DRUGCHECK SURE`CUP
Contents
1. Quarante 40 chantillons cliniques pour chaque toxique ont t test s en utilisant chaque puits du DRUGCHECK SURE CUP par un op rateur non form Bas sur des donn es de GC MS l op rateur non form a obtenu statistiquement des resultats positifs n gatifs et globaux similaires aux personnel qualifies REMARQUE les antid presseurs tricycliques ont t compar s la m thode HPLC Reproductibilit Des tudes de reproductibilit ont t effectu es en utilisant des normes disponibles dans le commerce Chacun standard a t dilu en urine normale et drogue libre pour donner la concentration appropri e Chaque sp cimen chaque concentration d analyte a t examin quatre fois quotidiennement deux fois pendant cinq jours cons cutifs Un total de 40 d terminations ont t faites chaque concentration Les r sultats sont donn s ci dessous AMPHETAMINE AMP Amphetamine ng mL Total R sultats Pr cision Pas de toxique pr sent 40 40 negative gt 99 500 40 40 negative gt 99 750 40 40 negative gt 99 1 000 40 40 positive gt 99 1 500 40 40 positive gt 99 BARBITURIQUES BAR Secobarbital ng mL Total R sultats Pr cision Pas de toxique pr sent 40 40 negative gt 99 150 40 40 negative gt 99 225 40 40 negative gt 99 300 40 40 positive gt 99 450 40 40 positive gt 99 BENZODIAZEPINES BZO Oxazepa2. 8 INTERPRETATION DES RESULTATS Voir illustration ci dessus NEGATIF Une bande color e dans la zone C et une bande color e dans la zone test T pour un toxique donn indiquent un r sultat n gatif Cela signifie que la concentration en toxique dans l urine est en dessous du seuil de d tection du toxique consid r NOTE L intensit de la coloration dans la zone test T peut varier mais le r sultat doit tre consid r comme n gatif m me si la bande color e est de tr s faible intensit POSITIF Une bande color e dans la zone de contr le C et une absence de ligne color e dans la zone test T pour un toxique consid r indiquent un r sultat positif Ceci signifie que la concentration en toxique dans l chantillon d urine est sup rieure au seuil de d tection pour le toxique consid r NON VALIDE Absence de bande contr le Un volume d chantillon inad quat ou une proc dure technique incorrecte sont les deux causes les plus probables d absence d apparition de bande contr le La proc dure doit tre relue et le test r p t sur une nouvelle savonnette Si le probl me persiste ne plus utiliser le lot consid r et contacter la soci t Alldiag 9 CONTROLE DE QUALITE Une proc dure de contr le interne est incluse dans le test L apparition d une bande mauve au niveau de la zone contr le C est consid r e comme un contr le de proc dure interne Cela confirme un
3. 0 10 0 10 0 tof o 10 0 10 0 50 Cut off 10 10 0 10 0 10 0 tof o 10 0 10 0 25 Cutoff 10 10 0 10 o 10 0 tof o to 0 10 0 Cut off 10 o 10 ol tof o 10 0 10 0 10 0 10 25 Cutoff 10 0 10 o 10 o 10 0 10 0 10 0 10 50 Cutoff 10 0 10 o 10 o 10 0 tof 0 10 0 10 Cut off n mAMP MDMA MOP OPI PCP TCA 0 Cut off 10 10 o 10 0 10 of tof o 10 0 10 0 50 Cutoff 10 10 0 10 o 10 0 tof o 10 0 10 O 25 Cutoff 10 10 o 10 o 10 0 tof 0 10 0 10 0 Cut off 10 o 10 of tof 0 10 0 tof 0 10 0 10 25 Cutoff 10 0 10 o 10 o 10 0 10 0 10 0 10 50 Cut off 10 0 10 o 10 o 10 0 10 0 10 0 10 Le tableau suivant r sume les concentrations ng ml qui sont d tect es positives par le DRUGCHECK SURE CUP 5 minutes Alldiag Sp cificit analytique Drug Concentration ng ml AMPHETAMINES AMP d amphetamine 1 000 D l amphetamine 1 000 l amphetamine 20 000 Phentermine 1 250 Methylenedioxyamphetamine MDA 1 500 BARBITURIQUES BAR Secobarbital 300 Amobarbital 300 Alphenol 150 Aprobarbital 200 Butabarbital 75 Butalbital 2 500 Butethal 100 Cyclopentobarbital 600 Pentobarbital 300 Phenobarbital 100
4. 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 The test contains a membrane strip coated with drug protein conjugates purified bovine albumin on the test line a goat polyclonal antibody against gold protein conjugate at the control line and a dye pad which contains colloidal gold particles coated with mouse monoclonal antibody specific 3 PRECAUTIONS For Professional Use Only For In Vitro Diagnostic Use Only Do not use after the expiration date The test panel should remain in the sealed pouch until use While urine is not classified by OSHA or the CDC as a biological hazard un
