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MTD test Cassette
Description
A visual one-step immunoassay for the qualitative detection of Methadone in human urine. For in Vitro diagnostic use only
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Drug Screen MTD

One-Step Methadone Test

A visual one-step immunoassay for the qualitative detection of Methadone in human urine. For in Vitro diagnostic use only.

INTENDED USE

The Drug Screen MTD is a lateral flow, one-step immunoassay for the qualitative detection of methadone in human urine at a cut-off of 300 ng/ml. This product is used to obtain a visual, qualitative result and is intended for professional use. The assay should not be without proper supervision and is not intended for over the counter sale to lay persons.

This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry(GC/MS) has been established as the preferred confirmatory method by the National Institute on Drug Abuse (NIDA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

SUMMARY

Methadone is synthetic analgesic drug that is originally used in the treatment of narcotic addicts. Among the psychological effects induced by using methadone are analgesia, sedation and respiratory depression. Overdose of methadone may cause coma or even death. It is administered orally or intravenously and is metabolized in the liver. The kidneys are a major route of methadone excretion. Methadone has a biological half-life of 15-60 hours.

Urine based screening tests for drugs of abuse range from simple immunoassay tests to complex analytical procedures. The speed and sensitivity of immunoassays have made them the most widely accepted method for screening urine for drugs of abuse. The Drug Screen MTD is based on the principle of the highly specific immunochemical reactions of antigens and antibodies which are used for the analysis of specific compounds in biological fluids. This test is a rapid, visual, competitive immunoassay that can be used for the qualitative detection of methadone in human urine at a 300 ng/ml cut-off concentration.

PRINCIPLE

The Drug Screen MTD is a one-step immunoassay in which a chemically labeled drug (drug-protein conjugate ) competes with the drug which may be present in urine for limited antibody binding sites. The test device contains a membrane strip which has been pre-coated with drug-protein conjugate on the test band region. A colored anti-methadone antibody-colloidal gold conjugate pad is placed at the end of the membrane. The colored antibody-colloidal gold conjugate moves along with urine, chromatographically by capillary action, across the membrane. In the absence of drug in the urine, the colored antibody colloidal gold conjugate attaches to the drug-protein conjugate on the test band region to form a visible line as the antibody/drug-protein conjugate complexes. Therefore, the formation of a visible precipitant in the test band region occurs when the test urine is negative for the drug. When the drug is present in the urine, the drug/metabolite antigen competes with the drug-protein conjugate on the test band region for the limited antibody sites. When a sufficient amount of drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored antibody colloidal gold conjugate to the drug-protein conjugate zone on the test band region. Therefore, absence of the color band on the test region indicates a positive result.

A control or reference band with a different antigen/antibody reaction is also added to the immunochromatographic membrane strip to indicate that test is performed properly. This control line should always appear regardless of the presence of drug or metabolite. This means that negative urine will produce two colored band, and positive urine will produce only one band. The presence of this colored band in the control region also serves as verification that 1) sufficient volume has been added, and 2) that proper flow was obtained.

STORAGE AND STABILITY

The test kit should be stored refrigerated or at room temperature 2-30℃ (36-86℉) Each device should remain in its sealed pouch for the duration of the shelf-life.

PRECAUTIONS

· FOR IN-VITRO DIAGNOSTIC USE.

· For professional use only.

· Urine specimens may be potentially infectious. Proper handing and disposal methods should be established.

· Avoid cross-contamination of urine samples by using a new specimen collection container and specimen pipette for each urine sample.

REAGENTS AND MATERIALS SUPPLIED

· 25 individually wrapped test strips which include one desiccant each. Each test strip contains a membrane coated with drug-protein conjugate and a colloidal gold conjugate pad coated with anti-methadone antibody.

· One instruction sheet.

MATERIAL REQUIRED BUT NOT PROVIDED

· Specimen collection container.

· Timer.

SPECIMEN COLLECTION AND HANDLING

The Drug Screen MTD is formulated for use with urine specimens. Fresh does not require any special hanging or pretreatment. Urine samples should be collected that testing can be performed as soon as possible after the specimen collection, preferably during the same day. The specimen may be refrigerated at 2-8℃ for 2 days or frozen at -20℃ for a longer period of time. Specimens that have been refrigerated must be equilibrated to room temperature prior to testing. Specimens previously frozen must be thawed, equilibrated to room temperature, and mixed thoroughly prior to testing.

Note: Urine specimens and all materials coming in contact will them should be handled and disposed of as if capable of transmitting infection. Avoid contact with skin by wearing gloves and proper laboratory attire.

TEST PROCEDURE

Review “Specimen Collection” instructions. Test strip, patient’s samples, and controls should be brought to room temperature (20-30℃) prior to testing. Do not open pouches until ready to perform the assay.

1.   Remove the test strip from its protective pouch (bring the test to room temperature before opening the pouch to avoid condensation of moisture on the membrane). Label the device with patient or control number.

2.    Immerse the test strip in the urine sample with the arrow end pointing toward the urine. Do not immerse the strip above the printed MAX line. After a minimum of 15 seconds, remove the test strip from the urine and lay fiat on a non-absorptive clean surface. Alternatively, the test strip may be left in the test sample, as long as the strip is not immersed above the MAX line. A separate test strip must be for each sample or control.

3.    Read result between 3 to 8 minutes after the addition of samples. Do not read result after 8 minutes.

INTERPRETATION OF RESULTS

Negative:

Two colored lines should be observed in the viewing window. The line in the test region (T) is the drug probe line, the line in the control region (C) is the control line, which is used to indicate proper performance of the device. The color intensity of the test line may be weaker or stronger than of the control line.

