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Salivascreen IV - Certified test for the detection of multiple drugs

DESCRIZIONE

A rapid screening test for the simultaneous, qualitative detection of multiple drugs, parents and metabolites, in human oral fluid. For professional in vitro diagnostic use only.

INTENDED USE
The SalivaScreen VI is a lateral flow chromatographic immunoassay for the qualitative detection of Amphetamines, Cocaine, Marijuana, Methamphetamines, Opiates and Methadone and their metabolites in oral fluid at the following cut-off concentrations.

SUMMARY

The SalivaScreen VI will detect other related compounds, too, please refer to the Analytical Specificity table in this package insert.
AMP: Amphetamine is a potent central nervous system stimulant currently prescribed to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and narcolepsy. Acute higher doses induce euphoria, alertness, and sense of increased energy and power. Although highly pH dependent, amphetamine is readily present and detectable in saliva; experiments indicate that the saliva/plasma ratio of amphetamine is 2.76. The cutoff level of the amphetamine assay (50 ng/mL) mirrors the saliva screening cutoff proposed by the Department of Health and Human Services (DHHS) for the Federal Drug Free Workplace Program.
COC: Cocaine is a potent central nervous system stimulant and a local anesthetic found in the leaves of the coca plant. The psychological effects induced by using cocaine are euphoria, confidence and sense of increased energy; physical effects including increased heart rate, dilation of the pupils, fever, tremors and sweating. Cocaine, as well as its primary metabolite benzoylecgonine, is readily present and detectable in saliva following drug use. The saliva/plasma ratio for parent cocaine is up to 5.00. The cutoff level of the cocaine test (20 ng/mL) mirrors the saliva screening cutoff proposed by the Department of Health and Human Services (DHHS) for the Federal Drug Free Workplace Program.
THC: Tetrahydrocannabinol, is generally accepted to be the principle active component in marijuana. When ingested or smoked, it produces euphoric effects. Abusers exhibit central nervous system effects, altered mood and sensory perceptions, loss of coordination, impaired short term memory, anxiety, paranoia, depression, confusion, hallucinations and increased heart rate. Unchanged THC is present and detectable in saliva for a short period of time following drug use. The saliva/plasma ratio of parent THC after smoking can be as high as 10, but only for a very limited time. The cutoff level of the THC test (100ng/mL) was taken from research showing that such levels correlate with blood concentrations of users showing signs of physiological effects of recent cannabis use.
MET: Like amphetamine, methamphetamine is a potent central nervous stimulant that induces euphoria, wakefulness, and a sense of increased power and energy. Methamphetamine can be manufactured clandestinely using either ephedrine or phenylacetone as a precursor. Street names for the drug include crank, crystal, ice and meth. Methamphetamine is readily present and detectable in saliva after use; the saliva/plasma ratio for methamphetamine is 3.98. The cutoff level of the methamphetamine test (50 ng/mL) mirrors the saliva screening cutoff proposed by the Department of Health and Human Services (DHHS) for the Federal Drug Free Workplace Program.
OPI: Opiates such as heroin, morphine, and codeine as well as synthetic analogs such as hydrocodone and hydromorphone, are central nervous system (CNS) depressants and analgesics. All opiates are present and detectable in saliva following drug use. The saliva/plasma ratio for codeine is 3.3; the saliva/plasma ratio for morphine is 0.2. The cutoff level of the opiates test (40 ng/mL) mirrors the saliva screening cutoff proposed by the Department of Health and Human Services (DHHS) for the Federal Drug Free Workplace Program.
MTD: Methadone is a synthetic analgesic drug originally used for the treatment of narcotic addiction. In addition to use as a narcotic agonist, methadone is being used more frequently as a pain management agent. The psychological effects induced by using methadone are analgesia, sedation, and respiratory depression. Based on the saliva/plasma ratio calculated over salivary pH ranges of 6.4-7.6 for therapeutic or recreational doses of methadone, a cutoff <50 ng/mL is suggested. Due to this recommendation, the cutoff level of the methadone test was calibrated to 30 ng/mL.

The SalivaScreen VI 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 spectrometry (GC/MS) and gas chromatography/tandem mass spectrometry (GC/MS/MS) are the preferred confirmatory methods. Professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated

PRICIPLE

The SalivaScreen VI is an immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid specimen compete against their respective drug conjugate for binding sites on their specific antibody.
During testing, a portion of the oral fluid specimen migrates upward by capillary action. A drug, if present in the oral fluid specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with the drug-protein conjugate and a visible coloured line will show up in the test line region of the specific drug strip. The presence of drug above the cut-off concentration in the oral fluid specimen will saturate all the binding sites of the antibody. Therefore, the coloured line will not form in the test line region.