5. Pas de toxique pr sent 40 40 negative gt 99 250 40 40 negative gt 99 375 40 40 negative gt 99 500 40 40 positive gt 99 750 40 40 positive gt 99 MORPHINE MOP 300 Morphine ng mL Total R sultats Pr cision Pas de toxique pr sent 40 40 negative gt 99 150 40 40 negative gt 99 225 40 40 negative gt 99 300 40 40 positive gt 99 450 40 40 positive gt 99 OPIACES OPI 2000 Morphine ng mL Total R sultats Pr cision Pas de toxique pr sent 40 40 negative gt 99 1 000 40 40 negative gt 99 1 500 40 40 negative gt 99 2 000 40 40 positive gt 99 3 000 40 40 positive gt 99 PHENCYCLIDINE PCP Phencyclidine ng mL Total R sultats Pr cision Pas de toxique pr sent 40 40 negative gt 99 12 5 40 40 negative gt 99 19 40 40 negative gt 99 25 40 40 positive gt 99 37 5 40 40 positive gt 99 ANTIDEPRESSEURS TRICYCLIQUES TCA Nortiptyline ng mL Total R sultats Pr cision Pas de toxique pr sent 40 40 negative gt 99 500 40 40 negative gt 99 750 40 40 negative gt 99 1 000 40 40 positive gt 99 1 500 40 40 positive gt 99 Version 3 Sensibilit analytique Un pool d urines n gatives a t charg en toxiques aux concentrations 50 25 du seuil de d tection cut off Les r sultats sont r sum s ci dessous Cut off n AMP BAR BZO COC THC MTD 0 Cut off 10 10
6. gt 99 500 40 40 positive gt 99 750 40 40 positive gt 99 OPIATE 300 MOP 300 Morphine Conc ng mL Total number of Determinations Result Precision No drug present 40 40 negative gt 99 150 40 40 negative gt 99 225 40 40 negative gt 99 300 40 40 positive gt 99 450 40 40 positive gt 99 OPIATES OPI 2000 Morphine Conc ng mL Total number of Determinations Result Precision No drug present 40 40 negative gt 99 1 000 40 40 negative gt 99 1 500 40 40 negative gt 99 2 000 40 40 positive gt 99 3 000 40 40 positive gt 99 PHENCYCLIDINE PCP Phencyclidine Conc ng mL Total number of Determinations Result Precision No drug present 40 40 negative gt 99 12 5 40 40 negative gt 99 19 40 40 negative gt 99 25 40 40 positive gt 99 37 5 40 40 positive gt 99 TRICYCLIC ANTIDEPRESSANTS TCA NortiptylineConc ng mL Total number of Determinations Result Precision No drug present 40 40 negative gt 99 500 40 40 negative gt 99 750 40 40 negative gt 99 1 000 40 40 positive gt 99 1 500 40 40 positive gt 99 Alldiag 11 Version 3 Analytical Sensitivity A drug free urine pool was spiked with drugs at concentrations listed The results are summarized below Drug concentration n AMP BAR BZO COC THC MTD Cut off Range 4 0 Cut off 10 10 0 0 0 0 0 0 50 Cut off 10 10 0 10 0 10 0 10 0 10 0 10 0 25 Cut off 10 10 0 0 0 0 0 0 Cut off 10 0 10 0 10 0 10 0 10 0 10 0 10 25 Cut
7. negative at 100 000 OPIATES OPI 2000 Codeine 2 000 Hydromorphone 5 000 Oxycodone negative at 100 000 Morphine Sulfate 2 000 Morphine 3 b D glucuronide 2 000 Morphine 6 b D glucuronide 2 000 Methadone negative at 100 000 Nalorphine negative at 100 000 Heroin 2 000 Ethylmorphine 5 000 Meperidine 5 000 000 PHENCYCLIDINE PCP Phencyclidine 25 Phencyclidine d5 10000 TCA Notriptyline 1 000 Nordoxepine 1 000 Trimipramine 3 000 Amitriptyline 1 500 Promazine 1 500 Desipramine 200 Imipramine 400 13 Version 3 Clomipramine 12 500 Doxepin 2 000 Maprotiline 2 000 Promethazine 25 000 samples The results demonstrate that varying ranges of urinary specific gravity do not affect the test results varying ranges of pH do not interfere with the performance of the test Effect of Urinary Specific Gravity Fifteen 15 urine samples of normal high and low specific gravity ranges 1 005 1 015 1 03 were spiked with drugs at 50 below and 50 above cut off levels respectively The DRUGCHECK SURE CUP was tested in duplicate using ten drug free urine and spiked urine Effect of the Urinary pH The pH of an aliquoted negative urine pool was adjusted to pH ranges of 4 0 4 5 5 0 6 0 and 9 0 and spiked with drugs at 50 below and 50 above cut off levels The spiked pH adjusted urine was tested with the DRUGCHECK SURE CUP The results demonstrate that Cross Reactivity A study was
8. of Toxic Drugs and Chemicals in Man 2nd Ed Biomedical Publ Davis CA 1982 487 OSHA The Bloodborne Pathogens Standard 29 Code of Federal Regulations 29 CFR 1910 1030 CDC Centers for Disease Control CDC Guidelines Morbidity and Mortality Weekly Report Volume 37 Number 24 1988 Version 3
9. volume ad quat d chantillon une migration correcte le long de la membrane et la bonne r alisation de la proc dure technique 10 LIMITES 1 Le DRUGCHECK SURE CUP fournit seulement un r sultat analytique pr liminaire Une m thode chimique alternative doit tre utilis e pour confirmer le r sultat La chromatographie gazeuse coupl e la spectrom trie de masse GC MS est la m thode de confirmation de r f rence 2 Des erreurs techniques ou de proc dure ainsi que la pr sence de substances interf rentes dans les urines peuvent tre l origine de r sultats erron s 3 Des substances adult rantes telles que les agents d colorants ou oxydants et l alun peuvent entra ner des r sultats erron s quelque soit la m thode analytique utilis e En cas de suspicion d adult rants le test doit tre r p t partir d un nouvel chantillon d urine 4 Un r sultat positif n informe ni sur le niveau d intoxication ni sur la voie d administration ni sur la concentration urinaire 5 Un r sultat n gatif ne signifie pas n cessairement absence de toxique dans les urines Un r sultat n gatif peut tre obtenu en pr sence du toxique un taux inf rieur au seuil de d tection du test Alldiag 2 Version 3 Le test ne permet pas de distinguer entre une prise licite ou illicite d un m dicament Certains aliments ou additifs alimentaires peuvent entra ner des r sultats positifs Le m
