SalivaScan Product Insert - Narcotic Testing Supplies & Equipment
Contents
1. Biomedical Publications 1982 2 Hawks RL Chiang CN eds Urine Testing for Drugs of Abuse Rockville Department of Health and Human Services National Institute on Drug Abuse 1986 3 Substance Abuse and Mental Health Services Administration Mandatory Guidelines for Federal Workplace Drug Testing Programs 53 Federal Register 1988 4 McBay AJ Drug analysis technology pitfalls and problems of drug testing Clin Chem 1987 Oct 33 11 Suppl 33B 40B 5 Gilman AG Goodman LS Gilman A eds Goodman and Gilman s The Pharmacological Basis of Therapeutics 6th ed New York Macmillan 19802. Express Diagnostics Int l Inc CEPartner4U 1550 Industrial Drive Esdoornlaan 13 Blue Earth MN 56013 USA 3951 DB Maarn The Netherlands CE DC202l INT March 2012 DruGCHECK SalivaScan aa a 3 FOR IN VITRO DIAGNOSTIC USE INTENDED USE The DrugCheck SalivaScan Oral Fluid Drug Test is a rapid visual immunoassay for the qualitative presumptive detection ot drugs of abuse in human oral fluid specimens The test system consists of one or 0 membrane strips mounted in a plastic cassette This test detects combinations of the following drugs at the concentrations listed below Specific combinations will vary according to he test in question Test Calibrator Cut off ng mL 50 Amphetamine AMP D Amphetamine Benzodiazepine BZ0 Oxazepam 10 Buprenorphine BUP Buprenorphine 5 Cocaine COC Benzoylecgonine 20 Cotinine COT Cotinine 50 EDDP EDDP 2 Ethyliden 1 5 Dimethyl 20 3 3 Diphenylpyrrolidine Ketamine KET Ketamine 50 Marijuana THC 11 nor A9 THC 9 COOH _ 12 Marijuana THC A9 THC 50 Methadone MTD Methadone 30 Methamphetamine MET _ D Methamphetamine 50 Opiates OPI Opiates 40 Oxycodone OXY Oxycodone 40 Phencyclidine PCP Phencyclidine 10 Propoxyphene PPX Propoxyphene 50 Barbiturate BAR Barbiturate 50 PRINCIPLE The DrugCheck SalivaScan is an immunoassay based on the principle of competitive binding Drugs that may be presen
3. Hydromorphone 2 000 Fenfluramine 3 000 Morphine 3 b d glucuronide 20 000 L Methamphetamine 500 Nalorphine 10 000 L Phenylephrine 2 500 MDEA 400 Propoxyphene Related Compounds 3 4 Methylenedioxy Propoxyphene PPX 50 methamphetamine MDMA 75 D Norpropoxyphene 200 Mephentermine 200 PMMA 50 Barbiturate Related Compounds Procaine 2 500 Barbiturate BAR 0 Allobarbital 200 Opiates Related Compounds Alphenal 100 Morphine Amobarbital 100 Codeine 10 Aprobarbital 30 Diacetylmorphine Heroin 50 Butabarbital 15 Ethylmorphine 24 Butalbital 400 Hydrocodone 50 Butethal 30 Hydromorphone 100 Cyclopentobarbital 60 6 Monoacetylmorphine Pentobarbital 150 6 MAM 25 Phenobarbital 300 Morphine 3 b d glucuronide 50 Nalorphine 10 000 Oxycodone 25 000 Oxymorphone 25 000 Thebaine 5 000 A study was conducted to determine the cross reactivity of the test with compounds spiked into arug free PBS stock The following compounds V demonstrated no false posi concentrations up to 100 ug mL Aspirin 4 Dimethylaminoantipyrine Albumine Diphenhydramine Atropine loxepin Alphenal D Propoxyphene a hydroxyalprazolam DL Tyrosine Alprazolam Dopamine Amantadine DL Tryptophan Amikacin EDDP Aminopyrine Erythromycine Amitriptyline Estron 3 sulfate Atenolol Ethanol Amoxicilline Etodolac Ampicilline Ephedrine Apomorphine Ephedrine Aspartame Epinephrine Baclofen entanyl Barbital Flupentixol Benzocaine Fluoxetine Bilirubin Furosemide Butethal Gastrozep
4. and cause false results 4 A positive result indicates the presence of a drug metabolite only and does not indicate or measure intoxication 5 A negative result does not at any time rule out the presence of drugs metabolites in urine as they may be present below the minimum detection level of the test 6 This test does not distinguish between drugs of abuse and certain medications PERFORMANCE CHARACTERISTICS A Sensitivity A phosphate buffered saline PBS pool was spiked with drugs to target concentrations of 50 cut off and 25 cut off and tested with this device The results are summarized below Drug Conc n AMP BUP BZO COC Cut off range SE see see eee 0 Cut off 30 30 0 30 0 30 0 30 0 50 Cut off 30 30 0 30 0 30 0 30 0 25 Cut off 30 29 1 28 2 30 0 29 1 Cut off 30 18 12 11 19 14 16 18 12 25 Cut off 30 5 25 8 22 4 26 2 28 50 Cut off 30 0 30 0 30 0 30 0 30 Drug Conc n COT EDDP KET MET Cut off range 2 fel Ss ees 0 Cut off 30 30 0 30 0 30 0 30 0 50 Cut off 30 30 0 30 0 30 0 30 0 25 Cut off 30 30 0 30 0 27 3 30 0 Cut off 30 11 19 13 117 9 21 13 17 25 Cut off 30 1 29 2 28 3 27 3 27 50 Cut off 30 0 30 0 30 0 30 0 30 Drug Conc n MTD OPI OXY PCP Cut off
