干扰 流程图-1
2025-05-05 11:13:04 0 举报美国CLSI EP07最新版本流程图
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The results areinterpreted(7.5.2–7.5.3)
The data are analyzed(5.3.1)
Measurement ProcedureComparison UsingPatient SamplesInterference is evaluatedusing patient specimens(7)
End
Yes
Patient test and controlspecimens are tested induplicate on both measurement procedures and theresults are recorded (7.4)
Measurand test concentrations are determined (3.2)
NO
Does the substance pass the screening test?
The data are analyzedand interpreted(6.2)
Patient specimens(unmodified)
Potentially interfering substances are determined (3.3)
The data are analyzed(7.5)
Acceptance criteria are determined (3.1)
Interferent test concentrations are determined (3.4)
Patient specimensknown to containinterferent (testspecimens) are selected(7.1)
Results are reported asclaims in themanufacturer’s labeling(9)
Patient specimensknown to not containinterferent (controlspecimens) are selected (7.2)
Paired Difference(test vs control) Interference screening using spiked samples is conducted (5)
The test and control samples are measured and the results are recorded (5.3)
STANDARDPROCEDURE
The samples aremeasured and theresults are recorded(6.1.2)
OPTIONAL(AS NEEDED)
Testing materials and samples are prepared (5.2)
Testing materials and samples are prepared(6.1.1)
Interference testing begins
Samples prepared by spiking interferent or measurand
Reference or comparative measurement procedureis determined (7.3)
Dose ResponseInterference effects arecharacterized(6)
The results areinterpreted(5.3.2)
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