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Introduction
The QuickVue® Influenza test allows
for the rapid, qualitative detection of influenza type A and type B antigens
directly from nasal swab, nasal wash and/or nasal aspirate specimens.
The test is intended for use as an aid in the rapid diagnosis of acute
virus infection.
Diagnosing influenza
can be confusing. One third of all upper respiratory infections are caused
by influenza. This leads to over 36,000 deaths, 114,000 hospitalizations
and accounts for over $12 billion spent in lost work and related medical
expenses each year in the U.S. There are three types of influenza viruses:
A, B, and C. Type A viruses are the most prevalent and are associated
with most serious epidemics. Type B viruses produce a disease that is
generally milder than that caused by type A. Type C viruses have never
been associated with a large epidemic of human disease.
Quidel's CLIA-waived
QuickVue® Influenza tests provide you with results in less than 10
minutes. Click here to view important information on being CLIA
Waived. This available information helps avoid the overuse of antibiotics,
and prevents healthcare costs related to unnecessary testing and treatment.
Product
Overview and Description
Influenza antigens
may be detected in clinical specimens by immunoassay. The
QuickVue® Influenza test is a lateral-flow immunoassay using highly
sensitive
monoclonal antibodies that are specific for influenza antigens. The test
is specific to
influenza types A and B antigens with no known cross-reactivity to normal
flora or other known respiratory pathogens.
The QuickVue® Influenza
tests involve the extraction of influenza A and B viral
antigens. The patient specimen is placed in the Extraction Reagent Tube,
during
which time the virus particles in the specimen are disrupted, exposing
internal viral
nucleoproteins. After extraction, the Test Strip is placed in the Extraction
Reagent Tube
where nucleoproteins in the specimen will react with the reagents in the
Test Strip.
If the extracted specimen
contains influenza antigens, a pink-to-red Test Line along with
a blue procedural Control Line will appear on the Test Strip indicating
a positive result. If influenza type A or type B antigens are not present,
or are present at very low levels; only a blue procedural Control Line
will appear.
Product
Use and Procedure
QuickVue®
A/B nasal swab procedure
Note: See current package insert for additional information and to perform
the test.
Features
and Benefits
| Rapid
Diagnosis and Treatment |
 |
Identify A or B
strain in positive samples, in 10 minutes or less, for better patient
management decisions. |
| Easy
to Use |
|
1 step (nasal wash/aspirate),
3 steps (nasal swab), 1 reagent, 30 seconds hands-on time. |
|
1 test procedure
provides results for both A and B. |
| Convenient
Packaging |
|
Each kit contains
everything needed to perform the test, including foam-tipped nasal
swabs, and controls. |
|
Room temperature
storage with up to 24-month shelf life. |
Frequently
Asked Questions
| Q. |
Does
the test differentiate type A from type B? |
| A. |
No, this product
does not differentiate but it will show results if the patient has
either A or B. There is a special order product made by Quidel that
will differentiate between the 2 strains. If this is something you
are interested in, call SH for pricing and information. That special
order product is QuickVue® Influenza A+B test (Quidel catalog
# 20183).
|
| Q. |
Can
a person have Influenza A and Influenza B? |
| A. |
Yes, but it would
be very unlikely.
|
| Q. |
What
is the gold standard for influenza testing? |
| A. |
Viral culture is
the gold standard for influenza testing.
|
| Q. |
Can
the same swab be used for culture after running the test? |
| A. |
No, the gold standard
or reference method for influenza testing is culture. If you were
previously sending this test out to a laboratory, you may still want
to "confirm" the results of our rapid test. If so, you would
need to collect a second swab for the culture test and not send the
swab that was used to perform the rapid test to an outside lab. Or,
use the swab to "streak" a culture plate (after running
the test) in the event you were performing the culture on site.
|
| Q. |
Does
the kit contain external controls? |
| A. |
Yes, the influenza
test kits include a positive control swab for influenza A, a positive
control swab for influenza B, and a negative control swab.
|
| Q. |
If
the influenza virus changes will the test detect it? |
| A. |
Yes, in all instances.
|
| Q. |
Where
should we go for technical support and questions? |
| A. |
Technical Support:
1-800-874-1517 Hours: 8-5 Pacific www.quidel.com
Quidel Corporation
10165 McKellar Court
San Diego, CA 92121
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Reimbursement
The reimbursement code used
for the QuickVue® Influenza test is CPT Code: 87804 QW.
Technical
Specifications
| Nasal
swab procedure: |
|
Sensitivity:
73%
Specificity: 96%
Accuracy: 87%
|
| Nasal
wash/nasal aspirate procedure: |
|
Sensitivity:
81%
Specificity: 99%
Accuracy: 94%
|
| Nasal
swab procedure: |
|
Sensitivity:
A - 72%, B - 73%
Specificity: 96%
Accuracy: A - 89%, B - 91%
|
| Nasal
wash/nasal aspirate procedure: |
|
Sensitivity:
A - 77%, B - 82%
Specificity: 96%
Accuracy: A - 95%, B - 96%
|
Product Ordering Information
| SH
Catalog # |
Product
Name |
| 90496 |
QuickVue®
Influenza test |
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