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     Two Drug screeen Test

 (MOR/MET)

　

Intended use

 

The Multi-Drug Strip Test is an immunochromatographic assay for rapid, qualitative detection of drugs and their principal metabolites in urine at specified cut-off concentrations.

A combination is composed from any the following drugs:

DRUG CLASS                                       SENSITIVITY        

Phencyclidine                                    25 ng/ml

            marijuana                                             50 ng/ml

           COCAINE/BENZOYLECGONINE            300 ng/ml

           barbiturates                                        200 ng/ml

           benzodiazepines                                 300 ng/ml

           Methadone                                           300 ng/ml

           Opiates/Morphine                              300 ng/ml

           Methamphetamine                             500 ng/ml

           AMPHETAMINE                                      1000 ng/ml

Note: The test provides only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS).  Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Summary and explanation of the test

The Multi-drug Strip Test is an easy, fast, qualitative, visually read competitive binding immunoassay method for screening without the need of instrumentation. The method employs unique mixture of monoclonal and polyclonal antibodies to selectively identify the drugs of abuse and their metabolites in test samples with a high degree of sensitivity.

Drug abuse remains a growing social and economical concern in many developed and developing countries throughout the world.  The above stated drugs are among the most frequently abused illicit drugs, according to the U.S. Substance Abuse and Mental Health Services Administration.  Opiates are among a class of heavily abused prescription drugs. 

The sensitivity of the Multi-drug Strip Test is set as required for the screening immunoassays of these drugs in the reference guidelines set by the National Institute on Drug Abuse (NIDA) and the U.S. Department of Health and Human Services.

 principle of the test

The Multi-drug Strip Test is a competitive binding immunoassay in which drug and drug metabolites in a urine sample compete with immobilized drug conjugate for limited labeled antibody binding sites.  By utilizing antibodies that are specific to different drug classes, the test permits independent, simultaneous detection of two drugs from a single sample. The approximate run time is 5 minutes.

In the assay procedure, urine mixes with labeled antibody-dye conjugate and migrates along a porous membrane. When the concentration of a given drug is below the detection limit of the test, unbound antibody-dye conjugate binds to antigen conjugate immobilized on the membrane, producing a rose-pink color band in the appropriate Test Zone for that drug. Conversely, when the drug level is at or above the detection limit, free drug competes with the immobilized antigen conjugate on the membrane by binding to antibody-dye conjugate, forming an antigen- antibody complex, preventing the development of a rose-pink color band.

Regardless of the drug levels in the sample, a rose-pink color band is produced in each Control Zone (marked “C”) by a parallel immunochemical reaction.  These bands serve as built-in quality control measures by demonstrating antibody recognition, verifying that the reagents are chemically active.

　

REAGENTS AND MATERIALS PROVIDED

1.     Test Devices.                               Contains dye-conjugated  

                                                          antibody and immobilized    

                                                          antigen in protein matrix with 

                                                       sodium azide.

 

Optional:

2.     Negative Control I.	Contains buffered protein solution with sodium azide.
3.     PCP Positive Control.	Contains PCP at 100 ng/ml  in a buffered protein  solution with sodium-azide.
4.     Marijuana Positive Control	Contains THC at 150 ng/ml in a buffered solution with sodium azide.
5.        Barbiturates Positive          Control	Contains BAR at 1000 ng/ml in a buffered protein solution with sodium azide.
6.        Benzodiazepines Positive          Control	Contains BZD at 1000 ng/ml in a buffered protein solution with sodium azide.
7.     Methadone Positive Control	Contains MAD at 1000 ng/ml in a buffered protein solution with sodium azide.
8.     Opiates Positive Control	Contains  MOR at 1000 ng/ml in a buffered protein solution with sodium azide.
9.     Cocaine Positive Control	Contains BEG at 1000 ng/ml in a buffered  protein solution with sodium azide.
10.     Methamphetamine Positive           Control	Contains MET at 1500 ng/ml in a buffered protein solution with sodium azide.
11.     Amphetamine Positive          Control	Contains AMP at 3000 ng/ml in a buffered protein solution with sodium azide.

 

　

MATERIALS REQUIRED BUT NOT PROVIDEd

1.     Clock or timer.

2.     Specimen collection containers.

 

WARNINGS AND PRECAUTIONStc "WARNINGS AND PRECAUTIONS"

1.     For in vitro diagnostic and professional use only.

2.     Do not use the test device beyond the expiration date.

3.     Urine specimens may be infectious; properly handle and dispose of all used reaction devices in a biohazard container.

4.        Visually inspect the foil package to insure it is intact.  If the package is not intact, the integrity of the device might be compromised.

