7.9 Optimization and Validation of the Measurement Procedure
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limit values above which medical interventions are necessary. The typical content of
cholesterol is far above the detection limit of commonly used procedures in clinical
labs.
Requirements for measuring procedure: the limit of detection is not as important,
but the value of uncertainty of the result is important, which means that this should
be evaluated carefully within validation.
Example 2 Monitoring of the emergency substances in an environment.
Suppose the client (e.g., a company dealing with soil phytoremediation) wants
to know the most contaminated places on the site; the rough and fast screening
procedure would then be required.
Requirements for the measurement procedure: the detection limit and uncertainty
of the result obtained are not critical parameters, whereas the working range (linear)
of the measurement procedure is important, which means that that this should be
evaluated carefully within validation.
Example 3 Doping control in sport.
Suppose the client (e.g. the anti-doping organization) is interested in whether the
presence of a prohibited chemical compound can be detected in the urine of an athlete
participating in a competition.
Requirements for measurement procedure: the detection limit and uncertainty
of the result parameters are extremely important, which means that this should be
evaluated carefully within validation. In this case, a large linear range of calibration
is not critical.
Both testing and calibration laboratories should estimate the uncertainty of
measurement according to their own implemented procedures. They need to
identify all the components of uncertainty and make a reasonable estimation
based on knowledge of the performance of the applied method and previous experience and validation data. Thus, laboratories should be aware of the
uncertainty of measurements.
The test report should at least include the test results with, where appropriate,
the units of measurement. The uncertainty value should be added on request
of customer, which should be always include as a part of review of the request
and contract with a given customer.
In terms of the calibration certificate, they should include the uncertainty of
measurement and/or a statement of compliance with an identified metrological
specification.
99
limit values above which medical interventions are necessary. The typical content of
cholesterol is far above the detection limit of commonly used procedures in clinical
labs.
Requirements for measuring procedure: the limit of detection is not as important,
but the value of uncertainty of the result is important, which means that this should
be evaluated carefully within validation.
Example 2 Monitoring of the emergency substances in an environment.
Suppose the client (e.g., a company dealing with soil phytoremediation) wants
to know the most contaminated places on the site; the rough and fast screening
procedure would then be required.
Requirements for the measurement procedure: the detection limit and uncertainty
of the result obtained are not critical parameters, whereas the working range (linear)
of the measurement procedure is important, which means that that this should be
evaluated carefully within validation.
Example 3 Doping control in sport.
Suppose the client (e.g. the anti-doping organization) is interested in whether the
presence of a prohibited chemical compound can be detected in the urine of an athlete
participating in a competition.
Requirements for measurement procedure: the detection limit and uncertainty
of the result parameters are extremely important, which means that this should be
evaluated carefully within validation. In this case, a large linear range of calibration
is not critical.
Both testing and calibration laboratories should estimate the uncertainty of
measurement according to their own implemented procedures. They need to
identify all the components of uncertainty and make a reasonable estimation
based on knowledge of the performance of the applied method and previous experience and validation data. Thus, laboratories should be aware of the
uncertainty of measurements.
The test report should at least include the test results with, where appropriate,
the units of measurement. The uncertainty value should be added on request
of customer, which should be always include as a part of review of the request
and contract with a given customer.
In terms of the calibration certificate, they should include the uncertainty of
measurement and/or a statement of compliance with an identified metrological
specification.