Intended Use
ELISA Toxoplasma gondii IgM are quantitative and qualitative tests for detection of human antibodies in serum or plasma against Toxoplasma gondii. 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, anti-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, anti-HBs (Hepatitis BVirus-surface antigen) and anti-HCV; preservative: < 0.1 % sodium azide, colouring: Lissamin green V. 2 ml
4. Anti-human-IgM-conjugate (ready-to-use), Anti-human-IgM 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 1 litre), 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 slightly yellow color. This does not reduce the quality of the product!). 13 ml
Storage
1. microtiter strips (antigen). Unopened: see expiry date on microtiter plate. after opening at 2-8°C in closed aluminum bag with desiccant: minimum shelf-life 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; 24 months from date of production
3. conjugate. ready-to-use solution at 2-8°C. Avoid contamination (sterile tips!). Until expiry date,
28 months from date of production.
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
Toxoplasma gondii - a eucaryotic pathogen - belongs to the group of sporozoes. This obligate intracellular parasite is spread worldwide. Typical for sporocytes is the "flip-flop" between sexual (which only takes place in cats, the final host) and asexual reproduction. After oral uptake of parasites, e.g. in contaminated food, the organism penetrates the gut and enters the reticuloendothelial system. Due to this haematogenous dissemination, Toxoplasma gondii is able to infect many different organs and tissues within the host.
The prevalence of infection with Toxoplasma gondii in the normal population is closely correlated with age. At age 50 years, nearly 50% of the population is seropositive; the seroprevalence of antibodies to Toxoplasma increases with a frequency of 10% per decade of life. Environmental and nutrition factors also play an important role and may significantly influence the seroprevalence.
About 50% of infections with Toxoplasma gondii show no clinical findings (subclinical course). The other 50% show - after an incubation period of 1-3 weeks - only non-specific symptoms like low fever, exhaustion, and headache as well as muscle and joint pain. A minority of patients suffers from high fever (up to 39°C) and swelling of cervical lymph nodes. In 1% of infected children and young adults, complications such as myocarditis, meningitis or pneumonia have been reported.
After recovery, Toxoplasma gondii cells persist in infected tissues by forming cysts which are resistant to the attacks of the immune system. Generally, this so-called latent infection is not reactivated in immunocompetent hosts. Probably as a result of permanent stimulation of the host's immune system by the presence of the antigens, a life-long immunity is induced.
Screening for Toxoplasma infections during pregnancy is of vital importance. The transmission of Toxoplasma gondii via the transplacental route has been observed in all stages of pregnancy, although the risk of prenatal transmission as well as the outcome of infection depends on the stage of pregnancy. The risk of an infection of the unborn child via transplacental transmission is limited to seronegative women who acquire a primary infection during pregnancy. When maternal primary infection is detected and subsequently eradicated by chemotherapy, the risk for transmission to the fetus is significantly decreased.
Immediately after birth, only 1-3% of infected newborns show clinical symptoms of toxoplasmosis. In contrast, up to 80% of subclinically infected children suffer from late damage and severe clinical manifestations. Early therapy of infected newborns can prevent later damage.
In cases of immunosuppression, activation of latent infections has been observed. In AIDS patients, Toxoplasma encephalitis is of significant importance as the final cause of death.
Citations
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