5. the color pad has a blue color before applying saliva sample do not use the test NOTE A result where the outer edges of the color pad produces a slight color but the majority of the pad remains colorless the test should be repeated to cise complete saturation of the pad with saliva The test is not reusable Limitations Failure to wait 15 minutes after placing food drink or other materials including smoking in the mouth before running the test can produce erroneous results due to possible contamination of the saliva by interfering substances 2 The Saliva Alcohol Test is highly sensitive to the presence of alcohol Alcohol vapors in the air are sometimes detected by the Saliva Alcohol Test Alcohol vapors are present in many institutions and homes Alcohol is a component in many household products such as disinfectant deodorizers perfumes and glass cleaners If the presence of alcohol vapors is suspected the test should be performed in an area known to be free of vapors 3 Ingestion or general use of over the counter medications and products containing alcohol can produce positive results Performance Characteristics The detection limit on the Saliva Alcohol Test is from 0 02 to 0 30 for approximate relative blood alcohol level The cutoff level of the Saliva Alcohol Test can vary based on local regulations and laws Test results can be compared to reference levels with color chart on the foil package Assay S
6. variable and depends on the urine s pH value dose and the patient s metabolism Therefore the detection of the metabolite EDDP instead of methadone itself is useful because interferences of the patient s metabolism are avoided Ketamine KET Ketamine is a derivative of phencyclidine It is used medically as a veterinary and human anaesthetic since 1970 About 90 percent of the ketamine legally sold is intended for veterinary use It can be injected or snorted but is sometimes sprinkled on tobacco or peta and smoked Ketamine is frequently used in combination with other drugs such as ecstasy heroin or cocaine Ketamine is also known as special K or vitamin K Certain doses of Ketamine can cause dream like states and hallucinations In high dose ketamine can cause delirium amnesia impaired motor function high blood pressure depression and potentially fatal respiratory problems Ketamine is metabolized in the liver and excreted through the kidney Marijuana THC Tetrahydrocannabinol the active ingredient in the arijuana plant cannabis sativa is detectable in saliva shortly after use The detection of the drug is thought to be primarily due to the direct exposure of the drug to the mouth oral and smoking administrations and the subsequent sequestering of the drug in the buccal cavity3 Historical studies have shown a window of detection for THC in saliva of up to 14 hours after drug use3 The Mariana THC 12 assay yi
7. D Glucuronide Cocaine Related Compounds Benzoylecgonine Cocaine Ecgonine Ecgonine methyl ester 5 10 5 10 200 4 000 10 000 above Cotinine Related Compounds Cotinine 50 Buprenorphine gt 100 000 EDDP Related Compounds EDDP 20 Meperidine 20 000 Methadone 20 000 Norfentanyl 20 000 Phencyclidine 20 000 Promazine 10 000 Promethazine 5 000 Prothipendyl 10 000 Prozine 2 500 Ketamine Related Compounds Ketamine KET Norketamine 50 Dextromethorphan 25 Dextrorphan tartrate 25 D Norpropoxyphene 1560 Meperidine 750 Mephentermine hemisulfate salt 1000 D Methamphetamine 3 4 Methylenedioxy ethylamphetamine MDEA 1500 Nordoxepin hydrochloride 1500 Phencyclidine 250 Promazine 400 Promethazine 1250 Marijuana Related Compounds 11 nor D9 THC 9 COOH 12 D8 Tetrahydrocannabinol 2 000 D9 Tetrahydrocannabinol 4 000 11 hydroxy D9 THC 300 D9 Tetrahydrocannabinol 50 D8 Tetrahydrocannabinol 75 11 nor D9 THC 9 COOH 12 11 hydroxy D9 THC 300 Cannabinol 2 000 Cannabidiol gt 10 000 Methadone Related Compounds 30 Methadone Oxycodone Related Compounds Alpha Methadol 125 Oxycodone 40 Biperiden 80 000 Hydrocodone 1000 Doxylamine 12 500 Hydromorphone 6250 2 Ethylidene 1 5 dimethyl 3 3 Naloxone 6250 diphenylpyrolidine EDDP 10 000 Oxymorphone 1000 Phencyclidine 12 500 Pheniramine 25 000 Phencyclidine Related Compounds Phencyclidine PCP 10 Methamphetamine Related Compounds Hydrocodone 2 000 D Methamphetamine
