Cobas Mira instructions rev 401.0.2 - 2010-07-20
Chema Diagnostica Via Camp Campani aniaa 2/ 4 I-60030 Monsano | An Italy T +39 +3 9 0731 07 31 605064 60 5064 | F +39 0731 605672 www.chema.com |
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Chema Diagnostica - Guidelines for automatic automatic analyzers - Roche R oche Cobas Mira
Cobas Mira instructions rev 401.0.2 - 2010-07-20
Warning! These programs should be used only as guideline. To check the reagent correct setting on the instrument, use only good quality control sera and work accordingly to with good laboratory practice. Instrumental factor must be checked. Chema Diagnostica will not be responsible for instrumental bad programming.
IUS.401.0.2
Directions for use
Edition 2010-07-20
page 3 of 42
Chema Diagnostica - Guidelines for automatic automatic analyzers - Roche R oche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation:
ACID PHOSPHATASE (TOTAL) - Codes AC 0120 TC POWDER SINGLE REAGENT. FOLLOW PREPARA PREPARATION TION PROGRAM INDICATED IN INSERT SHEET. REFRIGERATE AT 2-8°C 10 DA DAYS YS
Storage: Stability: Stabil ity:
PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION CALIBR ATION MODE: REAGENT BLANK: CLEANER: WAVELENGH WA VELENGHT: T: DECIMAL POSITION: UNIT:
ABSORB R-S FACTOR REAG/DIL NO 405 nm 2 U/L
CALIB. INTERV INTERVAL: AL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
NO NO NO NO
FACTOR:
1421
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR: SAMPLE VOL:
CONTROL
H2O 2.00 NO
25.0 µl
REAGENT VOL: 225 µl
CYCLE: DIL:
1 25.0 µl
CYCLE:
1
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
CALCULATION SAMPLE
LIMIT:
NO
REAC. DIRECTION: CHECK:
INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 60 NO NO
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST: REACTION LIMIT: POINT:
KINETIC 10 LAST: 0.9000 ∆A T1
IUS.401.0.2
Directions for use
U/L U/L
20
Edition 2010-07-20
page 4 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation:
ACID PHOSPHATASE (NON PROSTATIC) - Codes AC 0120 TC POWDER SINLE REAGENT. FOLLOW PREPARATION PROGRAM INDICATED IN INSERT SHEET. ADD THE RIGHT QUANTITY OF L-TARTRATE. REFRIGERATE AT 2-8°C 10 DAYS
Storage: Stability:
PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S FACTOR REAG/DIL NO 405 nm 2 U/L
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
NO NO NO NO
FACTOR:
1421
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR: SAMPLE VOL:
CONTROL
H2O 2.00 NO
25.0 µl
REAGENT VOL: 225 µl
CYCLE: DIL:
1 25.0 µl
CYCLE:
1
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
CALCULATION SAMPLE
LIMIT:
NO
REAC. DIRECTION: CHECK:
INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 60 NO NO
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST: REACTION LIMIT: POINT:
KINETIC 10 LAST: 0.9000 ∆A T1
IUS.401.0.2
Directions for use
U/L U/L
20
Edition 2010-07-20
page 5 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
ALBUMIN - Codes BC BC 0100 / 0500 / 1000 / 1500 CH LIQUID READY TO USE SINGLE REAGENT ROOM TEMPERATURE (2-30°C) UP TO DECLARED EXPIRATION ON REAGENT LABEL PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S SLOPE AVG REAG/DIL NO 600 nm 1 g/dl
ANALYSIS
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0500 A 0.3200 A -0.0500 A 0.1000 A
CALIBRATOR CAL-1:
CUP POS: 1 UTIL. DEF
REPLICATE: DEVIATION:
TRIPL. 6%
SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
H2O 2.00 NO
SAMPLE VOL:
CYCLE: DIL:
1 20.0 µl
CONTROL CS1 POS:
UTIL. DEF.
