Drug
Screen Test Card Principle
The
AutoSplit Integrated Drug Test Cup is an immunoassay
based on the principle of competitive binding.
Drugs which may be present in the urine specimen
compete against their respective drug conjugate
for binding sites on their specific antibody.
During testing, a urine specimen migrates upward
by capillary action. A drug, if present in the
urine specimen below its cut-off concentration,
will not saturate the binding sites of its specific
antibody. The antibody will then react with the
drug-protein conjugate and a visible colored line
will show up in the test line region of the specific
drug strip. The presence of drug above the cut-off
concentration will saturate all the binding sites
of the antibody. Therefore, the colored line will
not form in the test line region. A drug-positive
urine specimen will not generate a colored line
in the specific test line region of the strip
because of drug competition, while a drug-negative
urine specimen will generate a line in the test
line region because of the absence of drug competition.
To serve as a procedural control, a colored line
will always appear at the control line region,
indicating that proper volume of specimen has
been added and membrane wicking has occurred.
Intended Use
The AutoSplit Integrated Drug Test Cup is a lateral flow
chromatographic immunoassay for the qualitative detection of multiple drugs and
drug metabolites in urine at the following cut-off concentrations:
|
Test
|
Calibrator
|
Cut-off
|
|
Amphetamine (AMP)
|
D-Amphetamine
|
1,000 ng/mL
|
|
Barbiturates (BAR)
|
Secobarbital
|
300 ng/mL
|
|
Benzodiazepines (BZO)
|
Oxazepam
|
300 ng/mL
|
|
Cocaine (COC)
|
Benzoylecgonine
|
300 ng/mL
|
|
Marijuana (THC)
|
11-nor-A9-THC-9 COOH
|
50 ng/mL
|
|
Methadone (MTD)
|
Methadone
|
300 ng/mL
|
|
Methamphetamine (mAMP)
|
D-Methamphetamine
|
1,000 ng/mL
|
|
Morphine (MOP 300 or OPI 300)
|
Morphine
|
300 ng/mL
|
|
Opiates (OPI 2000)
|
Morphine
|
2,000 ng/mL
|
|
Phencyclidine (PCP)
|
Phencyclidine
|
25 ng/mL
|
|
Tricyclic (TCA)
|
Nortriptyline
|
1,000 ng/mL
|
The configurations of the One Step Multi-Drug Screen Test
Card 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 used.
Reagents
The test contains a membrane strip coated with drug-protein
conjugates (purified bovine albumin) on the test line, a goat polyclonal
antibody against gold-protein conjugate at the control line, and a dye pad
which contains colloidal gold particles coated with mouse monoclonal antibody specific
to Amphetamine, Cocaine, Methamphetamine, Morphine, THC, Phencyclidine,
Benzodiazepine, Methadone or Barbiturate.
Precautions
- For healthcare
professionals including professionals at point of care sites.
- For in vitro diagnostic
use only. Do not use after the expiration date.
- The test panel should
remain in the sealed pouch until use.
- All specimens should be
considered potentially hazardous and handled in the same manner as an
infectious agent.
- The used test cup should
be discarded according to federal, state and local regulations.
Storage and Stability
Store as packaged in the sealed pouch at 2-30°C.
The test strip is stable through the expiration date printed on the sealed
pouch. The test strips must remain in the sealed pouch until use. DO NOT
FREEZE. Do not use beyond the expiration date.
Specimen Collection and Preparation
Urine Assay
The urine specimen must be collected in a clean and dry
container. Urine collected at any time of the day may be used. Urine specimens
exhibiting visible precipitates should be centrifuged, filtered, or allowed to
settle to obtain a clear specimen for testing.
Specimen Storage
Urine specimens may be stored at 2-8°C for up to
48 hours prior to testing. For prolonged storage, specimens may be frozen and
stored below -20°C. Frozen specimens should be thawed and mixed well
before testing.
Materials
Materials Provided
Materials Required But Not
Provided
Quality Control
A procedural control is included in the test. A red line
appearing in the control region (C) is considered an internal procedural
control. It confirms sufficient specimen volume, adequate membrane wicking and
correct procedural technique.
Control standards are not supplied with this kit. However,
it is recommended that positive and negative controls be tested as good
laboratory practice to confirm the test procedure and to verify proper test
performance.
