Friday, January 18, 2008

FAQs - Oral fluid / Saliva Drug Testing - Frequently Asked Questions

FAQ – Oral Fluid-based / Saliva Workplace Drug Testing

What is a preliminary test?
A preliminary (qualitative) test is a single test result based on an initial screen, providing a negative or non-negative result. The technology used for the Avitar ORALscreen is lateral flow immunoassay.

Why is a confirmatory test necessary?
The purpose of a confirmation test is to eliminate any false positive test results from an initial screening. A confirmatory test provides a quantitative result through a GC/MS or LC/MS/MS instrumented process. The substance and the concentration of substance can be accurately determined.

Is there any health risk involved in placing the sample collection device in the test subject's mouth?
No. The sample collection device is stored in hygienic sealed packaging until it is used. When used correctly there is no direct contact between the sample collection foam an the test. Biocompatibility testing has been conducted on the basis of the requirements and has shown that the sample collection device can be classified as biocompatible with regard to its intended use.

How long is the shelf-life of the test kits?

The shelf-life is stated as expiration date, “Exp.” on the device packaging.

Can an opened test kit be left unused?
No. The test kit must be used immediately after opening.

How quickly must the result read once it has been developed?
Negatives can be read once all red lines (5), are visible. Non-negative results should be read at the 15 minute mark. No on-site device results should be interpreted after 15 minutes.

The test subject has a very dry mouth. Will it be possible to obtain a sufficient sample of oral fluid?
Certain drugs have an inhibitory effect on the production of oral fluid or saliva.
Prior the collection, instruct the donor to drink a glass (8 ounces) of water, and wait 5 minutes. If after three minutes of sample collection the collector foam is not completely saturated with oral fluid repeat the collection.

Which substances can be identified using the ORALscreen?
At the present time, the ORALscreen system can detect 96% or drugs typically tested for in the workplace, including the following substances or classes of substances; in samples of oral fluid: Amphetamines: METHAMPHETAMINE and MDMA / Ecstasy.
Opitates:CODIENE, HEROINEi, MORPHINE, 6-AM (heroin metabolite), OXYCODONE (Oxycontin, Peroset, etc.), OXYMORPHONE, HYDROCODONE (Vocodin, Lortab, etc.), HYDROMORPHONE, Di-hydrocodine,
Marijana: delta-9 THC,
Cocaine: COCAINE, BENZYCLONIE (cocaine metabolite)

Which prescription drugs and designer drugs can be detected?

The ORALscreen is one of the only on-site oral fluid-based devices available that can accurately dectect the commonly abused classes of prescription pain releivers. Common brand names are Oxycontin, Percoset, Vicodin, Lortab, etc.
The METH test of ORALscreen allows detection not only of methamphetamine, but also other important designer amphetamines such as methylenedioxymethamphetamine (MDMA,

What is the NIDA 5, SAMSHA, DOT-5 panel
This panel consists of tests for amphetamines, cocaine, morphine (heroin), PCP, and THC (marijuana). It is important to note the following:
1. PCP has a positivity rate of less that 0.3%
2. The cut-off level for OPIATES is set at 2000 ng/ml, thus making the test less effective than ORALscreen for detecting OPIATE use / abuse.
3. NIDA-5 / DOT-5, SAMSHA CAN NOT detect the commonly abuse prescription pain releivers OXYCODONE, HYDROCODONE, etc., perhaps the number one threat to workplace safety today.

Does the test show cross-reactions with other legal substances?
Because the ORALscreen system, is an immunoassay process, based on the
antigen/antibody reaction, cross-reactivity are possible. However, the antibodies used are very specific, thus cross reactivity is minimal. Confirmatory testing and MRO procedures are established to elminate false positives.

How quickly is the test result ready?
The entire on-site screen result, from the start of the sample-collection process to display of the result, takes 5 to 15 minutes on average.

Does the device have to be disposed of after analysis, or can it be sent off for a confirmation analysis?
For a negative result, the device can be disposed of. Oral fluid, without any visible signs of blood, is not considered a biohazard by the CDC.
For a non-negative result, a second sample can be collectef for confirmation analysis. Confirmation directly from the device is also available. Please discuss this option with your Avitar representative

Are there limits below which drugs cannot be detected? If so, what are these limits?
Detection windows (times) and sensitivity, cut-off values, exist for all drugs.
Thus a negative result means either that the tested saliva contains no drugs, or that they are present in concentrations below the respective cut-off value. In general detection of drugs in oral fluid ranges from within minutes of consumption up to 2-3 days. Available research indicates on that marijana (THC-delta 9) can not be detected beyond 18-24 hrs. in oral fluid at ng/ml levels, regardless of the test / test technique.