10. 00 40 40 positive gt 99 450 40 40 positive gt 99 COCAINE COC Benzoylecgonine Conc ng mL Total number of Determinations Result Precision No drug present 40 40 negative gt 99 150 40 40 negative gt 99 225 40 40 negative gt 99 300 40 40 positive gt 99 450 40 40 positive gt 99 Alldiag 10 Version 3 MARIJUANA THC 11 nor A THC 9 COOH Conc Mn eroralnuinbenotaDetenninanons Result Precision No drug present 40 40 negative gt 99 25 40 40 negative gt 99 37 5 40 40 negative gt 99 50 40 40 positive gt 99 75 40 40 positive gt 99 METHADONE MTD Methadone Conc ng mL Total number of Determinations Result Precision No drug present 40 40 negative gt 99 150 40 40 negative gt 99 225 40 40 negative gt 99 300 40 40 positive gt 99 450 40 40 positive gt 99 METHAMPHETAMINE mAMP Methamphetamine Conc ng mL Total number of Determinations Result Precision No drug present 40 40 negative gt 99 500 40 40 negative gt 99 750 40 40 negative gt 99 1 000 40 40 positive gt 99 1 500 40 40 positive gt 99 METHYLENEDIOXYMETHAMPHETAMINE MDMA Methylenedioxy methamphetamine Total number of Determinations Result Precision Conc ng mL No drug present 40 40 negative gt 99 250 40 40 negative gt 99 375 40 40 negative
11. 2 500 Flunitrazepam 390 Lorazepam 1 562 RS Lorazepam glucuronide 156 Midazolam 12 500 Nitrazepam 98 Norchlordiazepoxide 195 Nordiazepam 390 Temazepam 98 Triazolam 2 500 Alldiag 12 Version 3 Alldiag COCAINE COC Benzoylecogonine 300 Cocaethylene 300 Cocaine 300 MARIJUANA THC 11 Hydroxy A Tetrahydrocannabinol 5 000 11 Nor A Tetrahydrocannabinol 50 11 Nor A Tetrahydrocannabinol 50 11 Nor A Tetrahydrocannabinol 9 Carboxylic Glucuronide 2 500 Af Tetrahydrocannabinol 20 000 A Tetrahydrocannabinol 20 000 METHADONE MTD Methadone 300 Doxylamine 50 000 Methamphetamine mAMP 3 4 Methylenedioxy n ethylamphetamine MDEA 20 000 Procaine Novocaine 60 000 Trimethobenzamide 20 000 methamphetamine 1 000 methamphetamine 1 000 Ranitidine Zantac 500 000 3 4 Methylenedioxymethamphetamine MDMA 2 500 MDA 100 000 METHYLENEDIOXYMETHAMPHETAMINE MDMA D L 3 4 Methylenedioxymethamphetamine HCII MDMA 500 3 4 Methylenedioxyamphetamine HCI MDA 3 000 3 4 Methylenedioxyethyla amphetamine MDEA 300 OPIATES MOP 300 6 acetylmorphine 500 Codeine 300 Ethylmorphine 15 00 Heroin 300 Hydromorphone 2 000 Hydrocodone 1 250 Meperidine 300 000 Morphine 300 Morphine 3 glucuronide 300 Oxycodone
12. BENZODIAZEPINES BZO Oxazepam 300 Alprazolam 196 a Hydroxyalprazolam 1 262 Bromazepam 1 562 Chlordiazepoxide 1 562 Chlordiazepoxide HCI 781 Clobazam 98 Clonazepam 781 Clorazepate dipotassium 195 Delorazepam 1 562 Desalkylflurazepam 390 Diazepam 195 Estazolam 2 500 Flunitrazepam 390 Lorazepam 1 562 RS Lorazepam glucuronide 156 Midazolam 12 500 Nitrazepam 98 Norchlordiazepoxide 195 Nordiazepam 390 Temazepam 98 Triazolam 2 500 Version 3 Alldiag COCAINE COC Benzoylecogonine 300 Cocaethylene 300 Cocaine 300 MARIJUANA THC 11 Hydroxy A Tetrahydrocannabinol 5 000 11 Nor A Tetrahydrocannabinol 50 11 Nor A Tetrahydrocannabinol 50 11 Nor A Tetrahydrocannabinol 9 Carboxylic Glucuronide 2 500 A Tetrahydrocannabinol 20 000 A Tetrahydrocannabinol 20 000 METHADONE MTD Methadone 300 Doxylamine 50 000 Methamphetamine mAMP 3 4 Methylenedioxy n ethylamphetamine MDEA 20 000 Procaine Novocaine 60 000 Trimethobenzamide 20 000 methamphetamine 1 000 methamphetamine 1 000 Ranitidine Zantac 500 000 3 4 Methylenedioxymethamphetamine MDMA 2 500 MDA 100 000 METHYLENEDIOXYMETHAMPHETAMINE MDMA D L 3 4 Methylenedioxymethamphetamine HCII MDMA 500 3 4 Methylenedioxyamphetamine
13. CE NOTICE D UTILISATION DRUGCHECK SURE CUP INSTRUCTIONS FOR USE ALL DIAG 10 rue Ettor Bugatti BP 28006 67038 STRASBOURG Cedex 2 FRANCE T l 33 3 88 78 80 88 Fax 33 3 88 78 76 78 www alldiag com info alldiag com Liste des Symboles A Attention voir notice d utilisation Wy Tests par coffret peal Fabricant Pour diagnostic in vitro uniquement z P remption Usage unique A Conserver entre 2 30 C LOT No de lot REF Code produit Index of Symbols A Attention see instructions for use Y Tests per kit pas Manufacturer For in vitro diagnostic use only Use 0y Do not reuse Store between 2 30 C LOT Lot Number REF Catalog Directive 98 79 CE Version 3 Mise a jour le 21 08 2008 ALL DIAG 10 rue Ettor Bugatti BP 28006 Fabricant rant es 67038 STRASBOURG Cedex 2 FRANCE T l 03 88 78 80 88 Fax 03 88 78 76 78 www alldiag com info alldiag com DRUGCHECK SURE CUP Notice d utilisation pour tout test utilisant une combinaison des toxiques suivants Amph tamine Barbituriques Benzodiaz pines Cocaine Cannabis M thadone Methylenedioxymethamphetamine Morphine Opiac s Phencyclidine et Antid presseurs Tricycliques M thamph tamine Ref 5023 AMP THC MOP COC MDMA BZO TCA BAR MET MTD 5024 AMP THC MOP COC MDMA Pour diagnostic in v
