Abstract：
BACKGROUND:We used a difference in bias approach to evaluate the commutability of 4 frozen serum pools for 8 direct methods for measurement of HDL and LDL cholesterol (HDLC and LDLC). METHODS:Freshly collected nonfrozen sera from 138 diseased and 37 nondiseased patients and 4 frozen pools from the CDC Lipid Standardization Program were measured by direct methods and by the beta-quantification reference measurement procedure of the CDC. We used an error components model to estimate the difference in the bias component of error plus its uncertainty for frozen pools vs patient samples between the direct method and the reference procedure. Frozen pools with bias differences less than a critical value determined by either medical requirements for bias or the random error components of the measurement procedures were considered commutable. RESULTS:On the basis of medical requirement criteria, 1 of the 4 frozen pools was commutable for most of the HDLC methods for both diseased and nondiseased patients, and none was commutable for LDLC methods. On the basis of random error criteria, all of the frozen pools were generally commutable for all of the HDLC methods for both diseased and nondiseased patients, and 1 of the 4 frozen pools was generally commutable for most of the LDLC methods for both diseased and nondiseased patients. CONCLUSIONS:Commutability was assessed as the closeness of agreement of the difference in bias between a reference material and a set of patient samples. Criteria for commutability could be based on fixed medical requirements for bias or on random error components.
journal_name
Clin Chemjournal_title
Clinical chemistryauthors
Korzun WJ,Nilsson G,Bachmann LM,Myers GL,Sakurabayashi I,Nakajima K,Nakamura M,Shamburek RD,Remaley AT,Miller WGdoi
10.1373/clinchem.2015.240861subject
Has Abstractpub_date
2015-08-01 00:00:00pages
1107-13issue
8eissn
0009-9147issn
1530-8561pii
clinchem.2015.240861journal_volume
61pub_type
杂志文章abstract：:We describe modifications to two cartridges, those for alkaline phosphatase and creatinine, on an 18-channel SMAC (Sequential Multichannel Analyzer Computerized), which allow all 18 tests to be run with a commonly prediluted sample. This decreases the required sample size and eliminates the problem of fibrin clots in ...
journal_title：Clinical chemistry
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doi：
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