products/Coagulation/Coag-o-test FIB

Coag-o-test FIB


FIBRINOGEN REAGENT
Cat. No.: coag111  Size: 12 x 5 ml
Cat. No.: coag112  Size: 12 x 2 ml

DIMDI-Reg.-Nr.: DE/CA22/1116-157-IVD

PRODUCT NAME
Coag-o-test FIB

INTENDED USE
(For In Vitro Diagnostic Use Only)
Quantitative determination of plasma fibrinogen level.

SUMMARY AND BACKGROUND
Fibrinogen is a glycoprotein of molecular weight approximately 340 kD, present in the plasma in concentration in the range of 2 to 4 g/L. It’s presence and intact function has a vital importance for normal blood coagulation.
Thrombin breaks the fibrinogen into fibrin monomers. The fibrin monomers aggregate forming fibrin fibrils. The fibrin is stabilized by Factor XIII.

PRINCIPLE
The method of Clauss relies on the excess amount of thrombin, which forms fibrin rapidly. In this case the logarithm of clotting time is directly proportional to the logarithmic concentration of fibrinogen.

ACTIVE INGREDIENTS
Dia-FIB is a freeze-dried, highly purified human alpha thrombin in buffered medium with calcium and stabilizer.

PRECAUTIONS

  • Coag-o-test FIB due to its ingredients should be handled with care, observing the precautions recommended for biohazardous material!
  • The reagent contains sodium azide. It can form metallic azides, which may be potentially explosive in metal plumbing. Execute proper precaution!
  • Specimens, samples and all materials coming into contact with them should be handled as if capable of transmitting infection and disposed of with proper precautions.
  • Do not use the reagent beyond the expiration date printed on the label!
  • Avoid microbial contamination of the reagent or erroneous results may occur.
  • Each donor unit used in the preparation of this reagent tested by the presence of the antibody to HIV, hepatitis C and hepatitis B surface antigen and found to be negative.

PREPARATION
Coag-o-test FIB reagent is dissolved with distilled water.
Amount is indicated on the label. Keep the reagent at 18-25°C for 30 minutes. Swirl the vial gently before use and do not shake. Avoid the contact of fluid with the stopper.

SPECIMENS
Coag-o-test FIB requires freshly, decalcified plasma. To obtain it, mix nine parts of freshly drawn venous blood with one part trisodium citrate. Mix the blood carefully and centrifuge plasma before testing. Refer to National Committee for Clinical Laboratory Standards (NCCLS) guidelines H3-A3 and H21-A3.

INSTRUCTION FOR USE ON DIA-TIMER
Coag-o-test FIB test is a fibrinogen test, which is suitable for manual techniques according to the protocol detailed below and for automated assays according to the instructions outlined in the instrument manual. Duplicate determinations are recommended.

  1. Bring the sufficient volume of Coag-o-test FIB thrombin to room temperature.
  2. Prepare 1:10 dilution of the plasma (control or patient’s) with Coag-o-test Imidazol buffer.
  3. Add 100μl diluted plasma to the test tube.
  4. Incubate plasma at 37°C for 2 minutes.
  5. Add 50μl Dia-FIB reagent and simultaneously start the timer.
  6. Determine the coagulation time.

Normal and pathological controls are recommended for verified measuring. Each laboratory should establish its own quality control program.
In case of determination by any other coagulometer, please follow the instructions of the manual.

STORAGE AND STABILITY
Coag-o-test FIB reagent in intact vial is stable until the expiration date given on the vial, when stored at 2-8°C. Stability after reconstitution in the original vial: three days at 22°C, five days at 15°C and seven days at 2-8°C. Do not freeze!

EXPECTED RESULTS
Coag-o-test FIB test results can be reported in g/l. This dimension is calculated from a log-log calibration curve. Fibrinogen level in g/l.
Fibrinogen calibration: We recommend to use the master curve enclosed in the box !
The normal range of plasma fibrinogen by clotting assays is between 2,0–4,0 g/l.
In case of lower fibrinogen value (<1g/l) it is recommended to retest the plasma at 1:5 dilution.

LIMITATIONS
Person installing the reagent must be a trained laboratory professional.

MATERIALS REQUIRED BUT NOT PROVIDED

  • Sample dilutor (Coag-o-test Imidazol; Cat. No.: coag115).
  • Normal and pathological controls for quality control (Coag-o-trol I-II; Cat. No.: coag118).
  • Optical or mechanical coagulation analyser for measuring.

BIBLIOGRAPHY

  1. Clauss A: Gerinnungsphysiologische Schnellmethode zur Bestimmung des Fibrinogens. Acta Haematol; 17:237; 1957.
  2. Koepke JA, Gilmer PR, Filip DJ, Eckstein JD, Sibley CA: Studies of fibrinogen measurement in the CAP survey program. Am J Clin Pathol; 63:984; 1975.

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