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Q.E.D. Saliva Alcohol Test:
DOT Approved for evidentiary alcohol testing
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A Quantitative test device for the rapid determination of Equivalent Blood Alcohol Content (BAC) Using a non-invasive saliva sample. Approved by the Federal Department of Transportation (DOT) for commercial alcohol testing programs, the Q.E.D. test also meets USCG standards for on board maritime regulations. The QED saliva test uses a unique patented lateral flow method to rapidly determine alcohol presence in saliva expressed as % BAC and ml/dl concentration. Test result interpretation is as simple as reading a thermometer.
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• Meets 2006 U.S. Coast Guard Maritime Requirements • Non Invasive, Quantitative Results in 2-4 Minutes • Interpretation like Reading a Thermometer • Long Shelf Life of 10-12 Months • Individually Sealed in Foil Envelope with Cotton Swabs • Built-in Quality Control and Calibration • U.S. DOT Approved for Testing and Evidence • High Correlation (r = 0.98) to Blood Analysis results • No Special Equipment or Training Required
The Q.E.D.® Saliva Alcohol test is a technological breakthrough that can be used as an accurate, quantitative measurement device for obtaining blood alcohol levels using a saliva sample. The test can reliably be used in place of blood, urine, or breath testing methods which require expensive equipment and operator training. Through a preset chemical reactive process that requires no user intervention, a color bar rises to the level of alcohol present in the system in much the same way as a mercury thermometer. In extensive clinical trials, saliva alcohol levels measured by the Q.E.D.® Saliva Alcohol test demonstrated a high correlation rate of 98% (r=0.98) to blood analyzed by sophisticated laboratory gas chromatography methods.
TEST PROCEDURE:
The Q.E.D.® Saliva Alcohol Test is an easy to use diagnostic procedure with everything required contained in a sealed foil package. Total time required for the test is between 3 and 5 minutes. The three basic steps are as follows:
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1. Using the cotton swab included, actively swab around the cheeks, gums, and tongue for 30-60 seconds or until the cotton swab is completely saturated with saliva. |
2. Place the test device on a flat surface. Gently twist the swab with the collected saliva sample into the entry port and apply steady pressure to activate the capillary action until the pink fluid passes the QA Spot™ located at the top of the test device. |
3. Read the test results. Allow the test device to develop for two minutes. A distinct purple bar will form within the marked scale region. The highest point of the purple bar represents the level of Alcohol expressed as either a percentage (.0x%) or milligrams (ml/dL) concentration. |
The Q.E.D.® Saliva Alcohol Test will accurately measure a range of blood alcohol concentration of 0-145mg/dL or 0.0%-0.145% equivalent BAC, the top range being almost twice that of the legal limit of 0.08% BAC.
Frequently Asked Questions:
How accurate is the QED® test? The Q.E.D.® test can be used as an accurate screen in place of blood or breath tests. In clinical trials, saliva alcohol levels measured by the Q.E.D.® demonstrated high correlation to blood analyzed by gas chromatography (r=0.98).
What range of BAC will the Q.E.D.® test measure? The Q.E.D.® test has a quantitative range of 0 - 145 mg/dL (0.0% - 0.145% BAC).
What is an advantage of using the Q.E.D.® instead of an electronic breath analyzer? Unlike breath testers, you can make a permanent record of test results for a file by making a copy of the completed test on a copy machine.
What does a positive reading look like with the QED® test? When a QED® test result is positive, a dark purple color bar forms within the measurement scale. This color is distinctly darker than the pink or orange color seen as the sample fills the device. The color bar on a positive test -- the same color seen in the QA Spot™ -- develops in 2 minutes for the A150 test.
How hard should I press down with the QED® applicator? Gently apply slow and even pressure when placing the swab in the entry port. Too much pressure can jam the test. For best results, gently twist the collector into the entry port until the cotton touches the red filter pad and then begin pressing.
What does the Clinical Laboratory Improvement Act (CLIA) waiver mean for work site testing? Because work site testing is considered forensic testing, CLIA regulations do not apply. The waived status for the QED® Saliva Alcohol Test under CLIA '88 makes testing easier in hospitals, rehabilitation centers and treatment facilities where our test is used as an in-vitro diagnostic tool.
Does the QED® test measure residual alcohol in the mouth or is it measuring the alcohol within the entire body (blood stream)? Beverage alcohol (ethyl alcohol) is absorbed directly and unchanged into a person's body and is evenly distributed throughout the blood stream and other bodily fluids, including saliva. The QED® test measures the amount of alcohol in bodily fluids, commonly called blood-alcohol concentration, or BAC. Residual alcohol in the mouth just after a person takes a drink is quickly absorbed, swallowed, or evaporated, and a person's mouth is "clear" of residuals 10 minutes after eating or drinking.
Will the QED® test react with ketone often found in the saliva of diabetic patients? No. Unlike breath analyzers and other saliva tests, the QED® test is specific to ethyl alcohol and will not cross-react with acetone and ketone produced by diabetic patients.
Will the QED® device work if it is stored at temperatures outside the range on the packaging? Storing and using QED® tests at room temperature (15-30ºC, 59-86ºF) insures optimal performance and a full shelf life. However, the QED® test will work fine if exposed to temperatures outside that range for limited periods. We tested the QED® device under a wide range of temperatures and storage conditions -- simulating the inside of a vehicle glove box on a hot summer day (about 120ºF) and the lonely cold of North Dakota in January (about 0ºF). In all cases, the test performed as it should. Before using a QED® Saliva Alcohol Test exposed to extreme heat, allow the device to cool to room temperature; if the QED® device is exposed to extreme cold, put it into a pocket to warm it up.
How can companies using the QED® test in very remote areas comply with the DOT's requirement that confirmation tests on positive screening tests must be conducted within 30 minutes? The DOT will accept results of confirmation tests conducted more than 30 minutes after a positive screening test. Look to 49 CFR Part 40 section 40.65, paragraph (b). The DOT added a sentence which directs the Breath Alcohol Technician (BAT) to simply explain "why?" if a confirmation test is done more than 30 minutes after a screening test. This is not a fatal flaw.
Why should I buy the QED® Saliva Alcohol Test if I need an Evidential Breath Testing (EBT) to confirm positive test results? The QED® test is much less expensive to operate than a breath test, unless you conduct a very high volume of tests in a central location. By and large, each test done on saliva instead of breath saves money. Plus, performing two independent tests is more legally defensible on the rare occasion an employee does test positive for alcohol.
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