Alcolizer Oral Detect Saliva Drug Testing User Guide

Alcolizer Oral Detect Saliva Drug Testing

Product Specifications

• Product Name: Oral Detect
• Usage: Drug testing device for detecting the presence of illicit substances in saliva
• Collection Method: Sponge-based
• Test Strips: THC, BZO, and other strips
• Result Interpretation: Qualitative
• Test Result Time: Negative results can be read within 2 minutes, unconfirmed test results should be read within 10 minutes
• Standards: Complies with AU/NZ 4760:2019 Standard

Product Usage Instructions

• Collection Process
  • Place the sponge end of the device into the donor’s mouth.
  • Instruct the donor to gently sweep the sponge inside their mouth, across their inner cheeks, gums, and tongue.
  • Hold the device horizontally with the collection sponge under the tongue.
  • Ensure collection occurs for at least 1 – 2 minutes.
  • Do not bite, chew, or suck on the sponge during collection.
  • The collection is complete when the volume sufficiency indicator turns red.
• Sealing the Device
  • While holding the cap in one hand and the main body of the device firmly in the other hand, thread the sponge into the cap of the device.
  • Keep the device upright during this step, with the strips at the top and the cap at the bottom.
  • Continue turning the sponge into the cap until all the thread has been used up.
  • The device and contents are now sealed.
• Activating the Test Strips
  • Gently shake the device 5 times from right to left until each strip starts to wet in the viewing window.
  • If any drug strip is not activated, repeat shaking until the strip becomes wet and activated in the viewing window.
  • Note: The movement should be a gentle left-to-right motion, not a vigorous up/down movement.
• Reading the Results
  • Stand the device vertically.
  • Negative results can be read as soon as the test line and control line appear on any strip, often within 2 minutes.
  • ANY shade of color in the test region is considered negative, regardless of how faint the line is.
  • Unconfirmed test results should be read at 10 minutes.
• Frequently Asked Questions (FAQ)
  • What does an unconfirmed test result mean?
  • An unconfirmed test result does not always indicate that a person took illicit substances.
  • It simply means that the individual does not have a detectable amount of the drug in their system according to the AU/NZ 4760:2019 Standard.
  • What does a negative test result indicate?
  • A negative test result means that the drug concentration is absent or present but below the detectable level.
  • It is indicated by two colored bands appearing on the strip, one in the control region (C) and another in the test region (T).
  • Negative results can be read as soon as the test and control lines appear on any strip, often within 2 minutes.
  • What should I do if no line appears at the control region?
  • If no line appears at the control region, it indicates an invalid result. In such cases, the collection should be performed again, ensuring that enough saliva is collected.
  • Can the intensity of color in the test region vary?
  • Yes, the intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen.
  • Therefore, any shade of color in the test region, even if faint, should be considered negative. Please note that this test is qualitative and cannot determine the concentration of analytes.
  • What are the likely reasons for control line failure?
  • The most likely reasons for control line failure are insufficient specimen volume, incorrect operating procedures, or expired tests.
  • Why do THC and BZO strips wick slowly?
  • The THC and BZO strips are designed to wick slowly, allowing the sample and the antibody to incubate.

HOW TO USE

• To begin collection, place the sponge end of the device into the donor’s mouth. Have the donor gently sweep the sponge inside of their mouth, across their inner cheeks, gums, and tongue.
• Hold horizontally with collection sponge under the tongue. Collection should occur for at least 1 – 2 mins.
• Do not bite, chew or suck on the sponge.
• Collection is complete when the volume sufficiency indicator turns red as shown in figure B above.
• While holding the cap in one hand and main body of the device firmly in the other hand, thread the sponge into the cap of the device.
• Keep the device upright while doing this step (strips at the top, cap at the bottom).
• Continue to turn the sponge into the cap until all the thread has been used up.
• The device and contents are now sealed.
• Gently shake the device 5 times right to left, until each strip starts to wet in the viewing window.
• If any drug strip is not activated, repeat shaking until the strip becomes wet and activated in the viewing window.
  • Note: The movement is a gentle left-to-right motion. Not a vigorous up/down movement.
• Stand the device Vertical. Read the results below.
• Negative results can be read as soon as the test line and control line appear on any strip (often within 2 minutes).
• ANY shade of color in the test region is considered negative regardless of how faint the line is.
• Unconfirmed test results should be read at

INTERPRETATION OF RESULTS

• UNCONFIRMED: A colored band appears in the control region (C) but not in the test region. A positive result indicates that the drug concentration exceeds the detectable level.
• NEGATIVE: Two colored bands appear on the strip. One band appears in the control region (C) and another band appears in the test region (T). Negative results can be read as soon as the test and control lines appear on any strip (often within 2 minutes). A negative result indicates that the drug concentration is absent, or present but below the detectable level.
• INVALID: No line appears at the control region. An invalid result means that the collection should be performed again to ensure that enough saliva was collected.

