AMAX-190 血凝仪试剂与测试项目设置

 

Reagents / Tests Setup Procedures:

(Here we take example for prepare PT, APTT and Fibrinogen)

 

1.      Reagent setup

2.      Reagent layout

3.      Tests

4.      Test group

5.      Reconstitute the reagents and buffers

6.      Calibrate FIB-O and FIB-M

 

 

 

1.      Reagent setup:

Setup reagent for item 1-6 as below with the following procedure.

a. System

       b. Password

            c. Reagent

            Select on a blank line in the ‘Reagent list’.  (Create reagent)

d. Enter the following information in the ‘Reagent definition’ menu

¨       Reagent name (Same as printed on bottle)

¨       Manufacturer - Sigma Diagnostics

¨       Lot # - see bottle

¨       Expiration date - see bottle

¨       Dispense speed - see application *

¨       Wash                         

¨       Cleaner           

¨       Intra-Clean             

¨       Min volume

¨       Max volume

e. Press ‘ESC’ to main menu

 

REAGENT DEFINITION

1. Thromboplastin or ThromboMAX

Name                     PT

Manufact.              Sigma

Lot. No.                            Reagent lot number

Expiration              Lot number expiration date

Disp. Speed                   0

Wash Cycles                  4

Cleaner                           No

Intra-Clean            No

Min volume (ml)             1400

Max volume (ml)             10000

 

2. APTT Reagent

Name            APTT

Manufact.     Sigma

Lot. No.                  Reagent lot number

Expiration     Lot number expiration date

Disp. Speed          0      

Wash Cycles         4

Cleaner                  No

Intra-Clean   No

Min. Volume (mL)          700 

Max. Volume (mL) 10000      

 

3. CaCl2

Name            CaCl2

Manufact.     Sigma

Lot. No.                  Reagent lot number

Expiration     Lot number expiration date

Disp. Speed          0      

Wash Cycles         2

Cleaner                  No

Intra-Clean   No

Min. Volume (mL)          500 

Max. Volume (mL)10000         

 

4. Imidazole, Buffer

Name            Imidazole

Manufact.     Sigma

Lot. No.                  Reagent lot number

Expiration     Lot number expiration date

Disp. Speed          0      

Wash Cycles         1

Cleaner                  No

Intra-Clean   No

Min. Vol (μL)         1200        

Max. Vol (μL)        20000      

 

5. Thrombin-O Reagent (May need to set up Thrombin-O and Thrombin-M individually)

Name            FIB-O

Manufact.     Sigma

Lot. No.                  Reagent lot number

Expiration     Lot number expiration date

Disp. Speed          4       (FIB-O is +3 or +4 while FIB-M is 0)

Wash Cycles         8

Cleaner                  Yes

Intra-Clean   Yes

Min. Vol (μL)         500*

Max. Vol (μL)        6000*       

 

6. Thrombin-M Reagent (May need to set up Thrombin-O and Thrombin-M individually)

Name            FIB-M

Manufact.     Sigma

Lot. No.                  Reagent lot number

Expiration     Lot number expiration date

Disp. Speed          0       (FIB-O is +3 or +4 while FIB-M is 0)

Wash Cycles         8

Cleaner                  Yes

Intra-Clean   Yes

Min. Vol (μL)         500*

Max. Vol (μL)        6000*       

 

2. Reagent Layout:

       a. ‘System’

              ‘Password’

                     ‘Parameters’

                            ‘Reagent Layout’ (Pick a blank space, <enter>)

      

       b. At ‘Description’ enter “Routine”, <enter>

 

       c. Select the location for STAT :

Move cursor to position 1, press <F2>, repeat for position 2, 3 etc for those position that will be setup as STAT.

