Orient New Life Medical Co.,Ltd.
| Payment Terms | T/T, Western Union |
| Supply Ability | 2000000pcs/month |
| Delivery Time | 20-30days |
| Packaging Details | 1pc/pouch, 25pcs/box |
| Category | DOA TESGTING kits |
| Format | STRIP |
| Specimen | Urine |
| Testing time | 5-15 minutes |
| Shelf Life | 24 Months |
| application | TML DOA |
| cut-off | 100ng |
| Brand Name | New Life |
| Model Number | STRIP |
| Certification | ISO13485, CE |
| Place of Origin | China |
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Product Specification
| Payment Terms | T/T, Western Union | Supply Ability | 2000000pcs/month |
| Delivery Time | 20-30days | Packaging Details | 1pc/pouch, 25pcs/box |
| Category | DOA TESGTING kits | Format | STRIP |
| Specimen | Urine | Testing time | 5-15 minutes |
| Shelf Life | 24 Months | application | TML DOA |
| cut-off | 100ng | Brand Name | New Life |
| Model Number | STRIP | Certification | ISO13485, CE |
| Place of Origin | China | ||
| High Light | drug test strips ， accurate drug test kits | ||
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
| Product | Cat No | Specimen | Sensitivity | Format | Kit Size |
| TML | YD171S3 | Urine | 100 ng/mL | 3mm Strip | 100T |
| YD171C4 | 4mm Cassette | 25T |
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.
| Parameter | Calibrator | Cut-off (ng/mL) |
| TML | Tramadol | 100 |
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
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:
| Method | GC/MS | Total | |||
| Results | Positive | Negative | Results | ||
| TML Rapid Test Dipstick | Positive | 82 | 12 | 94 | |
| Negative | 11 | 145 | 156 | ||
| Total Results | 93 | 157 | 250 | ||
| % Agreement with GC/MS | 88.2% | 92.4% | 90.8% | ||
| Analytical Sensitivity | |||||
| Tramadol Concentration | Percent of | n | Visual Result | |
| (ng/mL) | Cut-off | Negative | Positive | |
| 0 | 0% | 30 | 30 | 0 |
| 50 | -50% | 30 | 30 | 0 |
| 75 | -25% | 30 | 27 | 3 |
| 100 | Cut-off | 30 | 15 | 15 |
| 125 | +25% | 30 | 4 | 26 |
| 150 | +50% | 30 | 0 | 30 |
| 300 | 3X | 30 | 0 | 30 |
| ORIENT NEW LIFE MEDICAL CO., LTD. | |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
Company Details
Business Type:
Manufacturer,Exporter
Year Established:
2009
Total Annual:
10,000,000-15,000,000
Employee Number:
200~300
Ecer Certification：
Active Member
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 diagnosti... 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 diagnosti...
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