NOTE:

1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region (T), even if faint, should be considered negative. Please note that this is a qualitative test only and cannot determine the concentration of analytes in the specimen.
2. Insufficient specimen volume, incorrect operating procedures, or expired tests are the most likely reasons for control line failure.
3. The THC and BZO strips do not wick as quickly as the other strips. These strips are designed to wick slowly, which allows the sample and the antibody to incubate.

UNDERSTANDING THE TEST RESULTS

1. An unconfirmed test result does not always mean a person took illicit substances and a negative test result does not always mean a person did not take illicit substances It indicates that the individual does not have a detectable amount of the drug in their system as per AU/NZ 4760:2019 Standard.
2. An unconfirmed result sample must be tested by the laboratory to determine if a drug of abuse is present. Please refer to the Confirmation Testing section of this labeling.
3. What Is A False Positive Test? The definition of a false positive test would be an instance where the Oral Detect device is positive even though target drugs are not in the sample. The most common causes of a false positive test are cross-reactants. Certain foods and medicines, diet plan drugs, and nutritional supplements may also cause a false positive test result with this product.
4. What Is A False Negative Test? The definition of a false negative test is that the initial target drugs are present but is not detected by Oral Detect. If the sample is diluted, or the sample is contaminated this may cause a false negative result.
   • Please refer to the Specimen Collection and Procedure Sections of the insert for instructions to minimize or prevent sample dilution or contamination (such as from food or drinks in the mouth).
   • Oral Detect should be only used for the qualitative detection of drugs of abuse in oral fluid.

LIMITATIONS

• This assay provides a presumptive analytical test result only. A more specific laboratory confirmation must be used to obtain a confirmed analytical result. Careful consideration and judgment should be applied to any test result, particularly when unconfirmed results are indicated.
• There is a possibility that technical or procedural errors, as well as other substances and factors, may interfere with the test and cause false results.
• An unconfirmed result indicates the presence of a drug/metabolite only and does not indicate or measure intoxication.
• A negative result does not at any time rule out the presence of drugs/metabolites in saliva, as they may be present below the minimum detection level of the test.
• This test does not distinguish between drugs of abuse and certain medications.

QUALITY CONTROL

• Oral Detect provides a built-in control band for each test strip to indicate that the test has been performed correctly.
• The control band should always appear regardless of the presence of drugs it confirms sufficient sample volume, adequate membrane wicking, and correct procedural technique.
• The unconfirmed positive sample should be mailed to the laboratory the same day.

PERFORMANCE CHARACTERISTICS

• B. Sensitivity
  • A pool of oral fluid control was spiked with drugs to target concentrations that were ±50% and 3X of the cut-off and tested with the Oral Detect Oral Fluid Drug Test. The results are summarized below where “N” is the number of samples evaluated.

Drug Conc.

(Cutoff range)

|

N

| A| MP| B| ZO| C| OC| M| ET| O| PI| O| XY| T| HC
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---
–| +| –| +| –| +| –| +| –| +| –| +| –| +
0% Cutoff| 30| 30| 0| 30| 0| 30| 0| 30| 0| 30| 0| 30| 0| 30| 0
-50% Cutoff| 30| 30| 0| 30| 0| 30| 0| 30| 0| 30| 0| 30| 0| 30| 0
+50% Cutoff| 30| 0| 30| 0| 30| 0| 30| 0| 30| 0| 30| 0| 30| 0| 30
3X Cutoff| 30| 0| 30| 0| 30| 0| 30| 0| 30| 0| 30| 0| 30| 0| 30

• C. Specificity

  • The following table lists the concentrations of compounds in (ng/mL) above which the Oral Detect Oral Fluid Drug Test identified unconfirmed results at 10 minutes.

• A. Interference

  • A study was conducted to determine the cross-reactivity of the test with compounds in either drug-free oral fluid or drug-positive oral fluids.
  • The following compounds show no cross-reactivity when tested with the Oral Detect Oral Fluid Drug Test at a concentration of 10 g/mL

LITERATURE REFERENCES

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 FOFT-TIAFT meeting in October 1998.
2. Jenkins, A.J., Oyler, J.M. and Cone, E.J. Comparison of Heroin and Cocaine Concentrations in Saliva with Concentrations in Blood and Plasma. J. Anal. Toxicology. 19: 359-374 (1995).
3. Kidwell, D.A., Holland, J.C., Athanaselis, S. Testing for Drugs of Abuse in Saliva and Sweat. J. Chrom. B. 713: 111-135 (1998).
4. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 10th ed.
5. Hawks RL, Chiang CN, eds. Oral Fluid Testing for Drugs of Abuse. Rockville: Department of Health and Human Services, National Institute of Drug Abuse; 1986.

GLOSSARY OF SYMBOLS

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• 1300 789 908
• [email protected].

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