigen of the hantavirus. In sensitive detection methods, IgM antibodies can be detected when clinical symptoms initially manifest. It is generally possible to detect IgG antibodies two weeks after infection.
Recombinant NEV-N protein of the hantavirus species Puumala is bound to the surface of the wells in the microtiter strips. Diluted patient samples as well as the controls are pipetted into these wells and incubated at 37 °C. Existing antibodies bind to the immobilized antigens. Unbound material is removed by washing.
Then a peroxidase-conjugated anti-human antibody (anti-IgG or anti-IgM) is added. Any unbound conjugate is removed by washing. Then the substrate (H2O2/TMB) is added that causes a blue color to develop in positive samples from the bound enzyme. This reaction is terminated by adding stop solution. This addition causes the color to change from blue to yellow. The final measurement is taken in a photometer at 450 nm (reference wavelength 620 nm) within 20 minutes.
|Test format||Microtiter plate with 96 wells (12 strips with 8 removable wells each)|
|Incubation time||3 x 30 min at 37 °C|