Q3 Innovations DrugHAWK ECO Cup - Manual (Page 3)

Forty (40) clinical samples for each drug were run using each strip contained within ECO CUP™
One Step Drug Test by an untrained operator at a Professional Point of Care site. Based on
GC/MS data, the untrained operator obtained statistically similar Positive Agreement, Negative
Agreement and
Overall Agreement rates as trained laboratory personnel.
*Note: TCA was based on HPLC data.
Reproducibility
Reproducibility studies were carried out using commercially available standards. Each standard
was diluted in normal, drug-free urine to give the appropriate concentration. Each specimen, at
each concentration of analyte, was tested four times daily, in duplicate, for five consecutive days.
A total of 40 determinations were made at each concentration. The results are given below:
membrane wicking and correct procedural technique.
LIMITATIONS
1. The ECO CUP™ One Step Drug Test 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 other 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 and a new test device.
4. A Positive result does not indicate intoxication of the donor, the concentration of drug in the
urine, or the route of drug administration.
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. 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.
PERFORMANCE CHARACTERISTICS
Accuracy
A side-by-side comparison was conducted using ECO CUP™ One Step Drug Test and other
commercially available rapid drug tests. Testing was performed on 120 samples per drug type. All
the presumptive positive and negative results were confirmed by GC/MS. The following
compounds were quantified by GC/MS and contributed to the total amount of drugs found in
presumptive positive urine samples tested.
The following results are tabulated from these clinical studies:
%Agreement with commercial kit
AMP
100%
100%
100%
THC
99%
100%
99%
BAR
99%
99%
99%
MTD
99%
99%
99%
COC
100%
97%
98%
BZO
99%
98.1%
99%
Positive
Agreement
Negative
Agreement
Total
Results
mAMP
98%
100%
99%
OXY
99%
99%
99%
PCP
100%
97%
98%
TCA
98.6%
99%
99.2%
MDMA
99%
99%
99%
OPI
100%
100%
100%
MOP
100%
100%
100%
Positive
Agreement
Negative
Agreement
Total
Results
Test
AMP
BAR
BZO
COC
THC
MTD
mAMP
MDMA
OPI
OXY
PCP
TCA
Compounds Contributed to the Totals of GC/MS
Amphetamine
Secobarbital
Oxazepam
Benzoylecgornine
11-nor-∆ 9 -tetrahydrocannabinol-9-carboxylic acid
Methadone
Methamphetamine
D,L-Methylenedioxymethamphetamine, Methylenedioxymethamphetamine
Morphine, Codeine
Oxycodone
Phencyclidine
Nortriptyline
%Agreement with GC/MS
AMP
98%
100%
99%
THC
98%
100%
98%
BAR
98.6%
98%
98.3%
MTD
98.6%
96%
97.5%
COC
98%
97%
97%
BZO
95.7%
98%
96.7%
Positive
Agreement
Negative
Agreement
Total
Results
mAMP
95%
100%
97.5%
Total number of
Determinations
Result Precision
40
40
40
40
40 No drug present
150
225
300
450
40 negative
40 negative
40 negative
40 positive
40 positive >99%
>99%
>99%
>99%
>99%
Oxazepam
conc.(ng/mL)
Benzodiazepines(BZO)
OXY
97.1 %
96%
96.7%
PCP
100%
97%
98%
MDMA
97.1%
98%
97.5%
TCA
95.7%
98%
96.7%
OPI
100%
100%
100%
MOP
100%
100%
100%
Positive
Agreement
Negative
Agreement
Total
Results
No drug present
500
750
1,000
1,500
Total number of
Determinations
Result Precision Amphetamine(AMP)
conc.(ng/mL)
Amphetamine(AMP)
40
40
40
40
40 40 negative
40 negative
40 negative
40 positive
40 positive >99%
>99%
>99%
>99%
>99%
Barbiturates(BAR)
Total number of
Determinations
Result Precision
40
40
40
40
40 No drug present
150
225
300
450
40 negative
40 negative
40 negative
40 positive
40 positive >99%
>99%
>99%
>99%
>99%
Secobarbital
conc.(ng/mL)
Total number of
Determinations
Result Precision
40
40
40
40
40 No drug present
150
225
375
450
40 negative
40 negative
40 negative
40 positive
40 positive >99%
>99%
>99%
>99%
>99%
Cocaine(COC)
Benzoylecgonine
conc.(ng/mL)
Total number of
Determinations
Result Precision
40
40
40
40
40 No drug present
25
37.5
50
75
40 negative
40 negative
40 negative
40 positive
40 positive >99%
>99%
>99%
>99%
>99%
Marijuana(THC)
11-nor-∆ 9 -THC-9-COOH
conc.(ng/mL)
Total number of
Determinations
Result Precision
40
40
40
40
40 No drug present
150
225
300
450
40 negative
40 negative
40 negative
40 positive
40 positive >99%
>99%
>99%
>99%
>99%
Methadone(MTD)
Methadone
conc.(ng/mL)
Total number of
Determinations
Result Precision
40
40
40
40
40 No drug present
500
750
1,000
1,500
40 negative
40 negative
40 negative
40 positive
40 positive >99%
>99%
>99%
>99%
>99%
Methamphetamine(mAMP)
Methamphetamine
conc.(ng/mL)
Total number of
Determinations
Result Precision
40
40
40
40
40 No drug present
250
375
500
750
40 negative
40 negative
40 negative
40 positive
40 positive >99%
>99%
>99%
>99%
>99%
MDMA (Ecstasy)
Methylenedioxymeth-
amphetamine
conc.(ng/mL)
Total number of
Determinations
Result Precision
40
40
40
40
40 No drug present
150
225
300
375
40 negative
40 negative
40 negative
40 positive
40 positive >99%
>99%
>99%
>99%
>99%
Opiate 300 (OPI 300,MOP,MOR)
Morphine
conc.(ng/mL)
Opiate 2000 (OPI 2000)
Total number of
Determinations
Result Precision
40
40
40
40
40 No drug present
1,000
1,500
2,000
3,000
40 negative
40 negative
40 negative
40 positive
40 positive >99%
>99%
>99%
>99%
>99%
Morphine
conc.(ng/mL)
Oxycodone (OXY)
Total number of
Determinations
Result Precision
40
40
40
40
40 No drug present
50
75
100
150
40 negative
40 negative
40 negative
40 positive
40 positive >99%
>99%
>99%
>99%
>99%
Nortiptyline
conc.(ng/mL)
2.3.7
PN:
Y031
11
11901