AMP • BZO • PCP • mAMP • COC • THC • BAR • OPI • TCA

106 Pages·2003·0.89 MB·English

TOX DRUG SCREEN
PRODUCT INSERT
TOX DRUG SCREEN
A RAPID QUALITATIVE PANEL FOR
DRUGS OF ABUSE
NOTICE D’UTILISATION
TOX DRUG SCREEN
UN PANEL QUALITATIF RAPIDE
POUR LE DÉPISTAGE DE SUBSTANCES
TOXICOMANOGÈNES
PACKUNGSBEILAGE
TOX DRUG SCREEN
EIN QUALITATIVER SCHNELLTEST
FÜR DROGEN
MANUALE DI ISTRUZIONE
TOX DRUG SCREEN
DOSAGGIO QUALITATIVO RAPIDO
PER DROGHE DA ABUSO
MANUAL DE INSTRUCCIONES
TOX DRUG SCREEN
PRUEBA CUALITATIVA RÁPIDA PARA
LA DETECCIÓN DE VARIAS DROGAS
• AMP • BZO • PCP
• mAMP • COC • THC
• BAR • OPI • TCA
11030 Roselle St.
San Diego, CA 92121
1-888-BIOSITE
(246-7483)
www.biosite.com
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TOX DRUG SCREEN
INTENDED USE
The Triage® TOX Drug Screen is a fluorescence immunoassay
intended to be used with the Triage® Meter for the point-of-care
qualitative determination of major metabolites of amphetamines,
methamphetamines, barbiturates, benzodiazepines, cocaine,
opiates, phencyclidine, THC, and tricyclic antidepressants in
urine. Please refer to the Triage® Meter manual instructions for
using the Triage® Meter.
The threshold concentrations are provided below:
AMP Amphetamines 1000 ng/mL
mAMP Methamphetamines 1000 ng/mL
BAR Barbiturates (calibrated to
Pentobarbital) 300 ng/mL
BZO Benzodiazepines 300 ng/mL
COC Cocaine 300 ng/mL
OPI Opiates 300 ng/mL
PCP Phencyclidine 25 ng/mL
THC THC 50 ng/mL
TCA Tricyclic Antidepressants
(calibrated to Desipramine) 1000 ng/mL
This test provides only a preliminary test result. Clinical
consideration and professional judgement must be applied
to any drug of abuse test result, particularly in evaluating a
preliminary positive result. In order to obtain a confirmed
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analytical result, a more specific alternate chemical method
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LIS is needed. Gas Chromatography/Mass Spectroscopy
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N (GC/MS) is the preferred confirmatory method.
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SUMMARY AND EXPLANATION OF THE TEST
Drug abuse in the United States continues to be an increasingly
significant social and economic problem. Opiates, cocaine,
THC, amphetamines and phencyclidine are recognized by the
Substance Abuse and Mental Health Services Administration
(SAMHSA) as the most frequently abused illicit drugs.
Tranquilizers, antidepressants, barbiturates, and opiate
compounds are among a group of prescription drugs that also are
frequently abused. The opiate class of compounds that may
produce a positive result include illicit opiates as well as cough
medications containing codeine and antidiarrheal preparations.
Urine-specific screening tests for drugs of abuse range from
simple immunoassay tests to complex analytical procedures. The
speed and sensitivity of immunoassays have made them the most
accepted method for screening urine for the presence of drugs.
The Triage®TOX Drug Screen uses distinct immunoassays for
the simultaneous detection of the major urinary metabolites of 8
different drug classes. The use of monoclonal antibodies that are
specific for the metabolites of the 8 drug classes ensures a high
degree of sensitivity and specificity.
TEST PRINCIPLE
The Triage® TOX Drug Screen is a competitive fluorescence
immunoassay used for the qualitative determination of parent
compound and major metabolites of drugs of abuse in urine
specimens. After addition of a urine sample to the sample port
of the test device, the urine passes through a filter. A
predetermined quantity of urine moves by capillary action into a
reaction chamber and is allowed to react with fluorescent
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antibody conjugates or mix with fluorescent drug conjugates
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within the reaction chamber to form a reaction mixture. After an G
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incubation period, the reaction mixture flows through the device IS
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detection lane. The presence of drug or drug metabolite in the
urine specimen prevents binding of the fluorescent conjugates to
the solid phase on the detection zone. Excess urine washes the
unbound fluorescent conjugates from the detection lane into a
waste reservoir. The concentration of the drug metabolite in the
urine specimen is inversely related to the fluorescence bound to
the detection zone.
