Download Package Insert - Sekisui Diagnostics

9.4 Limits of the Test
1.
2.
The interpretation of serological results shall alw ays include the clinical picture, epidemiological data and all further
available laboratory results.
Anti-doublestrand DNA ( dsDNA) sera (ANA, systemic lupus erithematodes) show crossreactivity to the Sekisui
Virotech MUMPS ELISA.
10. Performance Data
10.1 Sensitivity and Specificity
To determine the analytical sensitivity and specificity of Mumps IgG 302 sera w ere tested in an internal study. Tw o ELISAs of
different suppliers were used as reference test. The serapanel contains sera routinely used by the virology of the University
Cologne.
Reference ELISA
VT Mumps IgG Elisa
negative
borderline
positive
negative
72
0
0
borderline
2
2
0
positive
12
8
206
12 sera could neither in the Virotech ELISA nor in the tw o reference tests be clearly defined. They are not included in the
calculation of sensitivity and specificity.
The Virotech Mumps IgG ELISA show s follow ing values:
Sensitivity
94,5%
Specific ity
>99,8%
To determine the analytical sensitivity and specificity of Mumps IgM 258 sera w ere tested in an internal study. Tw o ELISAs of
different suppliers were used as reference test. The serapanel contains sera routinely used by the vir ology of the University
Cologne.
Reference ELISA
VT Mumps IgM Elisa
IgM n= 258
negative
borderline
positive
1
negative
237
0
borderline
5
0
0
positive
1
1
13
6 sera could neither in the Virotech ELISA nor in the tw o reference tests be clearly defined. They are not included in the
calculation of sensitivity and specificity.
The Virotech Mumps IgM ELISA show s follow ing values:
Sensitivity
92,9%
Specific ity
99,6%
10.2 Prevalence (Expected Values)
To the determine the Expected Values 80 blood bank sera w ere tested in IgG and IgM.
(n=80)
negative
Seite 7 v on 10
Mumps ELISA IgG/IgM GB
IgG
IgM
num ber
(%)
num ber
(%)
20
25,0
79
98,7
borderline
7
8,7
1
1,3
positive
53
66,3
0
0,0
REV 11
Druckdatum 03.02.2014