ACCU-TELL MDMA 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 Ecstasy (MDMA) Saliva Test is a rapid, immunoassay for the detection of MDMA and its metabolite in human saliva. The test is used to screen saliva for the presence of MDMA 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.

Accu-Tell ^®  MDMA is an abbreviation for the chemical methylenedioxymethamphetamine MDMA. It has street many name including Ecstasy, X, XTC, E, Love Doves, Clarity, Adam, Disco Biscuits and Shamrocks, etc. it is a stimulant with hallucinogenic tendencies, described as an empathogen as it releases mood-altering chemicals, such as cartooning and L-dopa, in the brain and may generate feelings of love and friendliness. MDMA is a Class A drug, in the same category as heroin and cocaine. The adverse effects of MDMA use include elevated blood pressure, hyperthermia, anxiety, paranoia, and insomnia. Overdoses of MDMA can be fatal, often resulting in heart failure or heart stoke.

MDMA belongs to a family of man-made drugs; its relatives include MDA (methylenedioxy MDMA), the parent drug of MDMA, and MDEA (methylenedioxyethyl MDMA), also know as EVE. They all share the MDMA-like effects. MDMA is administered either by oral ingestion or intravenous injection. MDMA tablets come in different sizes and colors, and often have logos such as doves on them. Its clinical dose is 50-100mg ; the threshold toxic dose is 500mg. The effects of MDMA begin 30 minutes after intake. They peak in an hour and last for 2-3 hours. it is detectible in the saliva for up to 3 days after use.

This assay is a one-step lateral flow chromatographic immunoassay. The test device /strip includes 1) a burgundy-colored conjugate pad containing mouse anti-MDMA antibody coupled to colloidal gold, and 2) nitrocellulose membrane containing a T line and a C line. The T line is coated with MDMA-BSA, and the C line is coated with goat anti-mouse antibody.

This test is a competitive binding immunoassay. The MDMA in the saliva specimen competes with the MDMA-BSA on the membrane for the limited binding sites of the anti-MDMA antibodies in the conjugate pad.

When an adequate amount of saliva specimen is applied onto the sample pad of the device/strip, the saliva migrates by capillary action through the test device/strip. If the level of MDMA in the saliva specimen is below the cut-off (50ng/ml), the T line should appear as a solid burgundy line. If the level of MDMA in the saliva specimen is above the cut-off, the T line should not develop within the reading time of the device/strip, 8minutes.

The C line should bind to the colored mouse antibody conjugate and form a burgundy colored line regardless of the presence of MDMA.

Store the kit at room temperature 2-30°C. Each device/strip maybe used until the expiration date printed on the label if it remains sealed in its foil pouch containing desiccant. Do not freeze the kit and/or expose the kit to the temperature over 30°C.

1.  Each saliva specimen must be collected in a clean container.

2.  Specimens may be kept at room temperature for 8 hours, at 2-8°C for up to 3 days and at -20°C or lower for prolonged storage. Do not mix specimens.

1 . The instructions must be followed to obtain accurate results.

2.  Do not open the sealed pouch, unless ready to operate the assay.

3.  Dispose of all specimens and used assay materials in a proper biohazard container.

4.  Do not use expired devices.

1.  Bring all materials and specimens to room temperature.

2.  Remove test strip from the sealed foil pouch.

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

4.  Using the pipette, dispense 80μl of saliva sample to the sample pad of the test strip. Start timing.

5.  Read result between 3-8 minutes after adding the sample. Do not interpret results after 10 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 10 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/strip.

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.  Built-in Control Features

This test contains a built-in control feature. The C line. The presence of the C line indicates that the proper sample volume was used and that the reagents migrated properly. If a C line does not form, the test is considered invalid. In this case, review the whole procedure and repeat the testing with a new device.

2.  External Quality Control

Users should always follow the appropriate federal, state, and local guidelines concerning the running of external quality controls. SAMHSA recommends that the concentration of drug(s) in positive and negative controls be approximately 25% above and below the cut-off concentration of the assay.

1.  There is a possibility that other substances and /or factor not listed in this instruction may interfere with the test and cause false results, e.g., technical or procedural errors.

2.  Some adulterants such as bleach or other strong oxidizing agents may produce erroneous test results if added in the strip. When suspected, collect a fresh specimen and repeat the test with a new strip.