14. HCI MDA 3 000 3 4 Methylenedioxyethyla amphetamine MDEA 300 MORPHINE MOP 300 6 acetylmorphine 500 Codeine 300 Ethylmorphine 15 00 Heroin 300 Hydromorphone 2 000 Hydrocodone 1 250 Meperidine 300 000 Morphine 300 Morphine 3 glucuronide 300 Oxycodone negative at 100 000 OPIACES OPI 2000 Codeine 2 000 Hydromorphone 5 000 Oxycodone negative at 100 000 Morphine Sulfate 2 000 Morphine 3 b D glucuronide 2 000 Morphine 6 b D glucuronide 2 000 Methadone negative at 100 000 Nalorphine negative at 100 000 Heroin 2 000 Ethylmorphine 5 000 Meperidine 5 000 000 PHENCYCLIDINE PCP Phencyclidine 25 Phencyclidine d5 10000 ANTIDEPRESSEURS TRICYCLIQUES TCA Notriptyline 1 000 Nordoxepine 1 000 Trimipramine 3 000 Amitriptyline 1 500 Promazine 1 500 Desipramine 200 Imipramine 400 Version 3 Clomipramine 12 500 Doxepin 2 000 Maprotiline 2 000 Promethazine 25 000 Effet de la densit urinaire SG Quinze 15 chantillons d urine de densit normale lev e et basse 1 005 1 015 1 03 taient m lang s aux toxiques respectivement 50 en dessous et 50 au dessus du cut off Le DRUGCHECK SURE CUP a t test deux fois en utilisant 10 urines n gatives Les r sultats montrent que les variations de densit urinaires n affectent pas les r sultats Effet du pH urinaire Le pH d un pool d urine n gatives a t ajust sur des gammes de pH de 4 0 4 5 5 0 6 0 et 9 0 et m lang s a
15. NTILLON Test urinaire L urine doit tre recueillie dans un r cipient sec et propre L urine peut tre collect e 4 n importe quel moment de la journ e Les urines pr sentant un pr cipit visible l il nu doivent tre centrifug s filtr s ou laiss s s diment s afin d obtenir un surnageant clair Conservation de l chantillon Les chantillons d urine peuvent tre conserv s 2 8 C pendant 48 heures Pour une conservation prolong e les chantillons doivent tre congel s et conserv s 20 C Les chantillons congel s doivent tre d congel s et m lang s de fa on homog ne avant utilisation 6 COMPOSITION DU COFFRET Aat riel fourni e Cup flacon de recueil cassette test e Mode d emploi fat riel n cessaire mais non fournil e Chronom tre 7 MODE OPERATOIRE Laisser les tests et les chantillons d urine ou contr les revenir temp rature ambiante 15 30 C avant utilisation D vissez le couvercle de s curit Recueil de l urine Refermez d finitivement le couvercle de s curit Poser le flacon sur une surface plane enlever la clef en forme d anneau et pousser le bouton pour d marrer la r action D coller l tiquette pour visualiser les r sultats Attendre l apparition des bandes Lire le r sultat au bout de 5 minutes Ne pas interpr ter au del de 10 minutes DIN A TE 3 NEGATIVE F POSITIVE AA ap INVALID e EN
16. conducted to determine the cross reactivity of the test with compounds in either drug free urine or drug positive urine containing Cocaine Barbiturates Benzodiazepines Amphetamine Methamphetamine Marijuana Methadone Methylenedioxymethamphetamine Opiates Phencyclidine or Tricyclic Antidepressants The following compounds show no cross reactivity when tested with The DRUGCHECK SURE CUP at concentrations of 100 pg mL Non Cross Reacting Compounds Acetaminophen Acetophenetidin Naloxone Naltrexone N Acetylprocainamide Acetylsalicylic acid Naproxen Niacinamide Aminopyrine Amoxicillin Nifedipine Norethindrone Ampicillin L Ascorbic acid D Norpropoxyphene Noscapine Apomorphine Aspartame D L Octopamine Oxalic acid Atropine Benzilic acid Oxolinic acid Oxymetazoline Benzoic acid Benzphetamine Papaverine Penicillin G Bilirubin D L Brompheniramine Pentazocine hydrochloride Perphenazine Caffeine Cannabidol Phenelzine Trans 2 phenylcyclo propylamine hydrochloride Chloralhydrate Chloramphenicol L Phenylephrine B Phenylethylamine Chlorothiazide D L Chloropheniramine Phenylpropanolamine Prednisolone Chlorpromazine Chloroquine Prednisone D L Propranolol Cholesterol Clonidine D Propoxyphene D Pseudoephedrine Cortisone L Cotinine Quinacrine Quinine Creatinine Deoxycorticosterone Quindine Ranitidine Dextromethorphan Diclofenac Salicylic acid Serotonin Diflunisal Digox
17. dicament Subutex mol cule buprenorphine n interf re pas avec MOP Les m dicaments Subutex Zolpidem Prozax Prosac et Imovane Zopiclone n inf rent pas avec le BZO ni le TCA Cependant un r sultat faux positif peut survenir si le patient est trait simultan ment par ces 3 m dicaments OND 11 PERFORMANCE Exactitude Une tude comparative a t r alis e entre le DRUGCHECK SURE CUP et un autre test commercial de d tection rapide des toxiques sur urine approximativement 120 chantillons par type de toxiques provenant de sujets test s dans le cadre d op rations de d pistage Les r sultats pr sum s positifs ont t confirm s par GC MS Les r sultats sont r sum s dans le tableau suivant de corr lation avec le kit commercial AMP BAR BZO COC THC MTD Positif 98 100 100 98 98 100 N gatif 100 100 98 100 100 100 Resultats 99 100 99 99 99 100 mAMP MDMA MOP OPI PCP TCA Positif 98 100 98 98 98 98 5 N gatif 100 100 100 100 100 100 Resultats 99 100 99 99 99 99 corr lation avec GC MS AMP BAR BZO COC THC MTD Positif 95 98 5 95 7 95 95 98 5 N gatif 100 98 98 100 100 96 Resultats 97 5 98 2 96 8 97 5 97 5 97 mAMP MDMA MOP OPI PCP TCA Positif 95 97 1 95 95 95 95 7 N gatif 100 98 100 100 100 98 Resultats 97 5 97 5 97 5 97 5 97 5 96 8
