SUMMARY
The OrALert™ Oral Fluid Drug Screen Device for AMP mAMP COC OPI THC PCP and their metabolites is a rapid, oral fluid screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in human oral fluid.
Amphetamine (AMP)
Depending on the route of administration, amphetamine can be detected in oral fluid as early as 5-10 minutes following use.1 Amphetamine can be detected in oral fluid for up to 72
hours after use.
The Amphetamine assay contained within the OrALert TM Oral Fluid Drug Screen Device yields a positive result
when the amphetamine concentration in oral fluid exceeds 50 ng/mL.
Cocaine (COC)
Cocaine is a potent CNS stimulant and a local anesthetic derived from the coca plant (erythroxylum coca).
The drug is often self-administered by nasal inhalation, intravenous injection
Opiates (OPI)
Using an immunoassay cutoff level
of 40 ng/mL, codeine can be detected in the oral fluid within 1 hour following a single oral dose and can
remain detectable for 7-21 hours after the dose.2 6-Monoacetylmorphine (6-MAM) is found more prevalently
in oral fluid, and is a metabolic product of heroin. Morphine is a major metabolic product of codeine and
heroin, and is detectable for 24-48 hours following an opiate dose.
The Opiates assay contained within the OrALert TM Oral Fluid Drug Screen Device yields a positive result when
the morphine concentration in oral fluid exceeds 40 ng/mL.
Marijuana (THC)
Historical studies have shown a window of detection for THC in oral fluid of up to 14 hours
after drug use.3
The THC assay contained within the OrALert TM Oral Fluid Drug Screen Device yields a positive result when the
Delta9-THC concentration in oral fluid exceeds 100 ng/mL.
Methamphetamine (mAMP)
Depending on the route of administration, methamphetamine can be detected in oral fluid as early
as 5-10 minutes following use.1 Methamphetamine can be detected in oral fluid for up to 72 hours after use.
The Methamphetamine assay contained within the OrALert TM Oral Fluid Drug Screen Device yields a positive
result when the methamphetamine concentration in oral fluid exceeds 50 ng/mL.
Phencyclidine (PCP)
Phencyclidine (PCP), the hallucinogen commonly referred to as Angel Dust, can be detected in oral fluid as a
result of the exchange of the drug between the circulatory system and the oral cavity. In a paired serum and
oral fluid sample collection of 100 patients in a hospital emergency department, PCP was detected in the oral
fluid of 79 patients at levels as low as 2 ng/mL and as high as 600 ng/mL.
The Phencyclidine assay contained within the OrALert TM Oral Fluid Drug Screen Device yields a positive result
when the PCP concentration in oral fluid exceeds 10 ng/mL.
The Oral Fluid Drug Test detection time
|
Cocaine (COC) |
up to 24 hours |
| Amphetamine (AMP) |
up to 72
hours |
| Methamphetamine (mAMP) |
up to 72 hours |
| Opiates (OPI) |
24-48 hours |
| Marijuana (THC) |
up to 14 hours |
INTENDED USE
Oral Fluid Drug Screen Device for ( AMP mAMP COC OPI THC PCP ) is a lateral flow
chromatographic immunoassay for the qualitative detection of amphetamine, methamphetamine, cocaine,
opiates, marijuana, phencyclidine and their metabolites in oral fluids at the following cut-off concentrations:
| Test |
Calibrator |
Cut-off |
| Amphetamine (AMP) |
d-Amphetamine |
50 ng/mL |
| Cocaine (COC) |
Benzoylecgonine |
20 ng/mL |
| Methamphetamine (mAMP) |
d-Methamphetamine |
50 ng/mL |
| Opiates (OPI) |
Morphine |
40 ng/mL |
| Phencyclidine (PCP) |
Phencyclidine |
10 ng/mL |
| Marijuana (THC) |
Delta9-THC |
100 ng/mL |
Analytical Specificity
The following table lists the concentration of compounds (ng/mL) above which the OrALert™ Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/PCP identified positive results at a read time of 10 minutes.
| AMPHETAMINE (AMP) |
| d-Amphetamine |
50 |
| d,l-Amphetamine |
125 |
| β-Phenylethylamine |
40000 |
| Tryptamine |
1500 |
| p-Hydroxyamphetamine |
800 |
| 3,4-Methylendioxyamphetamine (MDA) |
150 |
| l-Amphetamine |
4000 |
| COCAINE (COC) |
| Benzoylecgonine |
20 |
| Cocaine |
20 |
| Cocaethylene |
25 |
| Ecgonine |
1500 |
| Ecgonine methylester |
12500 |
| MARIJUANA (THC) |
| 11-nor-Delta9 -THC-9 COOH |
12 |
| Cannabinol |
3000 |
| Delta8 –THC |
100 |
| Delta9 –THC |
100 |
| METHAMPHETAMINE (mAMP) |
| d-Methamphetamine |
50 |
| p-Hydroxymethamphetamine |
400 |
| Fenfluramine |
60000 |
| Methoxyphenamine |
25000 |
| 3,4–Methylenedioxymethamphetamine (MDMA) |
50 |
| l-Phenylephrine |
4000 |
| Procaine |
2000 |
| (1R,2S) - (-) Ephedrine |
400 |
| OPIATES (OPI) |
| Morphine |
40 |
| Codeine |
10 |
| Ethylmorphine |
24 |
| Hydrocodone |
100 |
| Hydromorphone |
100 |
| Levorphanol |
400 |
| 6-Monoacetylmorphine (6-MAM) |
25 |
| Morphine 3-β-D-glucuronide |
50 |
| Norcodeine |
1500 |
| Normorphine |
12500 |
| Oxycodone |
25000 |
| Oxymorphone |
25000 |
| Diacetylmorphine (Heroin) |
50 |
| Thebaine |
1500 |
| Nalorphine |
10000 |
| PHENCYCLIDINE (PCP) |
| Phencyclidine |
10 |
| Tetrahydrozoline |
50000 |
The OrALert TM Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/PCP is a lateral flow chromatographic immunoassay for the qualitative detection of amphetamine, methamphetamine, cocaine, opiates, marijuana, phencyclidine and their metabolites in oral fluids at the following cut-off concentrations:
The OrALert TM Oral Fluid Drug Screen Device for AMP/mAMP/COC/OPI/THC/PCP is an immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid specimen compete against their respective drug conjugates for binding sites on their specific antibody.
During testing, a portion of the oral fluid specimen migrates upward by capillary action. A drug, if present in the oral fluid specimen below its cut-off concentration, will not saturate the binding sites of its specific
antibody. The antibody will then react with the drug-protein conjugate and a visible colored line will show up in the test line region of the specific drug strip. The presence of drug above the cut-off concentration in the oral
fluid specimen will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test line region.
A drug-positive oral fluid specimen will not generate a colored line in the specific test line region of the strip because of drug competition, while a drug-negative oral fluid specimen will generate a line in the test line
region because of the absence of drug competition.
To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.