Sample
Serum, plasma or cerebrospinal fluid
Intended Use
TBE Virus IgM is quantitative and qualitative test for detection of human antibodies in serum, plasma or cerebrospinal fluid against TBE Virus. Not for use in diagnostic procedures.
Contents of Kit
1. Break apart microtiter test strips each with 8 antigen coated single wells (altogether 96), 1 frame, the coating material is inactivated. 12×8 wells.
2. Standard serum (ready-to-use), 2 × 2 ml. Human serum in phosphate buffer with protein; negative for anti-HIV-Ab, anti-HBs-Ag (Hepatitis B-Virus-surface antigen) and anti-HCV-Ab; preservative: < 0.1% sodium azide, colouring: Amaranth O.
3. Negative control serum (ready-to-use), 2 ml. Human serum in phosphate buffer with protein; negative for anti-HIV-Ab, anti-HBs-Ag (Hepatitis B-Virus-surface antigen) and anti-HCV-Ab; preservative: < 0.1% sodium azide, colouring: Lissamine green V.
4. Anti-human-IgM-conjugate (ready-to-use), 13 ml. Anti-human-IgM from goat (polyclonal), conjugated to alkaline phosphatase, stabilized with protein stabilization solution preservative: 0.01 % methylisothiazolone, 0.01 % bromnitrodioxane.
5. Washing solution concentrate (sufficient for 1000ml), 33.3 ml. Sodium chloride solution with Tween 20, 30 mM Tris preservative: < 0.1% sodium azide.
6. Dilution buffer, 2 × 50 ml. Phosphate buffer with protein and Tween 20; preservative: < 0.1% sodium azide, 0.01 g/l Bromphenol blue sodium salt.
7. Stopping solution, 15 ml. 1.2 N sodium hydroxide.
8. Substrate (ready-to-use), 13 ml. Para-nitrophenylphosphate, solvent free buffer preservative: < 0.1 % sodium azide, (Substrate in unopened bottle may have a slightly yellow color. This does not reduce the quality of the product!)
Storage
1. microtiter strips (antigen), after opening at 2-8°C in closed aluminum-bag with desiccant. Strips which are not used must be stored in the press-seal bag of aluminum compound foil under dry and airtight conditions! minimum shelf-life 8 weeks, shelf-life in case of proper use and storage until expiry date.
2. control sera / standard sera, after opening at 2-8°C, until expiry date; 24 months from date of production.
3. conjugate, ready-to-use solution, avoid contamination (sterile tips!), at 2-8°C,
4. dilution buffer, after opening at 2-8°C (Discard cloudy solutions! ), 24 months. Unopened: until expiry date; 36 months from date of production.
5. washing solution, concentrate after opening at 2-8°C (until expiry date), working dilution at 2-8°C (2 weeks), working dilution at room temperature (1 week). Bottles used for the working dilution should be cleaned regularly, discard cloudy solutions.
6. substrate, ready-to-use solution at 2-8°C, protected from light! Until expiry date 24 months from date of production. Avoid contamination (sterile tips!) Discard when solution turns yellow (extinction against distilled water > 0.25).
7. stopping solution, after opening at room temperature, until expiry date
General Description
Tick Borne Encephalitis (TBE) Virus belongs to the group of Flaviviruses. There are two natural subtypes, the western subtype found in Europe and a second subtype found in the Far East, Siberia and China.
TBE Virus is generally passed on to humans by infected ticks (Ixodes ricinus) that transfer the virus into blood circulation. There is no human-to-human transmission since infected patients are not contagious. TBE infections can be asymptomatic. After an incubation of 2-28 days (depending on the location of the bite and the amount of viruses, average from 7-14 days). The first phase starts with influenza-like symptoms and a slight rise of temperature. This phase lasts for 2-4 days followed by an approximately 8-day symptom-free interval. Many infected individuals recover at this stage. Those that don't recover proceed to the second phase of disease. Meningitis may occur accompanied by strong headache, stiffness of the neck, fever up to 40°C, nausea and vomiting. Meningoencephalitis with unconsciousness, restlessness, speech disorders or paralysis can occur. Symptoms such as paralysis, seizures, or long-term headaches may last for several months, or even lifelong in severe cases. The disease is fatal in 1-2% of cases.
While the clinical course is generally severe for adults, it is significantly milder when children are infected.
Natural infection provides lifelong immunity. Vaccination provides immunity for a few years. Regular booster shots are recommended.
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