10 Panel Multi-Drug Test Card - vitro diagnostic
10 Panel Multi-Drug Test Card
THC (MARIJUANA) • COCAINE • PCP • OPIATES • METHAMPHETAMINES • METHADONE • AMPHETAMINES • BARBITURATES • BENZODIAZEPINES • Tricyclic Antidepressants
INTENDED USE
|SYMBOL |TARGET DRUG |CONC. |
|THC |MARIJUANA |50 ng/ml |
|COC |COCAINE |300 ng/ml |
|PCP |PHENCYCLIDINE |25 ng/ml |
|MOR |OPIATES |2000 ng/ml |
|MET |METHAMPHETAMINE |1000 ng/ml |
|MTD |METHADONE |300 ng/ml |
|AMP |AMPHETAMINE |1000 ng/ml |
|BAR |BARBITURATES |300 ng/ml |
|BZO |BENZODIAZEPINES |300 ng/ml |
|TCA |Tricyclic Antidepressants |30 ng/ml |
The Multi-Drug 10 Panel Test is an forensic, all inclusive, point of use screening test for the rapid detection of 11-nor- delta 9 -Tetrahydrocannabinol -9- carboxylic acid (THC/Marijuana), Cocaine and its metabolite, benzoylecgonine, PCP (Phencyclidine), Morphine and its related metabolites derived from opium (opiates), Methamphetamines (including Ecstasy), Methadone, Amphetamines, Barbiturates, Benzodiazepines and Tricyclic Antidepressants (TCA) in human urine at or above the system concentrations levels established as standard minimums by the National Institute on Drug Abuse (NIDA), the World Health Organization (WHO) and SAMHSA as shown in the chart to the right. Note system cut-off concentrations are expressed in nanograms per milliliter solution
SUMMARY AND EXPLANATION
|[pic] |[pic] |
|Front View |Back View |
Urine based screening tests for drugs of abuse range from simple immunoassay tests to complex analytical procedures. The speed and sensitivity of lateral flow based immunoassays identical to that employed in the Multi-Drug 10 Panel Screen Test have made them the most widely accepted method for screening urine for drugs of abuse. The Multi-Drug Screen Panel Test is based on the principle of the highly specific immunochemical reactions of antigens and antibodies which are used for the analysis of specific compounds in human urine. The Multi-Drug Screen is a rapid, visual, competitive panel immunoassay that can be used for the simultaneous, qualitative detection of the ten (10) targeted drugs and their metabolites listed above. The Ten Panel Multi-Drug Screen Panel Test is intended as an initial forensic screen for the presence of drug or drug metabolites at the time the test is performed. Because the test requires visual interpretation, it is recommended that a person other than the test subject interpret test results.
TEST PROCEDURE
• Read the enclosed instruction manual completely.
• Do not open the sealed test pouch until just prior to sample testing.
• Collect a fresh urine sample in a clean container preferably glass.
• Check the expiration date and remove the test device from the sealed pouch. Do not use the test past its expiration date. Remove the test cap exposing the 10 absorbent wicks. Do not touch the wicks or otherwise contaminate them.
• Dip the wicks only into the urine sample for approximately 20-30 seconds or until visible sample migration up the wicks and across the tests panels is observed.
• Dip only the wicks. Do not allow the sample to come in contact with any other part of the test device or its plastic housing.
• Read result within 3 to 8 minutes after the addition of samples. Do not read result after 8 minutes. If the drug test is left standing for longer than 8 minutes, the intensity of the colored lines may change or for technical reasons, a faint line may appear that should not be interpreted.
• Photocopy both sides of the test card for a permanent record of test results.
INTERPRETATION OF TEST RESULTS
|[pic] |[pic] |
|Result Side 1 |Result Side 2 |
Negative: Colored lines adjacent to each target drug name and in the control (C) regions will appear. The color intensity of the line for the target drug may be weaker or stronger than that of the control line however any line, no matter how faint should be interpreted as a negative result. Do not attempt to correlate the intensity or color of the test lines between the targeted drug panels. Also because development times vary for each target drug, results should not fully interpreted until 6-8 minutes have elapsed. Some drug panels, however, will develop test lines within 3 minutes or less producing negative results. A very faint line on the test region may indicate that the target drug in the sample is near the cutoff level for the test. While these results should be considered negative, confirmation of the sample by more analytical testing methods may be desired.
Positive: Colored lines appear in the control regions (C) but do not develop in the test region. The absence of any line in any target drug test region indicates a positive result for that drug or drug metabolite. The example shown is a positive test for THC and Opiates and negative test for all other drugs. Note that test lines are not of equal intensity or color. Because of the various sensitivity cutoff level for each specific drug this result is normal.
Invalid: No line appears in the control region. Under no circumstances should a positive sample be identified until the control line (C) forms in the control test area. If the control line (C) does not form, the test result is inconclusive and the assay should be repeated with a new test device.
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