ACCU-TELL CANNABINOID (THC) 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

                                                                                 BIBLIOGRAPHY 

 

INTENDED USE

Accu-Tell ^®  Rapid Cannabinoids (THC) Saliva Test is a rapid, qualitative, competitive binding immunoassay for the detection of Cannabinoids (THC) and its metabolite in human saliva. The test is used to screen saliva for the presence of Cannabinoids (THC) and its metabolite at a cutoff concentration of 4 ng/ml. The test is intended for use by healthcare professionals only.

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.

The agents of Marijuana that cause the various biological effects in humans are called Cannabinoid. Cannabinoid is a central nervous system stimulant that alters mood and sensory perceptions, produces loss of coordination, impairs short term memory, produces symptoms of anxiety, paranoia, depression, confusion, hallucination, and increased heart rate. Large doses of Cannabinoid could cause the development of tolerances and physiological dependency and lead to its abuse. A tolerance to the cardiac and psychotropic effects can occur and withdrawal syndrome produces restlessness, insomnia, anorexia and nausea. All forms of Cannabinoid including the principle ingredient, Δ9-THC, are quickly absorbed by inhalation or from the GI tract. Excretion of urinary metabolites occurs within 72 hours of exposure^2,6. Urinary concentrations are dependent on the time of sample collection, frequency of drug use, and the release rate from fatty tissue. All cannabinoid are controlled substances, and the SAMHSA (NIDA) recommended cutoff level for Cannabinoid screening tests is 4ng/ml in saliva⁴.

The test is a qualitative, visual screening immunoassay. The method employs unique antibodies to selectively identify the drug in the test saliva with a high degree of sensitivity and specificity.

The test device consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level suggested for the immunoassay method. Unbound dye conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.

A negative specimen produces two (2) distinct color bands, one in the test area and one in the control region. Apositive specimen produces only one (1) color band in the control region.

1.  For in vitro diagnostic use only.

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

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

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

5.  Saliva specimens may be infectious. Handle and dispose of all used specimens and devices in an approved biohazard container.

The test device can be stored under refrigeration and at room temperature (2-30°C) and will be stable until the expiration date. Do not open foil pouch until ready to test.

 0.5mI of saliva must be collected in a clean, dry, plastic or glass container, that does not contain preservative. Some plastics may adsorb drugs. If not tested immediately, saliva specimens may be stored refrigerated at 2-8^oC for up to 7 days and then frozen(-20°C or colder) prior to assaying. Refrigerated or frozen samples must be warmed to room temperature and gently mixed before testing. Saliva samples exhibiting visible precipitates or turbidity should be centrifuged or allowed to settle so a clear aliquot may be sampled for this assay. Collection of samples may require mandatory procedures and custody and control records. Poppy seed ingestion has been associated with positive test results in some samples.

1.  Bring all materials and specimens to room temperature.

2.  Remove test strip from the sealed foil pouch.

3.  Dip the test strip into the saliva sample with the arrows pointing toward the specimen.

4.  The saliva level should reach the maximum line marked on the strip, but must not exceed the maximum line.

5.  Hold the strip in the saliva until a reddish color appears at the lower edge of the test membrane (approximately 10 seconds).

6.  Withdraw the strip and place it face up on a clean, dry surface.

7.  Read the result between 3-8 minutes after adding the sample. Do not interpret results after 8 minutes.

1. Bring all materials and specimens to room temperature.

2. Remove test card from the sealed foil pouch.

3. Place the test card on a flat dry surface.

4. Using the provided plastic dropper, dispense 3 drops of saliva sample to the sample well of the test card. Start timing.

5. Read result between 3 – 8 minutes after adding the sample.

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 is no pink/purple band in the control area of the strip, 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 preliminary results are positive. Positive results should be confirmed by an alternate method such as GC/MS.

1. Each test device has a control band to indicate that the sample volume and migration is adequate, and that the colloidal gold is dissolving as expected. An invalid result must be repeated using a new test device.

2. Positive and negative, drug free saliva controls can be used to validate reagent performance and establish test reliability. Commercial drug saliva controls are available, but not provided with this test. NIDA recommended guidelines for drugs of abuse screening indicate controls should contain the drug at a level at least 20% above the NIDA cutoff value. If control values do not fall within the established limits, assay results are invalid.

THC Test identifies cannabinoid and its metabolites in human saliva at a concentration of 4ng/ml. The concentration of the drug cannot be determined using this test. The test is intended to screen saliva to separate a negative result from a presumptive positive result. All positive results must be confirmed using an alternate method, preferably GC/MS.

A comparative evaluation of 100 clinical specimens was performed using Accu-Tell ^®  Rapid Cannabinoids (THC) Saliva Test and a commercially available EIA screen/semi quantitative test(Table 1). The drug concentration of samples covered the entire assay range and included 20 samples around the cutoff concentration of 4ng/ml. The accuracy was 99%. Results of Cannabinoid Test were confirmed with GC/MS(Table

2) and the accuracy was 99%. The EIA results were also compared to GC/MS(Table 3) and the accuracy was greater than 99%.

