INTRODUCTION

Strip-Immunoassay with antigens produced by recombinant techniques for the detection of IgG and IgM antibodies against Hantavirus (serotypes Puumala, Hantaan, Dobrava and Seoul) as well as Sandfly Fever Virus (serotype Toscana, TOSV)

Most of the Bunyaviruses can be found in the tropics and subtropics with an exception of the genera Hantavirus und Phlebovirus which are also represented in Europe. Puu-malavirus, which belongs to the Hantavirus genus is found in Scandinavia, Europe and Eastern Europe countries. The Sandfly Fever Virus, belonging to the Phlebovirus genus, spreads out in the mediterranean countries.

Sandfly Fever Virus: A few Bunyaviruses in Europe are transmitted by insects (Sandfly, Phlebotomus). The Sandfly Fever (syn. pappataci fever), caused by the SF-Virus, is normaly characterised by a feverish disease associated with a mild headache. Only the infection with the serotype Toscana (TOSV) can cause fever, strong, frontal headache and an aseptic meningitis with strong neurological symptoms. The prevalence of anti-TOSV IgG is about 2 %.

Hantavirus: Hantaviruses are transmitted to humans in aerosols of rodent secretions. They cause haemorrhagic fever with renal syndrome (HFRS) and hantavirus pulmonary syndrome (HPS). The Puumalavirus causes a HFRS similar disease with a mild course (Nephropathia epidemica). The infection often proceeds asymptomatic. In Germany about 1,7 % of the population display antibodies against Puumalavirus.

The recomLine Bunyavirus allows the detection of IgG and IgM antibodies against genetically engineered Hantavirus N-antigens (serotype Puumala, Hantaan, Dobrava and Seoul). Two serotype clusters have to be discriminated here: a) Puumala/Sin Nombre and b) Hantaan/Dobrava/Seoul, which can result, according to the respective infection, in a typical band pattern on the recomLine Bunyavirus (see evaluation). Besides the Hantavirus infections, Sandfly Fever Virus infections (serotype TOSV) can be detected with the recomLine Bunyavirus too.

PRODUCT ADVANTAGES

• Recombinant antigens
• High sensitivity and specificity
• Easy and clear interpretation due to easy to read bands
• Easy test procedure; automation possible
• 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)
• Separate detection of IgG and IgM antibodies possible
• Detection of Hantavirus and Sandfly Fever Virus infections
• Discrimination of Hantavirus serotype clusters is possible mostly
• CE label: The recomLine Bunyavirus IgG/IgM meets 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 Bunyavirus 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 or IgM specific) are added. Incubate for 45 minutes.

wash 3 times

Color reaction
5 - 10 minutes after addition of the coloring solution, insoluble colored bands develop at the sites on the test strips occupied by antibodies.

RECOMBINANT BUNYAVIRUS ANTIGENS

EVALUATION

Blood donors

Positive sera

Sample strips

STORAGE AND SHELF LIVE

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

COMMERCIAL PRODUCT