8. EN COLLECTION AND STORAGE This device is intended for use with human oral fluid specimens only e Oral fluid specimens must be collected according to the directions in the Procedure section of this package insert e Perform testing immediately after specimen collection e If specimens are to be shipped pack them in compliance with all applicable regulations for transportation of etiological agents PROCEDURE Bring tests specimens and or controls to room temperature 15 30 C ore use Donors should avoid placing anything including food drink g m and tobacco products in their mouth for at least 10 minutes prior o specimen collection 1 Using the provided collection swab have donor sweep inside of mouth fa eek gums tongue several times then hold swab in mouth ntil color on the saturation indicator strip appears in the indicator window of collection swab Donor must leave swab in mouth until instructed to remove it NOTE If at 7 minutes color on the saturation indicator has not appeared in the indicator window proceed with the test 2 below 2 Remove collection swab from mouth and insert it sponge first into the screening device pushing until the locking flange locks in place in the bottom of the device 3 Set device upright on flat surface and keep upright while test is running Wait for the colored bands to appear in test results area Negative results can be read as soon as two lines appear on any test strip 0
9. GLOSSARY OF SYMBOLS RI F Catalog number CE Consult instructions for use ud Manufacturer A Temperature limitation Lot Batch code 2 Use by Do not reuse Do not use if package is damaged Y Sufficient for quantity Authorized representative in the European Community NOTE The following instructions pertain only to devices that contain an alcohol test strip Saliva Alcohol Test Intended Use The Saliva Alcohol Test is a rapid highly sensitive method to detect the presence of alcohol in saliva an iptv an approximation of relative blood alcohol concentration This test provides a preliminary screen only A more specific alternate chemical method must be used in order to obtain a confirmed analytical result Clinical consideration and professional judgment should be applied to any test screen result particularly when preliminary positive screens are indicated Summary Two thirds of all adults drink alcohol The blood alcohol concentration at which a person becomes impaired is variable dependent upon the individual Each individual has specific parameters that affect the level of impairment such as size weight eating habits and alcohol tolerance Inappropriate consumption of alcohol can be a contributing factor to many accidents injuries and medical conditions Principle It is well established that the concentration of alcohol in saliva is comparable to that of blood The Saliva Alcohol
10. Please note that this is a qualitative test only and cannot determine the concentration of analytes in the specimen 2 Insufficient specimen volume incorrect operating procedure or expired tests are the most likely reasons for control band failure QUALITY CONTROL e Internal procedural controls are included in the test A colored band appearing in the control region C is considered an internal positive procedural control confirming sufficient specimen volume and correct procedural technique e External controls are not supplied with this kit It is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance LIMITATIONS OF THE TEST 1 This device is for forensic use and should be only used for the qualitative detection of drugs of abuse in oral fluid 2 This assay provides a preliminary analytical test result only A more specific alternative chemical method must be used in order to obtain a confirmed analytical result Gas chromatography mass Spectrometry GC MS has been established as the preferred confirmatory method by he National Institute on Drug Abuse MDA Clinical consideration and professional judgment should be applied to any test result particularly when preliminary positive results are indicated 3 There is a possibility that technical or procedural errors as well as other substances and factors may interfere with the test
11. Test consists of a plastic strip with a reaction pad attached at the tip On contact with solutions of alcohol the reaction pad will rapidly turn colors depending on the concentration of alcohol present The pad employs a solid phase chemistry which uses a highly specific enzyme reaction Reagents e Tetramethylbenzidine Alcohol Oxidase EC 1 1 3 13 e Peroxidase EC 1 11 1 7 Other additives Precautions The Saliva Alcohol Test is a visually interpreted test where color matching is used to provide an approximation of relative blood alcohol concentration Test materials that have been exposed to saliva should be treated as cel infectious Do not use the One Step Saliva Alcohol Test after the expiration date marked on the foil package Storage