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Triple lipid screening test: a homogeneous sequential assay for HDL-cholesterol, total cholesterol, and triglycerides
M L Sampson1, A Aubry, G Csako
1Clinical Chemistry Service, Department of Laboratory Medicine, Clinical Center, National Institutes of Health, Bethesda, MD 20892, USA.
Insights
The triple lipid screening (TLS) test offers a simplified method for measuring HDL-cholesterol, total cholesterol, and triglycerides. This automated, single-tube assay provides accurate results for assessing coronary artery disease risk.
Area of Science:
- Clinical Chemistry
- Biochemistry
- Cardiovascular Disease Risk Assessment
Background:
- Assessing coronary artery disease (CAD) risk involves analyzing lipids in serum lipoprotein fractions.
- Traditional lipid analysis requires multiple tests, increasing complexity and time.
- The triple lipid screening (TLS) test is an automated, single-tube assay for measuring HDL-cholesterol (HDL-C), total cholesterol, and triglycerides (TGs) without specimen pretreatment.
Purpose of the Study:
- To evaluate the analytical performance of the automated triple lipid screening (TLS) test.
- To compare the TLS test results with standard lipid analysis methods.
- To determine the utility of the TLS test as a screening tool for hyperlipidemia.
Main Methods:
- The TLS assay employs a homogeneous method for HDL-C measurement, utilizing either an anti-apolipoprotein B antibody (TLS-A) or a polyanion (TLS-B) to block non-HDL cholesterol.
- Non-HDL cholesterol is solubilized with deoxycholate, and the remaining cholesterol is measured enzymatically.
- Triglycerides (TGs) are measured using the same enzyme detection system after the addition of TG assay enzymes.
Main Results:
- The TLS assay demonstrated acceptable analytical performance for all measured analytes.
- Correlation coefficients (R) between TLS-A and standard tests ranged from 0.974 to 0.997.
- Correlation coefficients (R) between TLS-B and standard tests ranged from 0.965 to 0.980.
- Specific regression equations showed strong agreement for HDL-C, total cholesterol, and TGs.
Conclusions:
- The TLS test is a single-tube, homogeneous assay suitable for analyzing major serum lipoprotein fractions.
- The assay exhibits favorable comparison with standard lipid tests.
- The TLS test can serve as a simple and effective screening tool for detecting hyperlipidemia.
Background:
The analysis of lipids in serum lipoprotein fractions is useful in assessing the risk for coronary artery disease, but it typically involves performing multiple tests. An automated single-tube assay, referred to as the triple lipid screening (TLS) test, can be used for measuring HDL-cholesterol (HDL-C), total cholesterol, and triglycerides (TGs) with no specimen pretreatment.
Methods:
The first part of the assay is based on a homogeneous assay for HDL-C that uses either an anti-apolipoprotein B antibody (TLS-A test) or a polyanion (TLS-B test) that blocks the enzymatic measurement of cholesterol on the non-HDL fraction. After the addition of deoxycholate, which solubilizes the unreacted cholesterol from the non-HDL fraction, the remaining cholesterol in the sample is subsequently measured enzymatically. Using the same enzyme detection system as the cholesterol assay, TGs are measured in the last step, after the addition of the enzymes for the TG assay.
Results:
The TLS assay (y) had acceptable analytic performance and compared favorably with standard tests (x) for each analyte: for HDL-C, TLS-A = 0.99x + 0.19 (R = 0.980); TLS-B = 1.00x - 0.15 (R = 0.974); for total cholesterol, TLS-A = 1.03x + 0.12 (R = 0.997); TLS-B = 1.07x - 0.30 (R = 0.965); and for TGs, TLS-A = 1.02x + 0.02 (R = 0.988); TLS-B = 1.04x - 0.28 (R = 0.980).
Conclusions:
The TLS test is a single-tube homogeneous assay for the analysis of all of the major serum lipoprotein fractions and can be used as a simple screening test for the detection of hyperlipidemia.