      

       d. Select the location for reagents:

Pos-9:  (with stirrer) Press <F1> to display the reagent list, select PT, <enter>

              Pos-10   Imidazole

              Pos-16   CaCl2

              Pos-17   (with stirrer) APTT FSL

              Pos-21   FIB-O

              Pos-22   FIB-M

(FIB-O and FIB-M have different setting on the dispense speed, typical FIB-O is +3 or +4 while FIB-M is 0)

 

       e. Press ‘ESC’ to main menu

 

3. Tests:

a.       ‘System’

‘Password’

    ‘Parameters’

‘Tests’ - Choose a location

       b.    Setup the ‘Test Parameters’ as in item 1-6 as below

 

TEST PARAMETERS

 

1. PT-O (Prothrombin Time Optical)

Description

Name:        PT - Optical (Long Name, Reporting Name)

Code:         PT-O (Short name )

 

Calibration

Curve Type :       0                         Curve:      Value       Sec/mE

Dilution r : 0                                  0       0

Max. Value :       6                                   0       0

Standard : 12 (User defined ¹)             0      0

ISI - Factor :        1.81 (User defined ²)                 0      0

Max. CV :   10                                 0       0

Max. Time :         85                                 0       0

Max. Time 2 :     120 ³                                     0       0      

Delay Time :       5                                   0       0

Impulse t. :          0                                  r = Instrument determined

 

¹ Geometric mean of normal range

² ISI assignment value

³ See Procedural Note section

 

Procedure

Meas. m. :30 mE Flex Pipet mode : 0

Mix volume : 0

Sample         Reagent            Volume   Incubation        Next Step

50                                              60             S4

S1 Reag 2                                                                   S

S2 Reag 3                                                                   S

S3 Reag 4                                                                   S

S4 Startr     PT⁴                     100

 

⁴ Name assigned in Reagent List

 

Data Reduction

Data Reduction           Measuring Unit                  Normal Range

T                           Sec                             11-14 (User defined)

R                           INR                    1-6 (User defined)

N

 

( A calculated result can only be displayed if “C” or “R” is listed as the first reporting option in Data Reduction.  If two calculated results are defined, only the first one is displayed.)

 

QC/Statistics

Range

Eval.                 Target      2SD          from         to

Statistics    T (T or R ⁵)                            10     50 (User Defined⁵)

 

Controls    T ⁶     QC1         User Defined   User Defined   User Defined

QC2           User Defined   User Defined   User Defined

QC3           User Defined   User Defined   User Defined

 

⁵ Range for population statistics. Must be set for distribution data to be collected. Only values within the range will be collected for statistics.

⁶ Must be set for QC data storage to occur. If set to “N”, no QC results will be stored.

 

2. PT-M (Prothrombin Time Mechanical)

Description

Name:        PT - Mechanical (Long Name, Reporting Name)

Code:         PT-M (Short name )

 

Calibration

Curve Type :       0                         Curve:      Value       Sec/mE

Dilution r : 0                                  0       0

Max. Value :       6                                   0       0

Standard : 12 (User defined ¹)             0      0

ISI - Factor :        1.89 (User defined ²)                 0      0

Max. CV :   10                                 0       0

Max. Time :         85 ³                              0       0

Max. Time 2 :     120 ³                                     0       0      

Delay Time :       3                                   0       0

Impulse t. :          52                                r = Instrument determined

 

¹ Geometric mean of normal range

² ISI assignment value

³ See Procedural Note section

 

Procedure

Meas. m. :M         Pipet mode : 0

Mix volume : 0

Sample         Reagent            Volume   Incubation        Next Step

25                                              60             S4

S1 Reag 2                                                                   S

S2 Reag 3                                                                   S

S3 Reag 4                                                                   S

S4 Startr     PT                                50

 

⁴ Name assigned in Reagent List

 

Data Reduction

Data Reduction           Measuring Unit                  Normal Range

T                           Sec                             11-14 (User defined)

R                           INR                    2-6 (User defined)

N

 

QC/Statistics

Range

Eval.                 Target               2SD                   from         to

Statistics    T (T or R ⁵)                                              5       20

 

Controls    T ⁶     QC1         User Defined   User Defined   User Defined

QC2           User Defined   User Defined   User Defined

QC3           User Defined   User Defined   User Defined

 

⁵ Range for population statistics. Must be set for distribution data to be collected. Only values within the range will be collected for statistics.

⁶ Must be set for QC data storage to occur. If set to “N”, no QC results will be stored.

