Product Manual

Page 6 of 55QuickVue One-Step hCG Urine test
FOR INFORMATIONAL USE ONLY
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FOR INFORMATIONAL USE ONLY
Not to be used for performing assay. Refer to most current package insert accompanying your test kit.
Physician’s Office Laboratory (POL) Studies
An evaluation of the QuickVue test was conducted at three Physicians’ Offices using a panel
of coded specimens. Testing was performed by physician’s office personnel with diverse
educational backgrounds and work experience at three geographically distinct locations.
The proficiency panel contained negative, low positive and moderate positive samples.
Each sample level was tested in multiple replicates at each site over a period of three days.
The results obtained at each site had 100% agreement with the expected results. No
significant differences were observed within run, between runs, or between sites.
Cross-Reactivity
hTSH, hLH, and hFSH were tested and showed no cross-reactivity in the test.
Interference Testing
The following compounds were tested and did not interfere with the performance
of the test.
Chemical Analytes Concentration
Acetominophen 20 mg/dL
Acetoacetic Acid 2000 mg/dL
Acetylsalicylic Acid 20 mg/dL
Ascorbic Acid 20 mg/dL
β-Hydroxybutyrate 2000 mg/dL
Benzoylecgonine (cocaine metabolite) 10 mg/dL
Caffeine 20 mg/dL
Cannabinol 10 mg/dL
Chlomiphene 100 mg/dL
Cocaine 10 mg/mL
Codeine 10 mg/mL
DMSO 3%
Ephedrine 20 mg/dL
Ethanol 1%
Heroin 1 mg/dL
Gentisic Acid 20 mg/dL
Methadone 10 mg/dL
Methamphetamine 10 mg/dL
Methanol 10%
Phenothiazine 20 mg/dL
Phenylpropanolamine 20 mg/dL
Salicylic Acid 20 mg/dL
Theophylline 20 mg/mL
Uric Acid 20 mg/dL