ACCU-TELL AMPHETAMINE 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

 

CATALOG

Catalog No.                    Product Name                                               Note

ABT-DOA-A46                Amphetamine Saliva Strip                           CE

ABT-DOA-B46               Amphetamine Saliva Cassette                    CE

 

INTENDED USE

Accu-Tell ^®  Rapid Amphetamine (AMP) Saliva Test is a rapid, immunochromatographic assay for the detection of amphetamine and its metabolites in human saliva. The test is used to screen saliva for the presence of amphetamine and its metabolites at a cutoff concentration of 50 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.

Accu-Tell ^®  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 develop tolerances and physiological dependency and lead to its abuse. Both d(+) and l(-) forms of the isomers are controlled substances. The legally allowable level for Amphetamine is set by the National Institute on Drug Abuse at 50ng/ml in saliva as measured by GC/MS.

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 2-8oC 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 cassette from the sealed foil pouch.

3.  Place the test cassette 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.

The Amphetamine Test identifies Amphetamine and its metabolites in human saliva at a cutoff concentration of 50ng/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.

Accu-Tell ^®  Rapid Amphetamine (AMP) Saliva Test was compared to a commercially available reference screening method using 260 human saliva samples (See Table 1).

Sensitivity: Accu-Tell ^®  Rapid Amphetamine (AMP) Saliva Test detects Amphetamine in human saliva at 50ng/ml, as suggested for the immunoassay method. Based on the data collected in this study, the sensitivity was 139/140 or 0.9929.

Specificity: Accu-Tell ^®  Rapid Amphetamine (AMP) Saliva Test can specifically detect both d and l forms of amphetamine and a mixture. The test has proven positive with 50ng/ml or greater concentrations of both Amphetamine and Methylenedioxyamphetamine. Using the data presented in Table 1 the specificity was calculated to be 120/120 or 1.00.

Reference Screen	Accu-tell(+)	Accu-tell(-)	Row Totals
(+)	139	1	140
(-)	0	120	120
Col. Totals	139	121	260

d-Amphetamine                                            50ng/ml

l-Amphetamine                                             25000 ng/ml

d, l-Amphetamine                                         625 ng/ml

± 3,4-Methylenedioxyamphetamine       1000 ng/ml

Pseudoephedrine                                        100000 ng/ml

± Phenylpropanolamine (PPA)               4000 ng/ml

Thyramine                                                     100000 ng/ml

Ephedrine                                                     100000 ng/ml

Phentermine                                                1000 ng/ml

Cannabidiol ± Deoxyephedrine + Methamphetamine – Deoxyephedrine Phencyclidine

Phenobarbital Morphine Phencycli Phencyclidine Phenobarbital

Acetaminophen Acetylsalicyclic acid Ampicillin Benzoic Acid Benzoylecgonine Hcl Caffeine Chlorpheniramine Chloropromazine Hcl Cimetidine Codeine Dextromethyorphan Ecgonine HCL Ecgonine Methyl Ester Hydrocodone Hydromorphone Indomathacin Ketoprofen Levorphanol Sodium Salicylate Meperidine Morphine Glucuronide

Morphine Sulfate Methylphenidate Methadone Methaqualone Oxazepham Oxycodone Propranollol Phencyclidine d-Propoxyphene Hydrochlorothiazide Phenylpropanolamine Pendimetrazine Phentobarbital Penicillin G 1-Phenylephrine Quinine Ranitidine Tryptophan Δ-9-THC 11-nor-Δ-9-carboxy-THC

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

2.  Although Accu-Tell ^®  Rapid Amphetamine (AMP) Saliva Test is very accurate in detecting the level of Amphetamine 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 Amphetamine 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.

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.

1.  Ellerbe, P., and Long, T., J. Anal. Toxicol., 17: 165170 (1993).

2.  Cody, J.T, and Schwarzhoff, R., J. Anal. Toxicol., 17: 26-30., (1993).,

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

4.  Dasgupta, A., Saldana, S., Kinnaman, G., Smith, M., and Johansen, K., Clin. Chem., 39 (1): 104-108 (1993).

5.  Department of Health and Human Services, Fed. Regist., 53(69): 11970-89 (1988).

6.  FDA Guidance for labeling Saliva Drugs of Abuse Screening Testing, Kshitij Mohan, 7/21/1987.

 

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