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US FDA 510k, CLEARED, CLIA WAIVED, Drug Free Test Screen Cup For Safety Workplace
Introduction
This Screening Test Cup is a competitive immunoassay that is used to screen for the presence of various drugs and drug metabolites in urine. It is chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody (mouse) conjugate binding sites.
When the test is activated, the urine is absorbed into each test strip by capillary action, mixes with the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug within the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test strip. This produces a colored Test line in the Test Region (T) of the strip, which, regardless of its intensity, indicates a negative test result.
When sample drug levels are at or above the detection level of the test, the free drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective 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, indicating a preliminary positive result. To serve as a procedure control, a colored line will appear at the Control Region (C), of each strip, if the test has been performed properly.
Drug testing item list
| Drug(Identifier) | Calibrator | Cut-off level |
| Amphetamine (AMP) | d-Amphetamine | 1000ng/mL |
| Barbiturates (BAR) | Secobarbital | 300 ng/mL |
| Benzodiazepines (BZO) | Oxazepam | 300 ng/mL |
| Buprenorphine(BUP) | Buprenorphine | 10 ng/mL |
| Cocaine /COC | Benzoylecgonine | 300 ng/mL |
| marijuana (THC) | 11-nor-Δ9-THC-9-COOH | 50 ng/mL |
| Methamphetamine (MET) | d-Methamphetamine | 1000ng/mL |
| Methadone (MTD) | Methadone | 300 ng/mL |
| Methadone Metabolite(EDDP) | 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine(EDDP) | 300 ng/mL |
| Methylenedioxymethamphetamine - ecstasy (MDMA) | 3,4-Methylenedioxymethamphetami ne HCl (MDMA) | 500 ng/mL |
| Morphine(MOP300) | Morphine | 300ng/mL |
| Opiate 2000 (OPI) | Morphine | 2000ng/mL |
| Oxycodone (OXY) | Oxycodone | 300 ng/mL |
| Phencyclidine (PCP) | Phencyclidine | 25 ng/mL |
| Propoxyphene(PPX) | Propoxyphene | 300 ng/mL |
| Tri-cyclic Antidepressants (TCA) | Notriptyline | 1000ng/mL |
Note:
The test you purchased may test for any combination of drugs listed in the table above. This assay provides only a preliminary analytical test 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 indicated.
Characteristic
Specificity:Over 99%.
Time to results:2- 5 minutes
Specimen: Urine.
Storage: 4°C - 30°C. in room condition
Shelf Life: 24 months
Insert
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