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One Step COCAINE (
COC ) Test Strip For Urine
INTENDED USE
The one step COC (Cocaine) test is a simple one step
immunochromatographic assay for the rapid,
qualitative detection of COC and primarily
benzoylecgonine as metabolites in urine. The cutoff
of the test is 300 ng/ml of COC. It is the same as
the SAMHSA recommended assay cutoff.
The COC test provides only a preliminary analytical
result. A more specific alternative chemical method
must be used in order to obtain a confirmed
analytical result. Gas chromatography, mass
spectrometry (GC/MS) is the preferred method.
Clinical consideration and professional judgment
should be applied to any drug of abuse test result,
particularly when preliminary positive results are
used.
EXPLANATION OF THE TEST
Cocaine, derived from the leaves of the coca plant,
is a potent central nervous system stimulant and a
local anesthetic. Cocaine induces euphoria,
confidence and a sense of increased energy in the
user; these psychological effects are accompanied by
increased heart rate, dilation of the pupils, fever,
tremors and sweating. Cocaine is used by smoking,
intravenous, intranasal or oral administration, and
excreted in the urine primarily as benzoylecgonine
in a short time. Benzoylecgonine has a longer
biological half-life (5-8 hours) than cocaine
(0.5-1.5 hours) and can generally be detected for
24-80 hours after cocaine use or exposure.
The COC test is based on the principle of the highly
specific immunochemical reactions between antigens
and antibodies, which are used for the analysis of
specific substances in biological fluids. The
sensitivity of the test is 300 ng/ml of COC.
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MATERIALS PROVIDED
The COC test kit contains the following items to
perform the assay:
1. COC test device.
2. Instructions for use.
MATERIALS REQUIRED
BUT NOT PROVIDED
1. Specimen collection container.
2. Clock or timer.
PRECAUTIONS |
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1. For professional in vitro diagnostic
use only.
2. Avoid cross contamination of urine samples by using a
new urine specimen container for each urine sample.
3. Urine specimens are potentially infectious. Proper
handling and disposal methods should be established
according to good laboratory practices.
4. Do not eat or smoke while handling specimens in the
laboratory.
5. The COC device should remain in its original sealed
pouch until ready for use.
6. Do not use the test if the pouch is damaged or the
seal is broken.
7. Do not use the test kit after the expiration date.
STORAGE AND STABILITY
The COC test kit should be stored at 4-30 oC in the
original sealed pouch. The expiration date given was
determined under normal laboratory conditions.
SPECIMEN COLLECTION AND PREPARATION
1. Fresh urine specimens do not require any special
handling or pretreatment.
2. Specimens should be collected in a clean glass or
plastic container.
3. If testing will not be performed immediately,
specimens should be refrigerated.
4. Specimens should be brought to room temperature
before testing.
5. Specimens containing precipitate may yield
inconsistent test results. Such specimen must be
clarified prior to assaying.
PROCEDURE OF THE TEST
1. Remove the test strip from its foil pouch.
2. Holding the strip vertically, carefully dip it into
the specimen. Do not immerse the strip past the maximum
line (Figure 1).
3. Interpret test results at 3 to 5 minutes.
INTERPRETATION OF THE TEST
1. As the test kit begins to work, a color band will
appear at the left section of the result window to show
that the test is working properly. This band is the
Control Band.
2. The right section of the result window indicates the
test results. If another color band appears at the right
section of the result window, this band is the Test
Band.
NEGATIVE: TWO COLOR BANDS
The appearance of two color bands within the result
window indicates a negative test result. No COC above
the cut-off level has been detected. The color of the
Test band may be lighter or darker than that of the
Control Band.
POSITIVE: ONE COLOR BAND
The appearance of only one color band within the result
window indicates the result is positive, i.e. the
specimen contains COC at a concentration above the
cut-off level.
INVALID:
A distinct color band should always appear in the left
section of the result window. The test is invalid if no
color band forms in the left section of the result
window.
Note. A very faint band in the right section of the
result window, visible in 5 minutes, indicates that the
amount of COC in the sample is near or below the cut-off
level of the test. The urine specimen should be
retested, or confirmed with a more specific alternative
method such as gas chromatography/mass spectrometry,
before a positive determination is made.
