Product Manual

Page 6 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.
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.
The Nasopharyngeal Swab Test Procedure described in this Package Insert should be
used when testing the external controls.
If the controls do not perform as expected, repeat the test or contact Quidel Technical
Support before testing patient specimens. Note that the External Positive Control Swab
provided in the kit is a moderately high positive sample which may not represent the
performance of a low positive RSV specimen in the QuickVue RSV test.
Additional Control Swabs may be obtained separately by contacting Quidel’s Customer
Support Services at [phone] (toll-free in the U.S.A.) or [phone].
CLIA WAIVER CONSIDERATIONS
A certificate of CLIA waiver is required to perform the QuickVue RSV test in a waived
setting. Waived laboratories must follow the manufacturer’s instructions in this
Package Insert for performing the test. For information on how to obtain a CLIA
certificate, go to the Centers for Medicare & Medicaid Services (CMS) website
(http://www.cms.hhs.gov/CLIA).
TEST PROCEDURE
All clinical specimens must be at room temperature before beginning the assay.
Performing the assay outside the time and temperature ranges provided may
produce invalid results. Assays not performed within the established time and
temperature ranges must be repeated.
Expiration date: Check expiration on each individual test package or outer box before
using. Do not use any test past the expiration date on the label.