SHANDONG BIO&MEDIA LABORATORIES CO., LTD.  

Product Name: Homocysteine (HCY) Assay Kit/Test Kit/Ivd Reagent/Cardiovascular Model NO.: HCY Type: Hcy Assay Kit Quality Guarantee Period: 12 Months Application: Hospital, Lab, School Classification: Biological Diagnostics Certification: ISO13485 Group: All Groups Trademark: Biomedia Transport Package: Foam Box Specification: R1: 1*37 ml, R2: 1*10 mL Origin: Jinan, Shandong Product Description Homocysteine (Hcy) test kit allows an accurate and quantitative in vitro measurement of homocysteine (Hcy) concentration directly from human plasma. Hcy measurement is applied as an index for diagnosis of hyperhomocysteinemia and assessment of cardiovascular disease (CVD) risk. Hcy level is related with carotid atherosclerosis, and the concentration increases along with exacerbation of the disease. In cases of diagnosis of carotid atherosclerosis, Hcy measurement provides a more sensitive and reliable result compared to other tests. In addition to vascular disease, the increase of Hcy level is affected by some diseases such as neural tube defects, preeclampsia, Parkinson's disease, intrauterine growth retardation and chronic kidney failure and some drugs. Product Features1. Absorbance of blankA (R1 reagent) ≥ 1.20ΔA/min (R2 reagent) ≤ 0.022. SensitivityThe difference of absorbance (ΔA) ≥ 0.01 while testing the specific Hcy sample of concentration of 10.00 μmol/L.3. Linear range(1) Linear correlation coefficient ∣r∣≥0.995(2) Linear range of Hcy level: [3.00, 70.00] μmol/LLinear rangeLinear deviation[3.00, 20.00]≤ ± 2.00 μmol/L[20.01, 70.00]≤ ± 10.00%4. Precision(1) Intra CV% Concentration of Hcy (μmol/L) Intra CV%10.00 ± 2.00 ≤ 5.0%20.00 ± 4.00≤ 3.0%(2) Inter-assay relative range is within 10.0% while testing the sample of 10.00 ± 2.00 μmol/L.5.AccuracyRelative deviation is within ±15%.Packing SpecificationsR1: 1×37 ml, R2: 1×10 mlR1: 2×37 ml, R2: 2×10 mlR1: 4×37 ml, R2: 4×10 mlStorage and stabilityUnopened: Store assay kits at 2 - 8ºC protected from light. Stable to expiration date printed on individual vials (for 12 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.