 

STORAGE and stabilitytc "STORAGE and stability"

Store test kit below 28°C; do not freeze.  Refer to the expiration date for stability.

　

Test procedure

1.     Bring a urine sample and a foil test pouch to room temperature (15°-28°C).

2.     Do not break the seal of the pouch until ready to begin testing.

3.     Remove a Test Device from the foil pouch.

4.     Remove the protective cap and place the revealed strips into the urine sample for 10 seconds. Do not allow the urine level to touch the plastic device.

5.     Read the results at 5 minutes.         

Note: The result must be interpreted at five minutes. Waiting more than five minutes may cause the reading to be inaccurate. To avoid confusion, discard the test device after interpreting the result.

　

INTERPRETATION OF RESULTS

Positive:  A rose-pink band is visible in each control zone. No color band appearing in the appropriate test zone indicates a positive result for the corresponding drug of that specific test zone.

Negative:  A rose-pink band is visible in each control zone and the appropriate test zone, indicating that the concentration of the corresponding drug of that specific test zone is below the detection limit of the test.

Invalid:  If a color band is not visible in each of the control zones, the test is invalid. Another test should be run to re-evaluate the specimen.

Note: There is no meaning attributed to line color intensity or width.

　

　

Quality control

An internal procedure control has been incorporated into the test to ensure proper kit performance and reliability.

The use of an external control is recommended to verify proper kit performance. Quality control samples should be tested according to quality control requirements established by the testing laboratory.

 

Limitations of the test

1.  This product is designed to be used for the detection of drugs of abuse and their metabolites in human urine only.

2.  Although the test is very accurate, there is the possibility false results will occur due to the presence of interfering substances in the specimen sample.

3.  The test is a qualitative screening assay and is not suggested for quantitative determination of drug levels in urine, or the level of intoxication.

4.  Adulterants such as bleach or other strong oxidizing agents, when added to urine specimens can cause erroneous test results regardless of the analysis method used.  If adulteration is suspected, obtain another urine specimen.

 

Performance characteristics

1.        Sensitivity.  The Multi-drug Strip Testdetects drugs of abuse and their major metabolites in urine at concentrations equal to or greater than the cut-off level for the specific drug, which is suggested by the National Institute on Drug Abuse (NIDA) for the immunoassay method.

2.        Specificity.  A study was conducted with the Multi-drug Strip Test to determine the cross-reactivity of drug-related compounds with the test.  Substances listed in Table I produced results approximately equivalent to the cutoff levels. A separate study was conducted to determine the cross-reactivity of non-related compounds with the test at concentrations much higher than normally found in the urine of people using or abusing them. No cross reactivity was detected with the substances listed in Table II.

Table I: Concentrations of drug-related compounds showing positive response approximately equivalent to the cut-off set for the test:

The following Opiates-related substances yield a positive result for Opiates:

Morphin                                    300ng/ml Morphine-3-b-D-Glucuronide      300 ng/ml Codeine                                  300ng/ml Heroin                                    300ng/ml Norcodeine                            2,000ng/ml Nalorphine                             300 ng/ml Hydrocodone                         500 ng/ml Hydromorphone                     300 ng/ml

Oxycodone                      1,000 ng/ml Levorphanol                        600 ng/ml Naloxone                            1,000 ng/ml Thebaine                            1,500 ng/ml Imipramine                         50,000 ng/ml Atropine                            100,000 ng/ml Meperidine                        100,000 ng/ml Ranitidine                          100,000 ng/ml

The following Methamphetamine-related substances yield positive results for Methamphetamine:

(+) 3,4-Methylenedioxymethamphetamine (MDMA, Ecstacy)              500 ng/ml

d-Amphetamine                                                                            50,000 ng/ml

(+) 3,4-Methylenedioxyamphetamine (MDA)                                     50,000 ng/ml

(+) Methamphetamine                                                                   50,000 ng/ml

D, 1-amphetamine                                                                        10,000 ng/ml

Pseudoephedrine                                                                         1,000 ng/ml

Ephedrine                                                                                  25,000 ng/ml

The following Phencyclidine-related substances yield positive results for Phencyclidine:

N-Acetylprocainamide                                                   10,000 ng/ml

Codeine                                                                        5,000 ng/ml

 p-Hydroxymethamphetamine                                          50,000 ng/ml

Thebaine                                                                      10,000 ng/ml

1-(1-phenylcyclohexyl)-morphine                                      600 ng/ml

N,N-Diethyl-1-phenyl-Cyclohexylamine                              2.0 ng/ml

1-[1-(2-Thienyl)cyclohexyl]-morphine                                 200 ng/ml

The following Marijuana-related substances yield positive results for Marijuana:

