Proscreen-cassette-australia cutoff.doc

ProScreenTM Drug Screen Cassette
injection. It produces hallucinations, lethargy, disorientation, loss of coordination, trance-like ecstatic states, a sense of euphoria and visual distortions. It is well absorbed following all routes of administration. Unchanged PCP is excreted in Testing
urine in moderate amounts (10% of the dose). FOR IN VITRO DIAGNOSTIC USE
1. Remove the cassette test device from the sealed pouch. Tetrahydrocannabinol is generally accepted to be the principle active component in marijuana. When ingested or
smoked, it produces euphoric effects. Abusers exhibit central nervous system effects, altered mood and sensory 2. Place the test on a clean level surface. Hold the dropper vertically and transfer 3 full drops of urine INTENDED USE
perceptions, loss of coordination, impaired short term memory, anxiety, paranoia, depression, confusion, hallucinations (approximately 100 ul total volume) to the specimen well (S) of the test device, and then start the timer. The ProScreenTM Drug Screen Ca ssette is a one -step immunoassay for the qualitative detection of multiple drugs and drug and increased heart rate. When marijuana is ingested, the drug is metabolized by the liver, the primary metabolite of 3. Read result in 5 minutes. Do not interpret result after 10 minutes. metabolites in human urine at the following cutoff concentrations: marijuana excreted in the urine is 11-nor-∆-9-tetrahydrocannabinol-9-carboxylic acid. Therefore, the presence of detected cannabinoids, including the primary carboxyl metabolite, in the urine indicate marijuana/cannabis use. Tricyclic antidepressants (TCAs) have been prescribed for depression and compulsive disorders. Because of the
possibility of causing serious cardiac complications, TCAs can be lethal if misused at high doses. TCAs are taken orally or sometimes by injection. TCAs are metabolized in the liver. Both TCAs and their metabolites are excreted in urine mostly in the form of metabolites for up to ten days. The length of time following drug use of which a positive result may occur is dependent upon several factors, including the frequency and amount of drug, metabolic rate, excretion rate, drug half -life, and the drug user’s age, weight, activity TEST PRINCIPLE
The ProScreenTM-Drug Screen Ca ssette is based on the principle of competitive immunochemical reaction between a chemically labeled drug (drug-protein conjugate) and the drug or drug metabolites which may be present in the urine sample for the limited antibody binding sites. The test contains a nitrocellulose membrane strip pre-coated with drug- protein conjugate (or antibody) in the test region and a pad containing colored antibody (or drug-protein)-colloidal gold conjugate. During the test, the urine sample is allowed to migrate upward and dehydrate the antibody (or drug-protein)- colloidal gold conjugate. The mixture then migrates along the membrane chromatographically by the capillary action to the immobilized drug-protein (or antibody) band on the test region. When drug is absent in the urine, the colored The configurations of this assay consist of any combination of the tests listed above. This assay is used to obtain a visual, antibody (or drug-protein)-colloidal gold conjugate and immobilized drug-protein (or antibody) bind specifically to form qualitative result and is intended for professional use only. a visible line in the test region as the antibody complexes with the drug-protein. When drug is present in the urine, it will INTERPRETATION OF RESULTS
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any
compete with drug-protein for the limited antibody sites. The line on the test region will become less intense with Negative (-): Colored lines appear in both Control Region (C) and Test Region (1, 2, or T). The line in the control
drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed
increasing drug concentration. When a sufficient concentration of drug is present in the urine, it will fill the limited region is the control line, which is used to indicate proper performance of the device. The line in the test region is the analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy
antibody binding sites. This will prevent attachment of the colored antibody (or drug-protein)-colloidal gold conjugate to drug probe line. The test line may have varying intensity either weaker or stronger in color than that of the control line. (GC/MS) is the preferred confirmation method.
the drug-protein (or antibody) on the test region. Therefore, the presence of the line on the test region indicates a
negative result for the drug and the absence of the test line on the test region indicates a positive result for the drug.
