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Country of Origin: USA
- Weight: 1.2 lb
- An FDA-cleared, CLIA-waived, and DOT-approved point-of-care test for saliva alcohol
- Easy, simple-to-use three-step procedure
- Results are ready in as little as two minutes and are similar to blood-based tests and a thermometer-like reading
- 98% correlation to blood gas chromatography
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Learn more:
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MFR:
OraSure
Ships from MFI Medical
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MPN: 31150B
- Phone: (800) 672-7873
Frequently asked questions
Is this saliva test FDA and DOT approved?
Yes, the OraSure Q.E.D. A150 is one of the most rigorously compliant saliva alcohol tests available, suitable for professional screening in regulated environments. It is both FDA-cleared and DOT-approved, in addition to being CLIA-waived.
This comprehensive regulatory status ensures broad applicability, including:
- DOT-Approved: Accepted by the Department of Transportation for mandatory workplace screening (e.g., random, post-accident, and follow-up testing).
- FDA-Cleared: Demonstrates compliance with strict US safety and efficacy standards.
- CLIA-Waived: Allows for easy, simple, point-of-care administration in various clinical and non-laboratory settings.
This device is a leading choice for institutions and occupational health due to its trusted, legally defensible results.
Is the Q.E.D. A150 test procedure simple?
Yes, the OraSure Q.E.D. A150 Saliva Alcohol Test is designed for simple and rapid point-of-care use. Its user-friendly design ensures accurate results without complex steps:
- Simple Procedure: The entire testing process involves an easy, simple-to-use three-step procedure.
- Rapid Results: Quantitative readings are delivered in as little as two minutes.
- Unambiguous Interpretation: Results are displayed clearly across a quantitative scale using a thermometer-like reading, which minimizes the chance of misinterpretation.
- Quality Assurance: The unique QA Spot™ feature confirms that the correct specimen quantity was applied in the proper location, ensuring reliable test administration.
Is this test approved for professional screening?
Yes, the OraSure Q.E.D. A150 is highly suitable and approved for professional screening due to its rigorous regulatory compliance. It is the first saliva alcohol test that is:
- FDA-cleared
- CLIA-waived
- DOT-approved (Department of Transportation)
This robust regulatory status establishes the device as a reliable instrument for quantitative alcohol measurement (0 to 145 mg/dL), demonstrating a 98% correlation to blood gas chromatography. Results are delivered rapidly in as little as two minutes.
This precision and compliance make it ideal for use in various mandated professional settings, including:
- Occupational Health: DOT and non-DOT worksite testing (e.g., random, post-accident, follow-up screening).
- Clinical Settings: Use in physician offices, emergency departments, and for admission screening.
- Justice Systems: Compliance testing, admissions, and intervention counseling.
Does it feature a reliable QA Spot™?
Yes, the OraSure Q.E.D. A150 Saliva Alcohol Test includes a built-in quality assurance feature called the QA Spot™.
This mechanism is crucial for test reliability and helps minimize errors by assuring the administrator that the specimen was applied correctly. The QA Spot™ verifies both:
- The correct quantity of the specimen was used.
- The specimen was placed in the proper location on the cassette.
This quality check is essential for ensuring the quantitative results remain highly accurate.
What components are included in each test kit box?
A standard box of the OraSure Q.E.D. A150 Saliva Alcohol Test contains all the necessary components for 10 individual tests.
Each box includes:
- 10 ready-to-use Q.E.D. A150 test devices
- Specimen collection swabs for safe and proper saliva collection
- A sheet of product instructions
Note that the product is generally sold in case quantities (e.g., a Case of 30 or Case of 100), which are composed of multiple 10-test boxes.
Is this product made in the USA?
Yes, the product is manufactured in the USA, ensuring adherence to specific quality standards.
Does this test provide precise quantitative results?
Yes, the OraSure Q.E.D. A150 is specifically designed to provide precise quantitative results, unlike simple pass/fail screening tests. Its ability to measure a specific numerical alcohol concentration is a key feature that makes it reliable and suitable for professional use.
This high level of accuracy and precision has earned the device regulatory compliance, as it is FDA-cleared, CLIA-waived, and DOT-approved.
Key specifications for quantitative measurement include:
- Quantitative Range: It measures alcohol concentration across the range of 0 to 145 mg/dL.
- Accuracy: The test demonstrates an outstanding 98% correlation to blood gas chromatography.
- Result Interpretation: Results are displayed in a clear, thermometer-like format for unambiguous interpretation.
- Speed: Results are delivered rapidly, in as little as two minutes.
Is each test single-use?
The OraSure Q.E.D. A150 Saliva Alcohol Test is designed for single-use, providing a fresh and accurate test for each application.
Is an insurance CPT code available?
Yes, this test has a CPT Code: 80305, which is accepted by major insurance carriers, potentially allowing for reimbursement.
Does the test provide precise quantitative results?
Yes, the OraSure Q.E.D. A150 Saliva Alcohol Test is designed to deliver precise quantitative results for alcohol concentration in saliva, which is why it is FDA-cleared, CLIA-waived, and DOT-approved.
This high degree of accuracy and reliability is demonstrated by:
- High Correlation: The test shows a remarkable 98% correlation to blood gas chromatography, providing results comparable to blood-based laboratory tests.
- Measurement Range: It provides quantitative measurements across the range of 0 to 145 mg/dL.
- Result Time: Test outcomes are delivered rapidly, typically in as little as two minutes.
- Clear Interpretation: Results are displayed using a clear, thermometer-like reading indicator to minimize the chance of misinterpretation.