Product Manual

Page 5 of 124QuickVue RSV 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.
SPECIMEN TRANSPORT AND STORAGE
Specimens should be tested as soon as possible after collection. If transport of the
specimens is required, the following transport media are recommended when
specimens are stored at 2–30°C for up to eight (8) hours prior to testing: Hank’s Balanced
Salt Solution, M4 – RT or M5 Media, Multitrans Media, Modified Liquid Stuart’s, UTM,
Bartels Viratrans or saline. For longer storage at 2–8°C for up to forty-eight (48) hours,
only Bartels Viratrans, M4 – RT and Multitrans Media are recommended. Alternatively,
samples may be stored at 2–30°C, in a clean, dry, closed container for up to eight (8)
hours prior to testing.
Note: M4-3 and Amies transport media are not compatible with this device.
QUALITY CONTROL
There are two primary types of Quality Control for this device: the built-in control
features defined below and the external controls.
Built-in Control Features
The QuickVue RSV test contains built-in procedural control features. The manufacturer’s
recommendation for daily control is to document these built-in procedural controls for
the first sample tested each day.
The two-color result format provides a simple interpretation for positive and negative
results. The appearance of a blue procedural Control Line provides several forms of
positive control by demonstrating sufficient flow has occurred and the functional
integrity of the Test Strip was maintained. If the blue procedural Control Line does
not develop within 15 minutes, the test result is considered invalid.
A built-in negative control is provided by the clearing of red background color, verifying
that the test has been performed correctly. Within 15 minutes, the result area should be
white to light pink and allow the clear interpretation of the test result. If background
color remains and interferes with interpretation of the test result, the result is
considered invalid. Should this occur, review the procedure and repeat the test with a
new Test Strip.