4mm Strip THC Marijuana Drug Test Kit 3mm Cassette Convenient Visual Reding Result

Drug test Marijuana Rapid Test strip ,4mm strip detecting Marijuana in urine, Quick, Gold colloidal method


Intended Use

THC (D9-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. They may also experience transient episodes of confusion and anxiety. Long term relatively heavy use may be associated with behavioral 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-D9-tetrahydrocannabinol-9-carboxylic acid (D9-THC-COOH).
The THC One Step Marijuana Test Strip (Urine) is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of Marijuana in urine. The THC One Step Marijuana Test Strip (Urine) yields a positive result when the concentration of Marijuana in urine exceeds 50 ng/mL. This is the suggested screening cut-off for positive specimens set by the Substance Abuse and Mental Health Services Administration (SAMHSA, USA).

Test Principle

The THC One Step Marijuana Test Strip (Urine) is a rapid chromatographic immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.
During testing, a urine specimen migrates upward by capillary action. Marijuana, if present in the urine specimen below 50 ng/mL, will not saturate the binding sites of the antibody coated particles in the test strip. The antibody coated particles will then be captured by immobilized Marijuana conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the Marijuana level is above 50 ng/mL because it will saturate all the binding sites of anti-Marijuana antibodies.
A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen or a specimen containing a drug concentration less than the cut-off will generate a line in the test line region. 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.


DIRECTIONS FOR USE

Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. For best results, the assay should be performed within one hour.
Using the provided disposable pipette, transfer 3 drops of specimen (approximately 120 µL) to the specimen well (S) of the device and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
As the test begins to work, color will migrate across the membrane.
Wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 8 minutes

INTERPRETATION OF RESULTS

(Please refer to the illustration above)
NEGATIVE:* A colored line appears in the Control region (C) and colored lines appears in the Test region (T). This negative result means that the concentrations in the urine sample are below the designated cut-off levels for a particular drug tested.
*NOTE: The shade of the colored lines(s) in the Test region (T) may vary. The result should be considered negative whenever there is even a faint line.
POSITIVE: A colored line appears in the Control region (C) and NO line appears in the Test region (T). The positive result means that the drug concentration in the urine sample is greater than the designated cut-off for a specific drug.
INVALID: No line appears in the Control region (C). Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for Control line failure. Read the directions again and repeat the test with a new test card. If the result is still invalid, contact your manufacturer.


QUALITY CONTROL

A procedural control is included in the test. A 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.

performance characteristics


Analytical Sensitivity

A drug-free urine pool was spiked with Marijuana at the following concentrations: 0 ng/mL, 25 ng/mL, 37.5 ng/mL, 50 ng/mL, 62.5 ng/mL, 75 ng/mL and 100 ng/mL. The result demonstrates >99% accuracy at 50% above and 50% below the cut-off concentration. Results are presented in Table 2 below.

Table 2: Analytical Sensitivity Summary

Conclusion: As indicated in table above: all specimens with THC concentration equal to or lower than 25ng/mL show negative results, all specimens with THC concentration of 50ng/mL are identified as “+/-”, and all specimens with THC concentration equal to or higher than 75ng/mL showed positive results. Therefore, the cut-off concentration of the THC One Step Marijuana Test Strip (Urine) is determined to be 50ng/mL THC.

Analytical Specificity

Table3 lists the compounds that are positively detected in urine by the THC One Step Marijuana Test Strip (Urine) at 5 minutes and the concentrations at which they are detected.

Table 3: Analytical Specificity

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

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Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.