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ORAL-VIEW™ Saliva Multi-Drug of Abuse Test

One Step Assay
PRINCIPLE OF THE PROCEDURE
Rapid Visual Results
For Forensic Use Only
The ORAL-VIEW™ Saliva Multi-Drug of Abuse Test is a one-step lateral flow chromatographic immunoassay based on the principle of INTENDED USE
competition for limited antibody binding sites between the drug in the The ORAL-VIEW™ Saliva Multi-Drug of Abuse Test is a one-step rapid sample and a drug-protein conjugate immobilized on a porous qualitative immunoassay for screening potential abuse of one or more drugs in human oral fluid at the following concentrations: During testing, oral fluid migrates to the testing area of the membrane by capillary action, mobilizing the colored antibody conjugates. The Abbreviation Test
Cutoff Detection
antibody conjugates then move along the membrane to the test area. In the absence of drug, or if the drug concentration in oral fluid is below the cutoff limit, the colored conjugates attach to the respective drug antigen immobilized in the test line region, forming a colored band (T line). If drug is present in oral fluid, the drug competes for limited antibody binding sites. If the drug concentration is at or above the cutoff limit, the This test provides only a preliminary result. A more specific alternate drug will saturate all the binding sites of the antibody, preventing the chemical method must be used in order to obtain a confirmed analytical attachment of the colored conjugates to the antigen in the test line area result. Gas chromatography/mass spectrometry (GC/MS) or high of the membrane. Therefore no colored line will form. performance liquid chromatography (HPLC) are the preferred confirmatory methods. Clinical consideration and professional judgment The control line (C line) serves as an internal quality control. It should should be applied to any drug of abuse test result, particularly when always appear as a colored band regardless of the presence of the drug. preliminary positive results are obtained. REAGENTS AND MATERIALS SUPPLIED
25 Individually pouched test devices with caps Amphetamine (AMP)
Amphetamines are central nervous system stimulating drugs. They may MATERIALS REQUIRED BUT NOT PROVIDED
induce alertness, wakefulness, increased energy, reduced hunger and overall feeling of well being. Overdose and extended usage of amphetamines may lead to substance abuse, which may cause severe and/or permanent damage to the human nervous system. TEST FORMAT
Benzodiazepines (BZD)
Benzodiazepines, including alprazolam, diazepam, lorazepam, triazolam,
chlordiazepoxide, flurazepam and temazepam are sedative, hypnotic
and anti-anxiety drugs commonly used as oral tranquilizers.
Benzodiazepines have a low potential for physical or psychological dependence. However, the same as other central nervous system stimulating drugs, they may induce drowsiness and muscle relaxation. Chronic abuse of benzodiazepine may result in intoxication, similar to drunken behavior. Overdose and extended usage of benzodiazepines may lead to coma and possibly death. Benzodiazepines are absorbed at different rates and their effects may vary with the absorption rate. Cocaine (COC)
Cocaine is a nervous system stimulant that can be addictive. Physical
effects of cocaine use include constricted peripheral blood vessels,
dilated pupils, and increased body temperature, heart rate and blood
pressure. Some cocaine users report feelings of restlessness, irritability
and anxiety, both while using and between periods of use. High doses of
cocaine and/or prolonged use can trigger paranoia. Smoking crack
cocaine can produce particularly aggressive paranoid behavior in users.
Long-term effects: Prolonged cocaine use can result in ulceration of the
mucous membrane of the nose and can damage the nasal septum
enough to cause it to collapse. Cocaine-related deaths are often a result
of cardiac arrest or seizures followed by respiratory arrest.
Morphine (OPI)
Morphine is a frequently prescribed drug (under the trade name Serax)
for treatment of moderate to severe pain. It is also a common metabolite
of opiates [morphine, codeine (methyl-morphine), and heroin (semi- Test device shown capped and uncapped to expose collection pad. synthetic derivatives of morphine)]. Opiates are administered either by PRECAUTIONS
smoking, intravenous injection, intramuscular injection or oral ingestion. Adverse or toxic effects of opiates usage include pupillary constriction, The instructions must be followed exactly to obtain accurate results. constipation, urinary retention, nausea, vomiting, hypothermia, Do not open the sealed pouch unless ready to perform the test. drowsiness, dizziness, apathy, confusion, respiratory depression, hypotension, cold and clammy skin, coma and pulmonary edema. Death Do not allow oral fluid specimens to contact the result window. Marijuana (THC)
Dispose of used devices according to local regulations. Tetrahydrocannabinols (THC, Δ9-THC) are the most active of the principal constituents of cannabinoids such as marijuana and hashish, as STORAGE AND STABILITY
well as the major metabolites. Cannabinoids have been used as central Store the product in the sealed pouch at room temperature 15-30°C nervous system depressants. Overdose and extended usage of (59-86°F). Each device may be used until the expiration date cannabinoids may lead to substance abuse, which may cause severe printed on the label if it remains sealed in its foil pouch. and/or permanent damage to the human nervous system. Do not freeze the kit or expose to temperatures over 30°C (86°F). ORAL-VIEW™ Saliva Multi-Drug of Abuse Test
SPECIMEN COLLECTION AND TESTING
LIMITATIONS
IMPORTANT: Test devices must be at room temperature (15-30°C)
before testing.
