Std x100 mean A forensic toxicology laboratory associated with a medical examiner's office routinely screens postmortem...
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Std x100 mean A forensic toxicology laboratory associated with a medical examiner's office routinely screens postmortem blood samples for morphine, which is a metabolite of heroin. To address the difficult matrix, the laboratory uses an internal standard method. The following curve was generated for a typical assay: [Morphine] (ppb) 20.0 80.0 150.0 250.0 400.0 600.0 800.0 Area Counts 1452 6108 13309 17009 30072 42234 61234 Calibration check 200 ppb Unknown replicate 1 Unknown replicate 2 Unknown replicate 3 [IS] (ppb) 250 250 250 250 250 250 250 Area Counts 15023 15865 14998 15000 15299 15308 15333 The SOP requires the analysis of an independent calibration check solution. In this case, the accepted true value of the check solution is 200.0 ppb. The calculated value of the calibration check solution must be within +/-5% of the accepted true value for the assay to proceed. There is also a requirement that the %RSD of the internal standard areas in the curve be less than 5%. An analyst performs three replicate analyses on a single blood sample in the batch and obtains the following data: Counts (Morphine) 14503 37249 37326 36636 Counts (internal standard) 15203 15235 15172 15299 a. What are the mean and %RSD of the internal standard areas? Should the assay have been stopped based on this finding? b. Why is this consistency a reasonable expectation? c. What was the bias found between the observed concentration of the calibration check solution and the accepted true value? Should the assay have been stopped based on this finding? Report the concentration of morphine calculated as a range based on the 95% confidence interval. d. Std x100 mean A forensic toxicology laboratory associated with a medical examiner's office routinely screens postmortem blood samples for morphine, which is a metabolite of heroin. To address the difficult matrix, the laboratory uses an internal standard method. The following curve was generated for a typical assay: [Morphine] (ppb) 20.0 80.0 150.0 250.0 400.0 600.0 800.0 Area Counts 1452 6108 13309 17009 30072 42234 61234 Calibration check 200 ppb Unknown replicate 1 Unknown replicate 2 Unknown replicate 3 [IS] (ppb) 250 250 250 250 250 250 250 Area Counts 15023 15865 14998 15000 15299 15308 15333 The SOP requires the analysis of an independent calibration check solution. In this case, the accepted true value of the check solution is 200.0 ppb. The calculated value of the calibration check solution must be within +/-5% of the accepted true value for the assay to proceed. There is also a requirement that the %RSD of the internal standard areas in the curve be less than 5%. An analyst performs three replicate analyses on a single blood sample in the batch and obtains the following data: Counts (Morphine) 14503 37249 37326 36636 Counts (internal standard) 15203 15235 15172 15299 a. What are the mean and %RSD of the internal standard areas? Should the assay have been stopped based on this finding? b. Why is this consistency a reasonable expectation? c. What was the bias found between the observed concentration of the calibration check solution and the accepted true value? Should the assay have been stopped based on this finding? Report the concentration of morphine calculated as a range based on the 95% confidence interval. d.
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Answer rating: 100% (QA)
a The mean of the internal standard areas is 1522175 and the RSD is 014 This is well below the required 5 RSD so the assay should not have been stoppe... View the full answer
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Service Management Operations Strategy Information Technology
ISBN: 978-0077841201
8th edition
Authors: James Fitzsimmons, Mona Fitzsimmons, Sanjeev Bordoloi
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