Saliva direct cup - royal medical supplies pty ltd, sydney australia

Saliva Direct Cup

Oral Fluid Drugtest THC - COC - OPI - MET - AMP - BZD
All Kits come
Security Seal for either
the Sample Cup or the
resealable Device Bag
Saliva Direct Cup
Oral Fluid Drugtest Saliva Direct Cup
Oral Fluid Drug Test
Professional judgment should be applied to Product Insert / Instructions
any drug of abuse test result, particularly when preliminary positive results are indica- Package Insert for the SUMMARY AND EXPLANATION OF TEST
The SalivaScreen Oral Fluid Drug Test Device
their metabolites is a rapid, oral fluid scree- ning test that can be performed without the Test for Oral Fluids use of an instrument. The test utilizes mono- clonal antibodies to selectively detect elevated A rapid, screening test for the simultaneous, levels of specific drugs in human oral fluid.
qualitative detection of Amphetamine, Marijuana, Benzodiazepine, Methadone AMPHETAMINE (AMP) - 50 ng/mL
and their metabolites in human oral fluid.
For professional and in-vitro diagnostic use only.
Amphetamine is a sympathomimetic amine with therapeutic indications. The drug is often selfadministered by nasal inhalation or oral INTENDED USE
Depending on the route of administration, The SalivaScreen Oral Fluid Drug Test Device
Amphetamine can be detected in oral fluid as for AMP/MET/COC/OPI/THC/BZD/MTD is a early as 5-10 minutes and up to 72 hours after lateral flow chromatographic immunoassay for the qualitative detection of Amphetamine, The Amphetamine assay contained within the SalivaScreen Oral Fluid Drug Test Device yields a positive result when the Amphetamine concentration in oral fluid exceeds 50 ng/mL.
Amphetamine (AMP) METHAMPHETAMINE (MET) - 50 ng/mL
D-Methamphetamine Methamphetamine is a potent stimulant chemi- cally related to amphetamine but with greater CNS stimulation properties. The drug is often selfadministered by nasal inhalation, smoking or oral ingestion. Depending on the route of 11-nor-∆9-THC-9 COOH administration, methamphetamine can be Benzodiazepine (BZD) detected in oral fluid as early as 5-10 minutes and up to 72 hours after use.
Methamphetamine, Cocaine, Opiates, The Methamphetamine assay contained within Marijuana, Benzodiazepine, Methadone and the SalivaScreen Oral Fluid Drug Test Device
their metabolites in oral fluids at the following yields a positive result when the Methamphe- cut-off concentrations: tamine concentration in oral fluid exceeds 50 This assay provides only a preliminary analyti- COCAINE (COC) - 20 ng/mL
cal test result. A more specific alternate che- mical method must be used in order to obtain Cocaine is a potent central nervous system a confirmed analytical result. Gas chromato- (CNS) stimulant and a local anesthetic derived graphy/mass spectrometry (GC/MS) and gas from the coca plant (erythroxylum coca). The chromatography/tandem mass spectrometry drug is often self-administered by nasal inha- (GC/MS/MS) are the preferred confirmatory lation, intravenous injection and free-base smoking. Depending on the route of admini- Saliva Direct Cup
Oral Fluid Drugtest stration, cocaine and metabolites benzoylecgo- BENZODIAZEPINES (BZD) - 50 ng/mL
nine and ecgonine methyl ester can be detected in oral fluid as early as 5-10 minutes following Benzodiazepines are frequently prescribed use. Cocaine and benzoylecgonine can be sedative and hypnotic drugs for the symptoma- detected in oral fluids for up to 24 hours after tic treatment of anxiety, insomnia, sleep and seizure disorders. Most Benzodiazepines are The Cocaine assay contained within the extensively metabolized in the liver and excre- SalivaScreen Oral Fluid Drug Test Device
ted in the urine and saliva as metabolites.
yields a positive result when the cocaine meta- Chronic abuse may increase the risk of physi- bolite in oral fluid exceeds 20 ng/mL.
cal dependence and may result in intoxication, drowsiness and muscle relaxation. Oxazepam OPIATE (OPI) - 40 ng/mL
is the major metabolic product of Benzodiazepines. The Benzodiazepines assay The drug class opiates refers to any drug that is contained within the SalivaScreen Oral Fluid
derived from the opium poppy, including natural- Drug Screen Device yields a positive result ly occurring compounds such as morphine and when the concentration of Oxazepam in oral codeine and semi-synthetic drugs such as fluids exceeds 50 ng/mL.
heroin. Opiates act to control pain by depres- sing the central nervous system. The drugs METHADONE (MTD)
demonstrate addictive properties when used for Under development sustained periods of time; symptoms of withdra- wal may include sweating, shaking, nausea and irritability. Opiates can be taken orally or by Under special request injection routes including intravenous, intramus- cular and subcutaneous; illegal users may also take the intravenously or by nasal inhalation.
