ACCU-TELL MORPHINE 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 Morphine (MOR/OPI) Saliva Test is a rapid, immunochromatographic assay for the detection of morphine and its metabolites in human saliva. The test is used to screen saliva for the presence of morphine and its metabolites at a cutoff concentration of 40 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.

Opium is a substance exuded from the seed pod of the opium poppy. The opiates include the compounds heroin, morphine and codeine.

Morphine and codeine are legal drugs and codeine is used widely as a cough suppressant and analgesic. Morphine has been a preferred drug for the management of pain in advanced cancer⁴, however, large doses of morphine could cause the development of tolerances and physiological dependency and lead to its abuse. Heroin is considered a drug of abuse which may be snorted, smoked or injected.

Opiate and heroin are converted to morphine very quickly and excreted in saliva as morphine and the glucuronidated metabolite. Excretion continues for about 48 hours. The presence of morphine and its metabolites in saliva may be the result of heroin, morphine, codeine, or poppy seed intake⁷.

The National Institute on Drug Abuse has recommended a cut off concentration of 40ng/ml for immunoassay screening for Opiates in saliva⁶. The Opiates Test will give a positive result if morphine is present at or above this concentration in human saliva.

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^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 cassette. 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 Morphine (MOR/OPI) Saliva Test identifies morphine and its metabolites in human saliva at a cutoff concentration of 40ng/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 Morphine (MOR/OPI) 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 40ng/ml. The accuracy was 96%.The few discrepant results were found at the cut off concentration i.e. between 220-310ng/ml. The results of Accu-Tell ^®  Rapid Morphine (MOR/OPI) Saliva Test were confirmed with GC/MS (Table 2) and the accuracy was greater than 99%. The EIA screen results were confirmed with GC/MS and the accuracy was 96%.

Commercial EIA	Accu-Tell(+)	Accu-Tell(-)	Row Totals
(+)	56	0	56
(-)	4	40	44
Col. Totals	60	40	100

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

GC/MS	Commercial EIA(+)	Commercial EIA(-)	Row Totals
(+)	56	4	60
(-)	0	40	40
Col. Totals	56	44	100

Precision Three lots of Accu-Tell ^®  Rapid Morphine (MOR/OPI) Saliva Test were assayed using control urines containing 0ng/mL, 30 ng/mL, 50 ng/mL and 60 ng/mL morphine for 20 days. Three individuals read the results independently. A correct positive result was obtained by all individuals, 100% of the time with the 50ng/ml and the60 ng/ml concentrations. A correct negative result was found by all individuals, 100% of the time with the 0 ng/ml concentration. The 20 ng/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% and 88% of the time.

Sensitivity 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 -35% of Accu-Tell ^®  Rapid Morphine (MOR/OPI) Saliva Test cut off. GC/MS testing must be performed to confirm positive results.

Compound	Level of Reactivity
Morphine	40ng/ml
Morphine-3-d-glucuronide	40 ng/mL
Hydromorphone	40 ng/mL
Nalorphine	40 ng/mL
Codeine	50 ng/mL
Ethylmorphine	50 ng/mL
Norcodeine	200 ng/mL
Hydrocodone Bitartrate	100 ng/mL
Normorphine	3700 ng/mL
Oxycodone	2500 ng/mL
Heroin	4000 ng/mL
Thebaine	5000 ng/mL
Naloxone	6000 ng/mL
Ofloxacin	30,000ng/mL
Naltrexone	160,000ng/mL

The following compounds did not interfere with Accu-Tell ^®  Rapid Morphine (MOR/OPI) 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	Ketamine
Acetylsalicyclic Acid	Lidocaine
Amikacin	Meperidine(200ug/mL)
Amitriptyline	Methadone
Amphetamine	Methamphetamine
Arterenol	3,4-Methylenedioxymeth
Aspartame	Amphetamine
Benzoylecgonine	Neomycin, niacinamide
Caffeine	11-Nor- 8-THC-9-COOH(10 ug/mL)
Camphor	11-Nor-9 THC-9-COOH(10 ug/mL)
Chloroquine	Oxazepam
Chlorpheniramine	Perphenazine
Cortisone	Phencyclidine
Deoxyepinephrine	Phenobarbital
Dextromethorphan	Phenylethylamine-a
Digitoxin	Phenylpropanolamine
Digoxin	Promethazine
Epinephrine	Pseudoephedrine
Ephedrine	Rantidine
Gentisic Acid	Salicyclic Acid
Glucose	Secobarbital
Guaiacol	Tetracycline
Glyceryl Ether	Tetrahydrozoline
Histamine	Theophylline
Imipramine	Thioridazine
Isoproterenol	Trifluoperazine

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

2.  Although the Rapid Opiates (Morphine) Test is very accurate in detecting Morphine 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 Morphine 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 interfere with the test and cause false results, e.g. technical or procedural errors.

6.  A positive result indicates the presence of morphine and its metabolites in saliva. This result does not indicate the level of intoxication nor is it intended to monitor drug levels.

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

8.  Floxin (ofloxacin) can interfere with this test at concentrations of 30 ug/mL and greater.

1.  Huang, W., Andollo, W., and Hearn W.L.: A Solid Phase Extraction Technique for the Isolation and Identification of Opiates in Saliva. J. Anal. Toxicol., 16: 307-310 (1992).

2.  Cone, E.J., Dickerson, S., Paul, B.D., and Mitchell, J.M.: Forensic Drug Testing For Opiates. V. Saliva Testing for Heroin, Morphine, and Codeine with commercial Opiate Immunoassays. J. Anal. Toxicol., 17: 156-64 (1993).

3.  Glare, P.A., Walsh, T.D., and Pippenger, C.E., A Simple, Rapid Method for the Simultaneous Determination of Morphine and Its Principal metabolites in Plasma Using High-Performance Liquid Chromatography and Fluorometric Detection. Therapeutic Drug Monitoring, 13: 226-232 (1991).

4.  Walsh, T.D., and Cheater, F.M.: Use of morphine for cancer pain. Pharmaceutical J., 10; 525-527 (1983).

5.  Mitchell, J.M., Paul, B.D., Welsh, P., and Cone, E.J.: Forensic Drug Testing for Opiates. II. Metabolism and Excretion Rate of Morphine In Humans after Morphine Administration. J. Anal. Toxicol., 15: 49-53 (1991).

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

7.  Hayes LW Krasselt WG, Mueggler PA Concentrations of morphine and codeine in serum and saliva after ingestion of poppy seeds. Clin. Chem, 1987, 33/6:806-808

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

9.  CSAP Technical Report 12 Saliva Specimen Collection Handbook for Federal Workplace Drug Testing Programs, SAMHSA, 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.