Product Manual

INTERPRETATION OF TEST RESULTS
Notes
A blue or red line which appears uneven in color density is considered a valid result.
P
ositive
A blue Test Line and a red Control Line is a positive result for the detection of
infectious mononucleosis heterophile antibody. Note that the blue line can be any
shade of color and can be lighter or darker than the line in the picture.
N
egative
A red Control Line but no blue Test Line is a negative result. No infectious
mononucleosis heterophile antibody has been detected.
Invalid
If after 5 minutes, no red Control Line appears or background color makes reading
the red Control Line impossible, the result is invalid. If this occurs, repeat the test on a
new Test Stick or call Sekisui Diagnostics Technical Assistance at [phone]
(U.S. only) or [phone]
The appearance of a dry white line located near the Test and/or Control line
positions has been observed on some test sticks. When present it can remain visible
at the read time. This artifact is most often seen with plasma or serum specimens and
has no impact on the performance of the assay.
EXPECTED VALUES
A heterophile antibody response is observed in approximately 80-90% of adults and
children with EBV-caused IM. This percentage drops to approximately 50% for
children under four years of age
1
.
While the incidence of IM reflects wide seasonal, ethnic and geographical variation,
a large epidemiological study noted that the highest incidence of symptomatic IM
occurred during late adolescence (15-24 years of age)
2
.
4