and Stability The Saliva Alcohol Test is to be stored at 2 27 C 36 80 F in its sealed foil package If storage temperatures exceed 27 C the test performance may degrade If the product is refrigerated the Saliva Alcohol Test must be brought to room temperature prior to opening the pouch Materials Provided e 25 Individually foil pouched test devices Package insert Materials Required But Not Provided e Timer Directions For Use Allow the pouched strip to equilibrate to room temperature 15 27 C prior to testing 1 Abstain from placing anything in the mouth for fifteen 15 minutes prior to beginning the test This includes non alcoholic drinks tobacco products coffee breath mints and foo
12. d etc 2 Open the foil package and remove the device Observe the reactive ad on the end of the test strip If the reaction pad has a blue color efore applying saliva sample do not use 3 For specimen collection follow Procedure instructions on page 2 of this package insert 4 Saturate the reactive pad with saliva It eal takes 6 8 seconds to be saturated Start timer immediately after saliva application Read result at two 2 minutes Compare the color of the reaction pad with the color chart provided to determine the relative blood alcohol level Interpretation of Results Positive The Saliva Alcohol Test will produce a color change in the resence of saliva alcohol The color will range from light blue color at 02 relative blood alcohol concentration to a dark blue color near 0 30 relative blood alcohol concentration Color pads are provided within this range to allow an approximation of relative blood alcohol concentration The test may produce colors that appear to be between adjacent color pads NOTE The Saliva Alcohol Test is very sensitive to the presence of alcohol A blue color that is lighter than the 0 02 color pad should be interpreted as being positive to the presence of alcohol in saliva but less than 0 02 relative blood alcohol Negative When the Saliva Alcohol Test shows no color change this should be interpreted as a negative result indicating that alcohol has not been detected Invalid If
13. ducts of animal origin Certified knowledge of the origin and or sanitary state of the animals does not comple ely uarantee the absence of transmissible pathogenic agents Itis therefore recommended that these products De treated as potentially infectious and handled by observing usual safety precautions e g do not ingest or inhale e Read the entire procedure carefully prior to testing e Do not eat drink or smoke in the area where specimens and kits are handled Handle all specimens as if they contain infectious agents Observe established precautions against microbiological hazards throughout the procedure and follow standard procedures for the proper disposal of specimens Wear protective clothing such as laboratory coats disposable gloves and eye protection when specimens are assayed e Humidity and temperature can adversely affect results e Used testing materials should be discarded in accordance with local regulations STORAGE AND STABILITY e The kit should be stored at 2 30 C until the expiry date printed on the sealed pouch e The test must remain in the sealed pouch until use e Do not freeze e Kits should be kept out of direct sunlight e Care should be taken to protect the components of the kit from contamination Do not use if there is evidence of microbial contamination or precipitation Biological contamination of dispensing equipment containers or reagents can lead to false results SPECIM
14. ed but Not provided e Timer Positive and negative controls INTRODUCTION The DrugCheck SalivaScan for AMP BAR BUP BZO COC COT EDDP KET MET MOR MTD OXY PCP PPX THC parent THC and metabolites is a rapid oral fluid screening test that can be performed without the use of an instrument The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in human oral fluid Amphetamine AMP Amphetamines amphetamine methamphetamine and the structurally related designer drugs e g Ecstasy are sympathomimetic amines whose biological effects include potent central nervous system CNS stimulation anorectic hyperthermic and cardiovascular properties They are usually taken orally intravenously or by smoking Amphetamines are readiy absorbed from the gastrointestinal tract and are then either deactivated by the liver Amphetamines increase the heart rate and blood pressure and suppress the appetite Some studies indicate that heavy abuse may result in permanent damage to certain essential nerve structures in the brain Benzodiazepine BZ0 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 ins
