TML Urine Drug Abuse Test Kit Gold Colloidal 100ng/Ml Cut Off Qualitative Detection

Drug Test Kit TML Rapid Diagnostic Test strip, detecting Tramadol in urine,Gold colloidal method, 100ng/ml cut-off

Product Name

One Step TML (Tramadol) Rapid Diagnostic Test Strip

Specimen: Urine

Intended Use

The TML Rapid Test Strip (Urine) is a rapid immunochromatographic assay for the qualitative detection of Tramadol in human urine at a cut-off concentration of 100 ng/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

Tramadol(TML) is a quasi-narcotic analgesic used in the treatment of moderate to severe pain. It is a synthetic analog of codeine, but has a low binding affinity to the mu-opioid receptors. Large doses of tramadol can develop tolerance and physiological dependency and lead to its abuse. Tramadol is extensively metabolized after oral administration. Approximately 30% of the dose is excreted in the urine as unchanged drug, whereas 60% is excreted as metabolites. The major pathways appear to be N - and O- demethylation, glucoronidation or sulfation in the liver.The TML Rapid Test Dipstick (Urine) is a rapid urine-screening test that can be performed without the use of an instrument. The test utilizes the antibody to selectively detect elevated levels of Tramadol in urine. The TML Rapid Test Dipstick (Urine) yields a positive result when Tramadol in urine exceeds 100 ng/mL. At present, the Substance Abuse and Mental Health Services Administration (SAMHSA) does not have a recommended screening cutoff for Tramadol positive specimens.

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.

EXPECTED VALUE

This negative result indicates that the Tramadol concentration is below the detectable level of 100ng/ml. Positive result means the concentration of Tramadol is above the level of 100ng/ml. The TML Rapid Test Dipstick has a sensitivity of 100ng/mL

PERFORMANCE

Accuracy

A comparison was conducted using the TML Rapid Test Dipstick (Urine) and GC/MS at 100 ng/mL cutoff. The following results were tabulated:

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.