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Quidel Corporation
10165 McKellar Court
San Diego, CA 92121

Tel: 800.874.1517
custserv@quidel.com




www.quidel.com


CORPORATE DESCRIPTION:

Quidel Corporation serves to enhance the health and well being of people around the globe through the discovery, development, manufacturing and marketing of rapid diagnostic solutions at the point of care in infectious diseases and reproductive health. The leading brand QuickVue® currently includes tests that aid in the diagnosis of influenza, Strep A, pregnancy, bacterial vaginosis, infectious mononucleosis, H. pylori and chlamydia. 

Quidel's products are sold to healthcare professionals with a focus on the physician office lab and acute care markets through leading medical distribution partners on a worldwide basis. By building value in rapid diagnostic tests, Quidel provides leadership to the industry and among healthcare professionals allowing for the movement of patient testing out of the central laboratory setting and into the physician office, urgent care and other outpatient settings where rapid testing and treatment has an impact on clinical outcomes and provides an economic benefit.


Analytes performed on this test CPT Code Test
methodology
Sample
volume
Time
to result
Units in which
test is reported
Picture MSDS Other
Influenza 87804 Lateral Flow
Immunoassay
Swab provided
with kit
10 min. Positive or
negative results

 

Contact Quidel
for specific
information
30 seconds hands-on time
1 reagent
3 steps nasal swab
1 step nasal wash/aspirate
Sens/Spec
NS = 73%/96%
NW = 81%/99%
Room temperature storage
24-month shelf life
Influenza 87804 Lateral Flow
Immunoassay
Swab provided
with kit
10 min. Positive or
negative results
Contact Quidel
for specific
information
A and B differentiation
30 seconds hands-on time
1 reagent
3 steps nasal swab
1 step nasal wash/aspirate
Sens/Spec
NS =  Type A 72%/96%,
Type B 73%/96%
NW = Type A 77%/96%,
Type B 82%/96%
Room temperature storage
24-month shelf life
Strep A 87880 Lateral Flow
Immunoassay
Swab provided
with kit
5 min. Positive or
negative results
Contact Quidel
for specific
information
Convenient dipstick format
2-color endpoint
High sensitivity at low levels of colony count
95% overall agreement
Room temperature storage
18-month shelf life
Strep A 87880 Lateral Flow
Immunoassay
Swab provided
with kit
5 min. Positive or
negative results
Contact Quidel
for specific
information
Simple in-line extraction
2-color endpoint
Single reagent
96% overall agreement with SBA culture
Room temperature storage
18-month shelf life
Strep A 87880 Lateral Flow
Immunoassay
Swab provided with kit 5 min. Positive or
negative results
Contact Quidel
for specific
information
Easy +/- readout
2-color endpoint
2 reagent extraction
98% overall agreement
Room temperature storage
14-month shelf life
Mono 86308 Lateral Flow
Immunoassay
50 μL 5 min. Positive or
negative results
Contact Quidel
for specific
information
Easy +/- readout
Sens/Spec
>99%/>99%
Room temperature storage 
12-month shelf life
H. pylori 86318 Lateral Flow
Immunoassay
1 hanging drop or 
50 μL
5 min. Positive or
negative results
Contact Quidel
for specific
information
2-color endpoint
No reagents
92% agreement with EIA
Room temperature storage
12-month shelf life
Chlamydia 87810 Lateral Flow
Immunoassay
Swab provided
with kit
12 min. Positive or
negative results

 
Contact Quidel
for specific
information
2-color endpoint
Sens/spec
92%/99%
Room temperature storage
9-month shelf life
hCG 81025 Lateral Flow I
mmunoassay
3 drops 3 min. Positive or
negative results
Contact Quidel
for specific
information
2-color endpoint
25 mIU/mL
Room temperature storage
18-month shelf life              
hCG 81025 Lateral Flow
Immunoassay
3 drops 3 min. Positive or
negative results
Contact Quidel
for specific
information
2-color endpoint
Room temperature storage 
25 mIU/mL
Room temperature storage
18-month shelf life              
84703 5 min.
hCG 81025 Lateral Flow
Immunoassay
4 drops 3 min. Positive or
negative results
Contact Quidel
for specific
information
Easy +/- readout
10 mIU/mL serum,
20 mIU/mL urine
Room temperature storage
18-month shelf life
  84703 5 min.
hCG 81025 Lateral Flow
Immunoassay
3 drops 3 min. Positive or
negative results
NA Contact Quidel
for specific
information
2-color endpoint
25 mIU reference line
10 mIU/mL serum,
20 mIU/mL urine
Room temperature storage
18-month shelf life          
  84703 5 min.
pH 83986 Layered Thin
Film (LTF)
Swab provided
with kit
2 min. Positive or
negative results
Contact Quidel
for specific
information
2 tests on 1 card
Room temperature storage
24-shelf life                        
Amines 82120
G. vaginalis 82657 Layered Thin
Film (LTF)
Swab provided
with kit
5 min. Positive or
negative results
Contact Quidel
for specific
information
Results show directly on swab
Room temperature storage
24-month shelf life
hCG 81025 Lateral Flow
Immunoassay
Dipstick 3 min. Positive or
negative results
Contact Quidel
for specific
information
25 mIU/mL
Room temperature storage
12-month shelf life              

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Last updated:  04/15/2005
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