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SERION ELISA classic
Toxoplasma gondii IgG / IgM
SERION ELISA classic Toxoplasma gondii IgG and IgM tests are quantitative and qualitative
immunoassays for the detection of human antibodies in serum or plasma directed against
Toxoplasma gondii. The assays are recommended to determine the immune status and to
differentiate acute from recent infections. The SERION ELISA classic Toxoplasma gondii
IgG can be used as a screening test and, in combination with avidity reagent, for avidity
determination. Additionally, the SERION ELISA classic Toxoplasma gondii IgM is suitable for
screening of newborn using dried blood spots (DBS).
Pathogen
Toxoplasma gondii is an obligatory intracellular parasite with a
worldwide distribution.
Disease
Following oral uptake of the parasite, e. g. with contaminated
Micrograph of Giemsa-stained Toxoplasma
food, the organism penetrates the gut and enters the reticulo-
gondii trachyzoites (Source: Centers for
endothelial system. Due to this haematogenous dissemination,
Disease Control and Prevention, US Depart-
Toxoplasma gondii is able to infect many different organs and
ment of Health and Human Services).
tissues within the host. The prevalence of infection with Toxo-
plasma gondii in the normal population is closely correlated with
age. At age 50 years, nearly 50 % of the population is seroposi-
tive. The seroprevalence of antibodies to Toxoplasma increases
with a frequency of 10 % per decade of life. Environmental and
serion
nutrition factors also play an important role and may significant-
ly influence the seroprevalence. Approximately 50 % of infec-
tions with Toxoplasma gondii proceed subclinically. The rema-
inder demonstrate only unspecific symptoms such as low fever,
exhaustion, headache as well as muscle and joint pain- after an
incubation period of one to three weeks.
multianalytTM
A minority of patients suffer from high fever (up to 39 °C) Validation of
and swelling of cervical lymph nodes. In 1 % of infected SERION ELISA classic Toxoplasma gondii
children and young adults complications such as myocar-
ditis, meningitis or pneumonia are reported.
For validation of SERION ELISA classic Toxoplasma IgG 450
After recovery, Toxoplasma gondii persists in infected tis-
sera derived from patients and healthy persons were analy-
sues by forming cysts which are resistant to attack by the zed for evaluation in comparison with an indirect immunofluo-
immune system.
rescence assay. 76 serum samples were tested in comparison
to a commercially available Toxoplasma IgM-µ-capture ELISA,
for evaluation of sensitivity and specificity of the SERION ELISA
Diagnosis
classic Toxoplasma IgM. Borderline values were not taken into
account.
ELISAs for the specific detection of IgG and IgM antibo-
dies are recommended for serological diagnosis. Scree-
SERION ELISA classic
Sensitivity
Specificity
ning for Toxoplasma infections during pregnancy is of vi-
Toxoplasma gondii IgG
98,2 %
> 99 %
tal importance. The transmission of Toxoplasma gondii via
Toxoplasma gondii IgM
> 99 %
97,2 %
the transplacental route has been observed in all stages
of pregnancy, although the risk of a prenatal transmission
as well as the outcome of infection depends on the stage SERION ELISA classic Toxoplasma gondii IgG
of pregnancy. The risk of an infection of the unborn child
Sample
Mean Intraassay
Mean Interassay
via transplacental transmission is limited to seronegative
value
CV (%)
value
CV (%)
women who acquire a primary infection during pregnan-
OD
(n=20)
OD
(n=10)
cy. In Germany, an incidence of 2 to 7 infected newborns
weak positive
0,559
8,3
0,535
14,4
per 1000 viable births is reported. Since IgM antibodies
positive
0,834
8,0
0,777
10,0
against Toxoplasma gondii can persist for months or even
strong positive
1,653
5,6
1,500
12,8
years after infection, the detection of pathogen-specific
IgM antibodies is no indication for an active infection by SERION ELISA classic Toxoplasma gondii IgM
Toxoplasma.
Sample
Mean Intraassay
Mean Interassay
The determination of avidity of anti-Toxoplasma IgG is
value
CV (%)
value
CV (%)
important for differentiating between primary and past
OD
(n=20)
OD
(n=10)
infection. The SERION ELISA classic Toxoplasma IgM is
weak positive
0,302
5,1
0,202
9,9
particularly suited for the screening of newborns using
positive
0,938
4,8
0,936
6,5
neonatal blood specimens dried on filter paper.
strong positive
1,146
5,3
1,142
5,8
Order Information
SERION ELISA classic Toxoplasma gondii IgG
Order Nr.: ESR 110 G
SERION ELISA classic Toxoplasma gondii IgM
Order Nr.: ESR 110 M
Reference serum Toxoplasma gondii IgG
Order Nr.: BR 110 G
Reference serum Toxoplasma gondii IgM
Order Nr.: BR 110 M
Reference serum Toxoplasma gondii avidity
Order Nr.: BR 110 AVID
Avidity reagent Toxoplasma gondii
Order Nr.: B 110 AVID
The SERION ELISA classic Toxoplasma gondii IgG is evaluated for the analysis of cerebrospinal fluid.
The SERION ELISA classic Toxoplasma gondii IgM is evaluated for neonatal screening on Dried Blood Spots (DBS).
Please visit our website www.virion-serion.com for more information on our SERION ELISA classic products.
Institut Virion\Serion GmbH
Tel.: +49 (0)931 3045-222
Institut Virion\Serion GmbH
Serion Immundiagnostica GmbH
Fax: +49 (0)931 3045-100
Beijing 100005, China
Friedrich-Bergius-Ring 19
dialog@virion-serion.de
97076 Würzburg, Germany
www.virion-serion.com
www.virion-serion.cn
Institut Virion \ Serion GmbH, V1.09/03
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