REAGENTS
The Triage® TOX Drug Screen contains all the reagents
necessary for the qualitative determination of metabolites of
drugs of abuse in urine. The device contains murine monoclonal
antibodies and drug metabolites labeled with a fluorescent dye or
immobilized on the solid phase, and stabilizers.
STORAGE AND HANDLING REQUIREMENTS
The Triage®TOX Drug Screen test device is stable while in the
sealed pouch up to the expiration date printed on the pouch
when stored refrigerated at 2-8 °C (35-46 °F). The sealed Triage®
TOX Drug Screen test device is stable for up to 14 days at room
temperature, but not beyond the expiration date printed on the
pouch. If the test device is not used on the same day it is
removed from refrigeration, use a soft, felt-tip marker to write
the date of removal from the refrigerator and the date to discard
on the sealed foil pouch and/or the kit box.
Once the Triage®TOX Drug Screen test device is removed from
refrigeration, allow a minimum of 15 minutes for the device to
reach room temperature while in the sealed pouch.
Do not remove the Triage®TOX Drug Screen test device from
the pouch until it is ready for use.
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H WARNINGS AND PRECAUTIONS
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E • FOR IN VITRO DIAGNOSTIC USE.
• For professional use only.
• Urine specimens are potentially infectious. Proper handling
and disposal methods should be established.
• The performance of this product has been established for
human urine only. Other specimen types have not been
evaluated.
• The performance of this product has not been established
when stored outside the recommended conditions.
SPECIMEN COLLECTION AND HANDLING
Freshly voided urine specimens should be collected in a clean,
previously unused glass or plastic container. If the specimen is
not tested immediately, it should be refrigerated at 2-8 °C for a
maximum of 2 days. If longer storage is required, specimens may
be stored frozen at –20 °C or colder. Frozen and refrigerated
specimens must reach room temperature and be mixed
thoroughly prior to testing. Specimens containing a large
amount of particulate matter may be clarified by centrifuging or
allowing the particulate matter to settle before testing.
MATERIALS PROVIDED
BIOSITE®TRIAGE®TOX DRUG SCREEN
Catalog No. 94000
Kit Contains:
Triage®TOX Drug Screen Test Devices 25
Transfer Pipettes 25
Reagent Code Chip® 1
Printer Paper 1 roll
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ADDITIONAL MATERIALS REQUIRED E
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BUT NOT PROVIDED L
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Triage®MeterPlus
Triage®TOX Drug Screen Controls
INSTRUCTIONS FOR USE
Using the Transfer Pipette:
1. Depress the larger (top) bulb completely and insert the tip
into the specimen.
2. Release the bulb slowly to draw the specimen into the tube.
The tube should fill completely and liquid will overflow
into the smaller (lower) bulb. Some liquid must remain in
the smaller (lower) bulb.
3. Place the tip of the pipette into the sample port of the
device and depress the larger (top) bulb completely. The
entire amount of specimen in the pipette tube must be
dispensed. The sample in the smaller (lower) bulb will not
be expelled.
4. Remove the pipette tip from the sample port and then
release the bulb.
5. Discard the transfer pipette.
Test Procedure:
STEP 1 Add Specimen to Triage®TOX Drug Screen test device
Open the pouch, remove the Triage® TOX Drug Screen test
device, and write the patient ID number on the label of the test
device. Add urine into the sample port using the transfer pipette
provided (refer to instructions for using the transfer pipette
described above).
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STEP 2 Insert device into the Triage®Meter
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G Insert the Triage®TOX Drug Screen test device into
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E the Triage® Meter and run the test according to the
instructions in the Triage® Meter Operator’s Manual. This step
must be completed no longer than 30 minutes after Step 1.
STEP 3 Read the Results on the Triage®Meter Display Screen
The results are displayed when the test is complete. After the
device has been analyzed, it is released by the Triage®Meter.
QUALITY CONTROL
The use of control specimens is recommended to test each newly
received shipment of product, and at least every 30 days or
whenever the operator wishes to verify the performance of the
controls or the test. Biosite Incorporated has two external
control specimens available for this purpose. One contains no
drugs and the other contains concentrations of each drug or
respective metabolite above the threshold concentration. It is
recommended that these controls be used to test each new
shipment or lot of product and to verify system and operator
proficiency. Users should follow the appropriate local, state, and
federal guidelines concerning the running of external quality
controls.
Each Triage®TOX Drug Screen test device has internal controls
to satisfy routine quality control requirements. These internal
controls check that sufficient sample was added to the panel,
that the unbound fluorescent label has been washed sufficiently
from the detection zone, and that the device was inserted and
read properly by the Triage®Meter. An unacceptable result from
either control causes a warning message on the Triage® Meter
and the test should be repeated.
