Product Manual

Page 1 of 77QuickVue+ Infectious Mononucleosis test
FOR INFORMATIONAL USE ONLY
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FOR INFORMATIONAL USE ONLY
Not to be used for performing assay. Refer to most current package insert accompanying your test kit.
Intended Use
QuickVue+ Infectious Mononucleosis test is a rapid Color lmmunoChromatographic
Assay (CICA) for the detection of Infectious Mononucleosis lgM heterophile antibodies in
serum, plasma or whole blood. This test is intended for use as an aid in the diagnosis of
Infectious Mononucleosis. For use by healthcare professionals.
sUMMARY And eXPLAnAtIOn
Infectious Mononucleosis (IM) is usually a self-limiting disease that is caused by the
Epstein-Barr Virus (EBV).
1,2
The most common symptoms are fatigue, pharyngitis,
fever, lymphadenopathy, splenomegaly and hepatitis.
3
In rare cases, complications
may develop including severe thrombocytopenia, hemolytic anemia, pericarditis,
myocarditis, pneumonitis, Reye’s syndrome, encephalitis and other neurological
syndromes. In industrialized countries, the peak incidence of IM occurs between 14 and
18 years of age. In developing or densely populated countries, most children become
infected before 3 years of age and symptoms may be mild or clinically inapparent.
4,5
During the acute phase of illness, certain heterophile antibodies appear in 85–90% of
IM cases. These antibodies, known as IM heterophile antibodies, are primarily of the
lgM class.
6,7
IgM to the viral capsid antigen appears early in infection and disappears
within 4 to 6 weeks. IgG to the viral capsid antigen appears in the acute phase, peaks at
2 to 4 weeks after onset, declines slightly, and then persists for life.
8
Although the exact
mechanism leading to IM heterophile antibody expression has not been determined,
the antibodies are specifically associated with the disease. The IM heterophile
antibodies are usually demonstrable one week after the onset of illness, peak at two to
four weeks, and decline to low levels by 12 weeks.
2
Heterophile antibodies have been
detected in patients’ serum over one year after the onset of illness.
9
CLIA Complexity: Waived – Whole Blood / Moderate – Serum, Plasma