SHANDONG BIO&MEDIA LABORATORIES CO., LTD.  

Product Name: Low Density Lipoprotein Cholesterol (LDL-C) Assay Kit/Ivd Reagent/Test Kit Model NO.: LDL-C Type: Ldl-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 LDL-C assay kit is intended for the direct quantitative measurement of low density lipoprotein cholesterol in human serum.Testing PrincipleDuring the assay, polyanions are absorbed on low density lipoprotein cholesterol(LDL-C) particles. In the meanwhile, the very low-density lipoprotein(VLDL) and high density lipoprotein (HDL) can be dissociated, generating cholesterol molecules. Cholesterol enzymes in the reagent can react with these cholesterol molecules, and the hydrogen peroxide generated in the reaction will be consumed due to the lack of coupling reagent. After the addition of specific surfactants, cholesterol molecules in LDL are released and then react with 4-AAP, CE, COD and POD. The reaction, also called Trinder reaction, generates purple chelate, and the color saturation of chelate is proportional to the concentration of LDL-C. The LDL-C level in samples can be calculated by comparing the results with that of the standard, which is prepared in the same way.Product FeaturesLinearity range: 0.07 - 10.40 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 3.89 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: 0.18 - 3.12 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.