Limitations
1. The AutoSplit Integrated Drug
Test Cup provides only a qualitative, preliminary
analytical result. A secondary analytical method
must be used to obtain a confirmed positive result.
Gas chromatography and 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.
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. Test does not distinguish between drugs of abuse and
certain medications.
AutoSplit Drug Test Cup Performance Characteristics
Accuracy
A side-by-side comparison was conducted using the One Step
Single Drug Test Strip and commercially available
drug rapid tests. Testing was performed on approximately
1,700 specimens previously collected from subjects
presenting for Drug Screen Testing. Presumptive
positive 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.
|
Test
|
Compounds Contributed to the Totls
of GC/MS
|
|
AMP
|
Amphetamine
|
|
BAR
|
Secobarbital, Butalbital, Phenobarbital, Pentobarbital
|
|
BZO
|
Oxazepam, Nordiazepam, -OH-Alprazepam, Desaky-frazepam
|
|
COC
|
Benzoylecgonine
|
|
THC
|
11-nor-9-carboxy-delta-9-tetrahydrocanabinol
|
|
MTD
|
Methadone
|
|
mAMP
|
Methamphetamine
|
|
OPI
|
Morphine, Codeine
|
|
PCP
|
Phencyclidine
|
|
TCA
|
Nortrptyline
|
The following results are tabulated from these clinical studies:
|
Method
|
GC/MS
|
|
Multi-Drug
Single-Line
Test Card
|
Neg.
|
Neg.
(<-25% cutoff)
|
Near
cutoff neg. (-25% cutoff to cutoff)
|
Near
cutoff pos. (cutoff to +25% cutoff)
|
Pos.
(>25% cutoff)
|
%
agreement with GC/MS
|
|
AMP
|
Positive
|
0
|
1
|
8
|
18
|
114
|
97%
|
|
Negative
|
149
|
1
|
5
|
4
|
0
|
95%
|
|
BAR
|
Positive
|
0
|
0
|
4
|
5
|
117
|
92%
|
|
Negative
|
150
|
1
|
5
|
1
|
9
|
98&
|
|
BZO
|
Positive
|
0
|
7
|
1
|
5
|
26
|
97%
|
|
Negative
|
149
|
7
|
1
|
3
|
1
|
95%
|
|
COC
|
Positive
|
0
|
2
|
15
|
16
|
103
|
98%
|
|
Negative
|
150
|
5
|
7
|
1
|
1
|
91%
|
|
THC
|
Positive
|
0
|
13
|
9
|
12
|
109
|
89%
|
|
Negative
|
150
|
6
|
0
|
0
|
1
|
99%
|
|
MTD
|
Positive
|
0
|
0
|
10
|
10
|
112
|
99%
|
|
Negative
|
150
|
17
|
0
|
0
|
1
|
94%
|
|
mAMP
|
Positive
|
0
|
0
|
10
|
9
|
126
|
99%
|
|
Negative
|
150
|
0
|
4
|
1
|
0
|
94%
|
|
MOP
|
Positive
|
0
|
2
|
7
|
10
|
131
|
97%
|
|
Negative
|
150
|
0
|
0
|
0
|
0
|
94%
|
|
OPI
|
Positive
|
0
|
0
|
16
|
18
|
116
|
>99%
|
|
Negative
|
150
|
0
|
0
|
0
|
0
|
90%
|
|
PCP
|
Positive
|
0
|
0
|
6
|
10
|
40
|
>99%
|
|
Negative
|
150
|
6
|
0
|
0
|
0
|
96%
|
|
*TCA
|
Positive
|
0
|
12
|
8
|
15
|
20
|
>99%
|
|
Negative
|
150
|
17
|
0
|
0
|
0
|
89%
|
Forty (40) clinical samples for each drug were run using each
of The One Step Single Drug Test Strip by an untrained
operator at a Professional Point of Care site.
Based on GC/MS data, the operator obtained statistically
similar Positive Agreement, Negative Agreement
and Overall Agreement rates as trained laboratory
personnel.
*Note: TCA was based on HP/LC data.
A study was conducted at three physician offices
by untrained operators using three different lots
of product to demonstrate the within run, between
run and between operator precision. An identical
panel of coded specimens, containing drugs at the
concentration of ± 50% and ± 25% cut-off level,
was labeled, blinded and tested at each site. The
results are given below:
