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    Assuring The Quality of Test Results

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    ASSURING THE QUALITY OF TEST RESULTS SAMEH SABER SAMY DECEMBER 2013. AAccuracy : is the nearness of a result or the mean of a set of measurements to the true value. BPrecision is the agreement between the set of replicate measurements without assumption of knowledge of the true value. CSpecificity is the ability to assess clearly the analyte in the presence of components which may be expected to be present.

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    Assuring The Quality of Test Results

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    ASSURING THE QUALITY OF TEST RESULTS SAMEH SABER SAMY DECEMBER 2013. AAccuracy : is the nearness of a result or the mean of a set of measurements to the true value. BPrecision is the agreement between the set of replicate measurements without assumption of knowledge of the true value. CSpecificity is the ability to assess clearly the analyte in the presence of components which may be expected to be present.

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    ASSURING THE QUALITY OF TEST RESULTS SAMEH SABER SAMY DECEMBER 2013. AAccuracy : is the nearness of a result or the mean of a set of measurements to the true value. BPrecision is the agreement between the set of replicate measurements without assumption of knowledge of the true value. CSpecificity is the ability to assess clearly the analyte in the presence of components which may be expected to be present.

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    36 views9 pages

    Assuring The Quality of Test Results

    Uploaded by

    AhmedFawzy
    ASSURING THE QUALITY OF TEST RESULTS SAMEH SABER SAMY DECEMBER 2013. AAccuracy : is the nearness of a result or the mean of a set of measurements to the true value. BPrecision is the agreement between the set of replicate measurements without assumption of knowledge of the true value. CSpecificity is the ability to assess clearly the analyte in the presence of components which may be expected to be present.

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    of 9

    ASSURING THE QUALITY OF TEST RESULTS

    SAMEH SABER SAMY


    DECEMBER 2013

    ASSURING THE QUALITY OF TEST RESULTS


    1- Calibration of Measuring and Test Equipment
    Set of operations which establishes, under specified
    conditions, the relationship between values
    indicated by a measuring instrument and the
    corresponding standard or known values derived
    from the standard.

    ASSURING THE QUALITY OF TEST RESULTS


    2- Use in-house working standards
    Working Standards are prepared from supplied raw
    materials and standardized against authentic
    Reference Substances or primary supplier standards
    (if it is not a pharmacopoeial product).

    ASSURING THE QUALITY OF TEST RESULTS


    3- Validate testing methods
    a- Accuracy : is the nearness of a result or the mean of
    a set of measurements to the true value.
    b- Precision : is the agreement between the set of
    replicate measurements without assumption of
    knowledge of the true value.
    c- Specificity : is the ability to assess clearly the
    analyte in the presence of components which may be
    expected to be present.
    d- Detection limit : is the lowest amount of analyte in
    a sample which can be detected but not necessarily
    quantitated as an exact value .

    ASSURING THE QUALITY OF TEST RESULTS


    e- Limit of quantitation: is the level above which
    quantitative results may be determined with
    acceptable accuracy and precision.
    f- Linearity : is the ability of the method to extract
    results that are directly proportional to analyte
    concentration within a given range.
    g- Ruggedness and robustness: is a measure of an
    analytical method's capacity to remain unaffected by
    small, but deliberate variations in method parameters
    and provide an indication of it's reliability during
    normal usage.

    ASSURING THE QUALITY OF TEST RESULTS


    4- Standard
    Standard solution is prepared in Duplicate, where
    standard 1 is injected five times to calculate the
    Relative standard deviation of the injections (N.M.T.
    2%)
    Precision
    and then the response factor between the two
    standards is calculated (98 % to 102 %)
    Accuracy
    and standard 1 is injected more than once during
    analysis for continual check of performance.

    ASSURING THE QUALITY OF TEST RESULTS


    5- Duplicate samples
    Test samples are prepared twice and each sample is
    measured twice.
    Duplicate sample results must be within the normal
    variation ( 98%--- 102%).
    Precision

    ASSURING THE QUALITY OF TEST RESULTS


    6- Calculations

    Thank You

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