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One-Step Morphine Test Cassette
Package insert for Morphine Test Cassette. This Instruction Sheet is for testing of Morphine. For professional and in vitro diagnostic use only.
Intended Use The MOP One-Step Morphine Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of Morphine in urine at the following cut-off concentration of 300ng/ml. This assay 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 spectrometry (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. Summary Opiate refers to any drug that is derived from the opium poppy, including the natural products, morphine and codeine, and the semi-synthetic drugs such as heroin. Opioid is more general, referring to any drug that acts on the opioid receptor. Opioid analgesics comprise a large group of substance which control pain by depressing the central nervous system. Large doses of morphine can produce higher tolerance level and physiological dependency in users, and may lead to substance abuse. Morphine is excreted unmetabolized, and is also the major metabolic product of codeine and heroin. Morphine is detectable in the urine for several days after an opiate dose. The MOP One-Step Morphine Test Cassette yields a positive result when the concentration of morphine in urine exceeds 300ng/ml. Principle The MOP One-Step Morphine Test Cassette is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against their respective drug conjugate for binding sites on their specific antibody. During testing, a urine specimen migrates upward by capillary action. A drug, if present in the urine specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with the drug-protein conjugate and a visible colored line will show up in the test line region of the specific drug cassette. The presence of drug above the cut-off concentration will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test line region. A drug-positive urine specimen will not generate a colored line in the specific test line region of the cassette because of drug competition, while a drug-negative urine specimen will generate a line in the test line region because of the absence of drug competition. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred. Warnings and Precautions For in vitro diagnostic use only. For healthcare professionals and professionals at point of care sites. Do not use after the expiration date. Please read all the information in this leaflet before performing the test.
The test panel should remain in the sealed pouch until use. All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent. The used test panel should be discarded according to federal, state and local regulations. Composition The test contains a membrane strip coated with drug-protein conjugates on the test line, a goat-anti-mouse IgG polyclonal antibody on the control line, and a dye pad which contains colloidal gold-monoclonal antibody specific to Morphine. Each box contains test panels and package insert. Storage and Stability Store as packaged in the sealed pouch at room temperature (2-30℃ or 36-86 ℉).The kit is stable within the expiration date printed on the labeling. Once open the pouch, the test should be used within one hour. Prolonged exposure to hot and humid environment will cause product deterioration. Additional Special Equipment Specimen collection containerTimerExternal controls Specimen The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day may be used. Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to settle to obtain a clear supernatant for testing. Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For prolonged storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed well before testing. Test Procedure Allow the test and urine samples to equilibrate to room temperature (15-30℃or 59-86℉) prior to testing. 1. Remove the test cassette from the sealed pouch. 2. Hold the dropper vertically and transfer 3 full drops(approx. 100l) of urine to the specimen well of the test cassette, and then begin timing. See the illustration below. 3. Wait for colored lines to appear. Interpret the test results at 3-5 minutes. Do not read results after 10 minutes.
Interpretation of Results Negative:*Two lines appear. One red line should be in the control region (C), and another apparent red or pink line adjacent should be in the test region (T). This negative result indicates that the drug concentration is below the detectable level. *NOTE: The shade of red in the test line region (T) will vary, but it should be considered negative whenever there is even a faint pink line. Positive: One red line appears in the control region (C). No line appears in the test region (T). This positive result indicates that the drug concentration is above the detectable level. Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review
the procedure and repeat the test using a new test panel. If the problem persists, discontinue using the lot immediately and contact your local distributor. Quality Control A procedural control is included in the test. A red line appearing in the control region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique. Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance. Limitations The MOP One-Step Morphine Test Cassette provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography and mass spectrometry (GC/MS) is the preferred confirmatory method. There is a possibility that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen. A Positive result does not indicate level or intoxication, administration route or concentration in urine. A Negative result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present but below the cut-off level of the test. Test does not distinguish between drugs of abuse and certain medications. A positive test result may be obtained from certain foods or food supplements. Performance Characteristics Accuracy A side-by-side comparison was conducted using the MOP One-Step Morphine Test Cassette and commercially available drug rapid tests. Testing was performed on approximately 300 specimens per drug type previously collected from subjects presenting for Drug Screen Testing. Presumptive positive results were confirmed by GC/MS. The following compounds were quantified by GC/MS and contributed to the total amount of drugs found in presumptive positive urine samples tested. Test Compounds Contributed to the Totals of GC/MS MOP Morphine, Codeine The following results are tabulated from these clinical studies: %Agreement with Commercial Kit
