ACCU-TELL COCAINE 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 Cocaine (COC) Saliva Test is a rapid, immunochromatographic assay for the detection of benzoylecgonine, the major metabolite of cocaine in human saliva. The test is used to screen saliva for the presence of benzoylecgonine at a cutoff concentration of 20 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.

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 which lead to its abuse. Cocaine is rapidly absorbed, almost completely metabolized by the liver and excreted in the saliva as Benzoylecgonine. 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 12-72 hours after cocaine use or exposure.^{5, 8}

Accu-Tell ^®  Rapid Cocaine (COC) Saliva Test detects benzoylecgonine in saliva at concentrations of 20 ng/mL and greater as recommended by SAMSHA(NIDA)2.

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.

 0.5 mI 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°C 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. 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 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.

Accu-Tell ^®  Rapid Cocaine (COC) Saliva Test identifies benzoylecgonine in human saliva at a cut off concentration of 20ng/ml. The concentration of the drug can not be determined using this test. The test is intended to screen saliva to separate a negative result form a presumptive positive result. All positive results must be confirmed using an alternate method, preferably GC/MS.

A comparative evaluation of 100 clinical saliva specimens was performed using Accu-Tell ^®  Rapid Cocaine (COC) Saliva Test and a commercially available EIA screen/semi quantitative test. Both tests have a cut off concentration of 20ng/ml benzoylecgonine (Table 1). The drug concentration of samples covered the entire assay range and included 20 samples around the cut off concentration. The accuracy of Accu-Tell ^®  Rapid Cocaine (COC) Saliva Test was 88%. All results were confirmed with GC/MS benzoylecgonine testing. The twelve discrepant results were between 272-471ng/ml of benzoylecgonine.

Commercial EIA	Accu-Tell (+)	Accu-Tell (-)	Row Totals
(+) (-) Col. Totals	48 0 48	12 40 52	60 40 100

Three lots of Accu-Tell ^®  Rapid Cocaine (COC) Saliva Test were assayed using urine controls containing 0ng/mL, 10 ng/mL,30ng/mL and 50ng/mL benzoylecgonine for 20 days. Three individuals read the results independently. A correct positive result was obtained by all individuals, 100% of the time with the 30 ng/ml and the 50ng/ml concentrations. A correct negative result was found by all individuals, 100% of the time with the 0 ng/ml concentration. The 10ng/ml level 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.

Sensitivity Different concentrations of benzoylecgonine were tested and results are summarized in Table 2. Some users, may find variable results up to +/- 35% of the Cocaine cut off. GC/MS testing must be performed to confirm results.

COMPOUND	LEVEL OF REACTIVITY
Benzoylecgonine	0ng/mL	10ng/mL	20ng/ml	375ng/mL
#Tested/#Results	25/25 Neg	25/25 Neg	25/25 Pos	25/25 Pos

Cocaine	15,000 ng/ml
Ecgonine	100,000 ng/ml
Tropacocaine	100,000 ng/ml

The following compounds did not interfere with Accu-Tell ^®  Rapid Cocaine (COC) Saliva Test.

Glucose	2000mg/dl	Uric Acid	10 mg/dl
Human Albumin	2000mg/dl	Urea	4000mg/dl
Hemoglobin	10mg/dl	Bilirubin	2 mg/dl

4-Acetamidophenol Acetylsalicylic Acid Amikacin ethyl-p-aminobenzoate Amitriptyline Amphetamine Arterenol Aspartame Atropine Caffeine Camphor Chloroquine Chlorpheniramine Cortisone Deoxyepinephrine Dextromethorphan Digitoxin Digoxin Epinephrine Ephedrine Gentisic Acid Guaiacol glyceryl ether Histamine Homatropine Imipramine Isoproterenol Ketamine Lidocaine

Meperidine(200ug/mL) Methadone d,l,Methamphetamine d,Methamphetamine Morphine Naloxone Neomycin Niacinamide 11-Nor- 8-THC-9-COOH(10 ug/mL) 11-Nor-9 THC-9-COOH(10 ug/mL) Oxazepam Perphenazine Phencyclidine Phenobarbital Phenylethylamine 5.5-diphenylhydantoin Phenylpropanolamine Procaine Promethazine Pseudoephedrine Rantidine Salicyclic Acid Secobarbital Tetracycline Tetrahydrozoline Theophylline Thioridazine Trifluoperazine

1.  This product is designed to be used for the detection of benzoylecgonine in human saliva only.

2.  Although the Rapid Cocaine Test is very accurate in detecting Cocaine metabolites in saliva, there is a possibility of false results due to the presence of interfering substances.

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

5.  There is the possibility that other substances and/or factors not listed may

6.  Interfere with the test and cause false results, e.g. technical or procedural errors.

7.  A positive result indicates the presence of benzoylecgonine in saliva. This result does not indicate the level of intoxication nor is it intended to monitor drug levels.

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

1.  Mandatory guidelines for federal workplace drug testing programs; Final guidelines: Notice, Fed. Regist., 53(69): 11970-11989 (1988) .

2.  Saliva Testing for Drugs of Abuse. National Institute on Drugs of Abuse (NIDA Research Monograph) 73, 1986.

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

4.  Pearman K: Cocaine : A review, J Laryngol Otol 1979; 93; 1191-1199.

5.  Stewart DJ et al: Cocaine metabolism: Cocaine and norcocaine hydrolysis by liver and serum esterases. Clin Pharmacol Ther 1978 25:: 464-468.

6.  Baselt RC, Cravey RH: Disposition of Toxic Drugs and Chemicals in Man, ed 3 Chicago, IL, Year Book Medical Publishers Inc, 1989, pp 208-213.

7.  Van Dyke C et al: Urinary excretion of immunologically reactive metabolites after intranasal administration of cocaine as followed by enzyme immunoassay. Clin. chem 1977; 23 241-244.8.

8.  Baselt, Randall C. Saliva Drug Screening by Immunoassay: Interpretation of Results, in Baselt Randall (ed) Advances in Analytical Toxicology, Volume 1, Biomedical Publications, Foster City. California, 1984, pp 81-123.

 

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