StatusFirst DOA Package Insert
Contents
1. EZR Neg too sf u 1f o mr eo o o 6 6 a Neg too 14 s 1f 0 ce es o of of Precision and Cutoff Validation Study For the precision and cutoff value validation of each drug test on the panel spiked urine controls with concentrations of 0 50 below cutoff 25 below cutoff cutoff 25 above cutoff 50 above cutoff and 100 above cutoff levels were tested Ten 10 devices at each concentration were tested on three readers for two days with two lots of test devices by three operators blindly The summary of the results are shown in table 2 All test results with the samples of negative or 100 above cutoff level agreed with expected results in both reader and visual reading With 50 cut off level the results showed from 98 to 100 agreements with expected results There were no significant differences between device lots and days Table 2 Precision Study for StatusFirst DOA 10 DOA 5 Drug Standards and Cutoff Values for Each Drug Test 1 1 nor A THC 9 COOH Secobarbital Tricyclic Antidepressant Nortriptyline of Pos of Neg Methamphetamine Test Agreement Agreement Cocaine Test Tested 120 223 120 300 120 315 120 450 120 THC Test 120 120 120 120 120 120 120 Phencyclidine Test Tested 120 O o 120 120 120 120 120 Tested 120 120 225 120 300 120 375 120 450 120 Agreement 0 120 v9 9 82. of abuse test result particularly when preliminary positive results are obtained Summary and Explanation Methamphetamine MET is a potent sympathomimetic agent with thera peutic applications The drug can be taken orally injected or inhaled Acute higher doses lead to enhanced stimulation of the central nervous system and induce euphoria alertness reduced appetite and a sense of increased energy and power Cardiovascular responses to methamphetamine include increased blood pressure and cardiac arrhythmias More acute responses include anxiety paranoia hallucinations psychotic behavior and eventually depression and exhaustion The effects of methamphetamine generally last 2 4 hours and the drug has a half life of 9 24 hours in the body Methamphetamine is excreted in the urine primarily as amphetamine and oxidized and deaminated deriva tives However 10 20 of methamphetamine is excreted unchanged Thus the presence of the parent compound in the urine indicates methamphetamine use Methamphetamine is generally detectable in the urine for 3 5 days depending on urine pH level Morphine codeine and semisynthetic derivatives of morphine belong to the class of drugs called opiates OPI An opiate exerts its effects on the central nervous system and can produce euphoria respiratory depression and coma when it is abused Morphine is the prototype compound of opiates Morphine is excreted in the urine as morphine 3 glucuro
3. 120 minutes after one cigarette Elevated levels of urinary metabolites are found within hours of exposure and remain detectable for 3 10 days after smoking The main metabolite excreted in the urine is 11 nor A tetrahydrocannabinol 9 carboxylic acid Phencyclidine PCP is an arylcyclohexylamine that is used as a veterinary anesthetic It is used illegally as a hallucinogen and is commonly referred to as PCP angel dust love boat hog or killer weed PCP can produce lethargy euphoria ataxia nystagmus and coma Currently anumber of PCP analogues with similar pharmacological effects are in use as street drugs including PCE PHP TCP and ketamine Phencyclidine is readily absorbed when smoked or ingested or even through skin contact It is metabolized in the liver Evidence indicates that PCP undergoes oxidative metabolism to at least 2 inactive metabolites 4 phenyl 4 piperidino cyclohexanol and 1 1 phenylcyclohexyl 4 hydroxypiperidine which are excreted as glucuronide conjugates in the urine About 10 of the dose is excreted in urine as the parent compound phencyc lidine Benzodiazepines BZO are a class of widely prescribed central nervous system CNS depressants and include widely used drugs suchas chlordiazepoxide diazepam and oxazepam They have medically useful properties including antianxiety sedative anticonvulsant and hypnotic effects They are taken orally or sometimes by injection and have a low potential f
