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, RSV (respitory syncytial virus), iFOB (immunochemical fecal occult blood) Strep A, pregnancy, 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 94%/90%, Type B 70%/97% NW = Type A 77%/91%, Type B 82%/97% Room temperature storage 24-month shelf life
RSV	87807	Lateral Flow Immunoassay	Swab provided with kit	15 min.	Positive or negative results		Contact Quidel for specific information	Convenient dipstick format 2-color endpoint 3-step procedure 1 reagent Overall accuracy: 92% - NPS 94% - NPA 87% - N/ NPW 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 accuracy 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 14-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% agreement to SBA culture Room temperature storage 18-month shelf life
iFOB	82274	Lateral Flow Immunoassay	Collection device included with kit	5-10 min.	Positive or negative results		Contact Quidel for specific information	Analytical sensitivity: 50 μg buffer or 50 μg hHb/g feces 1 step procedure Self contained collection device Specific to human hemoglobin (no dietary or medicine restrictions) Room temperature storage 24-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 14-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 Immunoassay	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.