Positive:

Only one colored line appears in the control region (C). The absence of test line indicates a positive result.

Invalid:

No line appears in the control region. Under no circumstances should a positive sample be identified until the control line forms in the viewing area. If the control line does not from , the test result is inconclusive and the assay should be repeated.

Note: A very faint line on the test region indicates that the methadone in the sample is near the cut-off level for the test. These samples should be re-tested or confirmed with a more specific method before a positive determination is made.

LIMITATIONS OF PROCEDURE

·The assay is designed for with human urine only.

·A positive result with any of the tests indicates the presence of a drug/metabolite only and does not indicate or measure intoxication.

·There is a possibility that technical or procedural errors as well other substances or factors not listed may interfere with the test and cause false results. See SPECIFICITY for substances that will produce positive results, or that do not interfere with test performance.

·If it is suspected that the samples have been mislabeled or tampered with, a new specimen should be collected and the test should be repeated.

QUALITY CONTROL

Good laboratory practice recommends the use of control materials to ensure proper kit performance. Before using a new kit with patient specimens, positive and negative controls should be tested. Quality control specimens are available from commercial sources. When testing the positive and negative controls, use the same assay procedure as with a urine specimen.

PERFORMANCE CHARACTERISTICS

A.    Accuracy

The accuracy of the Drug Screen MTD was evaluated in comparison to a commercially available immunoassay at a cut off of 300 ng/ml for methadone. One hundred twenty (120) urine samples, collected from presumed non-user volunteers, have been tested by both procedures with 100% agreement.

In a separate study, forty six (46) urine samples, (obtained from a clinical laboratory where they were screened and confirmed as positives by the commercially available immunoassay and GC/MS) were tested with the Drug Screen MTD. Of the forty six (46) samples with methadone concentration from 422 ng/ml to 198000 ng/ml, all were found positive by both methods (100% agreement).

B.     Reproducibility

The reproducibility of the Drug Screen MTD was evaluated at four different sites using blind controls. Of the sixty (60) samples without methadone all were determined negative. Of the sixty (60) samples with methadone concentration of 600 ng/ml, all were determined positive.

C.    Precision

The precision of the Drug Screen MTD was determined by conducting the test with spiked controls. The control at 150 ng/ml should give a negative result. The control at 600 ng/ml should give a positive result.

 

Concentration(ng/ml)   Number Tested     Correct Result    %Correct Result
   150  50 50 100
  600     50 50 100
D.    Specificity

 

The specificity for the Drug Screen MTD was tested by adding various drugs, drug metabolites, and other compounds that are likely to be present in urine. All compounds were prepared in drug-free normal human urine.

The following structurally related compounds produced positive results when tested at levels equal to or greater than the concentrations listed below.

Compound                                                                         Concentration (ng/ml)

2-ethylidene-1,5-dimethyl-3, 3-diphenylpyolidine                50,000

Methadol                                                                                      1,000

The following compounds were found not to cross-react tested at concentrations up to 100 µg/ml.

Acentaminophen                   Erythromycin

Acetone                                    Ethanol

Albumin                                    Furosemide

Amitriptyline                             Glucose

D-Amphetamine                     Guaiacol glyceryl ether

L-Amphetamine                      Hemoglobin

Ampillicin                                  Hydrocodone

Aspartame                               Hydromorphone

Aspirin                                       (+/-)-Isoproterenol

Benzocaine                               Lidocaine

Benzoylecgonine                      Meperidine

Bilirubin                                      Methamphetamine

(+)-Brompheniramine             Methaqualone

Caffeine                                     (1R, 2S)-(-)-N-Methyl-ephedrine

Chloroquine                              Methylphenidate

(+/-)-Chlorpheniramine           Morphine

Chlorpromazine                        Naloxone

Cocaine                                      Natrexone

Codeine                                     (+)-Naproxen

Creatine                                     (+/-)-Norephedrine

(-)-Deoxyephedrine                  Notriptyline

Dextromethorphan                   Oxalic Acid

Diazepam                                   Oxazepam

4-Dimethlaminoantipyrine      Oxycodone

Dopamine                                  Penicillin-G

Doxylamine                               Pentermine

Ecgonine                                   Pentobarbital

Ecgonine methyl ester            Pheniramine

(+/-)-Ephedrine                         Pheniramine

(-)-Ephedrine                            Phenobarbital

(+)-Epinephrine                        Phenothiazine

L-Phenylephrine                       Sulindac

β-Phenylethylamine                 11-nor-△9-tetrahydrocannabinol-9-

Procaine                                     cartboxylic acid

Promethazine                           Thioridazine

d-Propoxyhene                         Trifluoperazine

Ranitidine                                  Tyramine

Secobarbital                              Vitamin C

Sodium Chloride

BIBLIOGRAPHY OF SUGGESTED READING

1.   Baselt, R.C. Disposition of Toxic Drugs and Chemicals in Man. Biomedical Publications, Davis, CA, 1982.

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

3.    Fed. Register, Department of Health and Human Services. Mandatory Guidelines for Federal Workplace Drug Testing Programs, 53, 69, 11970-11979, 1988.

4.    Gorodetzkym, C.W., Detection of Drugs of Abuse in Biological Fluids, in Martin WR(ed): Drug Addiction 1, New York, Spring-Verlag, 1977.

5.   Hofmann F.E., A Handbood on Drug and Alcohol Abuse: The Biomedical Aspects, New York, Oxford University Press, 1983.

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