11-Nor-D 8-THC-9-COOH           50ng/ml 11-Nor-D 9-THC-9-COOH           50 ng/ml D-8-THC                                      1 mg/ml

D-9-THC                                       4 mg/ml Cannabinol                                10 mg/ml 11-hydroxy-D 9-THC                   10 mg/ml

 

The following Amphetamine-related substances yield positive results for Amphetamine:

d-Amphetamine                    1000 ng/mll Amphetamine                         25,000 ng/ml d,l-Amphetamine                   1000 ng/ml (+)Phenylpropanolamine         50,000 ng/ml B -Phenylthylamine                90,000 ng/ml

Thyramine                             100,000 ng/ml (±) 3,4-Methylenediox                600 ng/ml Amphetamine (MDA)                                 Psuedoephedrine                  100,000 ng/ml Ephedrine                          250,000 ng/ml

The following Cocaine-related substances yield positive results for Cocaine:

Benzoylecgonine                   300 ng/ml

Cocaine                                300 ng/ml

Isoxsurpine                          1,500 ng/ml

The following Benzodiazepine-related substances yield positive results for Benzodiazepine:

 

Alphahydroxyaltriazolam              200 ng/ml Alprazolam                                  62.5 ng/ml Bromazepam                              250 ng/ml Clobazam                                   2,500 ng/ml Clorazepate                              50 ng/ml Diazepam                                   50 ng/ml Desmethyldiazepam                  50 ng/ml Flunitrazepam                         250 ng/ml Flurazepam                               100 ng/ml

Lorazepam                               250 ng/ml Lormetazepam                         250 ng/ml Medazepam                            1,000 ng/ml Nitrazepam                              250 ng/ml Nordiazepam                           200 ng/ml Oxazepam                               300 ng/ml Prazepam                               100 ng/ml Temazepam                            200 ng/ml Triazolam                               500 ng/ml

The following Barbiturates-related substances yield positive results for Barbiturates:

Secobarbital                       200 ng/ml            Pentobarbital                                       200 ng/ml

Amobarbital                       200 ng/ml            Bromocriptine                                        200 ng/ml

Barbital                               200 ng/ml           Clean Jane                                          260 ng/ml

Butabarbital                      200 ng/ml                (sodium dodecylsulfate)                                         

Phenobarbital                       200 ng/ml             Zoloft                                              200 ng/ml

The following Methadone-related substances yield positive results for Methadone:

Methadone                               300 ng/ml Doxylamine                            10,000 ng/ml Laam                                      10,000 ng/ml n-methyldiethanolamine        50,000 ng/ml Pentazocaine                         50,000 ng/ml

Tetrahydrozoline                    50,000 ng/ml Dextromethorpham              100,000 ng/ml Diphenhydromine                100,000 ng/ml Leuorphanol                         100,000 ng/ml Promethizine                        100,000 ng/ml

 

Table II: Compounds tested and found not to cross-react with the test at a 10mg/ml concentration in urine.

 

The following compounds do not cross-react with Methamphetamine: 

Acetylsalicylic Acid Amikacin Amitriptyline Ampicillan Arterenol Aspartame Atropine Sulfate Benzoic Acid Benzoylecgonine HCl Caffeine Chlorpheniramine Chlorpropmazine HCl Cimetidine Codeine Deoxyephedrine Dextromethorphan Diazepam Diethylpropion Dephenylhydantoin Doxylamine

Ecgonine HCl Ecgonine Methyl Ester Glucose Histamine Hydrocodone Hydromorphone Indomathacin Ketoprofen Levorphanol D 9-TC 11-nor-D-9-carboxy-THC-9-COOH Meperdine Methylphenidate Methadone Methaqualone Morp. Glucuronide Morphine Sulfate Oxazepam Oxycodone

Pendimetrazine Penicillin G Pentobarbital d-Propoxyphene-  Hydrochlorthiazide Propanol Phencyclidine Phenobarbital Phentermine Phenylpropanolamine L-Phenylephrine Quinine Ranitidine Sodium Salicylate Tryptophan                Ecgonine Methyl Ester Tetracycline Tetrahydrozoline Theophylline Thioridazine Triflouperazine           Glucose

       The following compounds do not cross-react with Opiates:

 

Acetaminophen Acetylsalicylic Acid Amikacin Amitriptyline Ampicillin Arterenol Aspartame Atropine Sulfate Benzoic Acid Benzoylecgonine HCl Caffeine Chlorpheniramine Chlorpropmazine HCl Cimetidine Deoxyephedrine Dextromethorphan Diazepam Diethylpropion

