Product Manual

Page 3 of 55QuickVue One-Step hCG Urine 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.
QUALITY CONTROL
Built-in Quality Control Features
The QuickVue test provides several levels of internal procedural controls with each test
run. For daily quality control, Quidel recommends documenting these controls for the
first sample tested each day.
The appearance of a blue procedural Control Line is an internal positive control. This
indicates that sufficient sample fluid was added for capillary flow to occur and the
correct procedural technique was used. If this line does not develop, the test result
is considered invalid.
A clear background in the test result window is an internal background negative control.
If the test has been performed correctly, the background should be white to light pink
within 3 minutes and not interfere with the reading of the test result.
External Quality Control Testing
External controls may also be used to assure that the reagents are performing properly
and that you are able to correctly perform the Test Procedure. For this purpose, we
recommend using the hCG Control Set (Catalog Number 00272). Some commercial
controls may contain interfering additives and are not recommended for use in the
QuickVue test.
Good Laboratory Practice suggest that external controls should be tested with each
new lot or shipment of test materials, and as otherwise required by your laboratory’s
standard quality control procedures.
TEST PROCEDURE
When performing more than one test, ensure Test Cassettes are labeled correctly. Use a new
pipette for each sample/test.
 Remove the QuickVue Test Cassette from the foil pouch just before use and place
it on a clean, dry, level surface.
 Using one of the disposable pipettes supplied, collect sample and add 3 DROPS
(125 µL) of urine to the Round Sample Well on the Test Cassette. The Test Cassette
should not be handled or moved until the test is complete and ready for reading.
 WAIT THREE MINUTES AND READ.
Note: Some positive results may be seen sooner.