ACCU-TELL METHAMPHETAMINE 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

 

 

CATALOG

Accu-Tell ^®  Rapid Methamphetamine (MET) Saliva Test is a rapid, qualitative, competitive binding immunoassay for the detection of Methamphetamine and its metabolite in human saliva. The test is used to screen saliva for the presence of Methamphetamine and its metabolite 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.

Methamphetamines are central nervous system stimulants that produce alertness, wakefulness, increased energy, reduced hunger, and an overall feeling of well being. Large doses of methamphetamine 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 Methamphetamine 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 ml 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℃ for up to 7 days and then frozen(-20℃ 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.

 

 FOR CASSETTE TEST:

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 Methamphetamine (MET) Saliva Test identifies methamphetamine 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 Methamphetamine (MET) Saliva Test was compared to a commercially available reference screening method using 280 human saliva samples (See Table 1).

Sensitivity: Accu-Tell ^®  Rapid Methamphetamine (MET) Saliva Test is designed for the detection of Methamphetamine in human saliva at 50ng/ml, as suggested for the immunoassay method. Based on the data collected in this study, the sensitivity was 142/142 or 1.00.

Specificity: Accu-Tell ^®  Rapid Methamphetamine (MET) Saliva Test can specifically detect both d and l forms of methamphetamine and a mixture. The test has proven positive with 50ng/ml or greater concentrations of both Methamphetamine and Methylenedioxymeth-amphetamine. Using the data presented in Table 1 the specificity was calculated to be 138/138 or 1.00.

Reference Screen	Accu-Tell (+)	Accu-Tell (-)	Row Totals
(+)	142	0	142
(-)	0	138	138
Col. Totals	142	138	280

Compound	Level or Concentration
d-Amphetamine	5 ul/mL
Δ,1-Amphetamine	10 ul/mL
(+) Methamphetamine	50ng/ml
± 3,4-Methylenedioxyamphetamine	10 ul/mL
± 3,4-Methylenedioxymethamphetamine	1 ul/mL
Pseudoephedrine	10 ul/mL
Ephedrine	25 ul/mL
Phenyl propanolamine (PPA)	50 ul/mL

Acetaminophen Acetylsalicylic Acid Amikacin Amitriptyline d-Amphetamine Ampicillin Acetaminophen Acetylsalicyclic acid Amikacin Amitriptyline Ampicillin Arterenol Aspartame Atropine Sulfate Benzoic Acid Benzoylecgonine HCl Caffeine Chlorpheniramine Chlorpropamazine HCl Cimetidine Codeine Deoxyephedrine Dextromethorphan Diazepam Diethylpropion Diphenylhydantoin Doxylamine Ecgonine HCl Ecgonine Methyl Ester Glucose Histamine Hydrocodone Hydromorphone Indomathacin Ketoprofen Levorphanol Thioridazine

Ketoprofen Levorphanol Meperidine Methylphenidate Methadone 3,4-Methylenedioxyamphetamine Δ-9-THC 11-nor-Δ-9-carboxy-THC-9-COOH Meperidine Methylphenidate Methadone Methaqualone Morphine Glucuronide Morphine Sulfate Oxazepam Oxycodone Pendimetrazine Penicillin G Pentobarbital d-Propoxyphene Hydrochlorothiazide Propanol Phencyclidine Phenobarbital Phentermine Phenylpropanolamine L-Phenylephrine Quinine Ranitidine Sodium Salicylate Tryptophan Tetracycline Tetrahydrozoline Theophylline Trifluoperazine

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

2.  Although Step Methamphetamine Test is very accurate in detecting the level of Methamphetamine 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.  Baselt, R.C., Disposition of Toxic Drugs and Chemicals in Man, 2nd Ed., Biomedical Publ., Davis, CA, p. 488 (1982).

2.  Cody, J.T., and Schwarzhoff, R., J. Anal. Toxicol., 17: 2630 (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 Screening Testing, Kshitij Mohan, 7/21/1

 

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