Using an immunoassay cutoff level of 40 ng/mL, codeine can be detected in the oral fluid within The SalivaScreen Oral Fluid Drug Test Device
1 hour following a single oral dose and can for AMP/MET/COC/OPI/THC/BZD is an immu- remain detectable for 7-21 hours after the dose.
noassay based on the principle of competitive 6-monoacetylmorphine (6-MAM) is found more binding. Drugs that may be present in the oral prevalently in oral fluid, and is a metabolic pro- fluid specimen compete against their respecti- duct of heroin. Morphine is the major metabolic ve drug conjugate for binding sites on their product of codeine and heroin, and is detectable specific antibody. During testing, a portion of for 24-48 hours after an opiate dose. The the oral fluid specimen migrates upward by Opiates assay contained within the Oral Fluid capillary action. A drug, if present in the oral Drug Test Device yields a positive result when fluid specimen below its cut-off concentration, the concentration of Morphine in oral fluid will not saturate the binding sites of its speci- exceeds the 40 ng/mL cut-off level.
fic antibody. The antibody will then react with the drug-protein conjugate and a visible colo- MARIJUANA (THC) - 12 ng/mL
red line will show up in the test line region of the specific drug strip. The presence of drug Tetrahydrocannabinol, the active ingredient in above the cut-off concentration in the oral fluid the marijuana plant (cannabis sativa), is detec- specimen will saturate all the binding sites of table in saliva shortly after use. The detection of the antibody. Therefore, the colored line will the drug is thought to be primarily due to the not form in the test line region. A drug-positive direct exposure of the drug to the mouth (oral oral fluid specimen will not generate a colored and smoking administrations) and the subse- line in the specific test line region of the strip quent sequestering of the drug in the buccal because of drug competition, while a drug- cavity. Historical studies have shown a window negative oral fluid specimen will generate a of detection for THC in saliva of up to 14 hours line in the test line region because of the after drug use. The Marijuana assay contained absence of drug competition. To serve as a within the SalivaScreen Oral Fluid Drug Test
procedural control, a colored line will always Device yields a positive result when the appear at the control line region, indicating 11-nor-∆9-THC-9 COOH concentration exceeds that proper volume of specimen has been added and membrane wicking has occurred.
Saliva Direct Cup
Oral Fluid Drugtest DIRECTIONS FOR USE
The test contains membrane strips coated with Allow the test device to reach room temperatu- drug-protein conjugates (purified bovine albu- re [15-30°C] prior to testing. Do not place min) on the test line, a goat polyclonal antibo- anything in the mouth including food, drink, dy against gold-protein conjugate at the con- gum, mints or tobacco products for at least 10 trol line, and a dye pad which contains colloi- minutes prior to collection of oral fluid speci- dal gold particles coated with mouse monoclo- nal antibody specific to Amphetamine, 1. Bring the pouch to room temperature before
Morphine, 11-nor-∆9-THC-9 COOH and opening it. Remove the test from the sealed pouch and use it as soon as possible.
2. Remove the test device from the sealed
• For professional use only.
• Do not use after the expiration date.
3. Insert the sponge end of the collection device
• The Oral Fluid Drug Test Device should into the mouth. Close mouth and gently remain in the sealed pouch until use.
chew the sponge for saliva excretion. Soak • Saliva is not classified as biological hazard sponge into saliva in mouth and swab the unless derived from a dental procedure.
inside of the mouth, tongue and cheeks to • The used collector device should be collect oral fluid for approximately 3 minutes discarded according to federal, state until the sponge becomes completely soft and/or local regulations.
and fully saturated with saliva. No hard spots should be felt on the sponge when saturated.
4. Remove the collection device from the mouth.
Store as packaged in the sealed pouch at 2- With gentle pressure, place the collection 30°C. The test is stable through the expiration device with the saturated sponge into the date printed on the sealed pouch. The test Collection Chamber. devices must remain in the sealed pouch until 5. Screw the Collector Cap clockwise to secu-
re the cap tight and start the timer. SPECIMEN COLLECTION AND
6. Mark patient ID on the test device. Peel off
the label to read test results. Wait for the color line(s) to appear on the test strips. The oral fluid specimen should be collected Read results at 10 minutes. using the collection device provided in the kit.
Do not read results after 1 hour. Follow the detailed directions for use below.