18. equate membrane wicking and correct procedural technique 10 LIMITATIONS 1 The DRUGCHECK SURE CUP 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 7 2 There is a possibility that technical or procedural errors as well as other interfering substances in the urine specimen may cause erroneous results 3 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 and a new test device 4 A Positive result does not indicate intoxication of the donor the concentration of drug in the urine or the route of drug administration 5 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 6 Test does not distinguish between drugs of abuse and certain medications 7 A positive test result may be obtained from certain foods or food supplements 8 The drug Subutex buprenorphine molecule does not interfere with the MOP 9 The drugs Subutex Zolpidem Prozac Prosac and Imovane Zopiclone does not interfere neither with BZO nor with the TCA Nevertheless a false positive result can occur if the pat
19. euse coupl e la spectrom trie de masse GC MS est la m thode de confirmation de r f rence L analyse des donn es cliniques et un avis professionnel doivent toujours tre confront s un r sultat de d pistage de toxiques dans les urines en particulier en cas de r sultat pr liminaire positif 2 PRINCIPE DU TEST Le DRUGCHECK SURE CUP est un test immunologique sur urine bas sur une m thode de comp tition Des toxiques pr sents dans urine sont mis en comp tition avec leurs conjugu s respectifs vis vis d une liaison avec un anticorps sp cifique Lors de la r alisation du test un chantillon d urine migre par capillarit le long de la membrane En pr sence d un taux de toxique au dessous du seuil de d tection les sites anticorps sp cifiques ne seront pas totalement satur s L anticorps r agira donc avec le conjugu toxique prot ine marqu et une bande color e appara tra au niveau de la bande test correspondant au toxique consid r En pr sence d un taux de toxique au dessus du seuil de d tection les sites anticorps seront totalement satur s par le toxique il ne pourra alors se former de bande color e au niveau de la zone test consid r e Une urine positive pour un toxique donn ne g n rera pas de bande test color e au niveau de la zone test correspondante tandis qu une urine n gative entra nera l apparition d une bande test color e au niveau de la zone test correspondante e
20. ient is treated simultaneously with the three of them Alldiag 9 Version 3 11 PERFORMANCE CHARACTERISTICS Accuracy A side by side comparison was conducted using The DRUGCHECK SURE CUP and other commercially available rapid drug tests Testing was performed on 120 specimens per drug type previously collected from subjects presenting for drug screen testing All the presumptive positive and negative results were confirmed by GC MS The following compounds were quantified by GC MS and contributed to the total amount of drugs found in presumptive positive urine samples tested Agreement with Commercial Kit AMP BAR BZO COC THC MTD Positive Agreement 98 100 100 98 98 100 Negative Agreement 100 100 98 100 100 100 Total Results 99 100 99 99 99 100 mAMP MDMA MOP OPI PCP TCA Positive Agreement 98 100 98 98 98 98 5 Negative Agreement 100 100 100 100 100 100 Total Results 99 100 99 99 99 99 Agreement with GC MS AMP BAR BZO COC THC MTD Positive Agreement 95 98 5 95 7 95 95 98 5 Negative Agreement 100 98 98 100 100 96 Total Results 97 5 98 2 96 8 97 5 97 5 97 mAMP MDMA MOP OPI PCP TCA Positive Agreement 95 97 1 95 95 95 95 7 Negative Agreement 100 98 100 100 100 98 Total Results 97 5 97 5 97 5 97 5 97 5 96 8 Forty 40 clinical samples for each drug were run using each strip contained