The QC Simulator provided with the Triage® Meter should be
tested daily to verify instrument performance. The QC
Simulator should be tested upon setup of the Triage®Meter and
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when required by applicable local, state, and federal regulations.
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For further information regarding the QC Simulator and the G
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complete quality control of the system, refer to the Triage® IS
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Meter Operator’s Manual.
RESULTS
The following threshold concentrations are established for the
nine drug assays:
AMP 1000 ng/mL
mAMP 1000 ng/mL
BAR 300 ng/mL
BZO 300 ng/mL
COC 300 ng/mL
OPI 300 ng/mL
PCP 25 ng/mL
THC 50 ng/mL
TCA 1000 ng/mL
These threshold concentrations are used to separate a negative
result from a presumptive positive result. Results are displayed in
the following manner:
PAT.ID 123
AMP NEG OPI NEG
mAMP NEG PCP POS
BAR NEG THC POS
BZO NEG TCA NEG
COC POS
PAT.RESULT ABNORMAL
PRESS PRINT OR PRESS EXIT
The Triage®Meter displays the results as either “POS” if the
result is at or above the threshold or “NEG” if the result is
below the threshold.
A specimen may contain a measurable amount of drug
metabolite and still be considered negative. In order to obtain a
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confirmed analytical result, a more specific alternate chemical
H
LIS method is needed. Gas Chromatography/Mass Spectroscopy
G
N (GC/MS) is the preferred confirmatory method. Refer to the
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Performance Characteristics section for additional information.
LIMITATIONS OF THE PROCEDURE
Adulterants, such as bleach or other strong oxidizing agents,
added to urine specimens may produce erroneous results
regardless of the method of analysis. If adulteration is suspected,
obtain an additional specimen and re-test.
A presumptive positive result does not indicate the level of
intoxication, nor does it indicate the route of administration.
Refer to the Performance Characteristics section for information
regarding the test specificity, a list of drugs and drug metabolites
that produce a positive result, and other potentially interfering
substances.
There is a possibility that substances and/or factors may interfere
with the test and cause false results. Technical or procedural
errors can also contribute to erroneous results.
PERFORMANCE CHARACTERISTICS
Threshold Validation
Specimens used for threshold validation contained each
drug or drug metabolite spiked into drug-free urine at
concentrations in increments of 25% above and below
the threshold. Each specimen was tested using the
Triage® TOX Drug Screen. The data paralleled the
expected agreement based on the coefficient of
variation of the assays. It is important to use sound
clinical judgement with any result, particularly those
near the threshold concentration. If an aberrant result
is suspected, the sample should be re-tested using the
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Triage®TOX Drug Screen or a reference method such
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as GC/MS. G
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50% below threshold: H
AMP mAMP BAR BZO COC OPI PCP THC TCA
Concentration
500 500 150 150 150 150 12.5 25 500
(ng/ml)
Pos/Neg 0/10 0/10 0/10 0/10 0/10 0/10 0/10 0/10 0/10
Accuracy 100% 100% 100% 100% 100% 100% 100% 100% 100%
25% below threshold:
AMP mAMP BAR BZO COC OPI PCP THC TCA
Concentration
750 750 225 225 225 225 18.75 37.5 750
(ng/ml)
Pos/Neg 1/9 0/10 0/10 0/10 0/10 0/10 0/10 1/9 0/10
Accuracy 90% 100% 100% 100% 100% 100% 100% 90% 100%
25% above threshold:
AMP mAMP BAR BZO COC OPI PCP THC TCA
Concentration
1250 1250 375 375 375 375 31.25 62.5 1250
(ng/ml)
Pos/Neg 10/0 10/0 9/1 10/0 10/0 10/0 10/0 10/0 10/0
Accuracy 100% 100% 90% 100% 100% 100% 100% 100% 100%
50% above threshold:
AMP mAMP BAR BZO COC OPI PCP THC TCA
Concentration
1500 1500 450 450 450 450 37.5 75 1500
(ng/ml)
Pos/Neg 10/0 10/0 10/0 10/0 10/0 10/0 10/0 10/0 10/0
Accuracy 100% 100% 100% 100% 100% 100% 100% 100% 100%
Specificity
The specificity of each of the nine assays in the Triage®
TOX Drug Screen has been tested with over 100 drugs
and closely related compounds. A portion of the
compounds representative of each drug class is listed
below and is expressed as the concentration that
produces a positive result. The individual assays are
calibrated against the compounds marked with an
asterisk (*)1.
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