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 Five Drug Screen test

 

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 six 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.            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                                      300 ng/ml

Morphine-3-b-D-Glucuronide    300 ng/ml

Codeine                                      300 ng/ml

Heroin                                       300 ng/ml

Norcodeine                               2,000 ng/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           50 ng/ml

11-Nor-D 9-THC-9-COOH           50 ng/ml

D-8-THC                                      1 mg/ml

D-9THC                           4 mg/ml

Cannabinol                      10mg/ml

11-hydroxy-D 9-THC        10mg/ml

 

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

 

d-Amphetamine  1000ng/mll

Amphetamine      25,000ng/ml

d,l-Amphetamine  1000 ng/ml

(+)Phenylpropanolamine            50,000 ng/ml

B -Phenylthylamine          90,000 ng/ml

Thyramine                          100,000ng/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    200ng/ml

Alprazolam                        62.5 ng/ml

Bromazepam                    250 ng/ml

Clobazam                        2,500ng/ml

Clorazepate                     50 ng/ml

Diazepam                        50 ng/ml

Desmethyldiazepam        50 ng/ml

Flunitrazepam                25ng/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                               300ng/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

                                 

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

dPropoxyphene-

 Hydrochlorothiazide

Propanol

Phencyclidine

Phenobarbital

Phentermine

Phenylpropanolamine

LPhenylephrine

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

Acetylsalicylicacid

Alphenol

Alprazolam

Amitryptyline

Amobarbital

Amoxicillin

l-Amphetamine

d,l-Amphetamine

Ampicillin

Apomorphine

Aprobarbital

ASP-PHEMethylEster

Atropine

BarbitalAcid

BenzoicAcid

Benzoylecgonine

Benzphetamine

Bromazepam

Butabarbital

Butalbital

Cannabidiol

Clonazepam

ChloralHydrate

Chlorazepate

Chlordiazepoxide

Chlorothiazide

Chlorpromazine

Chloroquine

Cholesterol

Clobazem

Clomipramine

Clonazepan

Clonidine

Cocaine

Codeine

Cortisone

(-)Cotinine

Creatinine

Desmethyldiazepam

Deoxycorticosterone

Diazepam

Diclofenac

 

Diflunisal

Digoxin

4-(Dimethylamino)antipyrine

DLGlutethinide

Doxepin

(+)Ephedrine

(±)Ephedrine

(­-)y-Ephedrine

(-)Ephedrine

Erythromycin

b-Estradiol

Estrone-3-sulfate

Ethyl-p-Aminobenzoate

Flunitrazepam

Flurazepam

Furosemide

Gentisicacid

GuaiacolGlyceryl

EsterCarbonate

Glucuronicacid

5-Hydroxytryptamine

Hyppuricacid

Hydralazine

Hydrochlorothiazide

Hydrocodone

Hydrocotisone

O-Hydromorphone

Hydroxyhippuricacid

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-

Naphthaleneaceticacid

Methylphenidate

Methyprylon

Morphine-3-b-D-glucuronide

(±)3,4-Methylenedioxy

Methamphetamine

(±)3,4-Methylenedioxy

Amphetamine

Methoxyphenamine

Nalidixicacid

Nalorphine

Naloxone

Naltrexone

Niacinamide

Nifedipine

Nitrazepam

Norcodeine

Norethindrone

d-Norpropoxyphene

Noscapine

Nylidrin

d,l-Octopamine

Oxalicacid

Tetrahydrocortisone

Thebaine

Thiamine

(+)Thiopental

Thioridazine

d,1-Thyroxine

Tolbutamide

Triamterene

Triazolam

Trifluoperazine

Trimethoprim

Trimipramine

Tryptamine

d,1-Tryptophan

Tyramine

d,1-Tyrosine

Uricacid

Verapamil

Zomepirac

AcetylsalicylicAcid

Amikacin

Amitriptyline

Ampicillan

Arterenol

Aspartame

AtropineSulfate

BenzoicAcid

BenzoylecgonineHCl

Caffeine

Chlorpheniramine

ChlorpropmazineHCl

Cimetidine

Codeine

Deoxyephedrine

Dextromethorphan

Diazepam

Diethylpropion

Dephenylhydantoin

Doxylamine

EcgonineHCl

EcgonineMethylEster

Glucose

Histamine

Hydrocodone

Hydromorphone

Indomathacin

Ketoprofen

Levorphanol

D9-TC

11-nor-D-9-carboxy-THC-9-COOH

Meperdine

Methylphenidate

Methadone

Methaqualone

Morp.Glucuronide

MorphineSulfate

Oxazepam

Oxycodone

Pendimetrazine

PenicillinG

Pentobarbital

d-Propoxyphene-

Hydrochlorthiazide

Propanol

Phencyclidine

Phenobarbital

Phentermine

Phenylpropanolamine

L-Phenylephrine

Quinine

Ranitidine

SodiumSalicylate

TryptophanEcgonineMethylEster

Tetracycline

Tetrahydrozoline

Theophylline

Thioridazine\

Triflouperazine

 

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.