Positive (+): One colored line appears in the control region. No line appears in the test region. The complete
absence of a test line indicates a positive result for that drug. A visible line generated by a different antigen/antibody reaction is also present at the control region of the test strip. This Amphetamine/Methamphetamine , amphetamine, and metabolites are potent central nervous system stimulants. Acute
line should always appear, regardless of the presence of drugs or metabolites in the urine sample. This means that a Invalid: No colored line appears in the control region. If the control line does not form, the test result is inconclusive
higher doses induce euphoria, alertness, and sense of increased energy and power. More acute responses produce anxiety, negative urine sample will produce two lines (test line and control line), and a positive urine sample will generate only
paranoia, psychotic behavior, and cardiac dysrhythmias. Methamphetamine is excreted in urine as amphetamine and one line (control line). The presence of control line serves as a built-in control, which demonstrates that the test is
oxidized as deaminated and hydroxylated derivatives. However, methamphetamine is also excreted to some extent unchanged. Thus the presence of the parent compound in the ur ine indicates methamphetamine use. REAGENTS & MATERIALS SUPPLIED
Barbiturates are classified as central nervous system depressants. These products produce a state of intoxication that is
similar to alcohol intoxication. Symptoms include slurred speech, loss of motor coordination and impaired judgment. 25 individually wrapped test devices. Each device consists of different test strips in a plastic test strip holder. The Depending on the dose, frequency, and duration of use, one can rapidly develop tolerance, physical dependence and test strip contains a colloidal gold pad coated with antibody (or drug-protein) and rabbit antibody. It also contains a psychological dependence on barbiturates. Barbiturates are taken orally, or by intravenous and intramuscular injections. membrane coated with drug-bovine protein conjugate (or antibody) in the test band and goat anti-rabbit antibody in They are excreted in urine as parent compound as well as metabolites. the control band. A pipette is also enclosed. Benzodiazepines are central nervous system (CNS) depressants commonly prescribed for the short-term treatment of
anxiety and insomnia. In general, benzodiazepines act as hypnotics in high doses, as anxiolytics in moderate doses and as An internal procedural control is included in the test device. A line must form in the Control band region regardless of the sedatives in low doses. The use of benzodiazepines can result in drowsiness and confusion. Psychological and physical MATERIAL REQUIRED BUT NOT PROVIDED
presence or absence of drugs or metabolites. The presence of the line in the Control region indicates that the proper dependence on benzodiazepines can develop if high doses of the drug are given over a prolonged period. Benzodiazepines sample volume has been used and that the reagents are migrating properly. If the line in the Control region does not form, are taken orally or by intramuscular or intravenous injection, and are extensively oxidized in the liver to metabolites. Parent compounds, as well as metabolites are excreted in the urine. WARNINGS AND PRECAUTIONS
To ensure proper kit performance, it is recommended that the test devices be tested once a week with external controls. Cocaine is a potent central nervous system stimulant and a local anesthetic found in the leaves of the coca plant. The
• For professional in vitro diagnostic use only External controls are available from commercial sources. It is important to make sure that the control values are within psychological effects induced by using cocaine are euphoria, confidence and sense of increased energy. These • Urine specimens may be potentially infectious. Proper handling and disposal methods should be established. established limits. If the values of external control do not fall within established limits, the test results are invalid. psychological effects are accompanied by increased heart rate, dila tion of the pupils, fever, tremors and sweating. Cocaine Additional controls may be tested according to guidelines or requirements of local, state, and/or federal regulations or is excreted in the urine primarily as benzoylecgonine in a short period of time. Benzoylecgonine has a biological half -life Avoid cross-contamination of urine samples by using a new specimen collection container for each urine sample. of 5 to 8 hours, which is much longer than that of cocaine (0.5 to 1.5 hour), and can be generally detected for 24 to 60 • Test device should remain sealed until ready for use. LIMITATIONS OF PROCEDURE
Do not use the test kit after the expiration date. 3,4-methylenedioxymethamphetamine is classified as both a stimulant and a hallucinogen. Like methamphetamine,
• The assay is designed for use with human urine only. adverse effects of 3,4-methylenedioxymethamphetamine use include jaw clenching, teeth grinding, dilated pupils, perspiring, anxiety, blurred vision, vomiting, and increased blood pressure and heart rate. Overdose of 3,4- A positive result with any of the tests indicates only the presence of a drug/metabolite and does not indicate or The ProScreenTM -Drug Screen Ca ssette should be stored at 2-30°C (36-86°F) in the original sealed pouch. Do not methylenedioxymethamphetamine may cause heart failure or extreme heart stroke. 3,4-methylenedioxyme thamphetamine is taken orally in tablets or capsules and excreted in urine as parent compound as well as metabolic. • There is a possibility that technical or procedural error as well other substances as factors not listed may interfere with the test and cause false results. See SPECIFICITY for lists of substances that will produce positive results, or that do Methadone is a synthetic analgesic drug originally used for the treatment of narcotic addiction. The psychological effects