4. addition to the Test line that may appear in the Test window T a Control line is present in the Control window C to confirm the viability of the test This Control line validation line should always appear if the test is conducted properly Polyclonal sheep anti mouse antibody is immobilized on the control line The monoclonal antibody dye conjugates that pass the region will be captured and produce acolored line in the Control window validation line This works as a procedural control confirming that proper sample volume was used and the reagent system at the control line and the conjugate color indicator worked If insufficient sample volume is used there may not be a Control line indicating the test is invalid Materials Provided The StatusFirst DOA 10 DOA 5 test kit contains all the reagents necessary to perform the assay e StatusFirst DOA 10 DOA 5 device The test device contains membrane strips and dye pads Membrane strips are coated with THC protein from a purified bovine protein source conjugate PCP protein from a purified bovine protein source conjugate monoclonal anti methamphetamine anti morphine anti benzoylecgonine anti barbiturate and anti amphet amine antibodies as well as polyclonal sheep anti oxazepam anti methadone and anti tricyclic antidepressant antibodies Sheep anti mouse antibody is coated for the control bands Dye pads contain colloidal gold coated with monoclonal anti THC anti phencycli
5. 3 37 N A 120 0 120 0 120 0 120 0 120 0 100 100 Agreement 100 N A 100 Agreement 100 N A 100 Agreement 100 N A 100 100 Barbiturate Test er Reproducibility 0 5X cutoff and 2X cutoff levels of each of 10 drugs samples were prepared DOA 10 DOA 5 test for specificity The specificity of the StatusFirst DOA 10 test was determined by adding various drugs and drug metabolites to drug 120 0 negative urine specimens and testing with the StatusFirst DOA 10 DOA 5 test The results are expressed in terms of the minimum concentration required to 120 0 ae by spiking each drug standard solution into the drug negative urine The prepared ng mL Agreement samples including negative urine were aliquoted for each test and given blindly to each site Thirty 30 tests for each drug 10 tests at each concentration for a total of 300 tests per site were tested at three POL sites Results demonstrated 99 895 out of 900 tests agreement among the three sites Specificity The following table lists compounds that were evaluated with the StatusFirst 12010 Methadone Test Compound Cross reacting aie ft Concentration ng mL ng mL Tested Agreement MET po onw SE o 7100 000 120 0 120 D L Amphetamine gt 100 000 120 2 118 Ephedrine gt 100 000 225 120 32 88 Ephedrine gt 100 000 Isometheptene 12 500 300 120 90 30 D Methamphe
6. 5 test has been shown to detect each drug at following cutoff 1000 ng mL of methamphetamine 300 ng mL of morphine 300 ng mL of benzoylecgonine 50 ng mL of THC 25 ng mL of phencyclidine 300 ng mL of oxazepam 300 ng mL of secobarbital 300 ng mL of methadone 1000 ng mL of nortriptyline and 1000 ng mL of amphetamine in urine Performance Characteristics Accuracy The accuracy of StatusFirst DOA 10 DOA 5 was evaluated in comparison to the result of GC MS HPLC for TCA For each drug over 60 clinical samples containing some amount of the drug were tested and the results were compared to the GC MS or HPLC values In addition 100 drug free urine samples were collected from people who apparently were not taking the drug and were tested The summary of results is shown in Table 1 Table 1 The Results Summary of Comparison Study to Reference Method GC MS or HPLC with Clinical Samples Clinical samples were grouped A through E based on each drug concentration as Shown below A Drug free B Negative between 0 and 50 cutoff C Negative between 50 cutoff and cutoff D Cutoff between cutoff and 150 cutoff E Positive 2150 cutoff D Agreement with Reference Test 98 51 52 100 117 117 49 96 123 128 98 52 53 98 124 126 98 48 49 95 119 125 95 63 66 100 115 115 100 59 59 97 114 117 98 46 47 100 118 118 99 77 78 99 118 119 100 41 41 100 120 120 96 47 49 99 129 130