21. in Sulfamethazine Sulindac Diphenhydramine Ecgonine methyl ester Tetracycline Tetrahydrocortisone 3 acetate L Y Ephedrine b Estradiol Tetrahydrocortisone 3 b D Tetrahydrozoline glucuronide Estrone 3 sulfate Ethyl p aminobenzoate Thiamine Thioridazine 1R 2S Ephedrine L Epinephrine D L Tyrosine Tolbutamide Erythromycin Fenoprofen Triamterene Trifluoperazine Furosemide Gentisic acid Trimethoprim Tryptamine Hemoglobin Hydralazine D L Tryptophan Tyramine Hydrochlorothiazide Hydrocortisone Uric acid Verapamil O Hydroxyhippuric acid p Hydroxyamphetamine Loperamide Meperidine p Hydroxytyramine Ibuprofen Meprobamate Methoxyphenamine Iproniazid D L Isoproterenol Methylphenidate Nalidixic acid Isoxsuprine Ketamine Zomepirac Ketoprofen Labetalol Parent compound only metabolizes into amphetamine and methamphetamine in the body 19 BIBLIOGRAPHY CONINDARWNHE Alldiag 14 Stewart DJ Inaba T Lucassen M Kalow W Clin Pharmacol Ther April 1979 25 ed 464 264 8 Ambre J J Anal Toxicol 1985 9 241 Hawks RL CN Chiang Urine Testing for Drugs of Abuse National Institute for Drug Abuse NIDA Research Monograph 73 1986 Tietz NW Textbook of Clinical Chemistry W B Saunders Company 1986 1735 FDA Guidance Document Guidance for Premarket Submission for Kits for Screening Drugs of Abuse to be Used by the Consumer 1997 Robert DeCresce Drug Testing in the workplace 114 Baselt RC Disposition
22. ing and push the button Peel off the label to view results Test is read in the reaction well Read positive results at 5 minutes Do not interpret after 10 minutes HN HE QUE BE en TT NEGATIVE Bane ro J a POSITIVE l eee c PA J T Oo INVALID 8 INTERPRETATION OF RESULTS Please refer to the previous illustration NEGATIVE Two lines appear One red line should be in the control region C and another apparent red or pink line adjacent should be in the test region T This negative result indicates that the drug concentration is below the detectable level 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 device If the problem persists discontinue using the lot immediately and contact your supplier 9 QUALITY CONTROL A procedural control is included in the test A red line appearing in the control region C is considered an internal procedural control It confirms sufficient specimen volume ad
23. isone D L Propranolol Cholesterol Clonidine D Propoxyphene D Pseudoephedrine Cortisone L Cotinine Quinacrine Quinine Creatinine Deoxycorticosterone Quindine Ranitidine Dextromethorphan Diclofenac Salicylic acid Serotonin Diflunisal Digoxin Sulfamethazine Sulindac Diphenhydramine Ecgonine methyl ester Tetracycline Tetrahydrocortisone 3 acetate L Y Ephedrine b Estradiol Tetrahydrocortisone 3 Tetrahydrozoline b D glucuronide Estrone 3 sulfate Ethyl p aminobenzoate Thiamine Thioridazine 1R 2S Ephedrine L Epinephrine D L Tyrosine Tolbutamide Erythromycin Fenoprofen Triamterene Trifluoperazine Furosemide Gentisic acid Trimethoprim Tryptamine Hemoglobin Hydralazine D L Tryptophan Tyramine Hydrochlorothiazide Hydrocortisone Uric acid Verapamil O Hydroxyhippuric acid p Hydroxyamphetamine Meperidine Loperamide p Hydroxytyramine Ibuprofen Meprobamate Methoxyphenamine Iproniazid D L Isoproterenol Methylphenidate Nalidixic acid Isoxsuprine Ketamine Zomepirac Ketoprofen Labetalol 12 BIBLIOGRAPHIE OH U EUR Alldiag Stewart DJ Inaba T Lucassen M Kalow W Clin Pharmacol Ther April 1979 25 ed 464 264 8 Ambre J J Anal Toxicol 1985 9 241 Hawks RL CN Chiang Urine Testing for Drugs of Abuse National Institute for Drug Abuse NIDA Research Monograph 73 1986 Tietz NW Textbook of Clinical Chemistry W B Saunders Company 1986 1735 FDA Guidance Document Guidance for Premarket Submission for Kits f
24. itro 4 usage professionnel uniquement 1 INTRODUCTION Les tests de recherche multiple de toxiques dans les urines peuvent faire appel des techniques immunologiques simples ou des proc dures analytiques complexes La rapidit et la sensibilit des tests immunologiques en ont fait une m thode de d pistage dans l urine largement utilis e Le DRUGCHECK SURE CUP est un test immunochromatographique pour la d tection qualitative de toxiques et de leurs principaux m tabolites dans les urines aux seuils de d tection suivants 1 Test Calibrateur Seuil ng ml Amph tamine AMP d Amph tamine 1 000 Barbituriques BAR Secobarbital 300 Benzodiaz pines BZO Oxaz pam 300 Coca ne COC Benzoylecgonine 300 Cannabis THC 11 nor A THC 9 COOH 50 M thadone MTD M thadone 300 M thamph tamine mAMP ou MET d M thamph tamine 1 000 Methylenedioxymethamphetamine MDMA d l Methylenedioxymethamphetamine 500 Morphine MOP Morphine 300 Opiac s OPI Morphine 2000 Phencyclidine PCP Phencyclidine 25 Antid presseurs Tricycliques TCA Nortriptyline 1 000 Diff rentes configurations du DRUGCHECK SURE CUP peuvent tre propos es en combinant les diff rents analytes propos s ci dessus Le DRUGCHECK SURE CUP fournit seulement un r sultat analytique pr liminaire Une m thode chimique alternative doit tre utilis e pour confirmer le r sultat La chromatographie gaz
