Drug Abuse Test Kit MTD Rapid Diagnostic Test strip, professional use, 300ng/ml cut-off, detecting Methadone in urine

Product Name

MTD Rapid Diagnostic Test/ Methadone Rapid Diagnostic Test
Specimen: Urine


Intended Use


Methadone is a narcotic pain reliever for medium to severe pain. It is also used in the treatment of Heroin (Opiate dependence: Vicodin, Percolate, Morphine, etc) addiction. Oral Methadone is very different than the IV Methadone. Oral Methadone is partially stored in the liver for later use. IV Methadone acts more like Heroin.

Methadone is a long acting pain reliever producing effects that last between twelve to forty-eight hours. Ideally, Methadone frees the client from the pressures of obtaining illegal Heroin, from the dangers of injection, and from the emotional roller coaster that most Opiates produce. Methadone, if taken for long periods and at large doses, can lead to a very long withdrawal period. The withdrawals from Methadone are more prolonged and troublesome than those provoked by heroin cessation, yet the substitution and phased removal of methadone is an acceptable method of detoxification for patients and therapists.1
The MTD One Step Methadone 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 Methadone in urine. The MTD One Step Methadone Test Strip (Urine) yields a positive result when the Methadone in urine exceeds 300ng/mL.

Test Principle

The MTD One Step Methadone 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. Methadone, if present in the urine specimen below 300 ng/mL, will not saturate the binding sites of antibody-coated particles in the test strip. The antibody-coated particles will then be captured by immobilized Methadone 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 Methadone level exceeds 300 ng/mL because it will saturate all the binding sites of anti-Methadone antibodies.

A drug-positive urine specimen will not generate a colored line in the test line region, while a drug-negative urine specimen or a specimen containing a drug in a concentration less than the cut-off will generate a colored 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

1. Bring the pouch to room temperature before opening it. Remove the Test Dipstick from the sealed pouch and use it within one hour.
2. With arrows pointing towards the urine specimen, immerse the Test Dipstick vertically in the urine specimen in such a way that urine does not cross MAX line on the Test Dipstick for 10-15 seconds. See the illustration below.
3. Wait for the color line(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.

INTERPRETATION OF RESULTS


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 Methadone at the following concentrations: 0 ng/mL, 0 ng/mL, 150 ng/mL, 225 ng/mL, 300 ng/mL, 375 ng/mL, 450 ng/mLand600 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 MTD concentration equal to or lower than 150ng/mL show negative results, all specimens with MTD concentration of 300ng/mL are identified as “+/-”, and all specimens with MTD concentration equal to or higher than 450ng/mL showed positive results. Therefore, the cut-off concentration of the MTD One Step Methadone Test Strip (Urine) is determined to be 300ng/mL MTD.


Analytical Specificity

Table 3 lists the compounds that are positively detected in urine by the MTD One Step Methadone 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.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical  Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

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.