15. elds a posite result when the THC COOH concentration exceeds 12 ym he Marijuana THC 50 assay yields a positive result when the A9 THC concentration exceeds 50 ng mL Methadone MTD Methadone is a synthetic analgesic drug that is originally used in the treatment of narcotic addicts Among the psychological effects induced by using methadone are analgesia sedation and respiratory denressian Overdose of methadone may cause coma or even death It is administered orally or intravenously and is metabolized in the liver The kidneys are a major route of methadone excretion 3 Methamphetamine MET Methamphetamine and its metabolites are potent sympathomimetic agents Acute higher doses lead to enhanced stimulation of the central nervous system and symptoms include euphoria alertness and a sense of increased energy and power More acute responses produce anxiety paranoia psychotic behavior and cardiac dysrhythmias The pattern of psychosis which may appear at high doses may be indistinguishable trom schizophrenia Opiates Morphinea OPl Opiates such as heroin morphine and codeine are derived trom the resin of opium poppy Heroin is quickl metabolized to morphine Thus morphine and morphine glucuronide _ might both be found in the saliva of a person who has taken only heroin The body also changes codeine to morphine Thus the presence of morphine or the metabolite morphine glucuronide in the sali
16. en within 2 minutes Read presumptive positive results at 10 minutes Do not interpret results after 20 minutes NOTE Once the collection swab locks in place the device is airtight tamper evident and ready to be disposed or sent to lab for confirmation on presumptive positive result o co z NEGATIVE POSITIVE INVALID 0 INTERPRETATION OF RESULTS See previous illustration POSITIVE Only one colored band appears in the control region C No colored band appears in the test region T for the drug in question A positive result indicates that the drug concentration exceeds the detectable level NEGATIVE Two colored bands appear on the membrane One band appears in the control region Q and another band appears in the test region T for the drug in question A negative result indicates that the drug concentration is below the detectable level INVALID Control band fails to appear Results from any test which has not produced a control band at the specified read time must be discarded Please review the procedure and repeat with a new test If the problemn persists discontinue using the kit immediately and contact your local distributor NOTE 1 The intensity of color in the test region T may vary depending on the concentration of analytes present in the specimen Therefore any shade of color in the test feglon T should be considered negative
17. in Carbamazepine Gentamicin Cephalexin Gentisic acid Cotinine Guaiacol Glyceryl Ether Creatinine Glucose Creatine Haloperidol Chloramphenicol Hemoglobin Chloroquine Hexobarbital Chlorpheniramine Hydralazine Chlorprothixene Hydrochlorothiazide Cholesterol Hydrocortisone Chorptothixene Ibuprofen Cimetidine Imipramine Ciprofloxacin Indomethacin italopram Insulin Clindamycin lsoproterenol Clobazam Kanamycin Clomipramine Ketamine Clonidine Ketoprofen Clozapine L Thyroxine Caffeine Lincomycin Cyclobenzaprine Loperamide Delorazepam Lidocaine Desipramine Lindane DL Propanolol Lormetazepam Digoxin Metoprolol Dihydrocodeine Methadone Re Daze Maprotiline imenhydrinate Metronidazole LITERATURE REFERENCES e results on the device when tested at Midazolam Mirtazapin Metoclopramide N Methylephedrine Nordoxepinhydrochloride Norketamine Nortriptyline Olanzapine Opipramol Oxalic acid Oxymetazoline Paroxetine Pemoline Pennicilline G Perphenazine Phenothiazine Phenylpropanolamine b Phenylethylamine Phenytoin Prednisolone Prednisone Protriptyline Quetiapine Quinidine Ranitidine Rifampicine Risperidone Salbutamol Salicylic acid Secobarbital Sertraline Sodium chloride Spironolactone Sulfamethoxazole Thioridazine Tobramycin Triazolam Triamterene Trimethoprim Trimipramine Valproic acid Vancomycin Venlafaxine Verapamil Zolpidem 1 Baselt RC Disposition of Toxic Drugs and Chemicals in Man 2nd ed Davis