No other collection devices should be used 7. Send the collector with collected oral fluid
with this assay. Oral fluid collected at any time to the laboratory for GC/MS confirmation if of the day may be used.
necessary. (if needed for confirmation) Materials Materials Provided
• Package insert Materials Required But Not Provided:
Saliva Direct Cup
Oral Fluid Drugtest (hard, imbued with ascorbic acid for better saliva flow) 1 Remove collection device from test cylinder
2 Place the collection device/sponge in donors mouth and
move over the tongue and into both cheeks to collect as
much saliva as possible. Repeat for approx. 3 minutes.
3 Place collection device back in cylinder and tighten cap
4 Read results at approx. 5 minutes
Secure the
saliva sample with
You can seal the pouch.
.or the Collection Chamber
(Please refer to the previous illustration) POSITIVE: One color line appears in the con-
trol region (C). No line appears in the test NEGATIVE: Two lines appear. * One color line
region (T). This positive result indicates that should be in the control region (C), and anot- the drug concentration is above the detectable her apparent color line adjacent should be in the test region (T). This negative result indica- INVALID: Control line fails to appear.
tes that the drug concentration is below the Insufficient specimen volume or incorrect pro- detectable level.
cedural techniques are the most likely reasons *NOTE: The shade of color in the test line
for control line failure. Review the procedure region (T) will vary, but it should be conside- and repeat the test using a new test device. If red negative whenever there is even a faint the problem persists, discontinue using the lot distinguishable color line.
immediately and contact your supplier.
Saliva Direct Cup
Oral Fluid Drugtest A procedural control is included in the test. A color line appearing in the control region (C) is con- sidered an internal procedural control. It confirms sufficient specimen volume, adequate membra- ne wicking and correct procedural technique.
1. The SalivaScreen Oral Fluid Drug Test Device provides only a qualitative, preliminary
analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) or gas chromatography/tandem mass spectrometry (GC/MS/MS) is preferred confirmatory methods.
2. A positive test result does not indicate the concentration of drug in the specimen or the route of administration.
3. A negative result may not necessarily indicate a drug-free specimen. Drug may be present in the specimen below the cutoff level of the assay.
A phosphate-buffered saline (PBS) pool was spiked with drugs to target concentrations of ± 50% cut-off and ± 25% cut-off and tested with the SalivaScreen Oral Fluid Drug Test Device. The
results are summarized below.
Drug Concentration Drug Concentration *MTD: under development OPI Drug Concentration Drug Concentration Saliva Direct Cup
Oral Fluid Drugtest The following table lists the concentration of compounds (ng/mL) above which the SalivaScreen
Oral Fluid Drug Test Device for AMP/MET/COC/OPI/THC/BZD identified positive results at a read time of 10 minutes.
AMPHETAMINE (AMP) Diacetylmorphine (Heroin) b-Phenylethylamine 6-Monoacetylmorphine Morphine 3-b-D-Glucuronide p-Hydroxyamphetamine METHAMPHETAMINE (MET) D-Methamphetamine (1R,2S) Å (-) Ephedrine Methoxyphenamine 11-Nor-D9-THC-9 COOH Methylenedioxymethamphetamin 50 11-Nor-D8-THC-9 COOH BENZODIAZEPINES (BZD) Benzoylecogonine Chlordiazepoxide Ecgonine methyl ester

Saliva Direct Cup
Oral Fluid Drugtest A study was conducted to determine the cross-reactivity of the test with compounds spiked into drug-free PBS stock. The following compounds demonstrated no false positive results on the SalivaScreen Oral Fluid Drug Test Device when tested with concentrations up to 100 Ìg/mL.
Acetylsalicylic acid Tetrahydrocortisone 3- Pentazocine hydrochloride Tetrahydrocortisone 3 (b- 1. Moolchan, E., et al, "Saliva and Plasma Testing for Drugs of Abuse: Comparison of the Disposition and Pharmacological Effects of Cocaine", Addiction Research Center, IRP, NIDA, NIH, Baltimore, MD. As presented at the SOFT-TIAFT meeting October 1998.
2. Kim, I, et al, "Plasma and oral fluid pharmacokinetics and pharmacodynamics after oral codeine administration", Clin Chem, 2002 Sept.; 48 (9), pp 1486-96.
3. Schramm, W. et al, "Drugs of Abuse in Saliva: A Review," J Anal Tox, 1992 Jan-Feb; 16 (1), 4. McCarron, MM, et al, "Detection of Phencyclidine Usage by Radioimmunoassay of Saliva," J Anal Tox. 1984 Sep-Oct.; 8 (5), pp 197-201.
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