 

 

3. APTT-O (Activated Partial Thromboplastin Time - Optical)

Description

Name:        APTT - Optical         

Code:         APTT-O

Calibration

Curve Type :       0               Curve:      Value       Sec/mE

Dilution r : 0                         0      0

Max. Value :       0                         0      0

Standard : 0                         0      0

ISI - Factor :        0                         0      0

Max. CV :   10  ¹                           0      0

Max. Time :         180 ²                           0      0

Max. Time 2 :     240 ²                            0      0

Delay Time :       18 ³                     0      0

Impulse t. :          0                         r = Instrument determined

¹ See Procedural Note 1

² See Procedural Note 2

³ See Procedural Note 3

 

Procedure

Meas. m. :   30 mE Flex      Pipet mode : 0

Mix volume : 0

Sample                  Reagent            Volume   Incubation        Next Step

50                  APTT                            50    180                    S4

S1      Reag 2                                                                      S

S2      Reag 3                                                                      S

S3      Reag 4                                                                      S

S4      Startr                 Calcium Chloride  50

Data Reduction

Data Reduction Measuring Unit         Normal Range

T                  Sec                    20-35 (User defined)

N

N

Statistics

                                                 Range

Eval.                                   from         to

Statistics    T                                 10     120 (User Defined ⁵)

⁵ Range for population statistics. Must be set for distribution data to be collected. Only values within the range will be collected for statistics.

4. APTT-M (Activated Partial Thromboplastin Time - Mechical)

Description

Name:        APTT Mechanical              

Code:         APTT-M

Calibration

Curve Type :       0               Curve:      Value       Sec/mE

Dilution r : 0                         0      0

Max. Value :       0                         0      0

Standard : 0                         0      0

ISI - Factor :        0                         0      0

Max. CV :   10  ¹                           0      0

Max. Time :         180 ²                           0      0

Max. Time 2 :     240 ²                            0      0

Delay Time :       3                          0      0

Impulse t. :          103                             r = Instrument determined

¹ See Procedural Note 1

² See Procedural Note 2

³ See Procedural Note 3

 

Procedure*

Meas. m. :   M              Pipet mode : 0

Mix volume : 0

Sample                  Reagent            Volume   Incubation        Next Step

25                  APTT                            25    180                    S4

S1      Reag 2                                                                      S

S2      Reag 3                                                                      S

S3      Reag 4                                                                      S

S4      Startr                 Calcium Chloride  25

Data Reduction

Data Reduction Measuring Unit         Normal Range

T                  Sec                    20-35 (User defined)

N

N

Statistics                                         Range

Eval.                                   from         to

Statistics    T ⁴                               10     120 (User Defined ⁴)

⁴ Range for population statistics. Must be set for distribution data to be collected. Only values within the range will be collected for statistics.

5. FIBRINOGEN (Clauss Method) - Photo Optical Measurement

Description

Name:        FIB - Optical     

Code:         FIB-O

Calibration

Curve Type :       2               Curve:      Value ²     Sec/mE ³

Dilution r : 10                      542           1

Max. Value :       1084 User Defined ¹         271           2

Standard : 0                        180           3

ISI - Factor :        0                         135  4

Max. CV :   14                      120  5

Max. Time :         75                      100  6

Max. Time 2 :     0                         0      0

Delay Time :       2                         0      0

Impulse t. :          0                         r = Instrument determined

¹ Value of Standard 1 x 2. See “Calibration” sections

² See “Calibration” Sections

³ Initial values entered are arbitrary increasing values

 

Procedure

Meas. m. : 10 mE Linear             Pipet mode : 0

Mix volume : 0

Sample               Reagent                     Volume   Incubation        Next Step

10                Imidazole ⁴                                        90    60             S4

S1 Reag 2                                                                            S

S2 Reag 3                                                                            S

S3 Reag 4                                                                            S

S4 Startr     FIB-O ⁴                                  50

⁴ Name assigned in Reagent List

 

Data Reduction

Data Reduction Measuring Unit                  Normal Range

C                 mg/dL                         175 - 400

T                   SEC                    3 - 70

N

QC/Statistics

Range

Eval.                 Target               2SD          from         to

Statistics     C ⁵                                         100  900 (User Defined ⁵ )

Controls     C ⁶    QC1         User Defined   User Defined User Defined

QC2           User Defined   User Defined User Defined

QC3           User Defined   User Defined User Defined

⁵ Range for population statistics. Must be set for distribution data to be collected. Only values within the range will be collected for statistics.

