Intended Use
ELISA Influenza B Virus IgA are quantitative and qualitative tests for detection of human antibodies in serum or plasma against Influenza B Virus. For sale in the U.S. for Research Use Only. 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
2. Standard serum (ready-to-use), Human serum in phosphate buffer with protein; negative for anti-HIV-Ab, HBs-Ag (Hepatitis B-Virus-surface antigen) and anti-HCV-Ab; preservative: < 0.1% sodium azide colouring: Amaranth O 2 × 2 ml
3. Negative control serum (ready-to-use), Human serum in phosphate buffer with protein; negative for anti-HIV-Ab, HBs-Ag (Hepatitis B-Virus-surface antigen) and anti-HCV-Ab; preservative: < 0.1% sodium azide colouring: Lissamine green V. 2 ml
4. Anti-human-IgA-conjugate (ready-to-use), Anti-human-IgA from goat (polyclonal), conjugated to alkaline phosphatase, stabilized with protein stabilization solution preservative: 0.01 % methylisothiazolone, 0.01 % bromnitrodioxane. 13 ml
5. Washing solution concentrate (sufficient for 1000ml), Sodium chloride solution with Tween 20, 30 mM Tris preservative: < 0.1% sodium azide. 33.3 ml
6. Dilution buffer, Phosphate buffer with protein and Tween 20; preservative: < 0.1% sodium azide 0.01 g/l Bromphenol blue sodium salt. 2 × 50 ml
7. Stopping solution, 1.2 N sodium hydroxide. 15 ml
8. Substrate (ready-to-use), Para-nitrophenylphosphate, solvent free buffer preservative: < 0.1 % sodium azide (Substrate in unopened bottle may have a slight yellow coloring. This does not reduce the quality of the product!). 13 ml
9. Quality control certificate with standard curve and evaluation table (quantification of antibodies in IU/ml or U/ml)
Storage
1. Microtiter strips (antigen): after opening at 2-8°C in closed aluminum bag with desiccant (4 weeks). Strips which are not used must be stored in the press-seal bag of aluminum compound foil under dry and airtight conditions!
2. Control sera / standard sera: after opening at 2-8°C (until expiry date).
3. Conjugate: ready-to-use solution, at 2-8°C. Avoid contamination (sterile tips!). (until expiry date)
4. Dilution buffer: after opening at 2-8°C (24 months). Discard cloudy solutions! unopened (until expiry date)
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! Avoid contamination (sterile tips!) Discard when solution turns yellow (extinction against distilled water > 0.25). (Until expiry date)
7. Stopping solution: after opening at room temperature (until expiry date).
General Description
Influenza is caused by the orthomyxovirus family of viruses which can be subdivided into genus specific types A, B and C. These viruses primarily consist of a lipid membrane encapsulating the genetic material in the form of a nucleocapsid. In the case of Influenza types A and B, two specific glycoproteins protrude from the membrane. These glycoproteins are the neuraminidase and hemagglutinin (N and HA respectively) and are linked within the envelope to the virus matrix protein (M) located below the membrane. Influenza C virus has only one membrane glycoprotein.
Influenza viruses are characterised by a distinctive genetic variability, a result of a high mutation frequency and an ability to exchange genetic material with other influenza virus strains by virtue of their segmented genomes. Point mutations gradually increase the genetic variability resulting in antigenic drift and minor changes in the N and HA proteins and typically contribute to the endemic nature of the virus and regular epidemics of disease as immunity to the emerging antigenic variation wanes in the population.
The ability of the virus to exchange genetic information when more than one virus infects the same host results in more dramatic changes in the antigenic make-up of the virus and is known as "antigenic shift". This phenomenon is responsible for the occurrence of periodic pandemics of influenza disease such as in 1957 (Influenza A subtype H2N2) and 1968 (Influenza A subtype H3N2).
Influenza viruses are ubiquitous and are globally a significant cause of disease. The main reservoirs for the virus are man and a wide variety of other mammals and birds in the case of Influenza A. The occurrence in pigs and domestic birds presents a particular problem in some cultures and aids the process of antigenic shift. Influenza B infects only humans while Influenza type C is rarely encountered and has been isolated from both humans and pigs.
Influenza is an acute and highly contagious infection affecting the respiratory tract with transmission being effected by aerosol. The symptoms of infection are variable ranging from asymptomatic to acute respiratory distress and death. Sudden onset of symptoms is typical and classic symptoms include fever, cough, headache and muscle aches all developing within a few hours.
Particular sections of the community are particularly at risk of developing severe disease and prophylactic measures are recommended for those suffering from immunosuppression or metabolic diseases in addition to the elderly. Respiratory damage from Influenza infection may facilitate a bacterial superinfection resulting in pneumonia, and in some cases primary Influenza pneumonia may rapidly cause death.
An early diagnosis of infection may be effected using tests which directly detect the pathogen in patient samples such as nose and throat swabs and nasopharyngeal rinses. ELISA and IFT assays exist for direct pathogen/antigen detection and tend to be more rapid than isolation and identification of the agent in cell culture.
Serological tests for immunological evidence of infection include ELISA and CFT. These tests are a reliable method for identifying the serological type of the pathogen. In addition it is possible to differentiate between immunoglobulin classes with the ELISA format.
Citations
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