CYCLE:
1
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
3.0 µl
REAGENT VOL: 250 µl
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.1000 ∆A T1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0.0 6.0 4.2 5.5
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST:
ENDPOINT CB LAST:
IUS.401.0.2
Directions for use
g/dl g/dl g/dl g/dl
6
Edition 2010-07-20
page 6 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
ALKALINE PHOSPHATASE DGKC FL - Codes AL F080 / F245 / F400 / F600 CH AS INDICATED IN INSERT SHEET REFRIGERATE AT 2-8°C 30 DAYS PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S FACTOR REAG/DIL NO 405 nm 0 U/L
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0500 A 1.0000 A -0.0100 A 0.0100 A
FACTOR:
4595
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR: SAMPLE VOL:
CONTROL
H2O 5.00 NO
5.0 µl
REAGENT VOL: 240 µl
CYCLE: DIL:
1 10.0 µl
CYCLE:
1
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.2000 ∆A T1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 2800 0 270
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST: REACTION LIMIT: POINT:
KINETIC 4 LAST: 0.4300 ∆A T1
IUS.401.0.2
Directions for use
U/L U/L U/L U/L
8
Edition 2010-07-20
page 7 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
ALKALINE PHOSPHATASE IFCC FL - Codes AF F080 / F245 / F400 / F600 CH AS INDICATED IN INSERT SHEET REFRIGERATE AT 2-8°C 30 DAYS PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S FACTOR REAG/DIL NO 405 nm 0 U/L
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0500 A 1.0000 A -0.0100 A 0.0100 A
FACTOR:
4595
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR: SAMPLE VOL:
CONTROL
H2O 2.00 NO
5.0 µl
REAGENT VOL: 240 µl
CYCLE: DIL:
1 10.0 µl
CYCLE:
1
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.2000 ∆A T1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 3000 35 104
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST: REACTION LIMIT: POINT:
KINETIC 3 LAST: 0.4300 ∆A T1
IUS.401.0.2
Directions for use
U/L U/L U/L U/L
9
Edition 2010-07-20
page 8 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
AMYLASE FL - Codes AM F060 / F120 / F245 CH LIQUID READY TO USE SINGLE REAGENT REFRIGERATE AT 2-8°C UP TO DECLARED EXPIRATION ON REAGENT LABEL PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S FACTOR REAG/DIL NO 405 nm 0 U/L
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0500 A 0.2000 A -0.0100 A 0.0100 A
FACTOR:
5296
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR: SAMPLE VOL:
CONTROL
H2O 2.00 NO
7.0 µl
REAGENT VOL: 260 µl
CYCLE: DIL:
1 20 µl
CYCLE:
1
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.1500 ∆A T1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 2000 0 96
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST: REACTION LIMIT: POINT:
KINETIC 3 LAST: 0.4000 ∆A T1
IUS.401.0.2
Directions for use
U/L U/L U/L U/L
7
Edition 2010-07-20
page 9 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
AMYLASE EPS FL - Codes EA F080 / F245 CH AS INDICATED IN INSERT SHEET REFRIGERATE AT 2-8°C 30 DAYS PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S FACTOR REAG/DIL NO 405 nm 0 U/L
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0700 A 0.8000 A -0.0100 A 0.0200 A
FACTOR:
5800
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR: SAMPLE VOL:
8.0 µl
CONTROL
H2O 5.00 NO
DIL:
REAGENT VOL: 220 µl
CYCLE: 1 20.0 µl CYCLE:
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
1
CALCULATION SAMPLE
LIMIT:
NO
REAC. DIRECTION: CHECK:
INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 1500 28 100
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST: REACTION LIMIT:
KINETIC 8 LAST: NO
IUS.401.0.2
Directions for use
U/L U/L U/L U/L
16
Edition 2010-07-20
page 10 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation:
PANCREATIC ISOAMYLASE FL - Code PA F080 / F245 CH REAGENT A - INSTALL AS “REAGENT” REAGENT B - INSTALL AS “START REAGENT 1” REFRIGERATE AT 2-8°C UP TO DECLARED EXPIRATION ON REAGENT LABEL
Storage: Stability:
PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S-SR1 FACTOR REAG/DIL NO 405 nm 0 U/L
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0500 A 0.2000 A -0.0100 A 0.0100 A
FACTOR:
10460
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR: SAMPLE VOL:
CONTROL
H2O 2.00 NO
CYCLE: DIL:
1 10.0 µl
REAGENT VOL: 230 µl
CYCLE:
1
START REAGENT 1: VOL: 50 µl
CYCLE: DIL:
10 10.0 µl
6 µl
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.1500 ∆A T1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 2500 13 53
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST: REACTION LIMIT: POINT:
KINETIC 12 LAST: 0.4000 ∆A 12
IUS.401.0.2
Directions for use
U/L U/L U/L U/L
18
Edition 2010-07-20
page 11 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
BICARBONATE FL - Codes BR F060 / F245 / F400 CH AS INDICATED IN INSERT SHEET REFRIGERATE AT 2-8°C 30 DAYS PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S SLOPE AVG REAG/DIL NO 405 nm 1 mmol/l
ANALYSIS
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
0.4000 A 1.6000 A -0.2000 A 0.2000 A
CALIBRATOR CAL-1:
CUP POS: 1 UTIL. DEF
REPLICATE: DEVIATION:
TRIPL. 6%
SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
H2O 2.00 NO
SAMPLE VOL:
CYCLE: DIL:
1 10.0 µl
CONTROL CS1 POS:
UTIL. DEF.