7. Nordiazepam N Desmethyldiazepam Oxazepam Prazepam Temazepam Triazolam BAR Allobarbital Alphenal Amobarbital Aprobarbital Barbital Butalbital Cyclopentobarbital Pentobarbital Phenobarbital Penytoin Secobarbital Thiopental MTD Diphenhydramine Doxylamine EDDP EMDP Imipramine LAAM Methadone Meperidine Nor LAAM TCA Amitryptiline Chlorpromazine Clomipramine Cyclobenzaprine Desipramine Diphenhydramine Dothiepin Doxepin Imipramine Norclomipramine Nordoxepin Nortriptyline Perphenazine Promazine Protryptiline Trimipramine AMP D Amphetamine D L Amphetamine L Amphetamine Benzphetamine d Methamphetamine p OH Methamphetamine Methylenedioxyamphetamine Methlyenedioxymethamphetamine B Phenylethylamine 30 000 2000 1 500 2 500 10 000 gt 100 000 gt 100 000 1 500 100 000 10 000 2 500 25 000 10 000 25 000 100 000 7 500 300 gt 100 000 6 000 gt 100 000 400 250 5 000 400 1 500 800 400 2 000 5 000 4 000 300 gt 100 000 gt 100 000 gt 100 000 gt 100 000 gt 100 000 gt 100 000 900 300 gt 100 000 3 000 800 100 000 5 000 2 500 1 500 gt 100 000 2 000 1 500 1 000 850 5 000 1 000 41 000 5 000 2 000 3 000 1 000 1 800 37 500 gt 100 000 gt 100 000 gt 100 000 2 000 gt 100 000 40 000 Phenylpropanolamine Phentermine Tryptamine Tyramine 3 OH Tyramine gt 100 000 gt 100 000 50 000 70 000 50 000 Interfering Substances Endogenous compoun
8. P 58150 StatusFirst DOA 10 MET OPI COC THC PCP BZO BAR MTD TCA AMP StatusFirst DOA 5 MET OPI COC THC PCP New One Step Panel Test for Drugs of Abuse with DXpress Reader For in vitro Use Only Simple One Step Immunoassay for the Qualitative Detection of Methamphetamine Opiates Cocaine THC Phencyclidine Benzodiaz epines Barbiturates Methadone Tricyclic Antidepres sants Amphetamine and or their Metabolites in Urine LifeSign LLC Stock No DOA 10 30025 25 Test Kit 30010 10 Test Kit DOA 5 30525 25 Test Kit Intended Use StatusFirst DOA 10 test is a simple one step immunochromatographic assay for the rapid qualitative detection of methamphetamine opiates cocaine metabolites THC metabolites phencyclidine benzodiazepines barbiturates methadone tricyclic antidepressants amphetamine and or their metabolites present in human urine above the cutoff concentration of the drug specified StatusFirst DOA 5 test detects methamphetamine opiates cocaine metabo lites THC metabolites phencyclidine and or their metabolites The StatusFirst DOA 10 DOA 5 test provides only a preliminary analytical result A more specific alternative chemical method must be used in order to obtain a confirmed analyticalresult GC MS or HPLC for TCA is the preferred confirmatory method Other chemical confirmatory methods are available Clinical consideration and professional judgment should be applied to any drug
9. de drowsiness slurred speech and irritability Acute conditions include respiratory collapse and loss of consciousness Chronic conditions include addiction abstinence seizures and death The effects of short acting barbiturates such as pentobarbital and secobarbital last 3 to 6 hours The effects of long acting barbiturates last 10 to 20 hours Phenobarbital is an example of long acting ones Barbiturates normally remain detectable in urine for 4 to 6 days in the case of short acting ones and up to 30 days for long acting ones Short acting barbiturates is generally excreted as metabolites while long acting ones primarily appear unchanged Methadone MTD is a synthetic analogic drug which possesses many of the pharmacologic properties of morphine Unlike morphine however metha done produces marked sedative effects with repeated administration as a result of drug accumulation Over dosage with methadone is characterized by stupor muscle flaccidity respiratory depression cold and clammy skin pupillary constriction hypotension coma and circulatory collapse Fatalities in adults from methadone over dosage have increased significantly in many urban areas as a result of widespread availability of the drug both from licit and illicit sources Tricyclic antidepressants TCAs are a type of prescription drug intended for clinically depressed patients Unfortunately they are becoming more frequently abused and are now one ofthe leading ca
