About the product
HDLC4 (HDL-Cholesterol Gen.4) is Roche Diagnostics’ in vitro diagnostic test for the quantitative determination of HDL cholesterol concentration in human serum and plasma. According to Roche’s FDA submission, the reagent is used on Roche/Hitachi cobas c systems. For brand information, the Roche Diagnostics page can be consulted.
The parameter measured and its clinical meaning
According to MedlinePlus, HDL (high-density lipoprotein) is a type of cholesterol that helps remove LDL cholesterol from the blood. The lipid panel reports the HDL level in the same report as total cholesterol, LDL and triglyceride values. MedlinePlus classifies 60 mg/dL and above in adults as the best level, and below 40 mg/dL in men and below 50 mg/dL in women as low. A fast of 9 to 12 hours may be needed for the test. Results are evaluated by the physician.
Technical information
- Method: direct, homogeneous enzymatic colorimetric. Polyanions and detergent bind non-HDL lipoproteins such as LDL, VLDL and chylomicrons and prevent them from reacting (Roche's FDA submission)
- Reaction: HDL cholesterol forms hydrogen peroxide with cholesterol esterase and cholesterol oxidase. Peroxidase combines this peroxide with 4-aminoantipyrine and EMSE to form a dye. Color intensity is measured photometrically and is directly proportional to the HDL cholesterol concentration
- Measuring range: 3.09 to 150 mg/dL (Roche's FDA submission)
- Sample type: human serum and plasma. The submission compared serum, lithium heparin, K2 and K3 EDTA plasma and gel separator tubes
- Packs (Roche): 200 tests, 2 x 100 (cobas c 111). 350 tests (COBAS INTEGRA 400 plus, cobas c 303/311/501/502). 500 tests (cobas c 701/702). 700 tests (cobas c 303/503/703)
- Regulatory record: FDA 510(k) K162593, decision date October 19, 2016
Use and compatibility
The Roche product page lists the reagent for the cobas c 111, c 303, c 311, c 501, c 502, c 503, c 701, c 702 and c 703 systems and for the COBAS INTEGRA 400 plus. Some packs are valid only for certain systems. For platform information, the cobas c 111, cobas c 303 and COBAS INTEGRA 400 plus pages can be consulted. The Roche parameter list shows direct HDL cholesterol in the serum work area of these platforms. The conditions of use are on the relevant method page.
For product, quotation and technical information requests, the form on the contact page or info@tiliamedical.com can be used.
Frequently asked questions
According to Roche’s FDA submission, the test is a direct, homogeneous enzymatic colorimetric method. Polyanions and detergent block the reaction of non-HDL lipoproteins, while HDL cholesterol forms a dye that is measured photometrically.
According to Roche, the test is for the quantitative determination of HDL cholesterol in human serum and plasma. The FDA submission compared serum, lithium heparin and K2 and K3 EDTA plasma, and gel separator tubes.
Roche lists the 200-test pack for the cobas c 111, the 350-test pack for the COBAS INTEGRA 400 plus and cobas c 303, c 311, c 501 and c 502, the 500-test pack for the c 701 and c 702, and the 700-test pack for the cobas c 303, c 503 and c 703 systems.