25. less visibly contaminated with blood the use of gloves is recommended to avoid unnecessary contact with the specimen The used test card and urine specimen should be discarded according to federal state and local regulations 4 STORAGE AND STABILITY Store as packaged in the sealed pouch at 2 30 C 36 86 F The test is stable through the expiration date printed on the sealed pouch The test device must remain in the sealed pouch until use DO NOT FREEZE Do not use beyond the expiration date 5 SPECIMEN COLLECTION AND PREPARATION Urine Assay The urine specimen must be collected in a clean and dry container Urine collected at any time of the day may be used Urine specimens exhibiting visible precipitates should be allowed to settle to obtain a clear specimen for testing Alldiag 8 Version 3 Specimen Storage Urine specimens may be stored at 2 8 C 36 46 F for up to 48 hours prior to testing For prolonged storage specimens may be frozen and stored below 20 C Frozen specimens should be thawed and mixed well before testing 8 MATERIALS Materials Provided Test cup collection container device Package insert Materials Required But Not Provided Timer 7 DIRECTIONS FOR USE Allow the test card and urine specimen to come to room temperature 15 30 C 59 86 F prior to testing Remove cap Donor provides specimen Replace and secure cap On a flat surface remove the key r
26. m ng mL Total R sultats Pr cision Pas de toxique pr sent 40 40 negative gt 99 150 40 40 negative gt 99 225 40 40 negative gt 99 300 40 40 positive gt 99 450 40 40 positive gt 99 Alldiag 3 Version 3 Alldiag COCAINE COC Benzoylecgonine ng mL Total R sultats Pr cision Pas de toxique pr sent 40 40 negative gt 99 150 40 40 negative gt 99 225 40 40 negative gt 99 300 40 40 positive gt 99 450 40 40 positive gt 99 MARIJUANA THC 11 nor A THC 9 COOH ng mL Total R sultats Pr cision Pas de toxique pr sent 40 40 negative gt 99 25 40 40 negative gt 99 HRD 40 40 negative gt 99 50 40 40 positive gt 99 40 40 positive gt 99 METHADONE MTD Methadone ng mL Total R sultats Pr cision Pas de toxique pr sent 40 40 negative gt 99 150 40 40 negative gt 99 225 40 40 negative gt 99 300 40 40 positive gt 99 450 40 40 positive gt 99 METHAMPHETAMINE mAMP Methamphetamine ng mL Total R sultats Pr cision Pas de toxique pr sent 40 40 negative gt 99 500 40 40 negative gt 99 750 40 40 negative gt 99 1 000 40 40 positive gt 99 1 500 40 40 positive gt 99 METHYLENEDIOXYMETHAMPHETAMINE MDMA Methylenedioxy methamphetamine ng mL Total R sultats Pr cision
27. n l absence de comp tition avec le toxique Une bande color e au niveau de la zone contr le permet un contr le interne de la proc dure et indique qu un volume correct d chantillon a t utilis et que la migration sur la membrane a fonctionn correctement Le test contient des anticorps monoclonaux de souris et des particules color es coupl es un complexe toxique prot ine Un anticorps de ch vre anti souris est utilis au niveau de la bande contr le 3 PRECAUTIONS D EMPLOI e Seulement pour l usage de diagnostic in vitro m dical et professionnel Ne pas utiliser au dela de la date de p remption Le test doit tre conserv dans son sachet aluminium jusqu utilisation e Tous les chantillons doivent tre consid r s comme potentiellement infectieux et tre manipul s avec les pr cautions d usage r serv es aux chantillons infectieux Le test une fois utilis doit tre limin selon les proc dures appliqu es aux d chets potentiellement infectieux 4 CONSERVATION ET STABILITE La trousse peut tre conserv e temp rature ambiante ou r frig r e 2 30 C Le test peut tre utilis jusqu la date de p remption imprim e sur le sachet aluminium Le test doit tre conserv dans son sachet aluminium jusqu son utilisation NE PAS CONGELER Ne pas utiliser au del de la date de p remption Alldiag 1 Version 3 5 RECUEIL ET PREPARATION DE L ECHA
28. off 10 0 10 0 10 0 10 0 10 0 10 0 10 50 Cut off 10 0 10 0 10 0 10 0 10 0 10 0 10 Drug concentration n mAMP MDMA MOP OPI PCP TCA Cut off Range a 0 Cut off 10 10 0 10 0 10 0 0 0 0 50 Cut off 10 10 0 10 0 10 0 10 0 10 0 10 0 25 Cut off 10 10 0 10 0 10 0 0 0 0 Cut off 10 0 10 0 10 0 10 0 10 0 10 0 10 25 Cut off 10 0 10 0 10 0 10 0 10 0 10 0 10 50 Cut off 10 0 10 0 10 0 10 0 10 0 10 0 10 Analytical Specificity The following table lists the concentration of compounds ng mL that were detected positive in urine by DRUGCHECK SURE CUP at a read time of 5 minutes Drug Concentration ng ml AMPHETAMINE AMP d amphetamine 1 000 D l amphetamine 1 000 l amphetamine 20 000 Phentermine 1 250 Methylenedioxyamphetamine MDA 1 500 BARBITURATES BAR Secobarbital 300 Amobarbital 300 Alphenol 150 Aprobarbital 200 Butabarbital 75 Butalbital 2 500 Butethal 100 Cyclopentobarbital 600 Pentobarbital 300 Phenobarbital 100 BENZODIAZEPINES BZO Oxazepam 300 Alprazolam 196 a Hydroxyalprazolam 1 262 Bromazepam 1 562 Chlordiazepoxide 1 562 Chlordiazepoxide HCI 781 Clobazam 98 Clonazepam 781 Clorazepate dipotassium 195 Delorazepam 1 562 Desalkylflurazepam 390 Diazepam 195 Estazolam