10. dine and mouse IgG antibodies as well as conjugates of methamphetamine morphine benzoylecgonine oxazepam barbiturate methadone nortriptyline ana logue and amphetamine each drug is conjugated with purified bovine source protein Disposable sample dispenser Instructions for use Precaution For in vitro diagnostic use only e Avoidcross contamination of urine samples by using anew urine specimen container and dropper for each urine sample The test kit does not contain any HIV or hepatitis infective components e Urine specimens are potentially infectious Proper handling and disposal methods should be established according to good laboratory practices The StatusFirst device should remain in its original sealed pouch until ready for use Do not use the test if the pouch is damaged or the seal is broken Do not use the test kit after the expiration date Storage and Stability The StatusFirst DOA 10 DOA 5 test kit should be stored at 2 30 C 35 86 F in the original sealed pouch The expiration dating was established under these storage conditions Specimen Collection and Preparation Fresh urine specimens do not require any special handling or pretreatment Specimens should be collected in a clean glass or plastic container If testing will not be performed immediately specimens should be refrigerated 2 8 C or frozen Frozen specimens must be completely thawed and thoroughly mixed before us
11. ds The StatusFirst DOA 10 DOA 5 test showed no interference when the endogenous compounds were added at the concentrations given below to urine samples which had 50 cutoff concentration of each of the 10 drugs Table 4 Table 4 Endogenous Compounds Substance Added Bilirubin Creatinine Glucose Hemoglobin Protein Sodium Chloride Sodium Nitrite Exogenous compounds Concentration Added 2 mg dl 20 mg dl 1500 mg dl 25 mg dl 2000 mg dl 1500 mg ml 100 mg dl The following compounds show no interference when tested with the StatusFirst DOA 10 DOA 5 at a concentration of 100 ug mL Table 5 Table 5 Non Cross Reacting Compounds 4 Acetamidophenol Acetophenetidin Phenacetin N Acetylprocainamide Acetylsalicylic acid Aminopyrine Amoxapine Amoxicillin Apomorphine Aspartame Atropine Benzilic acid Benzoic acid Chloralhydrate Chloramphenicol Chlorothiazide Chlorquine Cholesterol Clonidine Cortisone Cotinine Deoxycorticosterone Dextromethorphan Diclofenac Diethylpropion Diflunisal Digoxin Domperidone Doxylamine Erythromycin R Estradiol Estrone 3 sulfate Ethyl p aminobenzoate Fenoprofen Furoxmide Gentisic acid Glutethimide Guaifenesin Hippuric acid Hydralazine Hydrochlorothiazide Hydrocortisone O Hydroxyhippuric acid Iproniazid Isoproterenol Isoxsuprine Ketoprofen Labetalol Lidocaine Loperamide Loxapine succinate Meprobamate Methaqualone Methoxyphenamine Me
12. he results on the screen NOTE To view results of all drugs press Left and Right navigation key to switch between the left and right windows Pressing PRINT will print results for both windows in one step Report of Results The result of positive or negative for each analyte is detrmined by the DXpress Reader e Results may be printed by pressing the PRINT button e At this point the test device may be removed and appropriately discarded Result Example Control Valid MET Negative OPI Positive COC Negative THC Negative PCP Negative Control Valid BZO Negative BAR Negative MTD Negative TCA Positive AMP Negative Invalid The instrument will automatically determine the control line is not present If the result is invalid the sample should be retested with a new device If the problem persists contact your local distributor of LifeSign Limitations e The test is designed for use with unadulterated urine only There is a possibility that factors such as technical or procedural errors as well as other substances in the urine sample which are not listed in Tables 11 below may interfere with the test and cause erroneous results e Adulterants such as bleach and or alum in urine specimens may produce erroneous results regardless of the method of analysis If adulteration is suspected the test should be repeated with a new sample Certain foods or medications containing opiates or opiate derivative
