ACCU-TELL MULTI-7 DRUG SALIVA TEST (CE)

Declaration: As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.

 

CATALOG

INTENDED USE

Accu-Tell ^®  Rapid Multi-Drug Saliva Test Panel is rapid, qualitative, competitive immunoassay for the determination of Drug-of-Abuse (DOA) and/or their metabolites in human saliva. The device allows the detection of multiple drugs in one simple step. Rapid Multi-Drug Screen Test is intended to be used in Professional Medical & Forensic laboratories.

This test 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 spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Accu-Tell ^® Rapid Multi-Drug Saliva Test Panel employs unique antibodies to selectively identify the following drugs of abuse and/or their metabolites in saliva with high degree of sensitivity and specificity:

AMPHETAMINES are central nervous system stimulants that produce alertness, wakefulness, increased energy, reduced hunger, and an overall feeling of well being. Large doses of Amphetamine could cause the development of tolerances and physiological dependency and lead to its abuse. SAMHSA (NIDA) recommended cutoff level for Amphetamine screening tests is 50 ng/ml in saliva.

COCAINE is derived from the leaves of the cocoa plant and is a potent central nervous system stimulant as well as a local anesthetic. Some of the psychological effects induced by Cocaine are: euphoria, confidence and sense of increased energy, accompanied by increased heart rate, dilation of the pupils, fever, tremors and sweating. Continued ingestion of Cocaine could induce tolerances and physiological dependency that lead to its abuse. Cocaine is excreted in the saliva primarily as Benzoylecgonine within a short period of time. Benzoylecgonine has a biological half-life of 5 to 8 hours, which is much longer than that of Cocaine (0.5 to 1.5 hours), and can be generally detected for 24-60 hours after cocaine use or exposure. SAMHSA (NIDA) recommended cutoff level for Benzoylecgonine screening tests is 20ng/ml in saliva.

OPIATES (Morphine) have been a preferred drug for the management of pain in advanced cancer. Large doses of Morphine could cause the development of tolerances and physiological dependency and lead to its abuse. Morphine and its metabolites detected in saliva may be present as a result of Heroin, Morphine, Codeine, or poppy seed intake. SAMHSA (NIDA) recommended cutoff level for Opiates screening tests is 40ng/ml in saliva.

THC (Marijuana) is a hallucinogenic agent derived from the flowering portion of the hemp plant. Smoking is the primary method of use of marijuana. Cannabinoids have been proposed for therapy for acute glaucoma and parsea due to chemotherapy. Higher doses used by abusers produce central nervous system effects, altered mood and sensory perceptions, loss of coordination, impaired short term memory, anxiety, paranoia, depression, confusion, hallucinations and increased heart rate. A tolerance to the cardiac and psychotropic effects can occur, and withdrawal syndrome produces restlessness, insomnia, anorexia and nausea. When marijuana is ingested, the drug is metabolized by the liver. The primary urinary metabolite of marijuana is 11-nor-Δ-9-tetrahydrocannabinol-9-carboxylic acid and its glucuronide. The presence of Cannabinoids, including the primary carboxyl metabolite, in saliva indicates marijuana use. All cannabinoids are controlled substances, and the SAMHSA (NIDA) recommended cutoff level for cannabinoid screening tests is 4ng/ml in saliva.

METHAMPHETAMINE is a potent sympathomimetic agent with therapeutic applications. Acute higher doses lead to enhanced stimulation of the central nervous system and induce euphoria, alertness, and a sense of increased energy and power. Large doses of methamphetamine could cause the development of tolerances and physiological dependency and lead to its abuse. SAMHSA (NIDA) recommended cutoff level for Methamphetamine screening tests is 50ng/ml in saliva.

BENZODIAZEPINES are therapeutically used for anxiolytic, hypnotic, anticonvulsant, and muscle relaxant effects. Acute higher doses lead to drowsiness, dizziness, muscle relaxation, lethargy and even coma. Many of the benzodiazepines share a common metabolic route, and are excreted as oxazepam and its glucuronide in saliva. Thus the presence of the oxazepam in the saliva indicates parent benzodiazepines use. SAMHSA (NIDA) recommended cutoff level for Benzodiazepines screening tests is 50ng/ml in saliva.

MDMA is a stimulant with hallucinogenic tendencies, described as an empathogen as it releases mood-altering chemicals, such as cartooning and L-dopa, in the brain and may generate feelings of love and friendliness. MDMA is a Class A drug, in the same category as heroin and cocaine. The adverse effects of MDMA use include elevated blood pressure, hyperthermia, anxiety, paranoia, and insomnia. Overdoses of MDMA can be fatal, often resulting in heart failure or heart stoke. SAMHSA (NIDA) recommended cutoff level for MDMA screening tests is 50ng/ml in saliva.

