Product Manual

Page 5 of 77QuickVue+ Infectious Mononucleosis test
FOR INFORMATIONAL USE ONLY

FOR INFORMATIONAL USE ONLY
Not to be used for performing assay. Refer to most current package insert accompanying your test kit.
 Gently rub the hand from wrist to palm to finger in order to form a rounded drop of
blood over the puncture site. Avoid squeezing around the puncture site.
 For Hanging Drop Sampling: position the finger so that the drops of blood are just
above the center of the “Add” well of the Reaction Unit.
 For Capillary Tube Sampling: touch the capillary tube to the blood until filled.
qUALItY COntROL
External Quality Control
External controls may also be used to demonstrate that the reagents and assay
procedure perform properly.
Quidel recommends that positive and negative controls be run once for each untrained
operator, once for each new shipment of kits — provided that each different lot received
in the shipment is tested — and as deemed additionally necessary by your internal
quality control procedures, and in accordance with local, state, and federal regulations
or accreditation requirements.
External Positive and Negative Controls are provided in the kit.
 External Positive Control: Put one drop of Positive Control in the “Add” well. Put
five drops of Developer in the “Add” well. Process the control as you would a patient
sample. A positive signal is indicated by a vertical blue line in the “Read Result”
window, resulting in a positive sign (+).
 External Negative Control: Put one drop of Negative Control in the “Add” well. Put
five drops of Developer in the “Add” well. Process the control as you would a patient
sample. A negative signal is indicated by a horizontal blue line (–), in the “Read Result”
window.
Internal Quality Control
Internal Positive Procedural Control: A blue line in the “Test Complete” window
is considered an internal positive procedural control. If the test has been performed
correctly and the Reaction Unit is working properly, this indicator will appear. If no blue
color is visible in the “Test Complete” window after 10 minutes, the test result is
invalid.
Internal Negative Procedural Control: A clear background in the “Read Result”
window is also considered an internal negative procedural control. If the test has been
performed correctly and the Reaction Unit is working properly, the background will clear
to give a discernible result.