This test is designed to detect the MDMA in human saliva at a cut-off concentration of 50ng/ml.

One hundred ten (110) MDMA-spiked saliva specimens calibrated with GC/MS method were used for the accuracy studies in this test. Among the 110 specimens, there were 55 negative and 55 positive. Within the negative specimens, 15 were negative (without MDMA), and 25 were 25% below cut-off (378ng/ml). Within the positive specimens, 25 were 25% above cut-off (615ng/ml), 15 were 50% above cut-off (709ng/ml), and 15 were positive (1417ng/ml).

Studies were carried out in a clinical reference laboratory and three (3) Physician’s Office Laboratories (POL) by personnel with diverse educational backgrounds and working experiences.

The results obtained from this MDMA Saliva Test were 57 negative and 53 positive. The negative results agreed 100% (55/55). The positive results agreed 96.4% (53/55). The two (2) discrepancies were within the range of 25% above the cut-off level (615ng/ml). The correlation of the results obtained from the four evaluation sites was 98%.

		MDMA Test
		Negative	positive	total
GC/MS test	Negative (<50ng/ml)	55	0	55
	Positive (>50ng/ml)	2	53	55
	total	57	53	110

The precision was determined by replicate assays of four different levels of samples with three different production lots. The devices were tested for five consecutive days five times each, for a total of 25 assays for each control.

The results obtained indicate 100% precision for the replicate within each lot and no appreciable inter-lot variation across the three different lots of devices.

The cross-reactivity of the structurally related compounds with the device was studied. The following compounds were spiked into known drug-free saliva pools and tested with the MDMA Saliva Test.

Description	Concetration(ng/ml)
Methylenedioxyampphetamine(MDA)	2000
MethylenedioxyethylMDMA(MDEA)	1000

Description	Concetration(ng/ml)
L-MDMA	100
d-MDMA	100
L-methMDMA	100
d- methMDMA	100
HydroxymethMDMA(HAM)	100
DihydroxymethMDMA(HMMA)	100
N-methyl-1(1-3-benzodioxol-5-yl)-2-butanamine(MBDB)	100

The following structurally unrelated analytes were spiked into known drug-free saliva pools, as well as the MDMA positive (50ng/ml) saliva pools and were tested with the MDMA Rapid Saliva Test. No interference was observed with either negative or positive specimens.

Compound	Conc.
Acetaminophen	100μg /ml
Acetylsalicylic Acid	100μg/ml
Amikacin	100μg/ml
Amitriptyline	100μg/ml
Ampicillin	100μg/ml
Arterenal	100μg/ml
Atropine	100μg/ml
Benzoic Acid	100μg/ml
Benzoylecgonine	100μg/ml
Caffeine	100μg/ml
(+)-Chlorpheniramine	100μg/ml
(+/-)-Chlorpheniramine	100μg/ml
Cocaine	100μg/ml
Codeine	100μg/ml
Cortisone	100μg/ml
Dextromethorphan	100μg/ml
Methadone	100μg/ml
Morphine	100μg/ml
Morphine-3-b-D-glucuronide	100μg/ml
Nortriptyline	100μg/ml
Oxalic Acid	100μg/ml
Oxazepem	100μg/ml
Penicillin-G	100μg/ml
Propoxyqhene	100μg/ml
Pheniramine	100μg/ml
Phencyclidine	100μg/ml
Phenylpropanalamine	100μg/ml
Ranitidine	100μg/ml
Secobarbital	100μg/ml
Salicylic Acid	100μg/ml
11-nor-△9-THC-9-COOH	100μg/ml
Thioridazine	100μg/ml
Trifluoperaine	100μg/ml
Albumin	200μg/ml
Bilirubin	100μg/ml
Creatine	100μg/ml
Glucose	100μg/ml
Hemoglobin	200μg/ml
PH	5.0-9.0
Vitamin C	100μg/ml
Uric Acid	100μg/ml

Note: There is a possibility that other substances and /or factors not listed above may interfere with the test and cause false results.

1.  S-J. Peroutka ed. Ecstasy: The clinical, pharmacological and neurotoxicological effects of the drug MDMA. Kluwer Academic Publishers, 1990.

2.  Wilson, John, Abused Drugs II, a Laboratory Pocket Guide., AACC Press. Washington, DC; p52, 1994.

 

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