A drug-positive oral fluid specimen will not generate a coloured line in the specific test line region of the strip because of drug competition, while a drugnegative oral fluid specimen will generate a line in the test line region because of the absence of drug competition. To serve as a procedural control, a coloured line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

REAGENTS & MATERIALS SUPPLIED

  • 25 individually wrapped test devices. Each device consists of two different test strips in a plastic test strip holder. The test strip contains a colloidal gold pad coated with antibody and rabbit antibody. It also contains a membrane coated with drug-bovine protein conjugate in the test band and goat anti-rabbit antibody in the control band adulterant pads when applicable.
  • One compression tube and one Eppendorf tube
  • One instruction sheet (must be used in conjunction with the SalivaScreen reader)
  • Timer (required, but not provided)

PRECAUTIONS

  • For in vitro diagnostic use only.
  • Do not use after the expiration date.
  • All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent
  • The test device should remain in the sealed pouch until use.
  • Do not moisten nitrocellulose membrane with samples.
  • The used test device should be discarded according to federal state and local regulations.
  • Use proper sample volume (min 180 μl per assay).

STORAGE AND STABILITY
Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test devices must remain in the sealed pouch until use.
 Do not freeze.  Do not use beyond the expiration date.

SPECIMEN COLLECTION AND HANDLING
A fresh saliva sample should be collected using the SalivaScreen Saliva Drug Test Device.
The donor should not have had anything to eat, chew, smoke or drink for at least 10 minutes prior to the collection of the specimen.

ASSAY PROCEDURE
Testing

  • Remove the test device, compression tube and Eppendorf tube from the sealed pouch.
  • Attach the Eppendorf tube to the end of the compression tube. Set this aside
  • Insert the test device into the mouth Allow saliva to pool around the collection material but do not force saliva into the device.
  • Keep the test device in the mouth until both strips show discoloration in the Test Windows. This may take as little as 1 minute or as long as 6 minutes.
  • Once both sides of the strips in the Test Windows start to discolor, remove the test device from the mouth, place the collection pad into the compression tube and return it to the test administrator.
  • Initiate the timing and interpretation of the test device using the Handheld reader as instructed in the reference manual.

INTERPRETATION OF RESULTS WITH HANDHELD READER
Do not interpret the SalivaScreen Saliva Drug Test without the reader
Valid Results
Valid (neg.): SalivaScreen Reader interprets all drug tests as negative. The line in the control region is the control; both control lines must be present for the reader to validate the test. A Pass result for a drug indicates that the concentration of that drug in the saliva is below the cutoff level of the test.
Valid (pos.): SalivaScreen Reader interprets one or more tests as preliminary positive. The line in the control region is the control; both control lines must be present for the reader to validate the test. A FAIL result (preliminary positive) for a drug indicates that the concentration of that drug in the saliva is at or above the cutoff level of the test
Invalid: No colored line appears in either or both control regions. If the control lines do not form, the test result is inconclusive and should be repeated. The Handheld reader will indicate such a finding.

  

INTERPRETATION OF RESULTS VISUAL

*NOTE: The intensity of colour in the test line region (T) may vary, but it must be considered negative whenever there is even a faint coloured line.

NEGATIVE* - A coloured line in the control line region (C) and another line in the test line region (T) indicate a negative result for a specific drug. This indicates that the drug is not present or the drug concentration in the oral fluid specimen is below the designated cut-off level for that specific drug.

POSITIVE - A coloured line in the control line region (C) but no line in the test line region (T) indicates a positive result for a specific drug. This indicates that the drug concentration in the oral fluid specimen exceeds the designated cut-off for that specific drug.

INVALID - Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test device. If the problem persists, discontinue using the lot and contact your local distributor.

QUALITY CONTROL
An internal procedural control is included in each strip of the test device. A line must form in the Control band region regardless of the presence or absence of drugs or metabolites. The presence of the line in the Control region indicates that the proper sample volume has been used and that the reagents are migrating properly. If the line in the Control region does not form, the test is considered invalid.

LIMITATIONS

  • The assay is designed for use with human saliva only.
  • A FAIL result with any of the tests indicates only the presence of a drug/metabolite and does not indicate or measure intoxication.
  • There is a possibility that technical or procedural error as well other substances as factors not listed may interfere with the test and cause false results. See SPECIFICITY for lists of substances that will produce FAIL results, or that do not interfere with test performance.
  • The SalivaScreen VI 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) is preferred confirmatory methods.
  • A positive test result does not indicate the concentration of drug in the specimen or the route of administration.
  • A negative result may not necessarily indicate a drug-free specimen. Drug may be present in the specimen below the cut-off level of the test.

PERFORMANCE CHARACTERISTICS
Accuracy
The accuracy of the SalivaScreen Saliva Drug Test Device was evaluated by testing three lots of the test devices with spiked drug sample solutions. Sample concentrations were confirmed by GC/MS or GC/MS/MS.
Analytical Specificity
The specificity for the SalivaScreen VI Drug Test Device was determined b y testing various drugs, drug metabolites, and other compounds that are likely to be present in human saliva. All compounds were prepared in drug-free, pooled human saliva. The following compounds produce FAIL results when tested at levels greater than the concentrations listed below.

salivascreeniv_06.jpg

Interference
The following compounds were evaluated for potential interference with the SalivaScreen Saliva Drug Test Device. All compounds were dissolved in the spiked sample solutions and tested with SalivaScreen VI Test Device.

salivascreeniv_08.jpg

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