Sample
Human Serum or Plasma (citrate, heparin)
Intended Use
Enzyme immunoassay for the quantitative determination of IgG class antibodies against Toxoplasma gondii in human serum or plasma (citrate, heparin).
Contents of Kit
1.Toxoplasma gondii Coated Microplate (IgG): 12 break apart 8-well snap-off strips coated with Toxoplasma gondii antigens; in resealable aluminium foil.
2.IgG Sample Diluent: 1 bottle containing 100 ml of phosphate buffer (10 mM) for sample dilution; pH 7.2 ± 0.2; coloured yellow; ready to use; white cap.
3.Stop Solution: 1 bottle containing 15 ml sulphuric acid, 0.2 mol/l; ready to use; red cap.
4.Washing Buffer (20× conc.): 1 bottle containing 50 ml of a 20-fold concentrated phosphate buffer (0.2 M), pH 7.2 ± 0.2, for washing the wells; white cap.
5.Toxoplasma gondii anti-IgG Conjugate: 1 bottle containing 20 ml of peroxidase labelled antibody to human IgG in phosphate buffer (10 mM); coloured blue; ready to use; black cap.
6.TMB Substrate Solution: 1 bottle containing 15 ml 3,3',5,5'-tetramethylbenzidine (TMB), < 0.1 %; ready to use; yellow cap; < 5% NMP (for hazard and precautionary statements see 12.1).
7.Toxoplasma gondii IgG Standards: 4 vials, each containing 2 ml standard (human serum or plasma); coloured yellow; ready to use.
Standard A: 0 IU/ml; blue cap
Standard B: 50 IU/ml; green cap
Standard C: 100 IU/ml; yellow cap
Standard D: 200 IU/ml; red cap
The standards are calibrated in accordance with the 3rd International Standard of the WHO.
8.1 Cover foil
9.1 Instruction for use (IFU)
10.1 Plate layout
Storage
Store the kit at 2 - 8°C. The opened reagents are stable up to the expiry date stated on the label when stored at 2 - 8°C.
Performance Characteristics
The diagnostic sensitivity is defined as the probability of the assay of scoring positive in the presence of the specific analyte. It is 98.25% (95% confidence interval: 93.81% - 99.79%).
The diagnostic specificity is defined as the probability of the assay of scoring negative in the absence of the specific analyte. It is 98.45% (95% confidence interval: 94.51% - 99.81%).
Precision
The results refer to the groups of samples investigated; these are not guaranteed specifications.
Detection Range
1.04 IU/ml - 200 IU/ml
General Description
Toxoplasma gondii is a small intracellular parasite, whose live cycle has a sexual and an asexual phase. Sexual development is restricted to the intestinal cells of (probably exclusively) cats; the oocysts formed are excreted and due to their resistant cell walls they may be infectious under advantageous circumstances for at least 1 year. Animals and man are intermediate hosts for theasexual proliferation of T. gondii: the ingested parasites will proliferate explosively within the host cells lysing them eventually. They disseminate throughout the body via circulation and lymphatic system and though may infect any cell type. In muscle and brain cells cysts are formed which are spheroidal and about 5-100 μm in diameter. Cysts are virtually immortal in the intermediate host.
Toxoplasma gondii is the most common parasite in humans, but its abundance (7-80%) is highly dependent on the geographic area, the socio-economic status and the nutritional customs. Infection only rarely causes toxoplasmosis and usually clinical symptoms are absent, but may produce severe problems in immunosuppressed persons and fetus. Because only a primary infection during pregnancy may be dangerous and even fatal for the unborn (the probability of congenital infection is about 50%), the recent onset of an infection must be excluded. In pregnant women in over 98% of cases, the absence of IgM excludes the possibility of recent infection. In newborns the very presence of anti-toxoplasma IgM is sufficient to confirm a congenital toxoplasmosis, since maternal IgM, unlike IgG, does not cross the placental barrier. But a significant number of infected infants do not develop detectable IgM levels and thus are false negative. In immunosuppressed patients toxoplasmosis causes severe complications mostly by reactivation of an earlier latent infection.
Infection or presence of pathogen may be identified by:
1.PCR
2.Serology: Detection of antibody production by IF; ELISA
Citations
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