SHANDONG BIO&MEDIA LABORATORIES CO., LTD.  

Product Name: High Density Lipoprotein Cholesterol (HDL-C) Assay Kit/Ivd Reagent/Test Model NO.: HDL-C Type: Hdl-C Assay Kit Quality Guarantee Period: 16 Months Application: Hospital, Lab, School Classification: Biological Diagnostics Certification: ISO13485 Group: All Groups Trademark: Biomedia Transport Package: Foam Box Specification: R1: 2*60 mL, R2: 2*20 mL Origin: Jinan, Shandong Product Description The HDL-C assay kit is intended for the direct quantitative measurement of high density lipoprotein cholesterol in human serum.Testing PrincipleThis assay kit is applied to test the HDL-C levels based on PPD (polyanion polymer/ detergent) method. During the reaction, LDL, VLDL and chylomicrons are suppressed by the polyanion polymer and detergent and can not react with cholesterol oxidase reagent. In the meanwhile, HDL-C is dissolved by the surfactant, resulting in the release of cholesterol and reaction with enzymes. The concentration of HDL can be calculated by the change of absorbance of the serum sample. Product FeaturesLinearity range: 0.50 - 3.90 mmol/L; linear correlation coefficient ≥0.990; linearity deviation is within ±10%.Absorbance of blank ≤ 0.10Sensitivity: the difference of absorbance per unit of concentration (ΔA) ≥ 0.01 while testing the specific sample of concentration of 1.87 mmol/L.Accuracy: Relative deviation is within ±10%. Precision: intra assay CV(%) ≤ 5%; inter assay CV(%) ≤ 5%.Technical ParametersMain WavelengthSecondary WavelengthMethodReaction DirectionSample VolumeR1 VolumeR2 VolumeReaction Time600 nm700 nm (optional)End point methodPositive3 μl240 μl80 μl300 sReference range: 1.19 - 1.69 mmol/LPackaging SpecificationR1: 2×60 mL, R2: 2×20 mLR1: 4×60 mL, R2: 4×20 mLR1: 1×30 mL, R2: 1×10 mL (Sample)Calibrator: additional purchaseQuality control: additional purchaseStorage and Period of Validity Unopened: Store assay kits at 2 - 8ºC protected from light. Stable to expiration date printed on individual vials (for 16 months).Opened: Store assay kits at 2 - 8ºC protected from light. Stable for 1 month if kept capped from original container and free from contamination.Do not freeze the assay kit.