Product Manual

Page 8 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.
this data, specificity was 98% and sensitivity was 95% for the QuickVue+ test. 95%
confidence intervals were calculated to be 97–99% and 91–99% for specificity and
sensitivity, respectively. Overall agreement between SBA culture and QuickVue+
Strep A was 98% (815/833).
In addition, the QuickVue+ Strep A test was used to confirm the identification of Group
A Streptococcus on SBA culture plates. As a culture confirmation, the QuickVue+ test was
100% sensitive and 100% specific.
Physician’s Office Laboratory (POL) Studies
An additional evaluation of the QuickVue+ test was conducted at three physicians’ offices
using a panel of coded samples. Testing was performed by physician’s office personnel
with diverse educational backgrounds and work experience. The panel contained
negative, low positive and moderate positive samples. Each sample level was tested in
sets of five at each site over a period of three days.
The results obtained at each site ranged from 97% to 100% agreement with the expected
results. No significant differences were observed within run, between runs or between
sites.
Cross-Reactivity
Cross-reactivity studies with 53 microorganism strains other than Group A Streptococcus
have been performed at levels exceeding 10
7
and produced negative results in the
QuickVue+ test.
ASSISTANCE
If you have any questions regarding the use of this product, please call Quidel’s Technical
Support number, [phone] (toll-free in the U.S.A.) or [phone], Monday
through Friday, between 7:00 a.m. and 5:00 p.m. Pacific Time, U.S.A. If outside the
United States, contact your local distributor or [e-mail].