Accu-Tell ^®  Rapid Multi-Drug Saliva Test Panel is a device composed of 2-7 chromatographic strips designed to detect 2-7(as per the format) individual drugs of abuse. Each strip consists of a sample pad treated with antibody colloidal gold conjugate and membrane treated with drug conjugate and control reagent. Saliva sample initially reacts with the antibody gold conjugate, and then migrates up the strip, by capillary action, to the test area. If sufficient drug is present in the saliva, it binds with the conjugate, preventing it from binding to the drug conjugate immobilized on the membrane in the test region. Any unbound conjugate continues to migrate up the strip to the control region where it binds to the control reagent producing a pink/purple band. The control band indicates that the result is valid.

A negative specimen produces two (2) distinct color lines, one in the test area and one in the control area. A positive specimen produces only one (1) color line in the control area.

1.  For in vitro diagnostic use only.

2.  For professional Medical and Forensic use only.

3.  Do not use the kit beyond the expiration date imprinted on the outside of the foil pouch.

4.  Do not open the foil pouch until the saliva is collected and ready to be tested.

5.  Avoid cross contamination of saliva samples by using a new saliva sample cup for each sample.

6.  Saliva specimens may be infectious. Upon completion of all testing dispose of residual saliva in an approved manner. Properly handle and dispose of all used reaction devices in a biohazard container.

The device can be stored under refrigeration or at room temperature (2-30°C) and will be stable until the expiration date.

The sample must be collected in the provided container or any clean dry plastic or glass container of a similar size. Saliva specimens may be refrigerated (2-8°C) and stored up to 48 hours, or frozen (-20°C or colder) prior to assaying. If samples are refrigerated or frozen, they should be allowed to come to room temperature before testing. Saliva samples exhibiting visible precipitates should be filtered, centrifuged or allowed to settle so that clear aliquots can be obtained for testing.

1.  Bring all materials and specimens to room temperature.

2.  Remove test device from the sealed foil pouch.

3.  Dispense 80 ul of saliva sample by pipette to each sample well of the test device.

4.  Read results between 3 – 8 minutes. Do not interpret results after 8 minutes.

Positive: One (1) pink/purple band appears in the control region. No band is found in the test region. This is an indication that the drug level is above the detection sensitivity level.

Negative: Two (2) pink/purple bands form. In addition to the control band, a pink/purple band also appears in the test region.

Note: This immunoassay is a screening test. A negative result indicates the drug level is below the detection sensitivity. It is important to understand that concentrations of the drug below cut off may cause a faint “ghost line” to form in the test region. This “ghost line” should be considered a negative result.

Invalid: If there are no distinct color bands in either the test or control region of the device, the test result is invalid. Retest the sample using a new device.

Note: Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when results are positive. Positive results should be confirmed by an alternate method such as GC/MS.

1.  Each strip has its own control band to indicate that the test is adequately performed. Any invalid result must be repeated using a new test panel.

2.  Good laboratory practice recommends the use of positive and drug free saliva controls to validate reagent performance and establish test reliability. Commercial drug saliva controls are available to assess the performance of this device.

Saliva specimens may be infectious. Upon completion of all testing discard the residual saliva in an approved manner. Properly handle and dispose of all used devices in a biohazard container.

PERFORMANCE CHARACTERISTICS

1.  This product is designed to be used for the detection of DOA and/or their metabolites in human saliva only.

2.  Although Accu-Tell ^® Rapid Multi-Drug Saliva Test Panel is very accurate in detecting the saliva drug levels, there is a possibility of false results due to the presence of interfering substances in the saliva.

3.  The test is a qualitative screening assay and is not suggested for determining the quantitative level of DOA in saliva.

4.  Adulterants, such as bleach or other strong oxidizing agents, when added to saliva specimens, may produce erroneous test results regardless of the analysis method used. If adulteration is suspected, obtain another saliva specimen.

1.  Ambre, J.J., Anal. Toxicol., 9;241-5, (1985).

2.  Baselt, R.C., Disposition of Toxic Drugs and Chemicals in Man, 2nd Ed., Biomedical Publ., Davis, CA, p. 488, 1982.

3.  Huang, W., Andollo, W., and Hearn W.L., J. Anal. Toxicol., 16: 307-310 (1992).

4.  Cone, E.J., Dickerson, S., Paul, B.D., and Mitchell, J.M., J. Anal. Toxicol., 17: 156-164 (1993).

5.  Glare, P.A., Walsh, T.D., and Pippenger, C.E., Therapeutic Drug Monitoring, 13: 226-232 (1991).

6.  Walsh, T. D., and Cheater, F.M., Pharmaceutical J., 10: 525527 (1983).

7.  Mitchell, J.M., Paul, B.D., Welsh, P., and Cone, E.J., J. Anal. Toxicol., 15: 49-53 (1991).

8.  Tietz, Norbert W., Textbook of Chemistry, W.B. Saunders Company, 1986, p. 1735.

9.  Stewart, D.J., Inoba T., Ducassen, M., and Kalow, W., Clin. Pharmacol. Ther. 25:264 (1979).

10.  Department of Health and Human Services, Fed. Regist., 53: (69): 11970-11989 (1988).

11.  Saliva Testing for Drugs of Abuse, NIDA, Research Monograph 73, 1986

 

The above information is just for reference. The actual technical specifications are subject to the insert provided with the product.