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Marijuana Please Read All the Information in This Package Insert Before Performing the Test

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Marijuana Please Read All the Information in This Package Insert Before Performing the Test PROFESSIONAL DRUG TEST DrugTest Marijuana Please read all the information in this package insert before performing the test. The Drug Test Marijuana Rapid Test Cassette (Urine) is a rapid urine screening test that can be performed without the use of expensive instruments. The test utilizes a monoclonal antibody to selectively detect elevated levels of marijuana in urine. The THC Rapid Test Cassette yields a positive result when the concentration of marijuana in urine exceeds 50ng/ml. This assay provides a preliminary analytical test result. A more specific alternate chemical method must be used 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. THC (Δ9-tetrahydrocannabinol) is the primary active ingredient in cannabinoids (marijuana). When smoked or orally administered, it produces euphoric effects. Users have impaired short term memory and slowed learning. Users may also experience transient episodes of confusion and anxiety. Long term relatively heavy use may be associated with behavioural disorders. The peak effect of smoking marijuana occurs in 20-30 minutes and the duration is 90-120 minutes after one cigarette. Elevated levels of urinary metabolites are found within hours of exposure and remain detectable for 3-10 days after smoking. The main metabolite excreted in the urine is 11-nor-Δ9-tetrahydrocannabinol-9- carboxylic acid (Δ9-THC-COOH). PRECAUTIONS • Do not use after the expiration date. • The test should remain in the sealed pouch until use. SPECIMEN COLLECTION AND PREPARATION • The urine must be collected in a clean and dry container. • Urine collected at any time of the day may be used. • Urine specimens exhibiting visible particles should be filtered, or allowed to settle to obtain clear specimen for testing. DIRECTIONS 1. Collect urine in a clean and dry container. 2. Bring the pouch to room temperature before opening it. 3. Remove the test from the pouch and use it within one hour. 4. Place the test cassette on a clean and level surface. 5. Hold the dropper vertically and transfer 3 full drops of urine to the specimen well of the test cassette, and then start the timer. 6. Avoid trapping air bubbles in the specimen well (see illustration below). 7. Wait for the colour line(s) to appear. 8. The result should be read at 5 minutes. 9. Do not interpret the result after 10 minutes. 3 Drops of Urine THC C T S C T THC S Positive Negative Invalid READING THE RESULTS QUESTIONS & ANSWERS POSITIVE Q: How does the result window appear if the results are positive? Only one band, the control band will appear and no band will develop when One colour line the target drug is present. appears in the control region (C). Positive Q: How does the result window appear if the results are negative? No line appears Two coloured bands will appear, a control band and a test band on the in the test region (T). This strip next to the target drug. positive result indicates that Q: What do I do if results show a very faint line? the marijuana concentration is Any very faint line on the test region could indicate that the drug in the above the detectable level of sample could be near the cut-off level for the test. However, any line in 50ng/ml. the test area, no matter how faint, should be interpreted as a negative test. Perform a second test or send the specimen to a laboratory to obtain NEGATIVE confirmatory results. Two lines appear. Q: What will the control region look like if the test is working? One colour line Negative should be in the The control line should always appear regardless of the presence of drugs control region (C), and the or metabolites. If the control line does not appear then all results are other in the test region (T). This invalid. THC Rapid Test Cassette (Urine) 【INTERPRETATION OF RESULTS】 11-nor-9-THC-9 COOH n Site A Site B Site C negative result indicates(Please refer to the thatillustration above) Concentration (ng/mL) per Site - + - + - + Package Insert NEGATIVE:* Two lines appear. One color line should be in the control region Q:(C), andUnexpected another results0 or test failure.10 What10 is0 the10 likelihood0 10 that0 REF DTH-102 English apparent color line should be in the test region (T). This negative result indicates that the Marijuana 25 10 10 0 10 0 10 0 concentrationthe marijuana is below the detectable concentration level of 50ng/ml. is the test device is defective?37.5 10 9 1 8 2 9 1 A rapid test for the qualitative detection of Marijuana in human urine. The intensity of the color in the test line region (T) may vary depending on the concentration *NOTE: 62.5 10 1 9 1 9 2 8 For professional in vitro diagnostic use only. of 11-nor-9 -THC-9 COOH (THC metabolite) present in the specimen. Therefore, any shade of color 【 】 below the detectable level of 98% of the time, unexpected test results or failure to obtain test results is the INTENDED USE in the test line region (T) should be considered negative. 