Drug Screen Test Card
A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine.
One Step Drug Screen Drug Test Card
Package Insert for Single and Multi Drug Screen Drug Test Cards
|Marijuana (THC)||11-nor-Δ9-THC-9 COOH||
|Morphine (MOP 300)||Morphine||
|Opiates (OPI 2000)||Morphine||
|Oxycodone (OXY)||Oxycodone||100 ng/mL|
|Tricyclic Antidepressants (TCA)||Nortriptyline||
BARBITURATES (BAR)Barbiturates are central nervous system depressants. They are used therapeutically as sedatives, hypnotics, and anticonvulsants. Barbiturates are almost always taken orally as capsules or tablets. The effects resemble those of intoxication with alcohol. Chronic use of barbiturates leads to tolerance and physical dependence.
Short acting Barbiturates taken at 400 mg/day for 2-3 months can produce a clinically significant degree of physical dependence. Withdrawal symptoms experienced during periods of drug abstinence can be severe enough to cause death.
Only a small amount (less than 5%) of most Barbiturates are excreted unaltered in the urine. The approximate detection time limits for Barbiturates are:
|Short acting (e.g. Secobarbital)||100 mg PO (oral)||4.5 days|
|Long acting (e.g. Phenobarbital)||400 mg PO (oral)||7 days1|
BENZODIAZEPINES (BZO)Benzodiazepines are medications that are frequently prescribed for the symptomatic treatment of anxiety and sleep disorders. They produce their effects via specific receptors involving a neurochemical called gamma aminobutyric acid (GABA). Because they are safer and more effective, Benzodiazepines have replaced barbiturates in the treatment of both anxiety and insomnia. Benzodiazepines are also used as sedatives before some surgical and medical procedures, and for the treatment of seizure disorders and alcohol withdrawal.
Risk of physical dependence increases if Benzodiazepines are taken regularly (e.g., daily) for more than a few months, especially at higher than normal doses. Stopping abruptly can bring on such symptoms as trouble sleeping, gastrointestinal upset, feeling unwell, loss of appetite, sweating, trembling, weakness, anxiety and changes in perception.
Only trace amounts (less than 1%) of most Benzodiazepines are excreted unaltered in the urine; most of the concentration in urine is conjugated drug. The detection period for the Benzodiazepines in the urine is 3-7 days.
The One Step Drug Screen Drug Test Card yields a positive result when the Benzodiazepines in urine exceed 300 ng/mL.
COCAINE (COC)Cocaine is a potent central nervous system (CNS) stimulant and a local anesthetic. Initially, it brings about extreme energy and restlessness while gradually resulting in tremors, over-sensitivity and spasms. In large amounts, cocaine causes fever, unresponsiveness, difficulty in breathing and unconsciousness. Cocaine is often self-administered by nasal inhalation, intravenous injection and free-base smoking. It is excreted in the urine in a short time primarily as Benzoylecgonine.2,3 Benzoylecgonine, a major metabolite of cocaine, has a longer biological half-life (5-8 hours) than cocaine (0.5-1.5 hours), and can generally be detected for 24-48 hours after cocaine exposure.3
The One Step Drug Screen Drug Test Card yields a positive result when the cocaine metabolite in urine exceeds 300 ng/mL. This is the suggested screening cut-off for positive specimens set by the Substance Abuse and Mental Health Services Administration (SAMHSA, USA).
The One Step Drug Screen Drug Test Card yields a positive result when the concentration of THC-COOH in urine exceeds 50 ng/mL. This is the suggested screening cut-off for positive specimens set by the Substance Abuse and Mental Health Services Administration (SAMHSA, USA).
Methadone is a long acting pain reliever producing effects that last from twelve to forty-eight hours. Ideally, Methadone frees the client from the pressures of obtaining illegal heroin, from the dangers of injection, and from the emotional roller coaster that most opiates produce. Methadone, if taken for long periods and at large doses, can lead to a very long withdrawal period. The withdrawals from Methadone are more prolonged and troublesome than those provoked by heroin cessation, yet the substitution and phased removal of methadone is an acceptable method of detoxification for patients and therapists.1
The MTD One Step Methadone Drug Test Card yields a positive result when the Methadone in urine exceeds 300 ng/mL.
