Audited Supplier
A rapid test for the simultaneous, qualitative detection of multiple drugs and drug metabolites and alcohol in human oral fluid. For healthcare professionals including professionals at point of care sites.
The test results can be used to provide evidence and basis for therapy and treatment plans of drug dependence and toxic psychosis. For laboratory professional in vitro diagnostic use only.
For professional use only.
For in vitro diagnostic use only.
| Storage | 2~30 º C |
| Specimen | Saliva |
| Component | Rapid Test + IFU |
| Principle | Colloidal gold rapid tests |
| Reading | Within 5mins |
| Package | 40tests/box Or other package according to customer's request. |
| Trademark | Dewei |
| Origin | China |
INTENDED USE
The Multi-Drug Rapid Test for AMP/ MET/ COC/ OPI/ MOP/THC/ PCP/ MTD/ MDMA/ BZO/ OXY/ COT/ K2/ KET/ BAR/ BUP/ 6-MAM/ TML/ FYL/CFYL/ MDPV/ α-PVP/ LSD/ALC is a lateral flow chromatographic immunoassay for the qualitative detection of multiple drugs and drug metabolites in oral fluid at the following cut-off concentrations:| Test | Calibrator | Cut-off (ng/ml) |
| Amphetamine (AMP) | d-Amphetamine | 50 |
| Methamphetamine (MET) | d-Methamphetamine | 50 |
| MarijuanaTHC) | 11-nor-Δ9 -THC-9 COOH | 50/12 |
| Phencyclidine (PCP) | Phencyclidine | 10 |
| Cocaine (COC) | Benzoylecgonine | 20 |
| Opiates (OPI/MOP) | Morphine | 50/40 |
| Methadone (MTD) | Methadone | 30 |
| Methylenedioxymethamphetamine (MDMA) | d,l-Methylenedioxymethamphetamine | 50/20 |
| Oxycodone (OXY) | Oxycodone | 20 |
| Cotinine(COT) | Cotinine | 20 |
| Benzodiazepines (BZO) | Oxazepam | 50/30/20/10 |
| SyntheticMarijuanaK2) | JWH -018, JWH- 073 | 25 |
| Ketamine(KET) | Ketamine | 100/50 |
| Barbiturates(BAR) | Secobarbital | 50 |
| Buprenorphine (BUP) | Buprenorphine | 10 |
| Tramadol(TML) | Tramadol | 30 |
| 6-mono-aceto-morphine (6-MAM) | 6-mono-aceto-morphine | 10 |
| Fentanyl(FYL) | Fentanyl | 50/20 |
| Carfentanyl(CFYL) | Carfentanyl | 50 |
| 3, 4-methylenedioxypyrovalerone (MDPV) | 3, 4-methylenedioxypyrovalerone | 300 |
| alpha-Pyrrolidinovalerophenone (α-PVP) | alpha-Pyrrolidinovalerophenone | 300 |
| Lysergic Acid Diethylamide (LSD) | Lysergic Acid Diethylamide | 10 |
| Test | Calibrator | Cut-off |
| Alcohol(ALC) | Alcohol | 0.02% |
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) and gas chromatography/tandem mass spectrometry (GC/MS) are the preferred confirmatory methods. Professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
DIRECTIONS FOR USE
Allow the test, specimen, and/or controls to reach room temperature (15-30°C) prior to testing. Instruct the donor to not place anything in the mouth including food, drink, gum or tobacco products for at least 10 minutes prior to collection.Put the absorbent wick under the tongue to collect oral fluid until the flow appear in the test windows (approximately 60 seconds) and then take out the device and start a timer.
If no flow, appeared repeat the procedure in steps above until the flow appear. If no flow appeared after triplicate of steps above, discard the device, review procedures with the donor and repeat the test using a new device.
NEGATIVE:* A colored line appears in the Control region (C) and colored line appears in the Test region (T). This negative result means that the concentration in the oral fluid sample is below the designated cut-off levels for a particular drug tested.
*NOTE: The shade of the colored line(s) in the Test regions (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 oral fluid 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. If the result is still invalid, contact your manufacturer.
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