75 10 0 10 0 10 0 10 The THC Rapid Test Cassette (Urine) is a rapid chromatographic immunoassay for the detection of Effect of Urinary Specific Gravity 9 POSITIVE: One color line appears in the control region (C). No line appears in the test region (T). This 11-nor- -THC-9 COOH (THC metabolite) in human urine at a cut-off concentration of 50ng/mL. positive50ng/ml. result indicates that the Marijuana concentration is above the detectable levelresult of 50ng/ml. of user error.Fifteen Failure urine specimens to follow of normal, instructions, high, and low specific inadequate gravity ranges weresampling, spiked with 25ng/mLdevice This assay provides only a preliminary analytical test result. A more specific alternate chemical method INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques and 75ng/mL of 11-nor- 9-Tetrahydrocannabinol-9-carboxylic acid. The THC Rapid Test Cassette must be used in order to obtain a confirmed analytical result. Gas chromatography/mass areNote: the most likely The reasons intensity for control line failure. of Reviewthe the procedure and repeat thecontamination, test with a new failure(Urine) wasto testeduse ina duplicatetimer usingor other the fifteen user neat relatedand spiked urinefactor. specimens. These The tests,results spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and test cassette. If the problem persists, discontinue using the test cassette immediately and contact your demonstrate that varying ranges of urinary specific gravity do not affect the test results. professional judgment should be applied to any drug of abuse test result, particularly when preliminary local distributor. while simple to use still require certain basicEffect oftesting Urinary pH disciplines. Unfortunately, positive results are used. 【colourQUALITY CONTROL in the】 test line region The pH of an aliquoted negative urine pool was adjusted to a pH range of 5 to 9 in 1 pH unit 【 】 SUMMARY A procedural control is included in the test. A color line appearing in the control region (C) is increments and spiked with 11-nor-9-Tetrahydrocannabinol-9-carboxylic acid to 25ng/mL and 9 people unfamiliar with these disciplines often ignore the test instructions THC ( -tetrahydrocannabinol) is the primary active ingredient in cannabinoids (Marijuana). When considered(T) may an internal vary procedural depending control. It confirms on sufficient specimen volume and correct 75ng/mL. The spiked, pH-adjusted urine was tested with the THC Rapid Test Cassette (Urine) in smoked or orally administered, it produces euphoric effects. Users have impaired short term memory procedural technique. duplicate. The results demonstrate that varying ranges of pH do not interfere with the performance of and slowed learning. Users may also experience transient episodes of confusion and anxiety. Long Controlthe standards concentration are not supplied with this of test THC cassette; however it is recommendedor that cautions positive and expectingthe test. the test device to be accurate regardless of how it is term relatively heavy use may be associated with behavioral disorders. The peak effect of smoking negative controls be tested as good laboratory testing practices to confirm the test procedure and to Cross-Reactivity Marijuana occurs in 20-30 minutes and the duration is 90-120 minutes after one cigarette. Elevated verify proper test performance. used. Additionally,A studythe was stringent conducted to qualitydetermine the control cross-reactivity checks of the test and with compounds required in either random drug-free levels of urinary metabolites are found within hours of exposure and remain detectable for 3-10 days 【metaboliteLIMITATIONS】 present in the urine or Marijuana positive urine. The following compounds show no cross-reactivity when tested with after smoking. The main metabolite excreted in the urine is 11-nor-9-tetrahydrocannabinol-9- THC Rapid Test Cassette (Urine) at a concentration of 100g/ml 9 1. THC Rapid Test Cassette (Urine) provides only a qualitative, preliminary analyticalsampling result. A methods mandated by the governmental regulatory authorities carboxylic acid ( -THC-COOH). specimen.secondary analytical methodTherefore, must be used to any obtain a shadeconfirmed result. Gas chromatography/mass Non Cross-Reacting Compounds The THC Rapid Test Cassette (Urine) is a rapid urine screening test that can be performed without the spectrophotometry (GC/MS) is the preferred confirmatory method. 1,2 4-Acetamidophenol Deoxycorticosterone (+) 3,4-Methylenedioxy- Prednisolone use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of 2. It is possible that technical or procedural errors, as well as other interfering substancesduring in the theurine productionAcetophenetidin process makeDextromethorphan the likelihoodamphetamine of receivingPrednisone a defective Marijuana in urine.
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