Product Manual

Page 2 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.
Reliable laboratory diagnosis of IM has been performed for over fifty years based
on the detection of IM heterophile antibodies. These heterophile antibodies are
directed against antigens found in bovine, sheep and horse erythrocytes (QuickVue+
Infectious Mononucleosis test utilizes an extract of bovine erythrocytes which gives a
greater sensitivity and specificity than similar extracts prepared from sheep and horse
erythrocytes.)
10,11
The Forssman antibody, which can interfere with some IM heterophile
antibody assays
7
, does not interfere with the QuickVue+ Infectious Mononucleosis test.
PRInCIPLe OF tHe test
The QuickVue+ Infectious Mononucleosis test assay uses Color lmmunoChromatographic
Assay (ClCA) technology for the qualitative detection of human heterophile IM
antibodies (lgM class) in serum, plasma or whole blood.
The Reaction Unit consists of a plastic housing containing a membrane strip which
provides the solid support for the immunochromatographic assay. The right end of
the membrane provides contact with the sample well. The sample well contains an
absorbent pad which provides an even flow of the sample fluid (from right to left )
along the membrane. The first zone of the membrane (which is covered by the Reaction
Unit label) is coated with blue latex beads that are conjugated to goat anti-human lgM
antibodies (antibody-blue latex). Two agents are immobilized on the second zone of
the membrane, which is exposed in the “Read Result” window. These agents include
blue latex beads (non-conjugated) immobilized on the membrane to provide a pre-
printed blue horizontal line. The second agent is a bovine erythrocyte extract, which is
immobilized on the vertical line. The third zone of the membrane (exposed in the “Test
Complete” window) contains an agent capable of binding the antibody-blue latex to
provide the vertical “Test Complete” line. An absorbent pad is situated at the left end of
the membrane to retain fluid after the reaction is completed. A drying agent is enclosed
in the Reaction Unit to stabilize the reactive agents.
In the Test Procedure, serum, plasma or whole blood is added to the “Add” well,
followed by the addition of the Developer. As the sample/developer fluid moves by
capillary action across the first zone of the membrane, it mobilizes the antibody-blue
latex. The fluid continues to move the antibody-blue latex across the membrane to the
immobilized bovine erythrocyte extract (antigen) zone. If the specific IM heterophile
antibodies are present in the sample, a “sandwich” of solid phase/IM antibody/antibody-
blue latex is formed. The vertical line will appear resulting in a positive sign (+) visible in
the “Read Result” window, which indicates the presence of IM heterophile antibody. If
the antibody is not detected, the “Read Result” window will only contain the preprinted
blue horizontal line, indicating a negative (–) result. As the fluid continues to move the
antibody-blue latex across the membrane, it comes in contact with the reagent in the
“Test Complete” window. A blue line will appear, indicating the test is complete.