Commercial EIA	Accu-Tell (+)	Acci-Tell (-)	Row Totals
(+)	59	1	60
(-)	0	40	40
Col. Totals	59	41	100

GC/MS	Accu-Tell (+)	Accu-Tell (-)	Row Totals
(+)	59	1	60
(-)	0	40	40
Col. Totals	59	41	100

GC/MS	Commercial EIA(+)	Commercial EIA(-)	Row Total
(+)	60	0	60
(-)	0	40	40
Col. Totals	60	40	100

Three lots of Accu-Tell ^®  Rapid Cannabinoids (THC) Saliva Test were assayed using control saliva containing 0ng/mL, 2ng/mL., 4ng/mL and 6ng/mL 11 nor-Δ9-THC-9-COOH, for 20 days. Three individuals read the results independently. A correct positive result was obtained by all individuals, 100% of the time with the4 and 6 ng/mL concentrations. A correct negative result was found by all individuals, 100% of the time with the 0 ng/mL concentration. The 2ng/mL results varied somewhat depending on the experience of the observer. The inexperienced observer reported this level as positive 100% of the time , while the two experienced readers reported negative results 100% of the time.

The compounds detected by this assay have been identified and the levels which produce a positive result are listed in Table 4. Some users, depending on experience in reading this test, may find presumptive positive results up to -50% of the cutoff, i.e. 25ng/mL. GC/MS testing must be performed to confirm positive results.

Compound	Level of Positive Reaction
11-nor-Δ8-THC-9-COOH	4ng/ml
11-nor-Δ9-THC-9-COOH	4ng/ml
Δ8-THC	1800 ng/mL
Δ9-THC	2000 ng/mL
Cannabinol	5000 ng/mL
11-hydroxy-Δ9-THC	800ng/mL

The following substances did not interfere with Accu-Tell ^®  Rapid Cannabinoids (THC) Saliva Test:

Glucose	2000 mg/dL	Uric Acid	10 mg/dL
Human Albumin	2000 mg/dL	Urea	4000 mg/dL
Hemoglobin	10 mg/dL	Bilirubin	2m g/dL

TABLE 5 – COMPOUNDS THAT GIVE NEGATIVE RESULTS AT CONCENTRATIONS UP TO 100μg/Ml

Acetaminophen	Hydrocodone
4-Acetamidophenol	Hydromorphone
Acetylsalicylic Acid	Homatropine
Amikacin	Imipramine
Ampicillin	Isoproterenol
d,l-Amphetamine	Ketamine
Amitriptyline	Lidocaine
Arterenol	d-Methamphetamine
Aspartame	Meperidine
Atropine Sulfate	Methadone
Benzoic acid	Methaqualone
Benzoylecgonine	Methylpehnidate
Caffeine	Morphine glucuronide
Camphor	Morphine sulfate
Chloroquine	Naloxone
Chlorpheniramine	Neomycin
Chlorpromazine HCI	Niacinamide
Cocaine Hydrochloride	Oxazepam Perphenazine
Cocaine	Penicillin G
Cimetidine	Phencyclidine
Cortisone	Phenobarbital
Deoxyephedrine	Phenylethylamine-α
Dextromethorphan	Phenylpropanolamine
Diazepam	Promethazine
Digitoxin	Pseudoephedrine
Digoxin	Rantidine
Ecgonine Hydrochloride	Salicylic acid
Ecgonine Methyl Esther	Secobarbital
Ephedrine	Tetracycline
Epinephrine	Tetrahydrozoline
Gentisic Glucose Acid	Theophylline
Guaiacol	Thioridazine
Glyceryl Ether	Trifluoperazine
Histamine	Tryptophan
Hydrochlorothiazide

1.  This product is designed to be used for the detection of Cannabinoid and its metabolites in human saliva only.

2.  Although Rapid Cannabinoid Test is very accurate in detecting the level of THC in saliva, 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 Cannabinoid in saliva.

4.  Adulterant, 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.

5.  There is the possibility that other substances and/or factors not listed above may interfere with the test and cause false results, e.g. technical or procedural errors.

6.  A positive result indicates the presence of cannabinoid and its metabolites in saliva . This does not indicate the level of intoxication not is it intended to monitor drug levels.

7.  Results should be confirmed using an alternate method. GC/MS is the preferred confirmatory method.

1.  Baselt, R.C., Disposition of Toxic Drugs and Chemicals in Man, 3rd Ed., Chicago IL. Year Book Medical Publishers Inc, 1990 pp 780-783.

2.  Blum, K., Handbook of Abusable Drugs, Gardner Press, Inc., New York, NY, 1st Ed., (1984).

3.  Mandatory Guidelines for Federal Workplace Drug Testing Programs, Fed. Reg. 53(69): 11970-89 1988.

4.  Saliva Testing for Drugs of Abuse, NIDA Research Monograph 73, (1986).

5.  Baselt, Randall C., Saliva Drug Screening by Immunoassay: Interpretation of Results, in Baselt, Randall C. Advances in Analytical toxicology, Volume 1, Biomedical Publications, Foster City, CA 1984, pp 81-123.

6.  Ellis, G.M. Jr. et al, Excretion Patterns of Cannabinoid Metabolites After Last Use in a Group of Chronis Users, Clin. Pharmacol. Ther., 38(5):572-578, November 1985.

7.  CSAP Technical Report 12 Saliva Specimen Collection Handbook for Federal Workplace Drug Testing Programs, SAMSHA, Center for Substance Abuse Prevention.

 

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