Diphenylhydantoin Doxylamine Ecgonine HCl Ecgonine Methyl Ester Glucose Histamine Indomathacin Ketoprofen Levorphanol D - 9 THC 11-nor-D-9-carboxy-THC-9-COOH Methylphenidate Methadone Methaqualone Morphine Sulfate Oxazepam Pendimetrazine

Penicillin G Pentobarbital d-Propoxyphene-  Hydrochlorothiazide Propanol Phencyclidine Phenobarbital Phentermine Phenylpropanolamine L-Phenylephrine Quinine Sodium Salicylate Tryptophan Tetracycline Tetrahydrozoline Theophylline Thioridazine Trifluoperazine

 

The following compounds do not cross-react with Phencyclidine:

 

Acetaminophen Acetylsalicyclic Acid Amikacin Amitriptyline Ampicillin Arterenol Aspartame Atropine Sulfate Benzoic Acid Benzoylecgonine HCl Caffeine Chlorpheniramine Chlorpropmazine HCl Cimetidine Deoxyephedrine Dextromethorphan Diazepam Diethylpropion Diphenylhydantion

Doxylamine Ecgonine HC1 Ecgonine Methyl Ester Glucose Histamine Hydrocodone Hydromorphone Indomathacin Ketoprofen Levorphanol D -9-THC 11-nor-D -9-carboxy-THC-9 COOH Meperidine Methylphenidate Methadone Methaqualone Morp. Glucoronide Morphine Sulfate Oxazepam

Oxycodone Pendimetrazine Penicillin G d-Propoxyphene Hydrochlorothiazide Propanol Phentermine Phenylpropanolamine L-Phenylephrine Quinine Ranitidine Sodium Salicyclate Tryptophan Tetracycline Tetrahydrozoline Theophylline Thioridazine Trifluoperazine

 

 

The following compounds do not cross-react with Amphetamine:

 

Acetaminophen           Acetylsaclicylic Acid Amikacin Amitriptyline Arterenol Aspartame Atropine Sulfate Benzoic Acid Benzoylecgonine HCl Caffeine Chlorpheniramine Chlorpropmazine HCl Cimetidine Codeine Deoxyephedrine Dextromethorphan Diazepam Diethylpropion

Diphenylhydantoin Doxylamine Ecgonine HCl Ecgonine Methyl Ester Glucose Histamine Hydrocodone Hydromorphone Indomathacin Ketoprofen Levorphanol D -9-THC 11-nor-D-9-carboxy-THC-9-COOH Meperidine Methylphenidate Methadone Methaqalone Morp. Glucuronide Morphine Sulfate Oxazepam

Oxycodone Pendimetrazine Penicillin G Pentobarbital d-Propoxyphene Hydrochlorothiazide Propanol Phencyclidine Phenobarbital Phentermine Phenylpropanolamine L-Phenylephrine Quinine Ranitidine Sodium Salicylate Tryptophan Tetracycline Tetrahydrozoline Theophylline Thioridazine Trifluoperazine

 

The following compounds do not cross-react with Cocaine:

 

Acetaminophen Actylsalicylic Acid Amikacin Amitriptyline Ampicillin Arterenol Aspartame Atropine Sulfate Benzoic Acid Benzoylecgonine HCl Caffeine Chlorpheniramine Chlorpropmazine HCl Cimetidine Codeine Deoxyephedrine Dextromethorphan Diazepam Hydromorphon Indomathacin

Ketoprofen Levorphanol D -9-THC Diethylpropion Dephenylhydantoin Doxylamine Ecgonine HCl Ecgonine Methyl Ester Glucose Histamine Hydrocodone 11-nor-D -9-carboxy-THC-9-COOH Meperidine Methylphenidate Methadone Methaqualone Morp. Glucuronide Morphine Sulfate Oxazepam

Oxycodone Pendimetrazine Penicillin G Pentobarbital d-Propoxyphene Hydro- chlorothiazide Propanol Phencyclidine Phenobarbital Phentermine Phenylpropanolamine L-Phenylephrine Quinine Ranitidine Sodium Salicylate Tryptophan Tetrahydrozoline Theophylline Thioridazine Trifluoperazine

 

The following compounds do not cross-react with Marijuana:

 

Acetaminophen 4-Acetamidophenol Acetylsalicyclic acid Amikacin Ampicillin d,l-Amphetamine Amitriptyline Arterenol Aspartame Atropine sulfate Benzoic Acid Benzoylecgonine        Caffeine Camphor Chloroquine Chlorpheniramine Chlorpromazine HCl Cocaine Hydrochloride Cocaine Cimetidine Cortisone Deoxyepinophrine Dextromethorphan

