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Quantitative Method -
a method of analysis whose response is the amount of the analyte
measured either directly (e.g., enumeration in a mass or volume), or indirectly (e.g., colour
absorbance, impedance, etc) in a certain amount of sample.
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Qualitative Method - is a method of analysis whose response is either the presence or
absence of the analyte detected either directly or indirectly in a certain amount of sample.
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Repeatability
(r)
– mM
easurement precision under a set of repeatability conditions of
measurement; the condition of measurement
,
out of a set of conditions
,
that includes the
same measurement procedure, same operators, same measuring system, same operating
conditions, and same location, and replicate measurements on the same or similar objects
over a short period of time. A condition of measurement is a repeatability
the precision with
which repeat measurements of the same sample give the same value with all conditions
unchanged between measurements, except time.
The closeness of agreement between
individual results, using the same method, test substance, and set of laboratory conditions.
This represent a measurement done with the least amount of variability
Repeatability is a measure of precision, not accuracy.
Altermative version:
The closeness of agreement between individual results, using the same method, test substance,
and set of laboratory conditions. Measurement precision under a set of repeatability conditions of
measurement; the condition of measurement, out of a set of conditions, that includes the same
measurement procedure, same operators, same measuring system, same operating conditions,
and same location, and replicate measurements on the same or similar objects over a short
period of time. A condition of measurement is a repeatability
This represent a measurement with the least amount of variability
Repeatability is a measure of precision, not accuracy.
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Reproducibility
(R):
measurement precision under reproducibility conditions of
measurement; a condition of measurement out of a set of conditions that includes different
locations, operators, measuring systems, and replicate measurements on the same or similar
objects.
the closeness of the agreement between the results of measurements of the same
analyte, where the measurements are carried out under changed conditions. Usually used to
imply agreement within a method as applied among different laboratories
Change all you can change to generate the maximum amount of variability
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Verification - the provision of objective evidence that a given item fulfills specified
requirements or to assess the performance of a method in the own laboratory situation
against the specifications of the method established during the validation study. The
laboratory must demonstrate that it is capable of performing the analysis.
3.7 Familiarization:
4. Verification for qualitative and quantitative methods
Verification is required when a new method is implemented in a laboratory or when a method is
updated
(new version is published)
. The verification process includes:
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ACTION: TG TO CHOSE
PREFERED DEFINITION
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Daniel to input explantion
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Daniel to input explantion
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Comment [L5]:
Daniel to draft
explanatory/interpretive note: one intra-lab repro.
study + PT panel
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TBD: a) will definitions stay
here + note in following section b) definitions + note
here c) no definition section, everything later?
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ACTION: Shelagh to draft a
definition
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