Saliva Drug Test Pen Midstream of Multi-Drug (Oral Fluid) Rapid Test Cassette

• Type: IVD Reagent
• Component: Rapid Test Pen
• Specimen: Saliva Oral Fluid
• Result Time: Within 5 Mins
• Storage: 2~30 º C
• Principle: Immunochromatography
• Model NO.: DOA
• Shelf Life: 24 Months
• Certificate: CE
• Usage: Professional Used
• Transport Package: 25tests/Box; 40tests/Box
• Specification: 1000tests/carton
• Trademark: Dewei
• Origin: China

Product Description

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.

1. Bring the pouch to room temperature before opening it. Remove the test from the sealed pouch and use it within one hour.

2. Take off the test cap and collect oral fluid specimen as follows.

Important: Place the tongue against the upper and lower jaws and roots to enrich the oral fluid. Insert the sponge end into the mouth, actively swab around the gums on both sides of the mouth (10-15 times) to assist saturation.
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.

3. Place the test device on a clean and level surface.

4. Read the test result at 3-10 minutes. 

If all lines are clearly visible at 3 minutes or sooner, then the test can be interpreted as negative and discarded. If any lines are not visible at 3 minutes, then the test should be re-read at 10 minutes.

5. Alcohol indicator, when applicable, the result should be read at 3-5 minutes. Compare the color of the reaction pad with the color chart provided separately/on foil pouch to determine the relative oral fluid alcohol level.

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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