Diazepam Digitoxin Digoxin Ecgonine Hydrochloride Ecgonine Methyl Ester Ephedrine Epinephrine Gentisic acid Glucose Guaiacol Histamine Hydrochlorothiazide Hydrocodone Hydromorphone Homatropine Imipramine Isoproterenol Ketamine Lidocaine d-Methamphetamine Meperidine Methadone Methaqualone Methylpehnidate

Morphine glucuronide Morphine sulfate Morphine Naloxone Neomycin Niacinamide Oxazepam Perphenazine Penicillin G Phencyclidine Phenobarbital Phenylethylamine-a Phenylpropanolamine Promethazine Pseudophedrine Rantidine Salycyclic acid Secobarbital Tetracycline Tetrahydrozoline Theophylline Thiridazine Triflouperazine Tryptophan

 

 The following compounds do not cross-react with Barbiturates:

Acetaminophen Acetylsalicyclic Acid Amikacin Amitriptyline Ampicillin Arterenol Aspartame Atropine Sulfate Benzoic Acid Benzoic Acid Benzoylecgonine HCl Caffeine Chlorpheniramine Chlorpropmazine HCl Cimetidine Codeine Deoxyephedrine Dextromethorphan Diazepam Diethylpropion

Diphenylhydantoin Doxylamine Ecgonine HCl Ecgonine Methyl Ester Glucose Histamine Hydrocodone Hydromorphone Indomathacin Ketoprofen Levorphanol D-9-THC 11-nor-D-9-carboxy-THC-9-COOH Meperidine Methylphenidate Methadone Methaqualone Morp. Glucuronide Morphine Sulfate

Oxazepam Oxycodone Pendimetrazine Penicillin G d-Propoxyphene Hydrochlorothiazide Propanol Phencyclidine Phentermine Phenylpropanolamine L-Phenylephrine Quinine Ranitidine Sodium Salicylate Tryptophan Tetracycline Tetrahydrozoline Theophylline Thioridazine Trifluoperazine

 

The following compounds do not cross-react with Benzodiazepines:

Acetaminophen Acetylsalicyclic Acid Amikacin Amitriptyline Ampicillin Arterenol Aspartame Atropine Sulfate Benzoic Acid Benzoylecgonine HCl Caffeine Chlorpheniramine Chlorpropmazine HCl Cimetidine Codeine Deoxyephedrine Dextromethorphan Diethylpropion Diphenylhydantoin Diazepam

Doxylamine Ecgonine HC1 Ecgonine Methyl Ester Glucose Histamine Hydrocodone Hydromorphone Indomathacin Ketoprofen Levorphanol D-9-THC 11-nor-D-9-carboxy-THC-9-COOH Meperidine Methylphenidate Methadone Methaqualone Morp. Glucoronide Morphine Sulfate Oxycodone

Pendimetrazine Penicillin G Pentobarbital d-Propoxyphene Hydrochlorothiazide Propanol Phencyclidine Phenobarbital Phentermine Phenylpropanolamine L-Phenylephrine Quinine Ranitidine Sodium Salicyclate Tryptophan Tetracycline Tetrahydrozoline Theophylline Thioridazine Trifluoperazine

 

The following compounds do not cross-react with Methadone:

4-Acetamidophenol Acetophenetidin N-Acetylprocainamide Acetylsalicylic acid Alphenol Alprazolam Amitryptyline Amobarbital Amoxicillin l-Amphetamine d,l-Amphetamine Ampicillin Apomorphine Aprobarbital ASP-PHE Methyl Ester Atropine Barbital Acid Benzoic Acid Benzoylecgonine Benzphetamine Bromazepam Butabarbital Butalbital Cannabidiol Clonazepam Chloral Hydrate Chlorazepate Chlordiazepoxide Chlorothiazide Chlorpromazine Chloroquine Cholesterol Clobazem Clomipramine Clonazepan Clonidine Cocaine Codeine Cortisone  (-) Cotinine CreatinineDesmethyldiazepam Deoxycorticosterone Diazepam Diclofenac	Diflunisal Digoxin 4-(Dimethylamino)antipyrine DL Glutethinide Doxepin (+) Ephedrine (±) Ephedrine (­-) y-Ephedrine (-) Ephedrine Erythromycin b-Estradiol Estrone-3-sulfate Ethyl-p-Aminobenzoate Flunitrazepam Flurazepam Furosemide Gentisic acid Guaiacol Glyceryl Ester Carbonate Glucuronic acid 5-Hydroxytryptamine Hyppuric acid Hydralazine Hydrochlorothiazide Hydrocodone Hydrocotisone O-Hydromorphone Hydroxyhippuric acid pHydroxymethamphetamine 3-Hydroxytyramine Ibuprofen Imipromine (-) Isoproterenol Iproniazid Isoxsuprine Ketamine Ketoprofen Labetalol Lidocaine Loperamide Lorazepam Lormetazepam Maprotiline Medazepam Meperidine		Meprobamate Methaqualone s) 6-Methoxy-a-Methyl-2- Naphthaleneacetic acid Methylphenidate Methyprylon Morphine-3-b-D-glucuronide (±) 3,4-Methylenedioxy Methamphetamine (±) 3,4-Methylenedioxy Amphetamine Methoxyphenamine Nalidixic acid Nalorphine Naloxone Naltrexone Niacinamide Nifedipine Nitrazepam Norcodeine Norethindrone d-Norpropoxyphene Noscapine Nylidrin d,l-Octopamine Oxalic acid Tetrahydrocortisone Thebaine Thiamine (+) Thiopental Thioridazine d,1-Thyroxine Tolbutamide Triamterene Triazolam Trifluoperazine Trimethoprim Trimipramine Tryptamine d,1-Tryptophan Tyramine d,1-Tyrosine Uric acid Verapamil Zomepirac
11-Nor-D 8-THC-9-COOH           50ng/ml 11-Nor-D 9-THC-9-COOH           50 ng/ml D-8-THC                                      1 mg/ml		D-9-THC                          4 mg/ml Cannabinol                      10 mg/ml 11-hydroxy-D 9-THC               10 mg/ml

