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On Site Opiate Test

Instant-ViewTM Urine Test Dip-Strip 5

ONE STEP ASSAY
RAPID VISUAL RESULTS
FOR QUALITATIVE IN VITRO DIAGNOSTIC USE

INTENDED USE

This device is a qualitative immunoassay intended to provide qualitative screening results for opiates in human urine at a cutoff level of 300 ng/ml. It is for health care professional use only.

The US Substance Abuse and Mental Health Services Administration (SAMHSA) commonly recommends the screening levels for opiates to be at a concentration of 2000 ng/ml.

Instant-ViewTM Morphine Urine Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.1

SUMMARY AND EXPLANATION OF THE TEST

The detection of morphine in human urine has been widely used to assess the abuse of opiates.

Morphine, codeine, hydrocodone, oxycodone etc. (hereafter referred to as opiates) belong to the class of drugs called opiates.2 Opiates are central nervous system stimulating drugs. Overdose and extended usage of opiates may lead to substance abuse, which may cause severe and/or permanent damage to the human nerve system.3,4 Morphine is rapidly absorbed from an oral dose and from intra-muscular and subcutaneous injection. It is metabolized extensively, with only 2-12% excreted as unchanged morphine in the urine. The quantitatively most important metabolite is excreted in the urine to an extent of 67-70% of the given dose in 48 hours.2 Heroin is rapidly metabolized to morphine in the body; the pattern of urinary excretion of heroin is similar to that of morphine. Codeine is extensively metabolized, 10-15% of the dose is demethylated to form morphine and norcodeine.

PRINCIPLE OF THE PROCEDURE

This assay is a one-step lateral flow chromatographic immunoassay. The test strip includes 1) a burgundy-colored conjugate pad containing monoclonal anti-morphine antibody conjugated to colloidal gold, and 2) a membrane containing a test region (T line) and a control region (C line). The T line is coated with morphine-BTG (bovine thyroglobulin) antigen, and the C line is coated with goat anti-mouse IgG antibody.

This test is a competitive binding immunoassay. Opiates in the urine specimen compete with the morphine-BTG antigen coated on the membrane for the limited binding sites of the anti-morphine antibodies in the conjugate pad.

When a proper amount of urine specimen is applied into the sample pad of the device, the urine specimen migrates by capillary action through the test strip. If the opiate level in the urine specimen is below the cutoff level of 300 ng/ml, the burgundy-colored anti-morphine conjugate will bind to the antigens coated on the T line. As a result, the T line becomes a visible burgundy line.

If opiates are present in the urine specimen at a cutoff level of 300 ng/ml or higher, it will bind to the anti-morphine antibody in the conjugate pad, so that no burgundy line develops in the T region indicating a positive result.

The C line is coated with goat anti-mouse antibody that will bind to the gold-antibody conjugate and form a burgundy colored line regardless of the presence of opiates.

REAGENTS AND MATERIALS SUPPLIED

  1. 50 test strips each sealed in a pouch with a desiccant.

  2. One package insert

MATERIAL REQUIRED BUT NOT PROVIDED

  1. Specimen collection containers

  2. Timer

STORAGE AND STABILITY

Store the kit at room temperature 59-86°F (15-30°C). Each device may be used until the expiration date printed on the label if it remains sealed in its foil pouch containing desiccant.

Do not freeze the kit and/or expose the kit to temperatures over 30°C.

SPECIMEN COLLECTION

  1. Each urine specimen must be collected in a clean container.

  2. Specimens may be kept at room temperature for 8 hours, at 2-8°C for up to 3 days and at -20°C or lower for prolonged storage. Do not mix specimens.

PRECAUTION

  1. The instructions must be followed to obtain accurate results.

  2. Do not open the sealed pouch, unless ready to operate the assay.

  3. Do not use expired device.

  4. Dispose of all specimens and used assay materials in a proper medical waste container.

ASSAY PROCEDURE

  1. Refrigerated specimens or other materials must be equilibrated to room temperature before testing.

  2. Open the foil pouch at the notch and remove the test device.

  3. Dip the device in the specimen for at least 10 seconds. Keep the specimen surface at the level indicated by the arrow sign on the device.

  4. Remove the device from the specimen, and place it on a flat, dry surface.

  5. Read the test result between four (4) to seven (7) minutes after adding the specimen.
    IMPORTANT: Do not read test results after seven (7) minutes.

INTERPRETATION OF RESULTS

POSITIVE:
If only the C line appears, the test indicates that opiate level is at a cutoff level of 300 ng/ml or higher.
Samples with positive results should be confirmed with a more specific method before a positive determination is made.		 Positive
NEGATIVE:
If both the C line and T line appear, the test indicates that the opiate level is below 300 ng/ml.
Note: A very faint line in the test region should be considered negative.		 Negitive
INVALID:
If no C line develops within 5 minutes, repeat the assay with a new test device.		 Invalid 1

Invalid 2

QUALITY CONTROL

  • Built-in Control Features
    This test contains a built-in control feature, the C line. The appearance of the burgundy C line indicates that the proper volume of specimen has been absorbed and the capillary flow has occurred. The C line should always appear regardless of the presence of the chemicals being detected. If the Control line does not develop within 5 minutes, the result is invalid. In this case, review the whole procedure and repeat test with a new device.
  • External Quality Control
    Good Laboratory Practice recommends using the external controls, positive and negative, to assure the proper performing of the assay.

