Coagulation Program Modules

Instructions: ACT Samples

(332 Activated Clotting Time)

CONTENTS: 2 ACT Specimens (white cap)

                   2 H2O Diluents (white cap)

                   2 *CaCl2 (yellow cap)

       *DO NOT USE the yellow capped CaCl2 vials, unless using a Hemochron or i-STAT instrument.

       

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

       a. Allow vials to reach room temperature. Equilibration may take up to 30 minutes.

       b. Be sure to use only H2O Diluent #1 to rehydrate ACT Specimen #1 and only H2O Diluent #2 to

       rehydrate ACT Specimen #2.

       c. Twist and flip up the caps on an ACT SPECIMEN vial and an ACT DILUENT vial with matching

       numbers (use only vials with white caps!).

       d. Use a plastic 3cc syringe to transfer 2.00cc of diluent to the specimen.

       e. DO NOT AGITATE THE SPECIMEN BEFORE 10 MINUTES. Allow at least 10 minutes for

       rehydration. Perform testing within 1 hour after rehydration.

2. 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

Instructions: XS Specimens

(330 CoaguChek XS Plus Prothrombin Time)

(331 CoaguChek XS Plus Prothrombin Time - Waived 2 Samples)

1. Remove the specimen vials and the diluent pipettes from the refrigerator and warm to room temperature (20-25°C). Remove the screw-cap and rubber

   stopper from the specimen vial.

2. Shake the contents of the diluent pipette down into the bulb portion with the tip pointing upward. All of the diluent does not have to be evacuated from

   the stem portion of the pipette before proceeding. Use scissors to cut off the tip of the diluent pipette.

CAUTION: Hold the diluent pipette vertically by the stem and do not squeeze the bulb to avoid diluent loss.

3. Transfer the entire contents of the pipette into the specimen vial. DO NOT discard the pipette.

4. Replace the cap and gently swirl the vial to dissolve the specimen. DO NOT shake or invert the vial.

5. Allow the specimen to stand undisturbed for at least one minute.

NOTE: You must test the specimens within 30 minutes of reconstitution.

6. Right before testing, gently swirl the vial to mix the specimen. Do not shake or invert the vial. Avoid creating air bubbles.

7. Test the mixed specimen in the same manner as you would a patient sample using the diluent pipette to dispense the specimen.

Instructions: XS Specimens

(331 CoaguChek XS Plus Prothrombin Time - Waived)

1. Remove the specimen vials and the diluent pipettes from the refrigerator and warm to room temperature (20-25°C). Remove the screw-cap and rubber

   stopper from the specimen vial.

2. Shake the contents of the diluent pipette down into the bulb portion with the tip pointing upward. All of the diluent does not have to be evacuated from

   the stem portion of the pipette before proceeding. Use scissors to cut off the tip of the diluent pipette.

CAUTION: Hold the diluent pipette vertically by the stem and do not squeeze the bulb to avoid diluent loss.

3. Transfer the entire contents of the pipette into the specimen vial. DO NOT discard the pipette.

4. Replace the cap and gently swirl the vial to dissolve the specimen. DO NOT shake or invert the vial.

5. Allow the specimen to stand undisturbed for at least one minute.

NOTE: You must test the specimens within 30 minutes of reconstitution.

6. Right before testing, gently swirl the vial to mix the specimen. Do not shake or invert the vial. Avoid creating air bubbles.

7. Test the mixed specimen in the same manner as you would a patient sample using the diluent pipette to dispense the specimen.

Instructions: CG Specimens

(320 Coagulation Module)

1. The specimens are lyophilized samples of citrated human plasma.

2. Use a class A volumetric pipette to add exactly 1.0 mL of distilled water (high purity) to each vial.

Note: You must test the specimens within one hour of reconstitution.

3. Restop each vial. Gently swirl and let stand undisturbed for 15 minutes at room temperature (20-25°C).

• Do not invert vial.

• Avoid vigorous mixing.

4. Before testing the specimen, mix contents by gently swirling. Test in the same manner as you would test a patient sample.

Instructions: PTI Specimens

(328 i-STAT Prothrombin Time)

NOTE: 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.

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.

5. 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.

6. Using a transfer pipette, immediately transfer the reconstituted plasma into a PT cartridge. Immediately seal the cartridge and insert it into the analyzer. Record the result.

7. Repeat steps 2 through 6 for the remaining samples.

Instructions: INX Specimens

(324 Roche Coaguchek INR – Waived)

1. Remove the specimen vials and the diluent pipettes from the refrigerator and warm to room temperature (20-25°C). Remove the screw-cap and rubber stopper from the specimen vial.

2. Shake the contents of the diluent pipette down into the bulb portion with the tip pointing upward. All of the diluent does not have to be evacuated from the stem portion of the pipette before proceeding. Use scissors to cut off the tip of the diluent pipette.

CAUTION: Hold the diluent pipette vertically by the stem and do not squeeze the bulb to avoid diluent loss.

3. Transfer the entire contents of the pipette into the specimen vial. DO NOT discard the pipette.

4. Replace the cap and gently swirl the vial to dissolve the specimen. DO NOT shake or invert the vial.

5. Allow the specimen to stand undisturbed for at least one minute.

NOTE: You must test the specimens within 30 minutes of reconstitution.

6. Right before testing, gently swirl the vial to mix the specimen. Do not shake or invert the vial. Avoid creating air bubbles.

7. Test the mixed specimen in the same manner as you would a patient sample using the diluent pipette to dispense the specimen.