 

3.        Accuracy:  The accuracy of the Multi-drug Multi-drug Strip Testwas first tested in urine samples in-house and subsequently in a clinical trial of urine samples submitted to a NIDA certified laboratory. In both cases the laboratories used EMIT II as their screening procedure. All positive samples by either screening method were confirmed by GC/MS. The data was combined and the results are summarized as follows:

 

        3.1   Phencyclidine   (PCP)

                                    Syva EMIT II Positive   Syva EMIT II Negative

        StripPositive               223                        0

        Strip Negative                0                     290

        When compared to EMIT II the relative sensitivity between positive samples was 100%. The relative specificity between negative samples was 100%. The concordance of the combined data with respect to EMIT II was 100%.

       

        3.2   Marijuana   (THC)

                                      Syva EMIT II Positive   Syva EMIT II Negative

        StripPositive               297                        4

        StripNegative                4                      259

When compared to EMIT II the relative sensitivity between positive samples was 98.67%. The relative specificity between negative samples was 98.48%. The concordance of the combined data with respect to EMIT II was 98.58%.

                   

        3.3      Barbiturate  (BAR)

                                          Syva EMIT II Positive   Syva EMIT II Negative

        Strip Positive               185                                    2

        Strip Negative                0                                    335

When compared to EMIT II the relative sensitivity between positive samples was 100%. The relative specificity between negative samples was 99.41%. The concordance of the combined data with respect to EMIT II was 99.62%.

 

        3.4    Benzodiazepine (BZD)

                  Syva EMIT II Positive   Syva EMIT II Negative

        Strip Positive               210                       0

        Strip Negative                9                     221

When compared to EMIT II the relative sensitivity between positive samples was 95.9%. The relative specificity between negative samples was 100%. The concordance of the combined data with respect to EMIT II was 97.95%.

 

        3.5      Cocaine  (BEG)

                  Syva EMIT II Positive   Syva EMIT II Negative

        Strip Positive               194                       1

        Strip Negative                0                     212

        When compared to EMIT II the relative sensitivity between positive samples was 100%. The relative specificity between negative samples was 99.55%. The concordance of the combined data with respect to EMIT II was 99.75%.

 

        3.6      Methamphetamine  (MET)

                     Syva EMIT II Positive   Syva EMIT II Negative

        Strip Positive               179                       14

        Strip Negative                0                      262

        When compared to EMIT II the relative sensitivity between positive samples was 100%. The relative specificity between negative samples was 94.9%. The concordance of the combined data with respect to EMIT II was 96.92%.

 

        3.7      Opiates  (OPI)

                                       Syva EMIT II Positive   Syva EMIT II Negative

        Strip Positive               172                        0

        Strip Negative                0                      190

        When compared to EMIT II the relative sensitivity  between  positive samples was 100% . The relative specificity between negative samples was 100%. The concordance of the combined data with respect to EMIT II was 100%.

        3.8      Amphetamine  (AMP)

                    Syva EMIT II Positive   Syva EMIT II Negative

        Strip Positive               188                       1

        Strip Negative                0                     340

        When compared to EMIT II the relative sensitivity between positive samples was 100%. The relative specificity between negative samples was 99.7%. The concordance of the combined data with respect to EMIT II was 99.8%.

 

        3.9      Methadone  (MAD)

                   Syva EMIT II Positive   Syva EMIT II Negative

        Strip Positive                32                       0

        Strip Negative                0                      78

When compared to EMIT II the relative sensitivity between positive samples was 100%. The relative specificity between negative samples was 100%. The concordance of the combined data with respect to EMIT II was 100%.

