Product Manual

Page 6 of 66QuickVue+ Strep A 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.
QC TESTING PROCEDURE
 Follow the instructions in the TEST PROCEDURE to dispense the Extraction Reagents
into the tube.
 Vigorously mix the Control Bottles. Add one (1) drop of the Negative or Positive Control
into the tube.
 Place a clean swab into the tube and follow the instructions for testing the patient swab.
QUALITY CONTROL
Built-in Control Features
The QuickVue+ Strep A provides three levels of internal procedural controls with each
test run. For daily quality control, Quidel recommends documenting that these internal
controls were checked for the first sample tested each day.
Built-in Extraction Reagent Control: The color of the Extraction Reagent changes
from clear to green as the reagents are mixed together. The color change is an internal
extraction reagent control and is an indication that the reagents were mixed and
functioning properly.
Built-in Positive Antigen Control: Pink color in the Control Window serves as a built-in
positive antigen control. The appearance of this control indicates that the detection
antibody is functionally active and is also evidence that the detection part of the test
is functioning properly.
Built-in Negative Background Control: The background area in the Read Result Window
should be white to light pink within 10 minutes and not interfere with the reading of the
result. A lack of interfering background serves as a built-in negative background control,
indicating that there are no immunological interfering substances in the sample.
External Quality Control Testing
External controls are provided and may also be used to ensure that the reagents are
performing properly and that you are able to correctly perform the test procedure. You
may also use controls derived from ATCC strain 19615. Some commercial controls may
contain interfering additives and are not recommended for use in the QuickVue+ test.
Positive and negative controls can be run with each shipment of a new kit lot number,
and as otherwise required by your laboratory's standard quality control procedures.