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COCII
COCII
COCII
Cocaine II
Order information
COBAS INTEGRA 200 Tests Cat. No. 03800130 190 Indicates analyzer(s) on which cobas c pack can be used
ONLINE DAT Cocaine II System-ID 07 6723 9
Preciset DAT Plus I 6 5 mL Cat. No. 03304671 190
CAL 1-6
C.f.a.s. DAT Qualitative Plus 6 5 mL Cat. No. 03304698 190
C.f.a.s. DAT Qualitative Plus Clinical 3 5 mL Cat. No. 04590856 190
Control Set DAT I Cat. No. 03312950 190
PreciPos DAT Set I 2 10 mL
PreciNeg DAT Set I 2 10 mL
Control Set DAT III Cat. No. 03312976 190
PreciPos DAT Set III 2 10 mL
PreciNeg DAT Set III 2 10 mL
Control Set DAT Clinical Cat. No. 04500873 190
PreciPos DAT Clinical 2 10 mL
PreciNeg DAT Clinical 2 10 mL
System information and paranoia.3,4 Users may revert to other drugs at this time
COBAS INTEGRA ONLINE DAT Cocaine II (COCII) to relieve the depressive effects of the crash.2
Test CO1S2, test-ID 0-126 for semiquantitative assay, 150 ng/mL Cocaine is traditionally administered intranasally or smoked in
Test CO3S2, test-ID 0-127 for semiquantitative assay, 300 ng/mL its purer, free-base form; oral ingestion is ineffective, as cocaine
Test CO1Q2, test-ID 0-015 for qualitative assay, 150 ng/mL is broken down in the gastrointestinal tract. It is absorbed
Test CO3Q2, test-ID 0-016 for qualitative assay, 300 ng/mL readily across the mucous membranes of the nose and lungs into
Test CO3QC, test-ID 0-115 for qualitative assay, 300 ng/mL; the circulation. Its effects are intense but short-lived. Cocaine
using C.f.a.s. DAT Qualitative Plus Clinical is rapidly inactivated by hydrolysis of its ester linkages.1,5,6
Blood cholinesterases hydrolyze cocaine to ecgonine methyl
Intended use
ester, while hydrolysis of the parent drug to benzoylecgonine is
Cocaine II (COCII) is an in vitro diagnostic test intended for the
thought to be non-enzymatic; both of these metabolites may
semiquantitative and qualitative detection of benzoylecgonine,
be further hydrolyzed to ecgonine. Unmetabolized cocaine has
the primary metabolite of cocaine, in human urine at cutoff
an affinity for fatty tissue and rapidly enters the brain; cocaine
concentrations of 150 ng/mL and 300 ng/mL on COBAS
metabolites, however, are more water soluble and are readily
INTEGRA systems. Semiquantitative test results may be
excreted in the urine along with some portion of unchanged
obtained that permit laboratories to assess assay performance
drug.5,7 The prominent benzoylecgonine metabolite is the
as part of a quality control program. Semiquantitative assays
primary urinary marker for detecting cocaine use.1,5
are intended to determine an appropriate dilution of the
Tolerance has been observed with some chronic, high-dose
specimen for confirmation by a confirmatory method such as
users.8 Physical dependence does not appear to occur in abusers,
gas chromatography/mass spectrometry (GC/MS).
although the development of strong psychological dependence
Cocaine II provides only a preliminary analytical test result. A
is well known. Cessation of drug use may result in depression,
more specific alternate chemical method must be used in order
hallucinations, and in extreme cases, psychosis.2
to obtain a confirmed analytical result. GC/MS is the preferred
confirmatory method.1 Clinical consideration and professional Test principle
judgment should be applied to any drug of abuse test result, Kinetic interaction of microparticles in a solution (KIMS)9,10
particularly when preliminary positive results are used. as measured by changes in light transmissions.
In the absence of sample drug, soluble drug conjugates bind
Summary
to antibody-bound microparticles, causing the formation of
Cocaine, a natural product found in the leaves of the coca
particle aggregates. As the aggregation reaction proceeds in the
plant, is a potent central nervous system (CNS) stimulant and
absence of sample drug, the absorbance increases.
a local anesthetic. Its pharmacological effects are identical to
When a urine sample contains the drug in question, this
those of amphetamines (also CNS stimulants), though cocaine
drug competes with the drug derivative conjugate for
has a shorter duration of action.2 Cocaine induces euphoria,
microparticle-bound antibody. Antibody bound to sample
confidence, and a sense of increased energy in the user; these
drug is no longer available to promote particle aggregation,
psychological effects are accompanied by increased heart rate,
and subsequent particle lattice formation is inhibited. The
dilation of pupils, fever, tremors, and sweating. The crash
presence of sample drug diminishes the increasing absorbance
following a cocaine high is profound, ranging from irritability,
in proportion to the concentration of drug in the sample.
lassitude, and the desire for more drug, to anxiety, hallucinations,
Sample drug content is determined relative to the value obtained
for a known cutoff concentration of drug.11
Materials provided
See Reagents - working solutions section for reagents.