induced by using methadone are analgesia, sedation, and respiratory depression. Overdose of methadone may cause coma Fresh urine does not require any special handling or pretreatment. A fresh urine sample should be collected in the or even death. Methadone is taken orally or intravenously and is metabolized in the liver and has a biological half -life of • If adulteration is suspected, the test should be repeated with new sample. container provided. Alternately, a clean, dry plastic or glass container may be used for specimen collection. If the specimen will not be tested after the specimen collection, the specimen may be refrigerated at 2-8°C up to 2 days or PERFORMANCE CHARACTERISTICS
Opiates, such as heroin, morphine, and codeine, are central nervous system (CNS) depressants. The use of opiates at high
frozen at -20°C for longer period of time. Specimens that have been refrigerated must be equilibrated to room doses produces euphoria and release from anxiety. Physical dependence is apparent in users and leads to depressed temperature prior to testing. Specimens previously frozen must be thawed and mixed thoroughly prior to testing. Accuracy
coordination, disrupted decision making, decreased respiration, hypothermia and coma. Heroin is quickly metabolized to Note: Urine specimens and all materials coming in contact with them should be handled and disposed as if capable of
The accuracy of the ProScreenTM Drug Screen Ca sse tte was evaluated in comparison to commercially available drug morphine, morphine glucuronide and 6-acetylmorphine. Thus, the presence of morphine (or the metabolite, morphine transmitting infection. Avoid contact with skin by wearing gloves and prope r laboratory attire. screen tests. Sixty (60) negative urine samples collected from presumed non-user volunteers were tested by both glucuronide) in the urine indicates heroin, morphine, and/or codeine use. ProScreenTM Drug Screen Ca ssette I and commercially available drug screen tests. Of these negative urine samples tested, Oxycodone is a semi-synthetic opioid with a structural similarity to codeine. It produces potent euphoria, analgesic and
all were found negatives by both methods. In a separate study, positive urine samples, obtained from clinical laboratories sedative effects, and has a dependence liability similar to morphine. Oxycodone is most often administered orally and is Preparation
where the drug concentrations were determined by GC/MS (TCA concentrations were determined by HPLC), were tested metabolized by demethylation to noroxycodone and oxymorphone followed by glucuronidation and excreted in urine. The by ProScreenTM Drug Screen Ca ssetteI and commercial drug screen tests. The results of accuracy study are presented window of detection for oxycodone in urine is expected to be similar to that of other opioids such as morphine. 1. If specimen, control, or test devices have been stored at refrigerated temperatures, allow them to warm to room Phencyclidine , commonly known as “angel dust” and “crystal cyclone", is an arylcyclohexylamine that is originally used
as an anesthetic agent and a veterinary tranquilizer. The drug is abused by oral or nasal ingestion, smoking, or intravenous
2. Do not open test device pouch until ready to perform the test. Specificity
The specificity for the ProScreenTM Drug Screen Ca ssette was determined by testing various drugs, drug metabolites, (<-50% C/O) (–50% C/O to C/O) (C/O to +50% C/O) and other compounds that are likely to be present in urine. All compounds were prepared in drug-free normal human The following compounds produce positive results when tested at levels greater than the concentrations listed below. Tricyclic Antidepressant
Conc. (ng/ml)
Conc. (ng/ml)
Two pools of drug-free urine were spiked with drug standards to 50% below and 50% above cutoff concentrations. The drug concentrations were confirmed by GC/MS. The following compounds were evaluated for potential positive and/or negative interference with the ProScreenTM Drug Screen Ca ssette . All compounds were dissolved in the spiked sample solutions and tested with ProScreenTM Drug Screen Ca ssette. An unaltered sample was used as a control. No positive interference or negative interference was found for the following compounds when tested at concentrations Benzodiazepines
Methamphetamine (300)
The precision of the ProScreenTM Drug Screen Card II was evaluated by testing three lots of the test devices at four study sites with spiked drug sample solutions on three consecutive days. Sample concentrations were confirmed by GC/MS. Effect of Specimen pH
Drug sample solutions with 50% below and 50% above cutoff concentrations were adjusted to pH 4-9 and tested using ProScreenTM Drug Screen Ca ssette . An unaltered sample was used as a control. The results demonstrate that varying ranges of specimen pH do not interfere with the performance of the test. Methamphetamine (1000)
Effect of Specimen Specific Gravity
Drug sample solutions with 50% below and 50% above cutoff concentrations were adjusted to specific gravity 1.003-1.04 and tested using ProScreenTM Drug Screen Ca ssette . An unaltered sample was used as a control. The results demonstrate that varying ranges of specimen specific gravity do not interfere with the performance of the test. BIBLIOGRAPHY OF SUGGESTED READING
1. Baselt, R. C., Disposition of Toxic Drugs and Chemicals in Man, Biomedical Publications, Davis, CA, 1982. 2. Urine testing for Drugs of Abuse. National Institute on Drug Abuse (NIDA), Research Monograph 73, 1986. 3. Fed. Register, Department of Health and Human Services, Mandatory Guidelines for Federal Workplace Drug Methadone
Testing Programs, 53, 69, 11970-11979, 1988. 4. Liu, Ray H. and Goldberger, Bruce A., Handbook of Workplace Drug Testing, AACC Press (1995). Opiates (300)
5. Gilman, A. G. and Goodman, L. S., The Pharmacological Basis of Therapeutics, eds. MacMillan Publishing, New Opiates (2000)


Microsoft word - mark 2.13-17.doc

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