13. ient samples 4 Press ENTER from the Self Check result screen to return to the RUN QC menu proceed to Step 2 of Performing Calibration QC Performing Calibration QC Each day of patient testing use the QC Calibration Set see DXpress Reader manual to ensure the DXpress Reader functions properly 1 From the Main Menu select 2 RUN QC 2 Select 2 CALIBRATION QC 3 Ether input Operator ID manually and press ENTER or scan Operator ID barcode 4 Scan the QC Calibrator ID barcode found on the back of the QC Calibrator 5 Insert the QC Calibrator into the reader be sure to close the Tray and press ENTER Follow prompts displayed on the screen 6 A CALIBRATION OK result will be displayed printed when the calibration is completed Press ENTER to perform Blank Calibration 7 Select CALIBRATE and press ENTER 8 Select Double Window Cassette and press ENTER 8 Insert a Blank Calibrator double window device and press ENTER Reader will display Successfully Performed 9 Press ENTER to return to the Main Menu Calibration should succeed before running daily patient testing Running QC with External Controls The manufacturer recommends the use of commercially available controls 1 From Main Menu select 2 RUN QC 2 Select 3 EXTERNAL QC See Reader procedure Reader reading at 5 minutes 3 Follow the same procedure as if running a patient sample please see section Testing Pa
14. ing Specimens containing a large amount of particulate matter may give inconsis tent test results Such specimens should be clarified by centrifuging or allowing settling before testing Test Procedure The test procedure consists of adding the urine sample to the Sample well of the device and reading the test result at 5 min after sample addition using a DXpress Reader DXpress Reader Procedure Consult the DXpress Reader User Manual For DXpress Reader installation start up and complete instructions refer to the DXpress Reader User Manual Operator must consult the DXpress Reader User Manual prior to use and become familiar with the processes and quality control procedures StatusFirst DOA 10 Add 2 drops in each sample well 0L voa 45411 1 M1EIS StatusFirst DOA 5 Add 3 drops in the sample well G VOd S414 SMJEIS Performing Self Check Each time the DXpress Reader is turned on Self Check is automatically performed and the operator may then proceed to Performing Calibration QC If the DXpress Reader is left on or in power save mode the operator should perform Self Check daily as follows 1 From the Main Menu select 2 RUN QC e Sekol 1 SELF CHECK 3 Self Check takes about 15 seconds PASS or FAIL results will be displayed printed when testing is completed All Self Check items should pass before testing pat
15. nide unchanged morphine and other minor metabolites Heroin is metabolized to morphine and codeine and excreted in the urine with a small amount of unchanged form Codeine is also excreted as morphine and in the form of conjugates Although some opiate metabolites appear in the feces urinary excretion is the primary route of elimination Cocaine COC derived from the leaves of coca plant is a potent central nervous system CNS stimulant and a local anesthetic Cocaine induces euphoria confidence anda sense of increased energy in the user these psychological effects are accompanied by increased heart rate dilation of the pupils fever tremors and sweating Cocaine is used by smoking intravenous intranasal or oral administration and excreted in the urine primarily as benzoylecgonine in a short time Benzoylecgonine has a longer biological half life S 8 hours than cocaine 0 5 1 5 hours and can generally be detected for 24 60 hours after cocaine use or exposure THC A tetrahydrocannabinol is the primary active ingredient in cannabinoids marijuana When ingested or smoked it produces euphoric effects Users experience impairment of short term memory and THC use slows learning Also it may cause transient episodes of confusion anxiety or frank toxic delirium Long term relatively heavy use may be associated with behavioral disorders The peak effect of smoking THC occurs in 20 30 minutes and the duration is 90