29. or Screening Drugs of Abuse to be Used by the Consumer 1997 Robert DeCresce Drug Testing in the workplace 114 Baselt RC Disposition of Toxic Drugs and Chemicals in Man 2nd Ed Biomedical Publ Davis CA 1982 487 OSHA The Bloodborne Pathogens Standard 29 Code of Federal Regulations 29 CFR 1910 1030 CDC Centers for Disease Control CDC Guidelines Morbidity and Mortality Weekly Report Volume 37 Number 24 1988 Version 3 nc USA DRUGCHECK SURE CUP This Instruction Sheet is for testing of any combination of Amphetamine Barbiturates Benzodiazepines Cocaine Marijuana Methadone Methamphetamine Methylenedioxymethamphetamine Morphine Phencyclidine and Tricyclic Antidepressants R f 5023 AMP THC MOP COC MDMA BZO TCA BAR MET MTD 5024 AMP THC MOP COC MDMA For Professional and In Vitro Diagnostic Use Only 1 INTENDED USE The DRUGCHECK SURE CUP is a competitive immunoassay utilizing highly specific reactions between antibodies and antigens for the detection of multiple drugs and drug metabolites in human urine The DRUGCHECK SURE CUP is a rapid urine screening test that utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine without the use of an instrument The DRUGCHECK SURE CUP is a lateral flow chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in urine at the following cut off concent
30. rations Test Calibrator Cut off Amphetamine AMP D Amphetamine 1 000 ng mL Barbiturates BAR Secobarbital 300 ng mL Benzodiazepines BZO Oxazepam 300 ng mL Cocaine COC Benzoylecgonine 300 ng mL Marijuana THC 11 nor A THC 9 COOH 50 ng mL Methadone MTD Methadone 300 ng mL Methamphetamine mAMP D Methamphetamine 1 000 ng mL Methylenedioxymethamphetamine MDMA D L Methylenedioxy methamphetamine 500 ng mL Morphine MOP 300 Morphine 300 ng mL Opiates OPI 2000 Morphine 2 000 ng mL Phencyclidine PCP Phencyclidine 25 ng mL Tricyclic Antidepressants TCA Nortriptyline 1 000 ng mL Configurations of the DRUGCHECK SURE CUP can consist of any combination of the above listed drug analytes This assay provides only a preliminary qualitative test result Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result Gas chromatography mass spectrometry GC MS is the preferred confirmatory method Apply clinical and professional judgment to any drug of abuse test result particularly when preliminary positive results are obtained 2 PRINCIPLE The DRUGCHECK SURE CUP 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
31. ux toxiques respectivement a 50 en dessous et 50 au dessus du cut off Le m lange a t test sur le DRUGCHECK SURE CUP Les r sultats montrent que les variations de pH des urines n interf rent pas sur le test Une tude a t r alis e pour d terminer les r actions crois es sur des urines n gatives ou contenant Amph tamine Barbituriques Benzodiaz pines Cocaine Cannabis M thadone M thamph tamine Methylenedioxymethamphetamine Morphine Phencyclidine et Antid presseurs Tricycliques Les compos s suivants ne montrent pas de r actions crois es avec le DRUGCHECK SURE CUP 4 la concentration de 100 ug ml Substances ne donnant pas de r actions crois es Acetaminophen Acetophenetidin Naloxone Naltrexone N Acetylprocainamide Acetylsalicylic acid Naproxen Niacinamide Aminopyrine Amoxicillin Nifedipine Norethindrone Ampicillin L Ascorbic acid D Norpropoxyphene Noscapine Apomorphine Aspartame D L Octopamine Oxalic acid Atropine Benzilic acid Oxolinic acid Oxymetazoline Benzoic acid Benzphetamine Papaverine Penicillin G Bilirubin D L Brompheniramine Pentazocine hydrochloride Perphenazine Caffeine Cannabidol Phenelzine Trans 2 phenylcyclo propylaminehydrochloride Chloralhydrate Chloramphenicol L Phenylephrine B Phenylethylamine Chlorothiazide D L Chloropheniramine Phenylpropanolamine Prednisolone Chlorpromazine Chloroquine Predn
32. within The DRUGCHECK SURE CUP by an untrained operator at a Professional Point of Care site Based on GC MS data the untrained operator obtained statistically similar Positive Agreement Negative Agreement and Overall Agreement rates as trained laboratory personnel Note TCA was based on HPLC data Reproducibility Reproducibility studies were carried out using commercially available standards Each standard was diluted in normal drug free urine to give the appropriate concentration Each specimen at each concentration of analyte was tested four times daily in duplicate for five consecutive days A total of 40 determinations were made at each concentration The results are given below AMPHETAMINE AMP Amphetamine Conc ng mL Total number of Determinations Result Precision No drug present 40 40 negative gt 99 500 40 40 negative gt 99 750 40 40 negative gt 99 1 000 40 40 positive gt 99 1 500 40 40 positive gt 99 BARBITURATES BAR Secobarbital Conc ng mL Total number of Determinations Result Precision No drug present 40 40 negative gt 99 150 40 40 negative gt 99 225 40 40 negative gt 99 300 40 40 positive gt 99 450 40 40 positive gt 99 BENZODIAZEPINES BZO Oxazepam Conc ng mL Total number of Determinations Result Precision No drug present 40 40 negative gt 99 150 40 40 negative gt 99 PDS 40 40 negative gt 99 3
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