MIKROGEN recomBlot Treponema IgG recomBlot Treponema IgM ...

Test Principle and Procedure
E E E
Evaluation
Blood
donors
( TPHA
negative)
Potential
cross
reactive
sera
( Borreliosis,
leptospirosis,
auto
immune
dis.
, pregn.
women)
Specificity
recomBlot Treponema
IgG IgM
total n egative
equiv. positive total n egative
equiv. positive
205 202 3 0 205 205 0 0
51 50 1 0 49 47 2 0
C alculation
of
positive
findings
only
1 00
%
100
%
C alculation
of
equivocal
findings
as
positive
9 8,
4 %
99,
2 %
TPHA positive/
IgG
FTA-ABS
positive
84 0 3 81
recomBlot Treponema
IgG IgM
total n egative
equiv. positive total n egative
equiv. positive
Positive for
IgM
antibodies
( 19S-IgM-FTA)
46 0 7 39
Sensitivity
1 st. Incubation: A test strip loaded with Treponema antigens is incubated with
diluted serum or plasma in a dish for 1 h.
Wash 3 times
2 nd. Incubation: Peroxidase conjugated anti-human antibodies (IgG or IgM specific)
are added. Incubate for 45 min.
Wash 3 times
3 rd. Incubation: 5 - 10 minutes after addition of the coloring solution, insoluble
colored bands develop at the sites on the test strips occupied by
antibodies.
In collaboration with an european expert for Treponema pallidum, Prof. Dr. H.-J. Hagedorn, more than 300 serum probes
with defined TPHA status were analysed with recomBlot Treponema IgG/IgM. TPHA negative serum probes were used
for calculation of specificity and TPHA and IgG FTA-ABS positive serum probes were used for calculation of sensitivity.
C alculation
of
positive
findings
only
9 6,
4 %
84,
8 %
C alculation
of
equivocal
findings
as
positive
1 00
%
100
%
Storage and Shelf Life At 4 °C 18 months from the time of production
Commercial Product Article No. 5102 recomBlot Treponema IgG
Reagents for 20 determinations
Article No. 5103 recomBlot Treponema IgM
Reagents for 20 determinations
MIKROGEN GmbH
Floriansbogen 2-4 · D-82061 Neuried · Germany · Tel.: +49 (0)89 54801-0 · Fax: +49 (0)89 54801-100
Internet: www.mikrogen.de · eMail: mikrogen@mikrogen.de
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