USER QUALITY CONTROL
Control standards are not supplied with this kit;
however, it is recommended that a control be tested as
good laboratory testing practice. For information on how
to obtain controls, contact Technical Service. Before
using a new kit with patient specimens, positive (cutoff
and 25% more than cutoff level) and negative (25% below
cutoff level) controls should be tested to confirm the
test procedure, and to verify the expected Q.C. results.
LIMITATIONS
1. The test is designed for use with unadulterated human
urine only.
2. There is a possibility that factors such as technical
or procedural errors, as well as other substances in the
urine samples may interfere with the test and cause
erroneous results.
3. Adulterants, such as bleach and/or alum, in urine
specimens may produce erroneous results regardless of
the method of analysis. If adulteration is suspected,
the test should be repeated with a new sample.
4. A positive test result does not provide any
indication of the level of intoxication or urinary
concentration.
5. The test results read after 5 minutes may not be
consistent with the original reading obtained within the
5 minutes reading period. The test must be read within 5
minutes of sample application.
6. Food and tea containing poppy products and/or coca
leaves may produce a positive result.
EXPECTED VAI.UES
The COC test is qualitative assay. The amount of drugs
and metabolites present in the urine cannot be estimated
by the assay. The assay results distinguish positive
from negative samples. A positive result indicates the
sample contains COC above the cut-off concentration.
PERFORMANCE CHARACTERISTICS AND COMPARISON STUDIES
The COC test has been shown to detect an average of 300
ng/ml or more of COC metabolites in urine. The accuracy
of COC was evaluated in comparison to a commercially
available immunoassay. A total of 50 negative real urine
patients samples (concentration of COC range of 0-220 ng/ml)
and 50 positive real patients urine samples
(concentration of COC range of 300-1200 ng/ml) were
tested by both procedures. Complete agreement was
observed in 100% of the samples. All positive and part
of negative urine samples were confirmed by GC/MS
PRECISION AND REPRODUCIBILLITY STUDIES
The precision of the COC assay was determined by
carrying out the test with serially spiked COC urine
samples. The four concentrations, at 0 ng/ml, at –25%
from the cutoff (225 ng/ml), at the cutoff (300 ng/ml)
and +25% from the cutoff (375 ng/ml) had been tested to
challenge the precision of the test device. A total of
50 tests were run at the 0 concentration, 50 run at 225
ng/ml, 200 run at 300 ng/ml and 50 run at 375 ng/ml. A
total of 350 tests were tested. About 99% of the samples
containing drug concentrations at or more than 25% over
the cut-off level consistently showed positive results.
The reproducibility studies were carried out at three
different sites. The urine samples contain 0, 300 ng/ml
and 900 ng/ml of COC were tested with a total of 360 COC
test kits. The samples were tested two times in the same
day, and in two different assays, each day for 20 days.
This permits separate tests of between-days,
between-assay and within day, which then show consistent
results.
CUTOFF STUDIES
There are a total of 200 urine samples including 50
samples contain zero, 50 samples below the cutoff (225
ng/ml), 50 samples at the cutoff (300 ng/ml) and 50
samples above the cutoff (375 ng/ml). All 200 urine
samples were tested with both and a commercially
available immunoassay test kit. Complete agreement was
observed as and the commercial test showed 99.43%
correlation of the test cutoff at 300 ng/ml of COC.
SPECIFICITY AND INTERFERENCE STUDIES
The following table lists compounds that are detected by
the COC test. The results are expressed in terms of the
concentration required to produce a positive result.
Compound Conc. (ng/ml)
Benzoylecgonine 300
Cocaine 300
Ecgonine HCL 1000
Potentially interfering chemicals such as pain
medication (Acetaminophen, 20 mg/dl), protein (2000
mg/dl), glucose (2000 mg/dl), hemoglobin (500 mg/dl) and
pH of 6.0, 7.0 and 8.0 were supplemented to normal urine
specimens devoid of cocaine. The test gave consistent
negative results. The base line urine with 300 ng/ml
cocaine scored consistently positive.
REFERENCES
1. Urine Testing for Drugs of Abuse, National Institute
for Drug Abuse (NIDA), Research Monograph 73, 1986.
2. Ambre, J.J. Anal. Toxicol. 9: 241-5, 1985.
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