Note: The above data for Methadone reflects the results of in-house urine sample testing only.

 

Bibliography

General

1.     Baselt, R.C., Disposition of Toxic Drugs and Chemicals in Man, 2nd Ed., Biomedical  Publ.,  Davis, CA, p.488 (1982).

2.     Cody, J.T., Schwarzhoff, R., J. Anal. Toxicol., 17: 2630 (1993).

3.     Urine Testing for Drugs of Abuse, NIDA Research Monograph 73, (1986).

4.     Dasguspta, A., Saldana, S., Kinnaman, G., Smith M., Johansen, K., Clin. Chem., 39(1): 104-108 (1993).

5.     Department of Health and Human Services, Fed. Regist., 53(69): 11970-11989 (1988),  (1989).

6.     FDA Guidence for Labeling Urine Drugs of Abuse Screening Testing, Kshitij Mohan, 7/21/1987.

 

Barbiturate Test

 

1.         Hoffmann, F.E. A Handbook of Drug and Alcohol Abuse: The Biomedical Aspects. Oxford University Press, New York, 1983.

2.         Wyngarrden, J.B., Smith, L.H. (eds.) Cecil Textbook of Medicine. W.B. Saunders Co., Philadelphia, 1988, pp. 53-54.

3.         Ellenhorn, M.J., Barceloux, D.J. Medical Toxicology. Elsevier Science Publishing Co., New York, 1988, pp. 575-580.

4.         Gorodetzky, Z.V. Detection of Drugs of Abuse in Biological Fluids. In: Martin, W.R. (ed.) Drug Addiction. I. Springer-Verlag, New York, 1977, pp. 319-409.

 

Opiate Test

1.         Huang, W., Andollo, W., Hearn W.L.J. Anal. Toxicol., 16: 307-310 (1992).

2.         Cone, E.J., Dickerson, S., Paul, B.D., Mitchell, J.M., J. Anal. Toxicol., 17: 156-164 (1993).

3.         Glare, P.A., Walsh, T.D., and Pippenger, C.E., Ther. Drug Monit., 13: 226-232 (1991).

4.         Walsh, T.D., Cheater, F.M., Pharm. J., 10: 525-527 (1983).

5.         Mitchell, J.M., Paul, B.D., Welch, P., Cone, E.J. J. Anal. Toxicol., 15: 49-53 (1991).

 

Methamphetamine/Amphetamine Test

 1.         Ellerbe, P., Long, T.,Welch, M.J., J. Anal. Toxicol., 17: 165-170 (1993). PCP Test

2.         Froelich, P.E., Gross, G.: Separation and Detection of Phencyclidine in Urine by Gas Chromatography. J. Chromatograph 1977;137;135-143.

3.         Gupta R.C. et al: Determination of Phencyclidine in Urine and Illicit Street Drug Samples.Clin. Toxicol 1975; 8:611-621.

4.        Oellerich, M.: Enzyme Immunoassays In Clinical Chemistry:Present Status and Trends. J. Clin. Chem. Biochem., 1980;18:197-208.

5.         Anilineo, Pitts, F.N.: Phencyclidine (PCP): A Review and Perspectives. CRC Crit. Rev. Toxicol 1982;10:145-177.

 

Marijuana Test

 1.         Johansson, E., Gillespie, H.K., Halldin, M.M. J. Anal. Toxicol., 14: 176-180 (1990).

2.         El Sohly, M.A., Jones, A.B., El Sohly, H.N. J. Anal. Toxicol., 14: 277-279 (1990)14: 227-279 (1990).

3.         Foltz, R.L., Sunshine, I.J. Anal. Toxicol., 14: 375-378 (1990).

4.         Wimbish, G.H., Johnson, K.D. J. Anal. Toxicol., 14: 292-295 (1990).

5.         Nakamura, G.R., Meeks, R.D., Stall, W.J. J. Forensic Sci., 35(4): 792-796 (1990).

6.         Jenkins, A.J., Mills, L.C., Darwin, W.D., Huestis, M.A., Cone, E.J., Mitchell, J.M. J. Anal. Toxicol., 17: 292-298 (1993).