16. or physical or psychological dependence Benzodiazepines induce drowsiness and muscle relax ation however their use can also result in intoxication similar to drunken behavior except without evidence of alcohol use and the loss of inhibitions Chronic abuse can result in addiction and tardive dyskinesia involuntary muscle movements of the face limbs and trunk Overdose can result in coma and possible death Withdrawal syndrome includes anxiety insomnia tremors delirium and convulsions The effects of benzodiazepine use last 4 8 hours The different benzodiazepines are absorbed at different rates and the timing of their psychoactive effects varies with the absorption rate The drugs are excreted in the urine primarily as the parent compounds or as oxazepam glucuronide an inactive metabolite in the case of chlordiazepoxide and diazepam and are detectable for 1 2 days Oxazepam may be detectable in the urine for up to 7 days Barbiturates BAR are a group of chemicals derived from barbituric acid Classified as hypnotics they depress the central nervous system Taken orally in pill or tablet form they are prescribed for many medical conditions usually for their sedative effect Abuse of barbiturates can however lead not only to impaired motor coordination and mental disorder but also to respiratory collapse coma and death The combination of barbiturates and alcohol is particularly dangerous Symptoms of barbiturate abuse inclu
17. s amphetamins methamphetamine barbiturate benzodiazepines or tricyclics may produce a positive result in any chemical or immunological assay Poppy seeds can contain opiates and ingestion of products containing poppy seeds can cause a positive result The test result read after 5 minutes may not be consistent with the original reading obtained at 5 minute reading period The test must be read at 5 minutes of sample application e A negative test result does not indicate the absence of drug in the sample it only indicates the sample does not contain drug above the cutoff level in qualitative terms A positive test result does not provide any indication of the level of intoxication or urinary concentration of the drug in the sample it only indicates the sample contains drug above the cutoff level in qualitative terms User Quality Control Internal Control Each StatusFirst test device has a built in control The Control line is an internal positive process control A distinct reddish purple Control line should always appear in the position if the test procedure is performed properly an adequate sample volume is used the sample and reagent are wicking on the membrane and the test reagents at the control line and the conjugate color indicator are working In addition ifthe test has been performed correctly and the device is working properly the background in the result window will become clear and provide a distinct result Thi
18. s Key Lot Number Transfer Pipette Expiration Date C CEMark ec REP Authorized Representative Do Not Reuse Contents For in vitro Diagnostic Use DEV Test Device Store at 2 30 C Catalog Number li Consult Instructions For Use Manufacturer Instructions For Use Contains sufficient for lt n gt tests 2000 PBM Printed in U S A Revised Feb 2008 P 58150 0226BL CE MT Promedt Consulting GmbH Altenhofstrasse 80 66386 St Ingbert Germany 49 68 94 58 10 20 MF Manufactured for LifeSign LLC 71 Veronica Avenue Somerset NJ 08873 800 526 2125 732 246 3366 www lifesignmed com Manufactured by Princeton BioMeditech Corporation Princeton NJ 08543 7139 U S A 1 732 274 1000 www pbmc com
