Product Manual

PERFORMANCE CHARACTERISTICS
A total of 439 specimens (183 serum, 176 plasma and 80 whole blood) were
evaluated by two clinical labs in a clinical study. Test results of the OSOM Mono
T
est were compared to results obtained with a commercially available latex particle
a
gglutination test for the qualitative determination of infectious mononucleosis
h
eterophile antibodies. Discrepancies between the results given by the OSOM
M
ono Test and the latex particle agglutination test were resolved by Epstein-Barr
Virus (EBV) specific serological assays. In these assays, the specific antibodies to the
EBV capsid antigen (IgM) and EBV nuclear antigen-1 (IgM and IgG) were determined.
Serum Specimens: Comparative Test
+-
O
SOM Mono Test
+ 74 8*
-0 101
*
6 out of 8 tested positive by EBV testing
Plasma Specimens: Comparative Test
+-
O
SOM Mono Test
+ 67 15*
-0 94
*8 out of 15 tested positive by EBV testing
Whole Blood Specimens: Comparative Test
+-
OSOM Mono Test
+ 30 3*
-0 47
*1 out of 3 tested positive by EBV testing
All Specimens: Comparative Test
+-
OSOM Mono Test
+ 171 26*
-0 242
*15 out of 26 tested positive by EBV testing
When compared to a commercially available latex particle agglutination test for
infectious mononucleosis heterophile antibodies, the OSOM Mono Test showed a
sensitivity of 100% and a specificity of 90.3%. The overall agreement was 94.1%.
Fifteen of the twenty-six discrepant samples were determined to be recent or acute
EBV infections by EBV serological testing, in which case the sample was considered
positive. Including the samples confirmed positive by EBV serological testing, the
overall clinical study specificity of the OSOM Mono Test is 95.9% and the overall
sensitivity is 100%.
POL Studies
An evaluation of the OSOM Mono Test was conducted at three physicians’ offices
or clinical laboratories where testing was performed by personnel with diverse
educational backgrounds. Each site tested the randomly coded panel consisting
of negative (5), low positive (3) and moderate positive (4) specimens for three days.
The results obtained had 99.1% agreement (107/108) with the expected results.
REORDER
No. 145 OSOM Mono Test (25 Tests)
5