%Agreement with GC/MS MOP MOP Positive Agreement 100% Positive Agreement 100% Negative Agreement 99% Negative Agreement 97% Total Results >99% Total Results 98% Forty (40) clinical samples for each drug were run using the MOP One-Step Morphine Test Cassette by an untrained operator at a Professional Point of Care site. Based on GC/MS data, the operator obtained statistically similar Positive Agreement, Negative Agreement and Overall Agreement rates as trained Laboratory personnel. Precision A study was conducted at three physician offices by untrained operators using three
different lots of product to demonstrate the within run, between run and between operator precision. An identical panel of coded specimens, containing drugs at the concentration of ± 50% and ± 25% cut-off level, was labeled as a blind and tested at each site. The results are given below: Morphine conc.(ng/ml) n per site Site A Site B Site C - + - + - + 0 15 15 0 15 0 15 0 150 15 13 2 13 2 15 0 225 15 6 9 7 8 10 5 375 15 0 15 1 14 0 15 450 15 0 15 0 15 0 15
Analytical Sensitivity A drug-free urine pool was spiked with drugs at concentrations listed. The results are summarized below. Drug concentration Cut-off Range n MOP - + 0% Cut-off 30 30 0 -50% Cut-off 30 30 0 -25% Cut-off 30 30 0 Cut-off 30 11 19 25% Cut-off 30 2 28
Analytical Specificity The following table lists the concentration of compounds (ng/ml) that are detected positive in urine by the MOP One-Step Morphine Test Cassette at 3-5 minutes. Morphine (MOP 300) Concentration (ng/ml) Morphine 300 Codeine 300 Ethylmorphine 6,250 Hydrocodone 50,000 Hydromorphone 3,125 Levorphanol 1500 6-Monoacetylmorphine 400 Morphine 3-β-D-glucuronide 1,000 Norcodeine 6,250 Normorphone 100,000 Oxycodone 30,000 Oxymorphone 100,000 Procaine 15,000 Thebaine 6,250
Effect of Urinary Specific Gravity Fifteen (15) urine samples of normal, high, and low specific gravity ranges (1.000-1.037) were spiked with drugs at 50% below and 50% above cut-off levels respectively. The MOP One-Step Morphine Test Cassette was tested in duplicate using fifteen drug-free urine and spiked urine samples. The results demonstrate that varying ranges of urinary specific gravity does not affect the test results. Effect of the Urinary pH The pH of an aliquoted negative urine pool was adjusted to a pH range of 5 to 9 in 1 pH unit increments and spiked with drugs at 50% below and 50% above cut-off levels. The spiked, pH-adjusted urine was tested with the MOP One-Step Morphine Test Cassette. The results demonstrate that varying ranges of pH does not interfere with the performance of the test.
Cross-Reactivity A study was conducted to determine the cross-reactivity of the test with compounds in either drug-free urine or Morphine positive urine. The following compounds show no cross-reactivity when tested with the MOP One-Step Morphine Test Cassette at a concentration of 100µg/ml. Non Cross-Reacting Compounds
Acetaminophen Acetophenetidin N-Acetylprocainamide Acetylsalicylic acid Aminopyrine Amoxicillin Ampicillin L-Ascorbic acid Apomorphine Aspartame Atropine Benzilic acid Benzoic acid Benzphetamine* Bilirubin D/L-Brompheniramine Caffeine Cannabidol Chloralhydrate Chloramphenicol Chlorothiazide D/L-Chloropheniramine Chlorpromazine Chloroquine Cholesterol Clonidine Cortisone L-Cotinine Creatinine Deoxycorticosterone Dextromethorphan Diclofenac Diflunisal Digoxin Diphenhydramine Ecgonine methyl ester L -Ψ-Ephedrine β-Estradiol Estrone-3-sulfate Ethyl-p-aminobenzoate [1R,2S] (-) Ephedrine L(–)-Epinephrine Erythromycin Fenoprofen Furosemide Gentisic acid Hemoglobin Hydralazine Hydrochlorothiazide Hydrocortisone O-Hydorxyhippuric acid p-Hydroxyamphetamine p-Hydroxytyramine Ibuprofen Iproniazid D/L-Isoproterenol Isoxsuprine Ketamine Ketoprofen Labetalol Loperamide Meperidine Meprobamate Methoxyphenamine Methylphenidate Nalidixic acid Naloxone Naltrexone Naproxen Niacinamide Nifedipine Norethindrone D-Norpropoxyphene Noscapine D/L-Octopamine Oxalic acid Oxolinic acid Oxymetazoline Papaverine Penicillin-G Pentazocine hydrochloride Perphenazine Phenelzine Trans-2-phenylcyclo-propylamine hydrochloride L-Phenylephrine β-Phenylethylamine Phenylpropanolamine Prednisolone Prednisone D/L-Propranolol D-Propoxyphene D-Pseudoephedrine Quinacrine Quinine Quindine Ranitidine Salicylic acid Serotonin
Sulfamethazine Sulindac Tetracycline Tetrahydrocortisone 3-acetate Tetrahydrozoline Tetrahydrocortisone 3 (β-D-glucuronide) Thiamine Thioridazine D/L-Tyrosine Tolbutamide Triamterene Trifluoperazine Trimethoprim Tryptamine D/L-Tryptophan Tyramine Uric acid Verapamil Zomepirac *Parent compound only; metabolizes amphetamine and methamphetamine in urine. Bibliography 1. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 6th Ed. Biomedical Publ., Davis, CA. 2002; 129. 2. FDA Guidance Document: Guidance for Premarket Submission for Kits for Screening Drugs of Abuse to be Used by the Consumer, 1997. 3. A Handbook of Drug and Alcohol Abuse, Gail Winger, Third Edition, Oxford Press, 1992, page 146. 4. Tietz NW. Textbook of Clinical Chemistry. W.B. Saunders Company. 1986; 1735. 5. Hawks RL, CN Chiang. Urine Testing for Drugs of Abuse. National Institute for Drug Abuse (NIDA), Research Monograph 73, 1986.
Index of Symbols Do not reuse For in vitro diagnostic use only Stored between 2-30℃ Consult instruction for use Caution Lot number Use by Contains sufficient for <n> tests
Keep away from sunlight
Manufacturer Do not use if package is damaged Authorized Representative in the European Community
Version No.:4.0 Effective Date: Feb. 24, 2012
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