19. s may be considered an internal negative process control The DXpress Reader will report Control Valid and test results when Internal Control QC is satisfied The positive and negative process controls contained in each StatusFirst test device satisfy the requirements of testing a positive control and a negative control on a daily basis Ifthe Control line does not appear in the Control window the test is invalid and a new test should be performed If the problem persists contact LifeSign for technical assistance External Control External controls may also be used to assure that the reagents and assay procedure are performing properly It is recommended that a control be tested at regular intervals as good laboratory testing process For information on how to obtain controls contact LifeSign s Technical Services Expected Values StatusFirst DOA 10 DOA 5 is a qualitative test The amount of methamphet amine opiates cocaine THC phencyclidine benzodiazepines barbiturates methadone tricyclic antidepressants amphetamine and or their metabolites present in the urine cannot be estimated by the test The test results distinguish positive from negative samples Positive results indicate the samples contain methamphetamine opiates cocaine THC phencyclidine benzodiazepines barbiturates methadone tricyclic antidepressants amphetamine and or their metabolites above the cutoff concentration The StatusFirst DOA 10 DOA
20. tamine 1 000 375 120 112 8 p OH Methamphetamine 3 000 Methylenedioxyamphetamine gt 100 000 oe mee bee Methylenedioxymethamphetamine 1 000 600 120 120 0 Methylenedioxyethylamphetamine MDEA gt 100 000 OPI Tricyclic Antidepressant Test Codeine 300 Hydrocodone 500 Hydromorphone 500 H Lavofloxacin 100 000 Levophanol 5000 Tested Agreement Meperidine gt 100 000 Morphine 300 Te 120 0 120 Morphine 3 B D glucuronide 300 500 120 0 120 Nalorphine 15 000 750 120 5 115 Naloxone gt 100 000 Norcodeine gt 100 000 1000 120 63 57 Oxycodone 5 000 1250 120 101 19 Oxymorphone 20 000 Thebaine 10 000 119 1 i E Tramadol gt 100 000 2000 120 120 0 COC Benzoylecgonine 300 Amphetamine Test Cocaine HCl gt 100 000 Ecgonine HCI gt 100 000 4 THC Cannabinol 10 000 Tested Agreement 1 1 nor A THC 9 COOH 100 1 1 nor A THC 9 COOH 50 Po 129 oe A THC 10 000 500 120 1 119 A THC 5 000 750 120 27 93 11 hydroxy A THC 4 000 1000 120 92 28 PCP 1250 120 116 4 Phencyclidine 25 1500 120 118 2 Thienylcyclohexyl piperidine 450 2000 120 120 0 BZO Alprazolam 100 000 Bromazepam 1 250 Chlordiazepoxide 500 Clobazam gt 100 000 produce a positive result Table 3 Table 3 Specificity Clonazepam Clorazepate dipotassium Delorazepam N Desalkylflurazepam Diazepam Estazolam Flunitrazepam 7 amino flunitrazepam a Hydroxyalprazolam a Hydroxytriazolam Lorazepam Lormetazepam Medazepam Midazolam Nitrazepam
21. thylphenidate Methyprylon Nalidixic acid Naltrexone Naproxen Niacinamide Nifedipine Norethindrone Noroxymorphone D Norpropoxyphene Quinine Norpseudoephedrine Rantidine Noscapine Salicylic acid Nylidrin Serotonin D L Octopamine Sulfamethazine Oxalic acid Sulindac Oxolinic acid Tetracycline Oxymetazoline Tetrahydrocortisone Papaverine Tetrahydrozoline Penicillin G Thiamine Pentazocaine Thioridazine Phendimetrazine D L Thyroxine Phenelzine Tolbutamide Phentoin Triamterene Prednisolone Trifluoperazine Prednisone Trimethoprim Promethazine D L Tryptophan D L Propanolol D L Tyrosine Propiomazine Uric acid D Propoxyphene Verapamil Quinidine Zomepirac References Tietz Norbert W Textbook of Clinical Chemistry W B Saunders Com pany 1986 p 1735 Hawks RL Chiang CN eds Urine Testing for Drugs of Abuse National Institute on Drug Abuse NIDA Research Monograph 73 1986 Baselt RC Disposition of Toxic Drugs and Chemicals in Man 2nd Ed Davis CA Biomedical Publ 1982 p 488 Stewart DJ Inoba T Ducassen M and Kalow W Clin Pharmacol Ther 1979 25 264 8 Ambre JJ Anal Toxicol 1985 9 241 5 Blum K Handbook of Abusable Drugs 1st ed New York Gardner Press Inc 1984 Fairlight Consulting http www fairlite com ocd articles tricyclic shtml Bickel MH Poisoning by Tricyclic Antidepressant Drugs Int J Clinical Pharmacol 11 1975 145 176 No 2 B wd ei A Wa Symbol
