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  Six Drug Screen test

  (MAD, MOR, THC, AMP, COC, BZD)

　

INTENDED USE

The OneStep 6-Drug Screen Test is a immuno-chromatographic assay for rapid, qualitative detection of the following drugs and their principal metabolites in urine at the specified cut-off concentrations:

　

TEST ZONE                    DRUG CLASS                                                                      SENSITIVITY                                         

          1                             Methadone                                                                          300 ng/ml

          2                             Opiates/Morphine                                                             300 ng/ml

          3                             Marijuana/Tetrahydrocannabinol                        50 ng/ml

          4                             Amphetamine                                                                      1000 ng/ml

          5                             Cocaine/Benzoylecgonine                                         300 ng/ml

          6                             Benzodiazepine                                                                  300 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 professionl 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 OneStep 6-Drug Screen 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 Methadone, Morphine, Marijuana, Amphetamine, Cocaine, Benzodiazepines 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.  Cocaine, marijuana, amphetamines, and morphine are the most frequently abused illicit drugs, according to the U.S. Substance Abuse and Mental Health Services Administration.  Benzodiazepines and opiates are also among a class of heavily abused prescription drugs.  The opiates detectable by this test include illicit opiates as well as components of common antidepressants, cough and anti-diarrheal medications.

The sensitivity of the OneStep 6-Drug Screen Test is set at 300 ng/ml for Methadone, 300 ng/ml for Morphine, 50 ng/ml for Marijuana, 1000 ng/ml for Amphetamine, 300 ng/ml for Cocaine, and 300 ng/ml for Benzodiazepines.

 

principle of the test

The OneStep 6-Drug Screen Test is a competitive binding immunoassay in which drug and drug metabolites in a urine sample compete with chemically labeled drug compounds for limited 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 10 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 appropiate Test Zone (marked “1 - 6”) for that drug. Conversely, when the drug level is at or above the detection limit, free drug competes with the 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 and 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. 

2.     Transfer Pipettes.                 Individually sealed in foil

pouch with test device.  

3.     Test Instructions.                

       Optional

4.    Urine Cups                   

5.    Negative Control                    Contains 1 ml of buffered

protein solution with sodium azide.                             

6.    Methadone Positive Control.           Contains 1 ml of MAD 1000

ng/ml in a buffered protein solution with sodium azide. 

7.    Morphine Positive Control              Contains 1 ml of MOR 1000

ng/ml in a buffered protein solution with sodium azide. 

8.    Marijuana (THC) Positive Control  Contains 1 ml of THC 150

ng/ml in a buffered protein solution with sodium azide. 

9.    AMP Positive Control           Contains 1 ml of AMP 3000

ng/ml in a buffered protein solution with sodium azide. 

10.    COC Positive Control          Contains 1 ml of COC 1000

ng/ml in a buffered protein solution with sodium azide. 

11.    BZD Positive Control          Contains 1 ml of BZD 1000

ng/ml in a buffered protein solution with sodium azide.  

 

MATERIALS REQUIRED BUT NOT PROVIDED

1.     Clock or timer.

 

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, discard the device.

 

Test procedure

1.     Bring patient samples and kit components to room temperature (15 - 28 °C).

2.     Remove a Test Cassette from the foil pouch and place it on a level surface.  Discard the pouch and dessicant.

3.     Holding the transfer pipette vertically, add 6 drops of urine to the sample well.

Note:  For optimal performance, allow each drop to be completely absorbed before adding the next.

4.   Wait 10 minutes and read the result.  

 

INTERPRETATION OF RESULTS

　

Important:  Two control lines are necessary in order to validate test results. If a rose-pink color band fails to appear in one or both Control Zones ("C"), discard the cassette and retest the sample using a new device.

       

    EXAMPLE

  (Actual test results may vary)

          POSITIVE                      INVALID

           MAD, MOR, THC

           NEGATIVE

         AMP, COC, BZD

  

Positive:  A rose-pink band is visible in each control zone. No color band

appearing in the appropiate 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 appropiate test zone, indicates that the concentration of the corresponding drug in that specific test zone is below the detection limit of the test.

Invalid:  If a color band is not visible in either or both 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 methadone, opiates, marijuana, amphetamine, cocaine and benzodiazepines 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 the 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 OneStep 6-Drug Screen Test detects methadone, morphine, marijuana, amphetamine, cocaine,  benzodiazepine and their major metabolites in  urine at concentrations equal to or greater than 300 ng/ml for methadone, opiate, cocaine, and benzodiazepine, 1000 ng/ml for amphetamine, and 50 ng/ml for marijuana.

2.     Specificity.  A study was conducted with the OneStep 6-Drug Screen 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 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

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

Morphine-3-b-D-Glucuronide               300 ng/ml Codeine                                             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                           5,000 ng/ml Thebaine                           1,500 ng/ml Naltrexone                        5,000 ng/ml Imipramine                        50,000 ng/ml Atropine                             100,000 ng/ml Meperidine                         100,000 ng/ml Ranitidine                           100,000 ng/ml

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

11-Nor-D -8-Tetrahydrocannabinol                                    50 ng/ml 11-Nor-D -9-Tetrahydrocannabinol                                  500 ng/ml D -9- Tetrahydrocannabinol                                       20,000 ng/ml Cannabinol                                                                 50,000 ng/ml Diflunisal                                                                   100,000 ng/ml

The following Amphetamine-related substances yield positive results for

Amphetamine:

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

Thyramine                                100,000 ng/ml (+)3,4-Methylenedio      xyamphetamine(MDA)         1,000 ng/ml Psuedoephedrine                       100,000 ng/ml Ephedrine                               250,000 ng/ml

