icup urine drug test cup product insert
TRANSCRIPT
![Page 1: iCup Urine Drug Test Cup Product Insert](https://reader031.vdocument.in/reader031/viewer/2022022202/5880e5ec1a28ab0d358b5957/html5/thumbnails/1.jpg)
A rapid, screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine. For healthcare professionals including professionals at point of care sites.Immunoassay for in vitro diagnostic use only.
INTENDED USE CLIA CATEGORIZATION: WAIVED
Test Target Drug Cut-off
Configurations of the Integrated iCup® can consist of any combination of the drug analytes listed above. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
SUMMARY
AMPHETAMINE (AMP)
COCAINE (COC)
MARIJUANA (THC) Δ
Δ Δ
METHAMPHETAMINE (mAMP)
METHYLENEDIOXYMETHAMPHETAMINE (MDMA)
OPIATES (OPI)
PHENCYCLIDINE (PCP)
S.V.T. SUMMARY
WHAT IS ADULTERATION?
• Oxidants/PCC
• Specific gravity
• pH
• Nitrite
• Glutaraldehyde
• Creatinine
PRINCIPLE
REAGENTS
S.V.T. REAGENTS
PRECAUTIONS •• in vitro•••
STORAGE AND STABILITY
SPECIMEN COLLECTION AND PREPARATION Urine Specimen
Specimen Storage
MATERIALS Materials Provided
•
••••
Materials Required But Not Provided ••
858-875-0265 / [email protected]
![Page 2: iCup Urine Drug Test Cup Product Insert](https://reader031.vdocument.in/reader031/viewer/2022022202/5880e5ec1a28ab0d358b5957/html5/thumbnails/2.jpg)
DIRECTIONS FOR USE Allow the test cup, urine sample, and/or controls to reach room temperature (15-30°C) before testing.
INTERPRETATION OF RESULTS
NEGATIVE:* Two lines appear
*NOTE:
POSITIVE: One colored line appears in the Control region (C). No line appears in the Test region (T).
INVALID: No line appears in the Control region (C).
QUALITY CONTROL
LIMITATIONS
S.V.T. ADULTERATION LIMITATIONS
PERFORMANCE CHARACTERISTICS Accuracy
Test Compounds Contributing to GC/MS Totals
Δ
%Agreement with GC/MS
%Agreement with Commercial Kit
Precision
Analytical Sensitivity
Analytical Specificity
Compound ng/mL Compound ng/mL AMPHETAMINE 1,000 METHYLENEDIOXYMETHAMPHETAMINE (MDMA) 500
OPIATE 2,000
COCAINE 300
MARIJUANA (THC) 50Δ β
ΔΔΔMETHAMPHETAMINE 1,000
PHENCYCLIDINE (PCP) 25
Effect of Urinary Specific Gravity
Effect of the Urinary pH
Cross-Reactivity
Non Cross-Reacting Compounds
β
β
BIBLIOGRAPHY Urine Testing for Drugs of Abuse
Clin. Pharmacol. Ther.J. Anal. Toxicol.
Drug Testing in the Workplace,
.
CLIA Complexity: Waived SVT/Adulterant Color Chart
Abnormal High NIT Normal OX PCC GLUT
Negative S.G. CRE Low pH
Confirm Bioscienceswww.confirmbiosciences.com
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