18. omnia Benzodiazepines are also used as sedatives before some surgical and medical procedures and for the treatment of seizure disorders and alcohol withdrawal Benzoylecgonine Cocaine COC Derived from leaves of the coca plant cocaine is a potent central nervous system stimulant and a local anesthetic Among the psychological effects induced by using cocaine are euphoria confidence and a sense of increased energy accompanied by increased heart rate dilation of the pupils fever tremors and sweating Cocaine is excreted in saliva primarily as benzoylecgonine in a short period of time Buprenorphine BUP Buprenorphine is a potent arialgesie often used in the treatment of opioid addiction The drug is sold under the trade names Subutex Buprenex Temgesic and Suboxone which contain Buprenorphine HCI alone or in combination whith Naloxone HCI Therapeutically Buprenorphine is used as a substitution treatment for opioid addicts Substitution treatment is a form of medical care offered to opiate addicts primarily heroin addicts based on a similar or identical substance to the drug normally used In substitution therapy Buprenorphine is as effective as Methadone but demonstrates a lower level of physical dependence Concentrations of free Buprenorphine and Norbuprenorphine in saliva may be less than 1 ng ml after therapeutic administration but can range up to 20 ng ml in abuse situations he plasma half life of Buprenorphine is 2 4 ho
19. pecificity The Saliva Alcohol Test will react with methyl ethyl and allyl alcohols Interfering Substances The following substances may interfere with the Saliva Alcohol Test when using samples other than saliva The named substances do not normally appear in sufficient quantity in saliva to interfere with the test A Agents which enhance color development e Peroxidases Strong oxidizers B Agents which inhibit color development Reducing agents Ascorbic acid Tannic acid Pyrogallol Mercaptans and tosylates Oxalic acid Uric Acid e Bilirubin L dopa L methyldopa Methampyrone Controls The Saliva Alcohol Test may be qualitatively verified by using a test solution prepared by adding 5 drops of 80 proof distilled spirits to 8 oz 1 cu of water This solution should produce a color reaction on the ad Tne color reaction with alcohol in saliva is somewhat slower and ess intense than with alcohol in an aqueous solution Bibliography 1 Volpicellim Joseph R M D Ph D Alcohol Dependence Diagnosis Clinical Aspects and Biopsychosocial Causes Substance Abuse Library University of Pennsylvania 1997 2 Jones A W Inter and intra individual variations in the salva blood alcohol ratio during n ethanol metabolism in man Clin Chem 25 1394 1398 3 MaCall L E L Whiting B Moore M R and Goldberg A Correlation of ethanol concentrations in blood and saliva Clin Sci 56 283 286 1979
20. range 2 ee ee ee 0 Cut off 30 30 0 30 0 30 0 30 0 50 Cut off 30 30 0 30 0 30 0 30 0 25 Cut off 30 30 0 28 2 28 2 28 2 Cut off 30 10 20 10 20 10 20 11 19 25 Cut off 30 2 28 9 21 4 26 5 25 50 Cut off 30 0 30 0 30 0 30 0 30 Drug Conc n THC THC parent BAR PPX Cut off range 2 h le aea e 0 Cut off 30 30 0 30 0 30 0 30 0 50 Cut off 30 30 0 30 0 30 0 30 0 25 Cut off 30 29 1 28 2 27 3 30 0 Cut off 30 17 13 16 14 9 21 10 20 25 Cut off 30 5 25 4 26 3 27 4 26 50 Cut off 30 0 30 0 30 0 30 0 30 B Specificity The following table lists the concentrations of compounds ng mL which the device identified positive results at 10 minutes D Amphetamine L Amphetamine 3 4 Methylene dioxyamphetamine MDA Phentermine PMA Tyramine Benzodiazepine Related Comp Oxacepam Alprazolam Bromazepam Chlordiazepoxide Clonazepam Clorazepate Clbazam Diazepam Estazolam Desalkyflurazepam Flunitrazepam Flurazepam Lorazepam Medazepam Nitrazepam Nordiazepam Prazepam Temazepam Triazola Concen ng mL Amphetamine Related Compounds 50 4 000 150 40 000 125 3 000 ounds Buprenorphine Related Compounds Buprenorphine Buprenorphine Glucuronide Buprenorphine 3 b D Glucuronide Norbuprenorphine Norbuprenorphine 3 b
21. system depressants They are used therapeutically as sedatives hypnotios and anticonvulsants Barbiturates are almost always taken oral Y 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 produce a clinically Significant degree of physical dependence Withdrawal symptoms experienced during periods of drug abstinence can be severe enough to cause death Propoxyphene PPX Propoxyphene or Dextropro ni isa narcotic analgesic compound with a structural similarity to methadone It is prescribed in the United States for the relief of moderate pain Darvocet one of the most common brand names for the drug contains 50 100 mg of propoxyphene napsylate and 325 650 mg of acetaminophen Physiological effects of propoxyghene include respiratory depression Propoxyphene is metabolized in the liver to yield norpropoxyphene Norpropoxyphene has a longer half life 30 to 3 hours than that of propoxyphene 6 to 12 hours Norpropoxyphene demonstrates substantially less central nervous system depression than propoxyphene but shows a greater local anesthetic effect PRECAUTIONS For professional in vitro diagnostic use only e Do not use after the expiration date indicated on the package Do not use the test if the foil pouch is damaged Do not reuse tests e This kit contains pro
