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Original ArticleOpen Access
Analytical and Clinical Performance of Two Homogeneous Assays for Measuring of LDL-Cholesterol
Leowallana W 
,
Narkrung S ,
Pokum S ,
Kiartivich S
,
Narkrung S ,
Pokum S ,
Kiartivich S A clinical laboratory currently estimates LDL-Cholesterol (LDL-C) concentration using
the Friedewald calculation, which requires fasting specimens and is subject to error with in-
creasing triglycerides levels. We evaluated the analytical and clinical performance of the direct
LDL-C assay from two companies, Roche Diagnostics (LDL-CRoch) and Wako Pure Chemical
(LDL-CwakJ Both methods meet current guidelines for precision with within-run coefficients of
variation less than 3 per cent. The LDL-CRoche assay correlated well with the LDL-C from the
Friedewald equation (LDL-CFriect' r
=
0.958, y
=
0.85x
+
17.08 mg/dL, n
=
422). The LDL-Cwako
assay also correlated with the LDL-CFriect (r
=
0.946, y
=
0.86x
+
7.81 mg/dL n
=
422). In
addition, at the medical decision cutoff points, LDL-CRoche assay and LDL-Cwako showed positive
predictive values of 87.44 per cent and 69.67 per cent respectively. We conclude that the LDL-CRoche
assay meets the currently established analytical and clinical performance, but LDL-Cwako assay
meets only analytical performance. Clinical performance needs further evaluation.
Key word : Homogeneous LDL-C Assays, Analytical and Clinical Performance
the Friedewald calculation, which requires fasting specimens and is subject to error with in-
creasing triglycerides levels. We evaluated the analytical and clinical performance of the direct
LDL-C assay from two companies, Roche Diagnostics (LDL-CRoch) and Wako Pure Chemical
(LDL-CwakJ Both methods meet current guidelines for precision with within-run coefficients of
variation less than 3 per cent. The LDL-CRoche assay correlated well with the LDL-C from the
Friedewald equation (LDL-CFriect' r
=
0.958, y
=
0.85x
+
17.08 mg/dL, n
=
422). The LDL-Cwako
assay also correlated with the LDL-CFriect (r
=
0.946, y
=
0.86x
+
7.81 mg/dL n
=
422). In
addition, at the medical decision cutoff points, LDL-CRoche assay and LDL-Cwako showed positive
predictive values of 87.44 per cent and 69.67 per cent respectively. We conclude that the LDL-CRoche
assay meets the currently established analytical and clinical performance, but LDL-Cwako assay
meets only analytical performance. Clinical performance needs further evaluation.
Key word : Homogeneous LDL-C Assays, Analytical and Clinical Performance
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