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1. What is the name of the assay/test and the name of the instrument, model used and manufacturer?
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2. Is this a screening or confirmatory test?
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3. Describe the indications for this test. Explain how results are used by clinicians to make diagnostic or treatment decisions. Your answer should provide the background information necessary to understand the clinical significance of the test.
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4. What are the specimen requirements? Include collection, preparation, type, storage, handling, etc. as applicable.
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5. Explain the analytical process of this assay. This is a detailed explanation of all the steps of the analysis in terms of biochemical reactions and how data/results are generated. This question is asking for the “why”, “what”, and “how” of the procedure. This question is NOT asking for the actual procedure steps, but an explanation of what happens within the assay.
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6. Complete the table below regarding the reagents used in the assay. You do not need to describe preparation or placement on an automated instrument.
NAME OF REAGENT PURPOSE IN THE ANALYSIS
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7. State the reference interval(s).
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8. What is the specificity of this assay?
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9. What is the sensitivity of this assay?
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10. Describe the limitations of the method and potential sources of error.
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11. Describe the quality control specimens used and how they are used.
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12. What was the availability and turn-around-time for this assay at your clinical site?
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13. State how results correlate with clinical conditions.
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14. State the CLIA testing category.
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15. What are the CLIA personnel requirements for performing the test? You need only describe the personnel requirements for “testing personnel”. Check the official CLIA (FDA/government) website and use this as your source. This information is found in the code of federal regulations. Do not cite a secondary source. Please do not “cut and paste” from the source document. Summarize this information in your own work and correctly cite the source.
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References: (Please list your sources cited here. You should have read MORE than the lab procedure or package insert for this assignment. Content should be referenced to source material such as your textbook, other texts, interviews, lectures, CLIA websites, journal articles, etc. These must be in ICMJE format and cited within the text above. Additional information about ICMJE can be found in the syllabus.)
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