The One Step Drug Screen Drug Test Card yields a positive result when the Methamphetamine in urine exceeds 1,000 ng/mL.
METHYLENEDIOXYMETHAMPHETAMINE (MDMA) ECSTASY
OPIATE (MOP 300)
Opioid analgesics comprise a large group of substances which control pain by depressing the central nervous system. Large doses of morphine can produce higher tolerance levels, physiological dependency in users, and may lead to substance abuse. Morphine is excreted unmetabolized, and is also the major metabolic product of codeine and heroin. Morphine is detectable in the urine for several days after an opiate dose.1
The One Step Drug Screen Drug Test Card yields a positive result when the concentration of opiate exceeds the 300 ng/mL cut-off level.
Oxycodone is known to metabolize by demethylation into oxymorphone and noroxycodone. In a 24-hour urine, 33-61% of a single, 5mg oral dose is excreted with the primary constituents being unchanged drug (13-19%), conjugated drug (7-29%) and conjugated oxymorphone (13-14%).2 The window of detection for oxycodone in urine is expected to be similar to that of other opioids such as morphine.
The Integrated E-Z Split Key® Cup II yields a positive result when the concentration of oxycodone in urine exceeds 100 ng/mL. At present, the Substance Abuse and Mental Health Services Administration (SAMHSA) does not have a recommended screening cut-off for oxycodone positive specimens.
Phencyclidine is used in powder, capsule, and tablet form. The powder is either snorted or smoked after mixing it with marijuana or vegetable matter. Phencyclidine is most commonly administered by inhalation but can be used intravenously, intra-nasally, and orally. After low doses, the user thinks and acts swiftly and experiences mood swings from euphoria to depression. Self-injurious behavior is one of the devastating effects of Phencyclidine.
PCP can be found in urine within 4 to 6 hours after use and will remain in urine for 7 to 14 days, depending on factors such as metabolic rate, user’s age, weight, activity, and diet.5 Phencyclidine is excreted in the urine as an unchanged drug (4% to 19%) and conjugated metabolites (25% to 30%).
The One Step Drug Screen Drug Test Card yields a positive result when the phencyclidine level in urine exceeds 25 ng/mL. This is the suggested screening cut-off for positive specimens set by the Substance Abuse and Mental Health Services Administration (SAMHSA, USA).
TRICYCLIC ANTIDEPRESSANTS (TCA)
The One Step Drug Screen Drug Test Card yields a positive result when the concentration of Tricyclic Antidepressants in urine exceeds 1,000 ng/mL.
The One Step Drug Screen Drug Test Card 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.
- 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 Drug Test Card should be discarded according to federal, state and local regulations.
STORAGE AND STABILITY
SPECIMEN COLLECTION AND PREPARATION
- Drug Test Cards
- Package insert
Materials Required But Not Provided
- Specimen collection container
- External controls
DIRECTIONS FOR USE
- Bring the pouch to room temperature before opening it. Remove the Drug Test Card from the sealed pouch and use it as soon as possible. Remove the cap from the end of the Drug Test Card. With arrows pointing toward the urine specimen, immerse the strip(s) of the Drug Test Card vertically in the urine specimen for at least 10-15 seconds. Immerse the Drug Test Card to at least the level of the wavy lines on the strip(s), but not above the arrow(s) on the Drug Test Card. See the illustration below.
- Place the Drug Test Card on a non-absorbent flat surface, start the timer and wait for the red line(s) to appear. The results should be read at 5 minutes. Results remain stable for up to four hours after test initiation.
|Note: This illustration shows a 5-drug Drug Test Card|
INTERPRETATION OF RESULTS
*NOTE: The shade of red in the test line region (T) will vary, but it should be considered negative whenever there is even a faint pink line.
POSITIVE: One red line appears in the control region (C). No line appears in the test region (T). This positive result indicates that the drug concentration is above the detectable level.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test panel. If the problem persists, discontinue using the lot immediately and contact your manufacturer.
- The One Step Drug Screen Drug Test Card provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.
- There is a possibility that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.
- 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.
- A Positive result does not indicate level or intoxication, administration route or concentration in urine.
- 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.
- Test does not distinguish between drugs of abuse and certain medications.