Fibrinogen assay kit (Clauss Improvement Act) Instruction Product Name 1. Common name: fibrinogen assay kit 2. English name: FIB Packing 10 × 2ml, 10 × 4ml, 5 × 2ml, 10 × 10ml expected Purpose This kit for the detection of human plasma fibrinogen levels. 1) fibrinogen levels increased common in acute inflammation, surgery, atherosclerosis, diabetes and other symptoms. 2) reduce fibrinogen levels common in congenital low (no) FIB hyperlipidemia, primary / secondary fibrinolysis, abnormal FIB hyperlipidemia, severe anemia. Test principle in plasma fibrinogen in excess of thrombin action, will change from soluble proteins into insoluble polymer, thereby forming a fibrin clot. Coagulation time and fibrinogen plasma is inversely proportional. The main constituent 50mM imidazole buffer thrombin 36.68IU / ml 2-8 ℃ storage conditions and period up to 12 months, unopened validity of the reagent stability. After opening at 37 ℃ reconstituted reagent is stable for seven days. Applicable instrument applies to SYSMEX CA-50 semi-automatic coagulation analyzer, SYSMEX CA-1500 automatic coagulation analyzer, STAGO COMPACT automated coagulation analyzer. Requires fresh blood samples and 0.109M sodium citrate by 9: 1 mixed, centrifuged at 3000rpm for 15 minutes (low temperature is recommended centrifuge), the supernatant liquid was collected (plasma), the experiment within two hours. If the sample can not be detected within two hours, the plasma should be frozen. -20 ℃ below freezing for two weeks, one month or less -70 ℃ can be stored frozen. It must be 37 ℃ rapidly thawing frozen samples before testing, not repeated freezing and thawing. Test method for setting the plasma and sample dilution: The value of plasma after reconstitution with FIB buffer respectively, for the 1: 5 (100μl plasma + 400μl buffer), 1:10 1: 15,1: 20,1: 30 diluted test sample diluted 1:10. 2. Procedure: 3. Calculate: Standard curve drawing: with different concentrations of fibrinogen reference plasma levels (mg / dl) as the abscissa, with the corresponding clotting time for the vertical axis, making the standard in double logarithmic paper curve, or the concentration of FIB and the corresponding clotting time of input into the coagulation analyzer. Different dilutions of reference plasma concentration ratio calculated as follows: measured by a ratio of 1:10 sample dilution dilution with other computing as the dilution factor. The following is an example (FIB standard plasma concentration of 260mg / dL): tested specimen FIB content can be isolated from the standard curve. The standard curve input semi-automatic or automatic coagulation instrument, sample results automatically reported. 4. Quality control Each laboratory should establish its own quality control range of normal and abnormal, to approve the operation of instruments and reagents. Reference interval 200-400mg / dl. The above values ??are for reference only. Since the instruments, laboratory, may differ between the local population are recommended to establish its own reference range. Factors that may affect the interpretation of test results of test results: 1. coagulation analyzer failure to require periodic maintenance abnormal. 2. Manual control materials failure to use proper operation. 3. pipettes, pipettes and other equipment not regularly check, abnormal. Limitations of test methods performance indicators 1. Linear range: 50-900mg / dL. 2. Accuracy: The reference material measure, the relative deviation should not exceed 15%. 3. Batch difference between: QC plasma with repeated reagents from different lots, the results coefficient of variation (CV) should not exceed 15%. 4. Repeatability: Repeat the test results obtained with a coefficient of variation of quality control plasma (CV) should not exceed 8 percent. Notes 1. Sample collection and coagulation tests must use disposable plastic or siliconized glass containers. 2. The sample should not be used oxalate, EDTA and heparin as an anticoagulant. 3. hematocrit is outside the range of 20-55%, the anticoagulant dosage should be adjusted. Anticoagulant amount (ml) = 0.00185 × volume of blood (ml) × (100- hematocrit). 4. labware must be clean, can not have the presence of detergents. Wear disposable gloves when measurement operation. 5. hemolysis can activate coagulation factors and affect the outcome, jaundice or hyperlipidemia also have an impact on the results. 6. Acute inflammatory response allows fibrinogen levels increased. 7. When the change reagent lot change or instrument, should re-create the standard curve.