Commutability Limitations Influence Quality Control Results with Different Reagent Lots

Miller, W. Greg; Erek, Aybala; Cunningham, Tina D.; Oladipo, Olajumoke; Scott, Mitchell G.; Johnson, Robert E.

doi:10.1373/clinchem.2010.148106

Cited by 101 publications

(65 citation statements)

References 15 publications

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“…It is known that noncommutable samples can give different lot-to-lot variation compared to commutable samples (28,29 ). This was also the case for some lot numbers in our study, for which significant differences were seen for the noncommutable samples and not for the native patient samples (Fig.…”

Section: Reagent Lot Numbersupporting

confidence: 74%

External Quality Assessment of Point-of-Care Methods: Model For Combined Assessment of Method Bias and Single-Participant Performance by the Use of Native Patient Samples and Noncommutable Control Materials

Stavelin

Petersen²,

Sølvik

et al. 2013

Clinical Chemistry

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Section: Reagent Lot Numbersupporting

confidence: 74%

External Quality Assessment of Point-of-Care Methods: Model For Combined Assessment of Method Bias and Single-Participant Performance by the Use of Native Patient Samples and Noncommutable Control Materials

Stavelin

Petersen²,

Sølvik

et al. 2013

Clinical Chemistry

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“…Degradation of samples during transportation and storage before measurement can affect results obtained for these samples differently than for samples collected in the clinical setting. For noncommutable samples, the magnitude of a matrix-related bias can be different for different lots of reagent causing a larger dispersion in results than would be observed for clinical samples (36 ).…”

Section: Acceptance Criteria For Pt/eqa Resultsmentioning

confidence: 97%

Proficiency Testing/External Quality Assessment: Current Challenges and Future Directions

et al. 2011

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BACKGROUND: Proficiency testing (PT), or external quality assessment (EQA), is intended to verify on a recurring basis that laboratory results conform to expectations for the quality required for patient care.CONTENT: Key factors for interpreting PT/EQA results are knowledge of the commutability of the samples used and the process used for target value assignment. A commutable PT/EQA sample demonstrates the same numeric relationship between different measurement procedures as that expected for patients' samples. Noncommutable PT/EQA samples frequently have a matrix-related bias of unknown magnitude that limits interpretation of results. PT/EQA results for commutable samples can be used to assess accuracy against a reference measurement procedure or a designated comparison method. In addition, the agreement of the results between different measurement procedures for commutable samples reflects that which would be seen for patients' samples. PT/EQA results for noncommutable samples must be compared to a peer group mean/ median of results from participants who use measurement procedures that are expected to have the same or very similar matrix-related bias. Peer group evaluation is used to asses whether a laboratory is using a measurement procedure in conformance to the manufacturer's specifications and/or in conformance to other laboratories using the same technology. A noncommutable PT/EQA sample does not give meaningful information about the relationship of results for patients' samples between different measurement procedures.

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“…Whereas many laboratory scientists, as well as the College of American Pathologists, believe that patient samples should be included in lot-to-lot comparisons (14 ), this can be difficult to do for assays with low testing volumes. Apart from the costs, smaller laboratories may not have enough residual patient samples to adequately cover the analytical range.…”

Section: Discussionmentioning

confidence: 99%

Failure of Current Laboratory Protocols to Detect Lot-to-Lot Reagent Differences: Findings and Possible Solutions

Algeciras‐Schimnich¹,

Bruns

Boyd

et al. 2013

Clinical Chemistry

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Commutability Limitations Influence Quality Control Results with Different Reagent Lots

Cited by 101 publications

References 15 publications

External Quality Assessment of Point-of-Care Methods: Model For Combined Assessment of Method Bias and Single-Participant Performance by the Use of Native Patient Samples and Noncommutable Control Materials

External Quality Assessment of Point-of-Care Methods: Model For Combined Assessment of Method Bias and Single-Participant Performance by the Use of Native Patient Samples and Noncommutable Control Materials

Proficiency Testing/External Quality Assessment: Current Challenges and Future Directions

Failure of Current Laboratory Protocols to Detect Lot-to-Lot Reagent Differences: Findings and Possible Solutions

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