Product Manual

Page 18 of 124QuickVue RSV 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.
Table 6
Lay Users vs. Trained Laboratorians – Overall Results
Participant
Type
Negative
% Negative
(95%CI)
Weak Positive
% Detection
(95% CI)
Low Positive
% Detection
(95% CI)
Positive
% Detection
(95% CI)
Lay User 100% (71/71)
(93.9-100)
89% (63/71)
(79.1-94.4)
97% (69/71)
(89.7-99.8)
100% (71/71)
(93.9-100)
Trained
Laboratorian
98% (59/60)
(90.3->99.9)
95% (57/60)
(85.8-98.8)
100% (60/60)
(92.8-100)
100% (60/60)
(92.8-100)
Table 7
Sample Testing by Site – Lay Users and Trained Laboratorians
Negative
% Negative
(95%CI)
Weak Positive
% Detection
(95% CI)
Low Positive
% Detection
(95% CI)
Positive
% Detection
(95% CI)
Lay User
Results
1 100% (21/21)
(81.8-100)
95% (20/21)
(75.6->99.9%)
100% (21/21)
(81.8-100)
100% (21/21)
(81.8-100)
2 100% (26/26)
(84.8-100)
81% (21/26)
(61.7-92.0)
96% (25/26)
(79.6-99.9)
100% (26/26)
(84.8-100)
3 100% (24/24)
(83.7-100)
92% (22/24)
(73.0-98.8)
96% (23/24)
(78.1-99.9)
100% (24/24)
(83.7-100)
Trained
Laboratorian
Results
1 97% (29/30)
(81.9->99.9)
97% (29/30)
(81.9->99.9)
100% (30/30)
(86.5-100)
100% (30/30)
(86.5-100)
2 100% (30/30)
(86.5-100)
93% (28/30)
(77.6-99.2)
100% (30/30)
(86.5-100)
100% (30/30)
(86.5-100)
ASSISTANCE
If you have any questions regarding the use of this product or if you want to report
a test system problem, 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]. Test system problems may also be reported to FDA
(http://www.fda.gov/medwatch) or CMS (http://www.cms.hhs.gov/clia).