icup urine drug test cup product insert

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2QH 6WHS 0XOWL'UXJ 6FUHHQ 7HVW &DUG ZLWK WKH ,QWHJUDWHG L&XS L&XS $' ,QVWUXFWLRQ 6KHHW IRU WHVWLQJ RI DQ\ FRPELQDWLRQ RI WKH IROORZLQJ GUXJV $03&2&7+&P$030'0$23,3&3 &XSV DUH DYDLODEOH ZLWK VSHFLPHQ YDOLGLW\ WHVWV 697 IRU R[LGDQWV3&& 2;3&& VSHFLILF JUDYLW\ 6* S+ QLWULWH 1,7 JOXWDUDOGHK\GH */87 DQG &UHDWLQLQH &5( 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 7KH ,QWHJUDWHG L&XS LV D ODWHUDO IORZ LPPXQRDVVD\ IRU WKH TXDOLWDWLYH GHWHFWLRQ RI PXOWLSOH GUXJV DQG GUXJ PHWDEROLWHV LQ XULQH DW WKH IROORZLQJ FXWRII FRQFHQWUDWLRQV OLVWHG EHORZ $ FHUWLILFDWH RI ZDLYHU LV QHHGHG IRU \RXU ODERUDWRU\ LQ RUGHU WR UXQ WKLV WHVW /DERUDWRULHV ZLWK D FHUWLILFDWH RI ZDLYHU PXVW IROORZ WKH PDQXIDFWXUHU¶V LQVWUXFWLRQV IRU SHUIRUPLQJ WKH WHVW RU WKH WHVW LV FRQVLGHUHG KLJK FRPSOH[LW\ DQG LV QR ORQJHU &/,$ ZDLYHG Test Target Drug Cut-off $PSKHWDPLQH $03 G$PSKHWDPLQH QJP/ &RFDLQH &2& %HQ]R\OHFJRQLQH QJP/ 0DULMXDQD 7+& QRUǻ 7+& &22+ QJP/ 0HWKDPSKHWDPLQH P$03 G0HWKDPSKHWDPLQH QJP/ 0HWK\OHQHGLR[\PHWKDPSKHWDPLQH 0'0$ (FVWDV\ GO 0HWK\OHQHGLR[\PHWKDPSKHWDPLQH QJP/ 2SLDWHV 23, 0RUSKLQH QJP/ 3KHQF\FOLGLQH 3&3 3KHQF\FOLGLQH QJP/ 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. 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Page 1: iCup Urine Drug Test Cup Product Insert

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

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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