This product is for testing human oral fluid only. 1. Bring the sealed pouch to room temperature before opening.
• Results obtained by this device provide only a preliminary, Remove the test device from the pouch and use it as soon as qualitative analytical test result. A more specific alternate oral fluid method must be used to obtain a confirmed analytical result. 2. Insert the collection pad end of the device into the subject’s
• A negative result may not necessarily indicate a drug-free mouth, wiping the pad in the subject’s mouth for about 1-3 minutes
specimen. Drugs may be present in the specimen below the cut-off until the collection pad is completely saturated. Keep the opposite
end of the device angled downward to ensure good flow (also refer
to the procedure card), and do not pull on or chew the collection
EXPECTED VALUES
3. When color appears in the result window, remove the device from
This test is capable of detecting specific drugs and/or drug metabolites in the subject’s mouth and replace the cap onto the collection pad end
human oral fluid at or above the cutoff concentrations indicated in the of the device. Lay the device on a flat surface. 4. Start timing once the C line is visible in the test window. Read
results 5-7 minutes after the C line appears.
PERFORMANCE CHARACTERISTICS
Accuracy
INTERPRETATION OF RESULTS
A comparison study was performed at an academy of science. Ninety (90) samples were blind labeled and tested for each analyte (drug or IMPORTANT: Do not read test results after seven (7) minutes following
drug metabolite). Each sample was tested with the test device, and the appearance of the C line. The T line should always be interpreted results were compared to HPLC/MS results. The test results were independently of the C line. Do not compare line intensities between grouped into: below 50% cutoff (Negative), between 50% cutoff and cutoff, between cutoff and 150% cutoff, and above 150% cutoff (Positive). Seven (7) discrepancies were observed at the cutoff to 150% cutoff level. Overall, this device exhibits greater than 95% agreement with the HPLC/MS results. The test results are tabulated as follows: Cutoff: 50 ng/mL
Positive Negative Total Agreement
PRELIMINARY
NEGATIVE
HPLC/MS Cutoff-150% 8
POSITIVE
Preliminary Positive
Cutoff: 20 ng/mL
Total Agreement
A colored line in the control line region (C) with no line in the test line
region (T) indicates a preliminary positive result for that drug. Preliminary positive results should be confirmed with a more
HPLC/MS Cutoff-150% 9
specific method before positive determinations are made.
Negative
A colored line in the control line region (C) and another line in the test Cutoff: 20 ng/mL
Total Agreement
line region (T) indicate that the respective drug is not present, or that the drug concentration in the oral fluid specimen is below the designated HPLC/MS Cutoff-150% 8
Faint T lines should be considered negative results.
If no C line develops, the result is invalid. Insufficient specimen volume Cutoff: 40 ng/mL
Total Agreement
or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test device. If the problem persists, stop testing and contact your local HPLC/MS Cutoff-150% 10
QUALITY CONTROL
Cutoff: 12 ng/mL
Total Agreement
Built-in Control:
This test contains a built-in control feature. The presence of the C line indicates that an adequate sample volume was used and that the HPLC/MS Cutoff-150% 8
reagents migrated properly. If no C line forms, the result is considered invalid. Review the procedure and repeat testing with a new device. External Quality Control:
It is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify Reproducibility
proper test performance. Users should always follow appropriate local The reproducibility of the test was determined by replicate assays of guidelines concerning the running of external quality controls. three product development lots with four levels of samples: negative, 50% cutoff, 150% cutoff and positive. A total of two hundred and sixteen devices were tested for three consecutive days, six replicates per day. The results indicate greater than 97% precision for the replicates within each lot and for inter-lot variation. ORAL-VIEW™ Saliva Multi-Drug of Abuse Test
Cross Reactivity
REFERENCES
The cross reactivity of the test was evaluated by spiking drug free samples with structurally related compounds. Compounds producing 1. Jenkins AJ, Goldberger BA, editors. On-Site Drug Testing. 2. Baselt RC, Cravey RH, editors. Disposition of Toxic Drugs and Drug Compound
Concentration
Chemicals in Man. 4th ed. Davis (CA): Biomedical Publications; 3. National Institute on Drug Abuse. Mandatory guidelines for federal workplace drug testing programs. Fed Regist 1988 Wilson J. Abused Drugs II: A Laboratory Pocket Guide. Washington ng/mL 5. Gilman AG, Rall TW, Nies AS, Taylor P, editors. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 8th ed. New ALFA SCIENTIFIC DESIGNS, INC.
MADE IN USA
REF 4231
Interference
The following common substances were evaluated in both drug free saliva pools and in pools spiked at the cutoff level of each substance. The following table lists the concentrations at which the analytes do not interfere with the test results: Substance Concentration
Substance
Concentration
Hydroxybutyric acid 1,000 µg/mL Ecgonine Substance Concentration
Substance
Concentration

Source: http://www.noblemedical.com/pdf/INSTAVIEW/nm_instaview-pac.pdf