US 2026/0276607 A1Published application

A method for quality check of at least one lc-ms measurement

AssigneeRoche Diagnostics Operations, Inc.

InventorsRuediger Laubender, Julian Michely

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Abstract

A method for quality check of at least one Liquid Chromatography-Mass Spectrometry (LC-MS) measurement on a sample comprising an analyte of interest and a defined amount of at least one internal standard is proposed. The method comprises the following steps a) (120) determining an information (peakAreaaqn) about an analyte signal and an information (peakAreaiqn) about an internal standard signal of the LC-MS measurement; b) (122) determining at least one monitoring parameter by using the information about the analyte signal and the information about the internal standard signal by using at least one processing device (114), wherein the monitoring parameter comprises a minimal limit for the internal standard signal for said analyte signal of said sample; c) (124) comparing the information about the internal standard signal to the monitoring parameter by using the processing device (114), wherein the LC-MS measurement is flagged by using the processing device (114) as to fulfil the quality check in case the information about the internal standard signal is greater or equal to the monitoring parameter or otherwise as failed.

Claims15

Dependent claims

determining an information (peakAreaaqn) about an analyte signal and an information (peakAreaiqn) about an internal standard signal of the LC-MS measurement, wherein qn refers to a quantifier, aqn relates to an analyte quantifier, and iqn relates to an internal standard quantifier;
determining at least one monitoring parameter including a first monitoring parameter by using the information about the analyte signal and the information about the internal standard signal by using at least one processing device, wherein the first monitoring parameter comprises a minimal limit for the internal standard signal for said analyte signal of said sample, wherein the first monitoring parameter is determined by
b
2
×
(
peakArea
aqn
)
2
-
a
×
b
×
(
peakArea
aqn
)
2
+
-
b
2
×
(
peakArea
aqn
)
2
×
(
b
+
(
a
-
CV
psd
)
×
peakArea
aqn
)
*
(
b
+
(
a
+
CV
psd
)
×
peakArea
aqn
)
,
wherein CVpsd is a predefined precision acceptance criterion for a coefficient of variation for an assay, wherein parameters a and b are predetermined by performing a plurality of LC-MS measurements on the sample, wherein the information about the analyte signal is determined for each measurement, wherein the method comprises, by using the processing device, determining at least one of a median or a mean of the information about the analyte signal and its CVaqn, and calculating the parameters a and b by using at least one regression fit according to one of
CV
aqn
=
a
+
b
×
1
peakArea
aqn
⁢
or
⁢
CV
aqn
=
a
+
b
×
1
peakArea
aqn
,
wherein CVaqn is the coefficient of variation of the analyte quantifier;
comparing the information about the internal standard signal to the first monitoring parameter by using the processing device, wherein the LC-MS measurement is flagged by using the processing device as to fulfil the quality check in case the information about the internal standard signal is greater or equal to the first monitoring parameter or otherwise as failed.

83 more elements

A system comprising;

at least one mass spectrometry device configured for performing at least one Liquid Chromatography-Mass Spectrometry (LC-MS) measurement on a sample comprising an analyte of interest and a defined amount of an internal standard;
at least one processing device configured for obtaining and/or retrieving an information peakAreaaqn about an analyte signal and an information peakAreaiqn about an internal standard signal of the LC-MS measurement, wherein qn refers to a quantifier, wherein the processing device is further configured for determining at least one monitoring parameter including a first monitoring parameter by using the information about the analyte signal and the information about the internal standard signal, wherein the first monitoring parameter comprises a minimal limit for the internal standard signal for said analyte signal of said sample, wherein the first monitoring parameter is determined by
b
2
×
(
peakArea
aqn
)
2
-
a
×
b
×
(
peakArea
aqn
)
2
+
-
b
2
×
(
peakArea
aqn
)
2
×
(
b
+
(
a
-
CV
psd
)
×
peakArea
aqn
)
*
(
b
+
(
a
+
CV
psd
)
×
peakArea
aqn
)
,
wherein CVpsd is a predefined precision acceptance criterion for a coefficient of variation for an assay, wherein the parameters a and b are predetermined by performing a plurality of LC-MS measurements on the sample, wherein the information about the analyte signal is determined for each measurement, wherein the method comprises, by using the processing device, determining at least one of a median or a mean of the information about the analyte signal and its CVaqn, and calculating the parameters a and b by using at least one regression fit according to one of
CV
aqn
=
a
+
b
×
1
peakArea
aqn
⁢
or
⁢
CV
aqn
=
a
+
b
×
1
peakArea
aqn
,
wherein CVaqn is the coefficient of variation of the analyte quantifier;
wherein the processing device is further configured for comparing the information about of the internal standard signal to the first monitoring parameter, wherein the processing device is configured for flagging the LC-MS measurement as to fulfil the quality check in case the information about the internal standard signal is greater or equal to the first monitoring parameter or otherwise as failed.

83 more elements

At least one non-transitory computer-readable storage media comprising a plurality of instructions stored thereon that, in response to execution by a computing system, causes the computing system to:

determine an information (peakAreaaqn) about an analyte signal and an information (peakAreaiqn) about an internal standard signal of a Liquid Chromatography-Mass Spectrometry (LC-MS) measurement, wherein qn refers to a quantifier, aqn relates to an analyte quantifier, and iqn relates to an internal standard quantifier;
determine at least one monitoring parameter including a first monitoring parameter by using the information about the analyte signal and the information about the internal standard signal by using at least one processing device, wherein the first monitoring parameter comprises a minimal limit for the internal standard signal for said analyte signal of said sample, wherein the first monitoring parameter is determined by
b
2
×
(
peakArea
aqn
)
2
-
a
×
b
×
(
peakArea
aqn
)
2
+
-
b
2
×
(
peakArea
aqn
)
2
×
(
b
+
(
a
-
CV
psd
)
×
peakArea
aqn
)
*
(
b
+
(
a
+
CV
psd
)
×
peakArea
aqn
)
,
wherein CVpsd is a predefined precision acceptance criterion for a coefficient of variation for an assay, wherein parameters a and b are predetermined by performing a plurality of LC-MS measurements on a sample, wherein the information about the analyte signal is determined for each measurement,
determine at least one of a median or a mean of the information about the analyte signal and its CVaqn, and calculate the parameters a and b by using at least one regression fit according to one of
CV
aqn
=
a
+
b
×
1
peakArea
aqn
⁢
or
⁢
CV
aqn
=
a
+
b
×
1
peakArea
aqn
,
wherein CVaqn is the coefficient of variation of the analyte quantifier;
compare the information about the internal standard signal to the first monitoring parameter by using the processing device, wherein the LC-MS measurement is flagged by using the processing device as to fulfil the quality check in case the information about the internal standard signal is greater or equal to the first monitoring parameter or otherwise as failed.

84 more elements

Dependencies are inferred from the claim text.