⁶ Must be set for QC data storage to occur. If set to “N”, no QC results will be stored.

6. FIBRINOGEN (Clauss Method) - Mechanical Measurement

Description

Name:        FIB - Mechanical      

Code:         FIB-M

Calibration

Curve Type :       2               Curve:      Value ²     Sec/mE ³

Dilution r : 10                      542           1

Max. Value :       1084 User Defined ¹         271           2

Standard : 0                        180           3

ISI - Factor :        0                         135           4

Max. CV :   14                      120  5

Max. Time :         60                      100  6      

Max. Time 2 :     0                         0      0

Delay Time :       2                         0      0

Impulse t. :          1                         r = Instrument determined

¹ Value of Standard 1 x 2. See “Calibration” sections

² See “Calibration” Sections

³ Initial values entered are arbitrary increasing values

 

Procedure

Meas. m. : M                         Pipet mode : 0

Mix volume : 0

Sample               Reagent                     Volume   Incubation        Next Step

10                Imidazole ⁴                                        90    60             S4

S1 Reag 2                                                                            S

S2 Reag 3                                                                            S

S3 Reag 4                                                                            S

S4 Startr     FIB-M ⁴                                  50

⁴ Name assigned in Reagent List

 

Data Reduction

Data Reduction Measuring Unit                  Normal Range

C                 mg/dL                         175 - 400

T                   SEC                    4 - 50

N

QC/Statistics

Range

Eval.                 Target               2SD          from         to

Statistics     C ⁵                                         50     900 (User Defined ⁵ )

Controls     C ⁶    QC1         User Defined   User Defined User Defined

QC2           User Defined   User Defined User Defined

QC3           User Defined   User Defined User Defined

⁵ Range for population statistics. Must be set for distribution data to be collected. Only values within the range will be collected for statistics.

⁶ Must be set for QC data storage to occur. If set to “N”, no QC results will be stored.

4. Test Group:

‘System’

‘Password’

    ‘Parameters’

‘Test Group’

Choose a location,then key in the following parameters:

Name: Routine

Batch Size: 8

Reagent layout: Press ‘F1’, select ‘Routine’

Tests - Replicate:

Press ‘F1’, select the tests as follow and have the replicate set to single:

1.      PT-O S

2.      PT-M       S

3.      APTT-O   S

4.      APTT-M  S

5.      FIB-O      S

6.      FIB-M      S

5.  Reconstitute the reagents and buffers

Reconstitute with the volumes indicated on each vial  (Don’t reconstitute the control and FIB-Reference).  Allow product to sit undisturbed for 10 minutes and then add stir bars to APTT reagents only and place in instrument.  Allow reagents to equilibrate in instrument for 30 minutes prior to running.

6. Calibrate FIB-O and FIB-M

a.       Load the Enzyclean, cassette of cuvettes.

b.      Under System - Password - Parameters - Tests, choose FIB-M.

c.       Choose Dilution r under Calibration, change from 10 to 5 before the calibration run. 

d.      Move the cursor to any figure of ‘Sec/mE’ of ‘Curve’, Press “F2” to start the calibration dialog, when it is prompt for “Autodilution ?”, answer “Y” so the instrument will do dilution automatically from the FIB-Reference to the empty plastic tube.  Load the FIB-Reference and plastic tube as shown on the screen and start the calibration.

e.       After finished, the CV will be displayed, Press “Print Screen” button to print it out.

f.       Print the calibration curve onto the same paper as in step e.

g.       Do calibration on the FIB-O. (same procedure as in step a to f above).

Acceptance criteria for FIB calibration:

              CVs for standards 1-6 should be less than or equal to 10%

              For the fifth and sixth curve points, one NC is acceptable

              Only one NC per calibration

              (NC = no clot)

Min / Max volumes chart:

Reagent                    Size Min vol (ml)         Max vol (ml)

  APTT-FSL                  10ml      700               10000

  Calcium Chloride (CaCl2) 10ml      500               10000

  Imidazole Buffer (Buffer) 20ml      1200                    20000

  Thrombin (886)                 6ml 500               6000

  ThromboMax (PT-MAX)   10ml      1500                    10000