6.         Hollister, L.E., Kanter, S.L., Board, R.D., Green D.E. Res. Com. Chem. Pathol. Pharmacol., 8: 579-584 (1974).

 

Cocaine Test

1.         D.W. Hoyt et al. J. Am. Med. Assoc., Vol. 258 (1987), pp. 504-509.

2.         R.R. MacGregor, J.S. Fowler, and A.P. Wolf. J. of Chromatography, Vol. 590 (1992), pp. 354-58.

3.         E.J. Cone, D. Yousefnejad, and S.L. Dickerson.  J. of Forensic Sciences, Vol. 35, No.4 (1990), pp. 786-91.

4.         E.J. Cone et al. J. of Forensic Sciences, Vol. 34, No. 1 (1989), pp. 15-31.

5.         B. Holmstedt and A. Fredga. J. of Ethnopharmacology, Vol. 3 (1981), pp. 113-47.

6.         T. Inaba and J. Can. Physiol. Pharmacol., Vol. 67 (1989), pp. 1154-57          

7.         A.R. Jeffcoat et al. Drug Metabolism and Disposition, Vol. 17, No. 2 (1989), pp. 153-59.

8.         R.C. Baselt and R. Chang. J. Anal. Toxicol., Vol. 11 (1987), pp. 81-82.

 

Benzodiazepine Test

 

1.         S.J., Mule and G.A. Gasella.  "Quantitation and Confirmation of the Diazolo and Ttazolobenzodiazepines in  Human Urine by GC/MS," J. Anal. Toxicol., Vol. 13 (1989), pp. 179-184.

2.         C. Drouet-Coassolo, C. Aubert, P. Coassolo, and J. Cano. "Capillary GC/MS Method for the Identification and qualification of some Benzodiazepines and Their Unconjugated Metabolites in Plasma," J. Chromatogr., Vol. 487 (1989), pp. 295-311.

3.         C. Ballanto, V. Reggi, G. Tognoni, et al. "Benzodiazepines: Clinical Pharmacology and Therapeutic Use, " Drugs, Vol. 19 (1980): 195-219.

4.         A.J. Giannini and E.A. Slaby.  Drugs of Abuse (MEDEC Books: 1989), Ch. 4, pp. 59-80.

 

5.         M.A. Pear and L. Kopjak, "The Screening and Quantitation of Diazepam, Flurazepam, Chlordiazepoxide, and Their Metabolites in Blood and Plasma by Electron-Capture Gas Chromatography and High Pressure Liquid Chromatography," J. Forensic Sci., Vol. 24(1979) pp. 46-54.

6.         H. Schultz, "Modern Screening Strategies in Analytical Toxicology with Special Regard to New Benzodiazepines," J. Legal. Med., Vol. 100 (1988) pp. 19-37.

7.         J.G. Langner, B.K. Gan, R.H. Liu, L.D. Baugh, P. Chand, J.L. Weng, et. al. "Enzymatic Digestion, Solid Phase Extraction, and GC/MS of Derivatized Intact Oxazepam in Urine," Clin. Chem., Vol. 37 (1991)  pp.1596-1601.

8.         R.L. Fitzgerald, D.A. Rexin, and D.A. Herold.  "Benzodiazepine Analysis by Negative Chemical Ionization GC/MS," J. Anal. Toxicol., Vol. 17, pp. 342-347.

 

Methadone Test

 

1.         B.J. Rounsaville, M.M. Weissman, P.H. Rosenberger, et.al. "Diagnosis and Symptoms of Depression in Opiate Addicts: Course and Relationship to Treatment Outcome", Arch. Gen. Psychiatry 39 (1982): 151-56.

2.         B.J. Rounsaville and H.D. Kleber, "Psychiatric Disorders and the Course of Diagnostic Stability", in S.M. Mirin,  e.d., Substance Abuse and Psychopathology (American Psychiatric Press, Washington, D.C., 1984):134-51.

3.         C.A. Dackis and M.S. Gold. "Depression in Opiate Addicts," ibid, pp. 20-40.

4.         J.B. Wyngarrden, LH Jr., eds., Cecil Textbook of Medicine (WB Saunders Co.: Philadelphia, 1988), pp. 57 and  60.

5.         M.J. Ellenhorn and D.G. Barceloux. Medical Toxicology (Elsevier Science Publishing Co., Inc., NY, 1988), pp. 714-18.

 

Phencyclidine (PCP) Test

1.         Froelich, P.E., Gross, G.: Separation and Detection of Phencyclidine in Urine by Gas Chromatography. J. Chromatograph 1977; 137;135-143.

2.         Gupta R.C. et al: Determination of Phencyclidine in Urine and Illicit Street Drug Samples. Clin. Toxicol 1975; 8:611-621.

3.         Oellerich, M.: Enzyme Immunoassays In Clinical Chemistry: Present Status and Trends. J. Clin. Chem. Biochem., 1980;18:197-208.

4.         Anilineo, Pitts, F.N.: Phencyclidine (PCP): A Review and Perspectives. CRC Crit. Rev. Toxicol 1982;10:145-177.