LIMITATIONS

  1. Results obtained by this device provide only a preliminary qualitative analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.
  2. This product is designed for testing human urine only.
  3. Adulterants such as bleach or other strong oxidizing agents may produce erroneous test results if added in the device. When suspected, collect a fresh specimen and redo the test with a new device.
  4. Samples in which bacterial contamination is suspected should not be used. These samples may interfere with the test and cause false results.

EXPECTED VALUES

This test is capable of detecting opiates at a cutoff level of 300 ng/ml or higher.

PERFORMANCE CHARACTERISTICS

  1. Sensitivity (Cutoff)

    This test can detect opiates in urine at a cutoff level of 300 ng/ml.

  2. Accuracy

    A Study was performed at a Reference Laboratory and three different Physician Office Laboratories (POL). Ninety-four clinical samples analyzed by GC/MS for morphine from a toxicology laboratory were blind labeled and tested. Each sample was tested at each site, with Instant-ViewTM Morphine, and compared with GC/MS results of morphine only. (Codeine was not considered during the analysis.) The test demonstrated an overall agreement of greater than 96.2%.
     Instant-View Test
    – +Total
    GC/MS–50 5*55
    +04040
     Total504595
    Note: * Samples are within 23% below the cutoff level of 300 ng/ml.

    *Resolution of Discrepant Results
    Sample ID # GC/MS Value Instant-View Result
    19 231 ng/ml +
    7 256 ng/ml +
    38 270 ng/ml +
    17 289 ng/ml +
    68 289 ng/ml +

  3. Precision

    Precision was determined at three different POL locations, by persons with diverse educational backgrounds and work experience. Forty-pooled drug-free human urine specimens were spiked with morphine at different levels. All specimens were blind labeled and tested. The results are as follows:
    Morphine
    Conc.
    (ng/ml)    		 No of
    Samples    		 POL 1 POL 2 POL 3
    + – + – + –
    0 8 0 8 0 8 0 8
    225 8 3 5 1 7 2 6
    300 8 7 1 7 1 7 1
    375 8 8 0 8 0 8 0
    600 8 8 0 8 0 8 0
    The results indicate a 92.5% concordance with the expected results.

  4. Specificity

    Cross-Reactivity
    A study was conducted using morphine-related compounds to determine the cross-reactivity of the test.

    Morphine structurally related compounds showing the lowest concentration of the drug producing a positive response equivalent to the cutoff level:
    Description Concentration (ng/ml)
    Morphine 300
    Codeine 300
    Ethyl Morphine 300
    Hydromorphine 400
    Hydrocodone 750
    Oxycodone 1000

    Interfering Substances The following compounds, often found in urine, were spiked in urine pools containing 0, or 300 ng/ml morphine were tested, accordingly, in the Instant-ViewTM Morphine Urine Test. No effects were observed from those Analytes at 1.0 mg/ml.

    Compounds tested and found not to interfere with the results of the test at 0, or 300 ng/ml morphine in urine. (Concentration at 1.0 mg/ml).
    Acetaminophen Cortisone
    Acetylsalicylic Acid Dextromethorphan
    Amikacin Ethanol
    Amitriptyline Lidocaine
    Ampicillin Methadone
    Arterenal Methanol
    Aspirin Oxalic Acid
    Benzoic Acid Penicillin-G (Benzylpenicillin)
    Benzoylecgonine b-phenylthylamine
    Caffeine Phenylpropanalamine
    (+)-Chlorpheniramine Ranitidine
    (+/-)-Chlorpheniramine Salicyclic Acid
    Cocaine Thioridazine


    Biological Analytes Concentration
    Albumin(serum) 2,000 mg/ml
    Bilirubin 1,000 mg/ml
    Creatine 1,000 mg/ml
    Hemoglobin 1,000 mg/ml
    Glucose 2,000 mg/ml
    pH 5.0 – 9.0
    Vitamin C (L-Ascorbic Acid) 1,000 mg/ml
    Uric Acid 1,000 mg/ml

    There is a possibility that other substances and/or factors not listed above may interfere with the test and cause false results.

REFERENCES

  1. FDA Guidance for Labeling Urine Drugs of Abuse Screening Testing, Kshit Mohan, 7/21/87.

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

  3. Baselt, R.C. Disposition of Toxic Drugs and Chemicals in Man, 4th ED., Biomedical Publ., Davis, CA; p528-530, 1995.

  4. Department of Health and Human Services, Mandatory Guidelines for Federal Workplace Drug Testing Programs, Fed. Register. p. 53 (69): 11970 (1988).

  5. Package insert Instant-ViewTM Morphine(300) Urine Test (Dip-Strip). Alfa Scientific Designs, Inc, Poway, CA. 33-3098 Rev J 112702.
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