Coagulation Programs

Previous Next

Coagulation


ACTIVATED CLOTTING TIME

Two lyophilized specimens per testing event, diluent provided.

The specimens provided are intended only for activated clotting times, using Actalyke, International Technidyne (ITC), i-STAT or Medtronic instruments. Code the method used by entering the appropriate numeric code from the list on the reporting form and use only the reconstitution instructions on the reporting form which are specific to your method.


PROCESS ONE SPECIMEN AT A TIME, including rehydration with the following instructions:

Perform the ACT in the same manner as you would test a patient specimen (according to the manufacturer's instructions), with the following exceptions:  


HemoTec LRACT method:  Before testing, shake the specimen vigorously for 20-30 seconds.  The specimen needs to be uniformly dispersed before testing.  Add the sample to each cartridge channel in the same manner as you would test a patient specimen, using the same syringe you used for rehydration.  Then add 40 uL (~1 drop) of CaCl2 (Medtronic Catalog #550-11 or equivalent) to each channel.


i-STAT system method:  Using the same syringe used for rehydration, transfer 0.5cc of ACT CaCl2 to specimen. Before testing, shake the specimen vigorously for 20-30 seconds.  The specimen needs to be uniformly dispersed before testing.  Draw sample back into same syringe, minimum of 2.5cc, and dispense necessary volume to fill line of i-STAT cartridge.  Close cartridge and immediately insert cartridge into i-STAT analyzer.


As per manufacturer recommendations, use the Proficiency Test path. See Technical Bulletin 17-Mar-11


COAGUCHEK XS/XS PLUS, BASIC

Two lyophilized specimens per testing event.

COAGUCHEK XS/XS PLUS, COMPREHENSIVE

Five lyophilized specimens per testing event


NOTE: These samples are compatible with Roche CoaguChek XS and XS Plus instruments only for testing of INR only on the XS, and Prothrombin Time (PT) / INR on the XS Plus.


Reconstitute according to directions below and test one vial at a time. The reconstituted PT solutions are stable for 30 minutes after the diluent has been added.


NOTE: These samples are compatible with Roche CoaguChek XS and XS Plus instruments only for testing of INR only on the XS, and Prothrombin Time (PT) / INR on the XS Plus.


Reconstitute according to directions below and test one vial at a time. The reconstituted PT solutions are stable for 30 minutes after the diluent has been added.


    1. Allow the samples to come to room temperature for 15-20 minutes before reconstituting.
    2. Remove the screw cap and rubber stopper from the bottle, taking care not to remove any of the dried plasma.
    3. Make sure there is no liquid at the tip of the dropper, then cut the tip off of the diluent dropper to dispense diluent into the bottle without touching the dried plasma or spilling any diluent.
    4. Gently squeeze the dropper bulb to dispense the entire contents of the dropper into the bottle and replace the rubber stopper.
    5. Do not discard the dropper as it will be used to dispense materials onto the test strip.
    6. Do not shake or invert the bottle. Gently swirl to dissolve the dried plasma.
    7. Allow the bottle to sit undisturbed for at least 1 minute, but test materials within 30 minutes.
    8. Follow the manufactures instructions for inserting a test strip into your meter.
    9. Use the dropper to take up and dispense materials onto the test strip.
    10. Repeat reconstitution instruction steps above, for each PT sample material.
    11. Enter results on your reporting form and enter the appropriate code from the list on the reporting form.

 


COAGULATION, PLASMA

Five lyophilized plasma specimens per testing event, 1.0 mL, for the following analytes:


Prothrombin Time (PT)

Activated Partial Thromboplastin Time (APTT)

INR

Fibrinogen


Reconstitute these specimens as follows:

1.        Add 1.0 mL reagent grade water with a volumetric pipet.

2.        Invert occasionally until completely dissolved (do not shake).

3.        Let stand for 15 minutes after dissolution.

4.        Invert again prior to sampling.


Once reconstituted, the five coagulation specimens should be processed as though they were fresh citrated patient plasma. If a result’s endpoints lack reproducibility, leave the result blank and paper clip a photocopy indicating an indeterminate result. When reporting online, use the comments section to report indeterminate results.


Participants using Roche CoaguChek XS or Roche CoaguChek XS Plus should enroll in the CoaguChek XS/ XS Plus Survey.  Participants using the i‐STAT instrument should enroll in the Whole Blood Prothrombin Time program.  


Code the reagent and instrument used by entering the appropriate codes from the lists provided on the reporting form. All manual coagulation methods must report instrument code 699 (tilt tube) or 700 (wire loop).


Users of Diagnostica Stago instruments, per manufacturer’s instructions, you must use the 0.85 slope correction factor when reporting APTT results.  You must use this correction regardless of whether or not you use it for patient results.


Fibrinogen-Report fibrinogen results only in mg/dL.


WHOLE BLOOD PROTHROMBIN TIME

Five specimens per testing event

These specimens are compatible with the Abbott CoaguSense and i-STAT coagulation systems. The Roche Coaguchek instruments are NOT compatible with these samples. Code the instrument by entering the appropriate code from the list on the reporting form.


NOTE:  Please read all instructions before testing.  It is recommended that you process one specimen at a time.  Specimens must be used IMMEDIATELY after reconstitution.  You will receive 5 vials of lyophilized plasma and 5 vials of calcium chloride diluent.

Combined Instructions for the i-STAT and CoaguSense Systems  

  1. Remove the five plasma specimens and five calcium chloride diluent vials from the refrigerator and warm to room temperature (18-30°C) for a minimum of 45 minutes.
  2. Remove the cap and stopper from one vial of lyophilized plasma and the cap from one vial of diluent.
  3. Pour the entire contents of the diluent vial into the vial of plasma.  Insert the stopper back into the vial of plasma.
  4. Allow the vial to sit at room temperature for 1 minute.  While this is occurring, be sure to have your analyzer turned on and the Prothrombin Time (PT) cartridges or test strips available.
  1. Mix the contents of the plasma vial by gently swirling for 1 minute and then slowly inverting for 30 seconds.  Do not shake the vial vigorously as this will cause bubbling and foaming of the sample.  Be sure all lyophilized material has been reconstituted within the vial before continuing with step 6.
  2. If you are using the i-STAT analyzer: Using a transfer pipette, immediately transfer the reconstituted plasma into a PT/INR cartridge.  Immediately seal the cartridge and insert it into the analyzer.  Record the result.
  3. Repeat steps 2 through 6 for the remaining samples.