22. tient Samples below The only difference is that RUN PATIENT requires a Patient ID whereas EXTERNAL QC requires a Sample ID Testing Patient Samples Patient samples may be tested using the DXpress Reader Scheduler mode as described below To use other modes batch mode or read now mode please consult the DXpress Reader User Manual 1 Open the pouch and remove the test device Label the patient ID on the test device with a permanent marker Place the test device on a level surface Testing the Patient Sample on the DXpress Reader From the Main Menu select 1 RUN PATIENT Scan lot number barcode from the pouch or kit box e Confirm test device information lot number and type of test device as displayed on the screen and press ENTER e Scan the Operator ID barcode or manually enter e Scan the Patient ID barcode or manually enter e From the Incubation Time window select SCHEDULER e Add patient sample to test device by holding the dropper in a vertical position and dispense we ee 2 drops for StatusFirst DOA 10 or 3 drops for StatusFirst DOA 5 of sample into EACH sample well When drawing sample into the dropper avoid introducing air bubbles Do not touch the sample well or test device with the tip of the dropper e Immediately press ENTER e Insert the test device in the Reader tray close the Reader tray e After 5 minutes of incubation the DXpress Reader will automatically read and display t
23. usFirst DOA 10 DOA 5 test uses solid phase chromatographic membrane immunoassay technology for the qualitative simultaneous detec tion of methamphetamine opiates cocaine THC phencyclidine benzodiaz epines barbiturates methadone tricyclic antidepressants and amphetamine in human urine The test is based on the principle of the highly specific immunochemical reactions between antigens and antibodies which are used for the analysis of specific substances in biological fluids The test relies on the competition to bind to the antibodies between the drug conjugates and the drugs which may be present in the urine sample In the test procedure a sample of urine is placed in the Sample well of the device and is allowed to migrate upward If the drug is present in the urine sample it competes with the drug conjugate which is bound to the dye for the limited antibodies immobilized on the membrane If the drug or drug metabolite levels are above the cutoff level the drug will saturate the antibodies thus inhibiting the binding of the dye coated with drug conjugates to the antibodies on the membrane This prevents the formation of a line on the membrane Therefore a drug positive urine sample will not generate a line in the test window indicating a positive result from positive drug competition while a negative urine sample will generate a line in the test window indicating a negative result from an absence of competition with free drugs In
24. uses of death by drug overdose in the United States There are two broad chemical classes of TCAs The tertiary amines amitriptyline imipramine trimipramine and doxepin boost sero tonin levels and are prescribed for insomnia irritability and over stimulation The secondary amines nortriptyline desipramine and protryptiline en hance norepinephrine levels and are prescribed for opposite types of symp toms such as excessive fatigue withdrawal and inertness Abuse of TCAs may lead to coma respiratory depression convulsions blood pressure deviations hyperprexia and severe cardiac conditions TCAs are excreted in urine mostly in the form of metabolites for up to ten days Amphetamine AMP is a potent sympathomimetic agent with therapeutic applications The drug can be taken orally injected or inhaled Acute higher doses lead to enhanced stimulation of the central nervous system and induce euphoria alertness reduced appetite and a sense of increased energy and power Cardiovascular responses to amphetamine include increased blood pressure and cardiac arrhythmias More acute responses include anxiety paranoia hallucinations psychotic behavior and eventually depression and exhaustion The effects of amphetamine generally last 2 4 hours and the drug has a half life of 9 24 hours in the body Amphetamine is excreted in the urine in unchanged form and also as hydroxylated and deaminated derivatives Principle The Stat
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