22. t in the oral fluid specimen compete against their respective drug conjugate for binding sites on their specific antibody During testing a portion of the oral fluid specimen migrates upward by capillary action A drug if present in the oral fluid specimen below its cut off concentration will not saturate the binding sites of its specific antibody The antibo y then react with the drug protein conjugate and a visible colored line will show up in the test line region T of the specific drug strip The presence of rug above the cut off concentration in the oral fluid specimen will saturate all the binding sites ofthe antibody Therefore the colored line will not form in the test line region A drug positive oral fluid specimen will not generate a colored line in the specific test line region of the strip because of drug competition while a drug negative oral fluid 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 wil always appear at the control line region C indicating that proper volume of specimen has been added and membrane wic ing has occurred MATERIALS Materials Provided e Individually packed screening devices and oral fluid collection swabs Combined Test Procedure Results Record sheet e Package insert Test strips Saturation indicator window strip Locking flange Sponge Materials Requir
23. urs While complete elimination of a single dose of the drug can take as long as 6 days the detection window for the parent drug in urine is thought to be approximately 3 days Cotinine COT Cotinine is the first stage metabolite of nicotine a toxic alkaloid that produces stimulation of the autonomic ganglia and central nervous system when in humans Nicotine is a drug to which virtually every member of a tobacco smoking society is exposed whether through direct contact or second hand inhalation In addition to tobacco nicotine is also commercially available as the active ingredient in smoking replacement therapies such as nicotine gum transdermal patches and nasal sprays EDDP EDDP Methadone MTD is a synthetic analgesic drug that is originally used in the treatment of narcotic addicts Among the psychological effects induced by using methadone are analgesia sedation and res ee of methadone may cause coma or even death It is administered orally or intravenously and is metabolized in the liver The kidneys are a major route of methadone excretion Methadone has a biological half life of 16 50 hours EDDP 2 i hy iden 1 5 Dimethyl 3 3 phenyipyrrolidine is the most important metabolite of methadone It is excreted into the bile and urine ace ith the other metabolite EMDP 2 E ayi Methyl 3 3 Diphenylpyrrolidine EDDP is formed by N demethylation and cyclization of methadone in the liver The part of the unchanged excreted methadone is
24. va often indicates heroin morphine and or codeine use Oxycodone OXY Oxycodone is a semi synthetic opioid witha structural similarity to codeine The drug is manufactured by modifying hebaine an alkaloid found in the opium poppy Oxycodone like all opiate agonists provides pain relief by acting on opioid receptors in he spinal cord brain and possibly directly in the affected tissues Oxycodone is prescribed for the relief of moderate to high pain under he well known pharmaceutical trade names of OxyContin Tylox Percodan and Percocet While Tylox Percodan and Percocet contain only small doses of oxycodone hydrochloride combined with other analgesics such as acetaminophen or aspirin OxyContin consists solely of oxycodone hydrochloride in a time release form Oxycodone is known io metabolize by demethylation into oxymorphone and noroxycodone Phencyclidine PCP Phencyclidine is an arylcyclohexylamine that was originally used as an anesthetic agent and a veterinary tranquilizer Phencyclidine can produce hallucinations lethargy disorientation loss of coordination trance like ecstatic states a sense of euphoria and visual distortions It has many street names such as angel dust and crystal cyclone etc Phencyclidine can be administered orally by nasal ingestion smoking or intravenous injection It is metabolized in the liver and excreted through the kidneys Barbiturate BAR Barbiturates are central nervous
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