What result does the ORALscreen test window display?
The test window displays the results of the analysis, distinct for each class of drugs, in the form of a qualitative reading with either an absent line for a non-negative sample (potentially containing drugs) or a line for a negative sample (not containing drugs or drugs below the cut-off level). A control line is also visible to indicate proper operation of the device.

What is the best measure of accuracy?
Accuarcy is a comparative ratio of sensitivty and specificity. Accuracy for any device should be measured by comparing the device to a quantitative test (GC/MS or LC/MS/MS) on a “paired sample” basis using the same speciment type. Accuracy should not be measured by comparing results between two device or between different specimen types due to varying detection windows and other factors.

Sensitivity refers to the ratio of true positive (TP) samples to the total number of samples rated positive by the test kit ((TP + FP, false positive).
Specificity refers to the ratio of true negative (TN) samples to the total number of samples rated as negative by the test kit (TN + FN, false negative).

Accuracy refers to the ratio of correctly identified samples to the total number of samples.




How were the system's key performance data determined?
By tests with spiked synthetic saliva the system's key performance data of sensitivity, specificity, and accuracy were determined, and some limited field trials were conducted by Avitar and third parties.

Can the test kits be purchased individually?
The test kits are available in boxes (containing 20 test kits), or cases (containing 5 boxes).

The test subject has just eaten or drunk something or has just been smoking. Will this affect the test result?
The test subject must have nothing in their mout for a minimum of 5 minutes berfore the test.

Can eating poppy seeds cause a false positive drug test for heroin?
Eating poppy seeds cannot turn a confirmatory drug test positive for heroin. However, poppy seeds to contain morphine. Therefore, eating poppy seeds (e.g. a poppy seed bagel) can result a in a non-negative on-site result. This effect can be mitigated by waiting 45 minutes and retesting the individuals, as it’s a very short term issues

Can passive inhalation of marijuana cause a false positive drug test?
Sometimes people who test positive for marijuana will claim it was the result of passive inhalation.
Available research show that an individual must have been in an confined space, such as an automobile, for a period of time in order for detectable levels of THC-delta 9 to be found in oral fluid. Any potential effect is also of short (45min-one hour) duration. Thus, claims of passive inhalation “over the weekend” or even “last night”, would not cause a non-negative on-site test result.

Can over-the-counter cold medications cause a false positive drug test?
No. Avitar’s methamphetamine tests are very specific, and will not react with OTC cold remedies, with the GC/MS confirmatory test also serving as a safeguard.

By the end of the sampling process, the sampling collector doesn’t appear
saturated with oral fluid . Will this affect the test result?

The device will not run (no read wash and/or no control line) without adequate sample. It is important that the foam collector is completely saturated, thus extend the collection time and provide additional water as needed.

Do the on-site results provide legal proof of drug abuse?
No. An on-site drug test can only deliver general qualitative "screening" results.
Any “non-negative” screening result should be following with a confirmatory (GC/MS or LC/MS/MS) analysis with all associated processes and documentation completed properly.

After collecting a sample, the sponge is found to contain some blood. Does this affect the test result?
No. Blood does not affect the test result, however, the specimen should be considered a bio-hazard.

How is it possible to tell which test result relates to which test subject?
By means donor ID inscribed into the device, and or chain of custody number assigned for confirmatory testing.

Can the test subject manipulate the test result?
No. Sample collection can directly observed during the entire process avoiding any type of manipulation. The subject may attempt to hold the foam collector away from any oral fluid, however, this practic is also observable. If intentional, the practice should be considered an attempt to interfere with the testing process and be handled per company policy.

How comparable are oral fluid / saliva and blood substance abuse readings?
Study data reveal an overall correlation / correspondence in positive oral fluid samples with positive blood samples in more than 95 percent of cases.

Which method of analysis is most suitable for a confirmation analysis?
The usual reference method is gas chromatography mass spectrometry (GC-MS) or liquid chromatography (LC/MS/MS).

How quickly can drug consumption be detected by means of an oral fluid analysis?
The individual drugs and/or their metabolites can be detected in the saliva immediately, or within minutes after oral ingestion. On average, it takes several hours for drug metabolites to be detected post-consumption in urine.

How long after consumption can the individual drugs be detected in saliva?

The time window during which drugs can be detected in oral fluid depends on various factors; e.g. the quantity consumed, the frequency of consumption, the time between the drug consumption and the test and a person's individual metabolism.
Various studies have shown that amphetamines/methamphetamines remain in the saliva in sufficient quantities for detection for up to 50 hours; cocaine can be detected for up to 12-36 hours, opiates for up to 24 hours and longer, and cannabinoids for up to 24 hours.

Do the test results provide legal proof of drug abuse?
Any on-site drug test can only deliver general "screening" results. After any non-negative screening result a confirmation analysis (e.g. with GC-MS / LC/MS/MS) should be performed.
The quantitative result is legally defensable.

1 comment: said...

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