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

Benzoylecgonine                                     300ng/ml Cocaine                                                  300 ng/ml Isoxsurpine                                           1,500 ng/ml

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

 

Alprazolam                          62.5 ng/ml Bromazepam                       250 ng/ml Clobazam                           2,500 ng/ml Chlordiazepoxide               2,500 ng/ml Clorazepate                          50 ng/ml Clonazepam                       500 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 Oxazepam                         250 ng/ml Prazepam                          100 ng/ml Temazepam                       100 ng/ml Triazolam                          100 ng/ml

Table II: Compounds tested and found not to cross-react with the test

N-Acetylprocainamide         200 mg/ml Acetylsalicylic acid               300 mg/ml Amitryptyline                        100 mg/ml Amobarbital                         100 mg/ml Amoxicillin                           130 mg/ml l-Amphetamine                  100 mg/ml Apomorphine                       100 mg/ml ASP-PHE Methyl Ester        100 mg/ml Benzilic Acid                        300 mg/ml Benzoic Acid                         280 mg/ml Benzphetamine                  100 mg/ml Chlorothiazide                    320 mg/ml Chlorpromazine                 100 mg/ml Cholesterol                          160  mg/ml Clomipramine                   230 mg/ml Clonidine                           100 mg/ml Cortisone                          120 mg/ml (-) Cotinine                        100 mg/ml Creatinine                         190 mg/ml Deoxycorticosterone         170 mg/ml Ibuprofen                          100 mg/ml  (-) Isoproteronol                 120 mg/ml Iproniazid                             120 mg/ml Isoxsuprine                        130 mg/ml Ketamine                           130 mg/ml Ketoprofen                         140 mg/ml Labetalol                         100 mg/ml Lidocaine                          100 mg/ml Loperamide                        150 mg/ml Niacinamide                       170 mg/ml

Difclofenac                                      100 mg/ml Diflunisal                                          100 mg/ml Digoxin                                            150 mg/ml Diphenhydramine                            200 mg/ml -Dimethylamoantipyrine                 100 mg/ml (+) Ephedrine                                  130 mg/ml (+) Ephedrine                                  160 mg/ml d-y-Ephedrine                                 290 mg/ml Emg/mlrythromycin                         150 mg/ml b-Estradiol                                       110 mg/ml Estrone-3-sulfate                             100 mg/ml Ethyl-p-aminobenzoate                   180 mg/ml Gentisic acid                                    200 mg/ml Guaiacol Glyceryl Ether Carbonate      226 mg/ml Glucuronic acid                                200 mg/ml 5-Hydroxytryptamine                      100 mg/ml Hippuric acid                                   200 mg/ml  Hydralazine                                   100 mg/ml Hydrochlorothiazide                        100 mg/ml 3-Hydroxytryamine                          160mg/ml Nifedipine                                         140 mg/ml Maprotiline                                      140 mg/ml Meprobamate                                  100 mg/ml Methaqualone                                  100 mg/ml (S)-6-methoxy-a-methyl-    2-naphthaleneacetic acid                 250 mg/ml Methylphenidate                              100 mg/ml Methyprylon                                    100 mg/ml Nalidixic acid                                   130 mg/ml

3.    Accuracy:  Approximately 55 positive specimens above the cut-off  concentration for each of the 6 specific drugs were evaluated using the , gas chromatography/mass spectrophotometry (GC/MS), and a commercially available enzyme immunoassay (EIA) for drug abuse.  More than 100 drug-free specimens were also evaluated. The results are presented in Table III below.

Table III:

Drug/MetabolitE	Syva EMIT EIA II	GC/MS	Strip
	(+/-)	(+/-)	(+/-)
MAD (Methadone)
> 300 ng/m	53/0	53/0	53/0
< 300 ng/ml	1/102	1/103	2/101
MOR (Morphine)
> 300 ng/ml	56/0	54/2	56/0
< 300 ng/ml	2/103	1/105	1/104
THC (Marijuana/TetrahydRocannabinol)
> 50 ng/ml	63/0	63/0	63/0
< 50 ng/ml	1/142	0/142	0/142
AMP (Amphetamine)
> 1000 ng/ml	49/0	48/1	49/0
< 1000 ng/ml	1/110	2/109	0/111
COC (Cocaine/Benzoylecgonine)
> 300 ng/ml	53/0	52/1	53/0
< 300 ng/ml	1/108	1/109	1/108
BZD (Benzodiazepine)
> 300 ng/ml	58/4	60/2	62/0
< 300 ng/ml	5/116	2/119	3/118

 

BIBLIOGRAPHY

Methadone Test

1.         Urine Testing for Drugs of Abuse, National Institute on Drug Abuse (NIDA), Research Monograph 73 (1986).

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

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

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

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

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

7.         D.S. Woolf.  "Opioids," in N. Bennett, C. Vourakis and D.S. Woolf, eds., (John Wiley & Sons: NY, 1983) pp. 70-85.

8.         F.E. Hofmann.  A Handbook on Drug and Alcohol Abuse: The Biomedical Aspects (Oxford University Press: NY, 1983).

9.         R.C. Baselt and R.H. Cravey, Disposition of Toxic Drugs and Chemicals in Man, ed.3 (Year Book Medical Publishers Inc.: Chicage, IL 1989), pp. 379-83.    

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).

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

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).

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

8.         Ferderal Register 53: 11970-11983 (1988).

Amphetamine Test

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

2.         Cody, J.T., Schwarzhoff, R., J. Anal. Toxicol., 17: 23-33 (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: 104-108 (1993).

5.         Department of Health and Human Services, Fed. Regist., 53(69): 11970-89 (1988).

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.

9.         Federal Register, Vol. 53, No. 69 (1988), pp. 11970-89.

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.