Microsoft word - w19-s thc strip .doc

When sample drug levels are at or above the target cutoff, the free drug in the sample binds to the antibody-dye conjugate preventing the antibody-dye conjugate from binding to the drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, One Step Marijuana/Cannabinoids
indicating a potentially positive result. To serve as a procedure control, a colored line will appear at the Control Region (THC) Urine Test
(C), if the test has been performed properly. PRECAUTIONS
INTERPRETATION OF RESULTS
This kit is for external use only. Do not swallow. Positive (+)
One Step THC Urine Test is a rapid one step test for the qualitative detection of Discard after first use. The test cannot be used more than once. A rose-pink band is visible in the control region. No color band appears in the test Marijuana/Cannabinoids and its principal metabolites in human urine at specified Do not use test kit beyond expiration date. region. This positive result indicates that the Marijuana/Cannabinoids Do not use the kit if the pouch is punctured or not well sealed. concentration is equal to or higher than the detection limit(50 ng/ml). For in vitro diagnostic use only. For professional use only. Negative (-)
INTENDED USE
A rose-pink band is visible in the control region and the test region. This negative CONTENT OF THE KIT
result indicates that the Marijuana/Cannabinoids concentration is zero or below the The One Step THC Urine Test is a lateral flow chromatographic immunoassay for the detection of Marijuana/Cannabinoids in human urine at the cut-off One pouch containing a test and a desiccant. The desiccant is for storage concentration of 50 ng/ml. This assay provides only a qualitative, preliminary purposes only, and is not used in the test procedures. analytical test result. A more specific alternate chemical method must be used in If a color band is not visible in the control region or a color band is only visible in order to obtain a confirmed analytical result. Gas chromatography/mass the test region, the test is invalid. Another test should be run to re-evaluate the spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration STORAGE AND STABILITY
specimen. If test still fails, please contact the distributor or the store, where you and professional judgment should be applied to any drug of abuse test result, bought the product, with the lot number. particularly when preliminary positive results are used. Store at 4 ºC ~30 ºC in the sealed pouch up to the expiration date. Keep away from direct sunlight, moisture and heat. Note: There is no meaning attributed to line color intensity or width.
Marijuana/Cannabinoids is a hallucinogenic agent derived from the flowering SPECIMEN COLLECTION AND PREPARATION
portion of the hemp plant. The active ingredients in marijuana, THC& Cannabinol can be metabolized and excreted as 11-nor-9-tetrahydrocannabinol-9-carboxylic Collect a urine sample in the urine cup. Urine specimens may be refrigerated acid with a half-life of 24 hours. It can be detected for 1 to 5 days after use. (2ºC~8°C) and stored up to forty-eight hours. For longer storage, freeze the Smoking is the primary method of use of marijuana/cannabis. Higher doses used by abusers produce central nervous system effects, altered mood and sensory Bring frozen or refrigerated samples to room temperature before testing. Use only perceptions, loss of coordination, impaired short-term memory, anxiety, paranoia, depression, confusion, hallucinations and increased heart rate. A tolerance to the cardiac and psychotropic effects can occur, and withdrawal syndrome produces QUALITY CONTROL
TEST PROCEDURE
restlessness, insomnia, anorexia and nausea. Though there is an internal procedural control line in the test device of Control Test must be in room temperature (10ºC to 30ºC) region, the use of external controls is strongly recommended as good laboratory Remove the test strip from the sealed pouch. PRINCIPLE
testing practice to confirm the test procedure and to verify proper test performance. Immerse the strip into the urine with the arrow pointing towards the urine. Positive and negative control should give the expected results. When testing the Take the strip out after at least 3 seconds and lay the strip flat on a clean, One Step THC Urine Test is a competitive immunoassay that is used to screen for positive and negative control, the same assay procedure should be adopted. dry, non-absorbent surface (such as the mouth of the urine container). the presence of Marijuana/Cannabinoids in urine. It is chromatographic absorbent Read results in 5 minutes. Do not read results after more than 5
device in which Marijuana/Cannabinoids and its metabolites in a sample LIMITATIONS OF PROCEDURE
minutes.
competitively combined to a limited number of antibody-dye conjugate binding This test has been developed for testing urine samples only. The IMPORTANT： Do not allow the urine level to exceed the MAX (marker line), When the absorbent end of the test device is immersed into the urine sample, the performance of this test using other specimens has not been otherwise the test will not perform correctly. urine is absorbed into the device by capillary action, mixes with the antibody-dye conjugate, and flows across the pre-coated membrane. When sample drug levels Adulterated urine samples may produce erroneous results. Strong are zero or below the target cut off (the detection sensitivity of the test), oxidizing agents such as bleach (hypochlorite) can oxidize drug analytes. If antibody-dye conjugate binds to the drug-protein conjugate immobilized in the Test a sample is suspected of being adulterated, obtain a new sample. Region (T) of the device. This produces a colored Test line that, regardless of its This test is a qualitative screening assay. It is not designed to determine the quantitative concentration of drugs or the level of intoxication BIBLIOGRAPHY OF SUGGESTED READING
PERFORMANCE CHARACTERISTICS
1. Baselt, R.C. Disposition of Toxic Drugs and Chemicals in Man. Biomedical A.Sensitivity
One Step THC Urine Test has set the screen cut-off for positive specimens at 50 2. Ellenhorn, M.J. and Barceloux, D. G Medical Toxicology. Elservier Science ng/mL for 11-nor –9-THC-9-COOH as a calibrator. The test device has been Publishing Company, Inc., New York, 1988 proved to detect above 50 ng/mL of Marijuana in urine at 5 minutes. 3. Gilman, A. G., and Goodman, L. S. The Pharmacological Fluids, in Martin WR(ed): Drug Addiction I, New York, Spring – Verlag, 1977. B. Specificity and cross reactivity
4. Harvey, R.A., Champe, P.C. Lippincotts Illustrated Reviews. Pharmacology. To test the specificity of the test, the test device was used to test 5. Hawwks RL, CN Chiang. Urine Testing for drugs of Abuse. National Institute for marijuana/cannabinoids, drug metabolites and other components of the same Drug Abuse (NIDA), Research Monography 73, 1986 class that are likely to be present in urine, All the components were added to 6. Hofmann F.E., A Handbook on Drug and Alcohol Abuse: The Biomedical drug-free normal human urine. These concentrations below also represent the Aspects, New York, Oxford University Press, 1983. limits of detection for the specified drugs or metabolites. McBay, A. J. Clin. Chem. 33,33B-40B, 1987. MEANING OF SYMBOLS ON PACKAGE
C. Interfering substances
Considering the complexity of clinical urine specimens and the possibility that various urine specimens contain potentially interfering substances, for example Acetoacetic Aci, Acetone, Albumin etc., we simulated above situations by adding the potentially interfering substances to a certain concentration as specimen. The following components show no cross-reactivity when tested with One Step THC Urine Test at a concentration of 100 μg/ml.

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