Fibrinogen (Fbg) Assay Kit – Bulk Reagents

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US$299.00

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Selling unit: per 100ml

Product Name

  1. Common name: Fibrinogen (Fbg) test kit (immunoturbidimetric method)
  2. English name: Fbg Reagent Kit (Immunoturbidimetric Method)

Reagent Ratio

3:1, 4:1, 5:1, common ratio 3:1, other ratios need to be customized

Intended Use

This kit is used to determine the amount of Fbg in human plasma.

Fibrinogen levels are decreased when severe liver injury or cirrhosis and diffuse intravascular coagulation (DIC) are present. Elevated plasma Fbg levels are an independent risk factor for coronary thrombosis and are positively associated with myocardial infarction and stroke. Increased plasma fibrinogen leads to thrombosis.

Test Principle

Fbg in plasma and its corresponding antibody (sheep anti-human Fbg serum) meet in the liquid phase and immediately form an antigen-antibody complex, creating a certain turbidity. The level of turbidity is proportional to the amount of antigen in the presence of a certain amount of antibody.

Main Components

Reagent components included in the product.

Fibrinogen (Fbg) Assay Kit & Bulk Reagents

*Components are not interchangeable in kits with different lot numbers.

*Reagent components not included in the product, but necessary for the test: outsourced normal and abnormal QCs and calibrators.

Storage Conditions And Expiration Date

The kit is stored at 2-8°C away from light and is valid for one year.

Reagents that have been opened are taken care not to be contaminated and the reagents are stabilized in the instrument compartment (2-8°C) for one month.

The reagents must not be frozen.

Applicable Instruments

Hitachi 7180/7600; Olympus AU680/2700; Toshiba TBA120; Myriad BS2000M/480; Siemens ADVIA 1800/2400 series automatic biochemical analyzers.

Sample Request

Anticoagulate plasma specimens with citrate, heparin or EDTA and isolated for testing as soon as possible. Samples can be stored at room temperature (15-25°C) for 4 hours and -18°C for 1 month to stabilize.

Test Method

  1. Reagent preparation: liquid reagents are ready to use out of the bottle.
  2. test conditions: (different test instruments can be requested according to the different parameters on the machine)

Fibrinogen (Fbg) Assay Kit & Bulk Reagents

Operation steps.

Fibrinogen (Fbg) Assay Kit & Bulk Reagents

*Reagents and sample volumes can be increased or decreased in proportion to the requirements of different biochemical analyzers.

  1. Calibration procedure.

The use of a matching calibration serum is recommended.

  1. QC control procedures.

It is recommended that each laboratory establish its own quality control system and select appropriate quality control products for quality control. The measured values of QC products should be within the specified range. If outside the specified range, it is necessary to take appropriate measures or contact the manufacturer.

  1. Calculation.

With △A as the vertical coordinate and concentration as the horizontal coordinate, draw a standard curve, and correct this standard curve using the non-linear method Spline, Logit-Log4P and other modes, and save this standard curve for calculating the results. The reagents of different batches must be re-calibrated.

Positive Judgment Value Or Reference Interval

2.2~3.8 g/L

It is recommended that each laboratory establish its own reference range of normal values.

Interpretation Of Test Results

The determination of Fbg in plasma is only one of the indicators used by the clinician to make a diagnosis of the patient. The clinician must also make a comprehensive judgment based on the patient’s physical symptoms, medical history, and other diagnostic items and diagnostic tools.

Limitations Of The Test Method

Ascorbic acid ≤ 20 mg/dl, bilirubin ≤ 20 mg/dL, hemoglobin ≤ 500 mg/dL and celiac disease ≤ 500 mg/dL did not interfere with the determination.

Product Performance Index

Absorbance of reagent blank: wavelength 340 nm, optical diameter 1.0 cm, temperature 37°C, A0 ≤ 0.15.

Analytical sensitivity: the absorbance change value ΔA≥ 0.05 when the kit tests 0.8 g/L of the analyte.

Linearity interval: For testing serum samples, the linear correlation coefficient|r| should be not less than 0.990 in the interval of 0.5~6.0 g/L. In the interval of 0.5~4.0 g/L, the absolute deviation of linearity should not exceed 0.4 g/L; in the interval of (4.0~6.0 g/L, the relative deviation of linearity should not exceed ±10%.

Precision: repeatability CV ≤ 5%; relative extreme difference between batches ≤ 10%.

Accuracy: Relative deviation ≤ 15%.

Caution

  1. 1. This product is for in vitro diagnosis only.
  2. 2. Avoid contamination when using the reagent, the container used must be clean, and please take necessary precautions, do not swallow, and avoid contact with skin and mucous membrane.
  3. 3. Please dispose of the measured samples and waste liquids in accordance with the relevant national and local laws and regulations.
  4. 4. When changing the reagent lot number, please recalibrate.

Reference

  1. Jackson CM: Annul, Rev, Biochem, 49:765, 1980
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