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Products

Multi Drug Urine Cup
Multi Drug Urine Cup

Catalog No.              Product Name           

ABT-DOA-G122-1   Multi-2 Drug Urine Cup

ABT-DOA-G123-1   Multi-3 Drug Urine Cup

ABT-DOA-G124-1   Multi-4 Drug Urine Cup

ABT-DOA-G125-1   Multi-5 Drug Urine Cup

ABT-DOA-G126-1   Multi-6 Drug Urine Cup

ABT-DOA-G127-1   Multi-7 Drug Urine Cup

ABT-DOA-G128-1   Multi-8 Drug Urine Cup

ABT-DOA-G129-1   Multi-9 Drug Urine Cup

ABT-DOA-G130-1   Multi-10 Drug Urine Cup

ABT-DOA-G131-1   Multi-11 Drug Urine Cup

ABT-DOA-G132-1   Multi-12 Drug Urine Cup

ABT-DOA-G133-1   Multi-13 Drug Urine Cup

ABT-DOA-G134-1   Multi-14 Drug Urine Cup

ABT-DOA-G135-1   Multi-15 Drug Urine Cup

ABT-DOA-G136-1   Multi-16 Drug Urine Cup

ABT-DOA-G137-1   Multi-17 Drug Urine Cup

ABT-DOA-G138-1   Multi-18 Drug Urine Cup

Instruction Sheet for testing of any combination of the following drugs:

AMP/BAR/BZO/BUP/COC/THC/MTD/MET/MDMA/MOP/MQL/OPI/PCP/PPX/TCA/TML/KET/OXY/COT/EDDP/FYL/K2/6-MAM

A rapid 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 invitro diagnostic use only.

 INTENDED USE

ACCU-TELL® Rapid Multi-Drug Test Cup (Urine) is a rapid chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in urine at the following cut-off concentrations:

Test

Calibrator

Cut-off (ng/mL)

Amphetamine (AMP 1000)

d-Amphetamine

1,000

Amphetamine (AMP 500)

d-Amphetamine

500

Amphetamine (AMP 300)

d-Amphetamine

300

Barbiturates (BAR)

Secobarbital

300

Benzodiazepines (BZO)

Oxazepam

300

Benzodiazepines (BZO)

Oxazepam

200

Benzodiazepines (BZO)

Oxazepam

100

Buprenorphine (BUP)

Buprenorphine

10

Cocaine (COC)

Benzoylecgonine

300

Marijuana (THC)

11-nor-Δ9-THC-9 COOH

50

Marijuana (THC)

11-nor-Δ9-THC-9 COOH

150

Marijuana (THC)

11-nor-Δ9-THC-9 COOH

25

Methadone (MTD)

Methadone

300

Methamphetamine

(MET 1,000)

d-Methamphetamine

1,000

Methamphetamine

(MET 500)

d-Methamphetamine

500

Methamphetamine

(MET 300)

d-Methamphetamine

300

Methylenedioxymethamphetamine

(MDMA)

d,l-Methylenedioxymethamphetamine

500

Morphine (MOP )

Morphine

300

Morphine (MOP )

Morphine

100

Methaqualone(MQL)

Methaqualone

300

Opiate (OPI)

Morphine

2,000

Phencyclidine (PCP)

Phencyclidine

25

Propoxyphene (PPX)

Propoxyphene

300

Tricyclic Antidepressants (TCA)

Nortriptyline

1,000

Tramadol (TML)

Tramadol

100

Ketamine (KET)

Ketamine

1,000

Oxycodone (OXY)

Oxycodone

100

Cotinine(COT)

Cotinine

200

2-ethylidene-1,5-dimethyl-

3,3-diphenylpyrrolidine (EDDP)

2-ethylidene-1,5-dimethyl-

3,3-diphenylpyrrolidine

300

2-ethylidene-1,5-dimethyl-

3,3-diphenylpyrrolidine (EDDP)

2-ethylidene-1,5-dimethyl-

3,3-diphenylpyrrolidine

100

Fentanyl(FYL20)

Norfentanyl

20

Fentanyl(FYL10)

Norfentanyl

10

Configurations of ACCU-TELL® Rapid Multi-Drug Test Cup Urine come with any combination of the above listed drug analytes. 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.


PERFORMANCE CHARACTERISTICS

Accuracy

A side-by-side comparison was conducted using ACCU-TELL® Rapid Multi-Drug Test Cup Urine and commercially available drug rapid tests. Testing was performed on approximately 250 specimens per drug type previously collected from subjects presenting for Drug Screen Testing. Presumptive positive results were confirmed by GC/MS.

Method

GC/MS

% agreement with GC/MS

Multi-Drug Rapid Test Cup

Positive

Negative

AMP 1,000

Positive

121

2

98.4%

Negative

2

125

98.4%

AMP 500

Positive

131

3

99.2%

Negative

1

114

97.4%

AMP 300

Positive

127

2

98.4%

Negative

1

120

99.2%

BAR 300

Positive

109

1

97.3%

Negative

3

137

99.3%

BAR 200

Positive

117

2

98.3%

Negative

2

129

98.5%

BZO 500

Positive

99

2

99.0%

Negative

1

148

98.7%

BZO 300

Positive

120

1

98.4%

Negative

2

127

99.2%

BZO 200

Positive

142

1

99.3%

Negative

1

106

99.1%

BZO 100

Positive

135

3

98.5%

Negative

2

110

97.3%

BUP

Positive

124

0

99.2%

Negative

1

125

>99.9%

COC 300

Positive

99

1

98.0%

Negative

2

148

99.3%

COC 100

Positive

108

0

99.1%

Negative

1

141

>99.9%

THC 150

Positive

133

2

97%

Negative

2

113

98.5%

THC 50

Positive

141

1

>99.9%

Negative

0

108

99.1%

THC 25

Positive

149

1

99.3%

Negative

1

109

99.1%

MTD 300

Positive

106

2

99.1%

Negative

1

141

98.6%

MTD 200

Positive

106

3

98.1%

Negative

2

139

97.9%

MET 1,000

Positive

93

10

98.9%

Negative

1

146

93.6%

MET 500

Positive

100

1

99.0%

Negative

1

148

99.3%

MET 300

Positive

109

2

99.1%

Negative

1

138

98.6%

MDMA 1000

Positive

112

1

96.6%

Negative

4

130

97.0%

MDMA 500

Positive

126

3

96.2%

Negative

5

116

97.5%

MOP 300

Positive

105

6

96.3%

Negative

4

135

95.7%

MOP 100

Positive

116

10

95.9%

Negative

5

119

92.2%

MQL

Positive

108

12

90.8%

Negative

11

119

90.8%

OPI

Positive

116

11

94.3%

Negative

7

116

91.3%

PCP

Positive

98

8

95.1%

Negative

5

139

94.6%

PPX

Positive

LIMITATIONS

  1. ACCU-TELL® Rapid Multi-Drug Test Cup Urine provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.

  2. There is a possibility that technical or procedural errors, as well as interfering substances in the urine specimen may cause erroneous results.

  3. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen.

  4. A positive result does not indicate level or intoxication, administration route or concentration in urine.

  5. A negative result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present but below the cut-off level of the test.

  6. This test does not distinguish between drugs of abuse and certain medications.

  7. A positive test result may be obtained from certain foods or food supplements.