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2010 ; 56
(6
): 977-86
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Seven direct methods for measuring HDL and LDL cholesterol compared with
ultracentrifugation reference measurement procedures
#MMPMID20378768
Miller WG
; Myers GL
; Sakurabayashi I
; Bachmann LM
; Caudill SP
; Dziekonski A
; Edwards S
; Kimberly MM
; Korzun WJ
; Leary ET
; Nakajima K
; Nakamura M
; Nilsson G
; Shamburek RD
; Vetrovec GW
; Warnick GR
; Remaley AT
Clin Chem
2010[Jun]; 56
(6
): 977-86
PMID20378768
show ga
BACKGROUND: Methods from 7 manufacturers and 1 distributor for directly measuring
HDL cholesterol (C) and LDL-C were evaluated for imprecision, trueness, total
error, and specificity in nonfrozen serum samples. METHODS: We performed each
direct method according to the manufacturer's instructions, using a Roche/Hitachi
917 analyzer, and compared the results with those obtained with reference
measurement procedures for HDL-C and LDL-C. Imprecision was estimated for 35 runs
performed with frozen pooled serum specimens and triplicate measurements on each
individual sample. Sera from 37 individuals without disease and 138 with disease
(primarily dyslipidemic and cardiovascular) were measured by each method.
Trueness and total error were evaluated from the difference between the direct
methods and reference measurement procedures. Specificity was evaluated from the
dispersion in differences observed. RESULTS: Imprecision data based on 4 frozen
serum pools showed total CVs <3.7% for HDL-C and <4.4% for LDL-C. Bias for the
nondiseased group ranged from -5.4% to 4.8% for HDL-C and from -6.8% to 1.1% for
LDL-C, and for the diseased group from -8.6% to 8.8% for HDL-C and from -11.8% to
4.1% for LDL-C. Total error for the nondiseased group ranged from -13.4% to 13.6%
for HDL-C and from -13.3% to 13.5% for LDL-C, and for the diseased group from
-19.8% to 36.3% for HDL-C and from -26.6% to 31.9% for LDL-C. CONCLUSIONS: Six of
8 HDL-C and 5 of 8 LDL-C direct methods met the National Cholesterol Education
Program total error goals for nondiseased individuals. All the methods failed to
meet these goals for diseased individuals, however, because of lack of
specificity toward abnormal lipoproteins.
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