Product Manual

Page 3 of 64QuickVue Dipstick Strep A 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.
KIt storage and stabIlIty
Store the kit at room temperature 59–86°F (15–30°C), out of direct sunlight. Kit
contents are stable until the expiration date printed on the outer box. Do not freeze.
specImen collectIon and storage
Collect throat swab specimens by standard clinical methods. Consult standard reference
procedures such as the collection method described by Miller and Holmes.
5
Depress the
tongue with a tongue blade or spoon. When swabbing the throat, be careful not to touch
the tongue, sides or top of the mouth with the swab. Rub the swab on the back of the
throat, on the tonsils and in any other area where there is redness, inflammation or pus.
Use rayon tipped swabs to collect throat specimens. Do not use calcium alginate, cotton
tipped or wooden shaft swabs.
It is recommended that swab specimens be processed as soon as possible after
collection. Swabs can be held in any clean, dry plastic tube or sleeve up to 72 hours
at room temperature (15–30°C), or refrigerated (2–8°C) before processing. The use of
charcoal or agar medium is not recommended.
If a culture is desired, lightly streak the swab on a 5% sheep blood agar plate before using
the swab in the QuickVue Dipstick Strep A test. Do not perform the QuickVue Dipstick Strep
A test before streaking the swab, as the Extraction Solution will destroy the bacteria on
the swab, thereby rendering the organism incapable of successful culturing. Alternatively,
throat swab specimens can be obtained by dual swabs or by two sequential swabs for the
culture procedure.
cUltUre confIrmatIon
The QuickVue test can be used to confirm the identification of Group A Streptococcus
on blood agar plates. Lightly touch a colony using a sterile swab. Do not sweep the
plate. Follow the instructions in the TEST PROCEDURE section to test the swabs.
QUalIty control
Built-in Control Features
The QuickVue Dipstick Strep A test 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.
 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.