Assay
For optimum performance of the assay follow the
directions given in this document for the analyzer
concerned. Refer to the appropriate operators manual for
analyzer-specific assay instructions.
CO3Q2, CO3QC (300 ng/mL cutoff) Interfering substances were added to drug free urine at twice the
concentration listed below. These samples were then spiked to
Flag COBAS INTEGRA Value range
300 ng/mL using a 600 ng/mL benzoylecgonine stock solution.
No flag Negative < 1000
Samples were tested and the following results were obtained:
<TEST RNG Negative <0
>TEST RNG Positive > 4000 % Cocaine
POS 1000 Positive 1000 Concentration Metabolite
Substance Tested Recovery
Value ranges above are based on assigning the cutoff
Acetone 1% 99
of 300 ng/mL a value of 1000.
Ascorbic Acid 1.5 % 112
Semiquantitative result reporting Bilirubin 0.25 mg/mL 102
The semiquantitation of preliminary positive results should only Creatinine 5 mg/mL 104
be used by laboratories to determine an appropriate dilution of
Ethanol 1% 99
the specimen for confirmation by a confirmatory method such
Glucose 2% 104
as GC/MS. It also permits the laboratory to establish quality
control procedures and assess control performance. Hemoglobin 0.1 g/L 104
Hemoglobin 1 g/L 104
Note: When using the post-dilution function (1:10 dilution), to
ensure the sample was not over-diluted, the diluted result must Hemoglobin 7.5 g/L 104
be at least half the analyte cutoff value times 10. If the diluted Human Albumin 0.025 % 105
result falls below half the analyte cutoff value times 10, repeat Human Albumin 0.05 % 103
the sample with a smaller dilution. A dilution that produces a Human Albumin 0.5 % 106
result closest to the analyte cutoff is the most accurate estimation. Oxalic Acid 2 mg/mL 102
To estimate the preliminary positive samples concentration, Sodium Chloride 0.5 M 96
multiply the result by the appropriate dilution factor. Dilutions Sodium Chloride 1M 95
should only be used as an estimation for GC/MS.
Urea 6% 101
Limitations - interference
See the Specific performance data section of this document ACTION REQUIRED
for information on substances tested with this assay. There Special wash programming: The use of special wash steps is
is the possibility that other substances and/or factors mandatory when certain test combinations are run together
may interfere with the test and cause erroneous results on COBAS INTEGRA analyzers. Refer to the Method Manual,
(e.g., technical or procedural errors). Introduction, Extra Wash Cycles for further instructions.
A preliminary positive result with this assay indicates Where required, special wash/carry-over evasion programming
the presence of cocaine metabolite in urine. It does not must be implemented prior to reporting results with this test.
measure the level of intoxication. Specific performance data
Interfering substances were added to drug free urine at twice the Representative performance data on the COBAS INTEGRA
concentration listed below. These samples were then spiked to analyzers are given below. Results obtained in individual
150 ng/mL using a 300 ng/mL benzoylecgonine stock solution. laboratories may differ.
Samples were tested and the following results were obtained:
Precision
% Cocaine Precision was determined in an internal protocol by using
Concentration Metabolite a series of benzoylecgonine calibrator and controls in
Substance Tested Recovery replicates of 20, once a day, for 5 days.
Acetone 1% 96 The following results were obtained on a COBAS
Ascorbic Acid 1.5 % 113 INTEGRA 700 analyzer:
Bilirubin 0.25 mg/mL 106 Semiquantitative precision (150 ng/mL cutoff)
Creatinine 5 mg/mL 107 Repeatabilitye Mean SD CV
Ethanol 1% 96 ng/mL ng/mL %
Glucose 2% 109 Level 1 (113 ng/mL) 118 5 4.4
Hemoglobin 0.1 g/L 101 Level 2 (150 ng/mL) 161 6 3.8
Hemoglobin 1 g/L 99 Level 3 (188 ng/mL) 184 5 2.8
Hemoglobin 7.5 g/L 106
Intermediate Mean SD CV
Human Albumin 0.025 % 104
precisionf ng/mL ng/mL %
Human Albumin 0.05 % 107
Level 1 (113 ng/mL) 119 6 5.3
Human Albumin 0.5 % 104
Level 2 (150 ng/mL) 155 7 4.5
Oxalic Acid 2 mg/mL 106
Level 3 (188 ng/mL) 188 7 3.7
Sodium Chloride 0.5 M 94
Sodium Chloride 1M 91
Urea 6% 110
Semiquantitative precision (300 ng/mL cutoff) Cocaine II Clinical Correlation (Cutoff = 150 ng/mL)
e Mean SD CV
Repeatability GC/MS values (ng/mL)
ng/mL ng/mL % Negative
Level 1 (225 ng/mL) 199 5 2.7 COBAS samples Near Cutoff 344 -
296 7 2.3 INTEGRA 113 188 106072
Level 2 (300 ng/mL)
Level 3 (375 ng/mL) 355 7 2.0 700 + 0 0 10 50