CYCLE:
1
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
3.0 µl
REAGENT VOL: 300 µl
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.1000 ∆A T1 DECREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0.00 50.00 8.60 10.30
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST:
ENDPOINT CB LAST:
IUS.401.0.2
Directions for use
mmol/l mmol/l mmol/l mmol/l
6
Edition 2010-07-20
page 12 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation:
BILIRUBIN TOTAL FL - Code DT F125 / F500 CH REAGENT A - INSTALL AS “REAGENT” REAGENT B - INSTALL AS “START REAGENT 1” REFRIGERATE AT 2-8°C UP TO DECLARED EXPIRATION ON REAGENT LABEL
Storage: Stability:
PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S-SR1 SLOPE AVG REAG/DIL NO 500 nm 2 mg/dl
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH: CALIBRATOR CAL-1:
NO NO NO NO CUP POS: DEF UTIL. DEF
H2O 2.00 NO
REPLICATE: DEVIATION:
TRIPL. 3%
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
CONTROL SAMPLE VOL:
CYCLE: DIL:
10.0 µl
REAGENT VOL: 200 µl
CYCLE:
START REAGENT 1: VOL: 50 µl
CYCLE: DIL:
1 10.0 µl
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
1
13 10.0 µl
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.5000 ∆A 1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 20 0.2 1.0
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST: REACTION LIMIT:
ENDPOINT 5 LAST: NO
IUS.401.0.2
Directions for use
mg/dl mg/dl mg/dl mg/dl
14
Edition 2010-07-20
page 13 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation:
BILIRUBIN DIRECT FL - Code DD F125 / F500 CH REAGENT A - INSTALL AS “REAGENT” REAGENT B - INSTALL AS “START REAGENT 1” REFRIGERATE AT 2-8°C UP TO DECLARED EXPIRATION ON REAGENT LABEL
Storage: Stability:
PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S-SR1 SLOPE AVG REAG/DIL NO 550 nm 2 mg/dl
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH: CALIBRATOR CAL-1:
NO NO NO NO CUP POS: DEF UTIL. DEF
H2O 2.00 NO
REPLICATE: DEVIATION:
TRIPL. 3%
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
CONTROL SAMPLE VOL:
CYCLE: DIL:
10.0 µl
REAGENT VOL: 200 µl
CYCLE:
START REAGENT 1: VOL: 50 µl
CYCLE: DIL:
1 10.0 µl
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
1
12 10.0 µl
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.5000 ∆A 1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 13 0.0 0.2
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST: REACTION LIMIT:
ENDPOINT 11 LAST: NO
IUS.401.0.2
Directions for use
mg/dl mg/dl mg/dl mg/dl
25
Edition 2010-07-20
page 14 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
CALCIUM - Code CA 0305 / 0505 CH AS INDICATED IN INSERT SHEET REFRIGERATE AT 2-8°C 10 DAYS PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: AFTER TESTS: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S SLOPE AVG REAG/DIL SELECT AMYLASE 550 nm 2 mg/dl
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0500 A 0.5000 A -0.0100 A 0.5000 A
CALIBRATOR CAL-1:
CUP POS: 1 UTIL. DEF
H2O 2.00 NO
REPLICATE: DEVIATION:
TRIPL. 6%
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
CONTROL SAMPLE VOL:
CYCLE: DIL:
4.0 µl
REAGENT VOL: 250 µl
CYCLE:
1 20.0 µl
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
1
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.1000 ∆A CB INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0.00 20.00 8.60 10.30
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST:
ENDPOINT CB LAST:
IUS.401.0.2
Directions for use
mg/dl mg/dl mg/dl mg/dl
4
Edition 2010-07-20
page 15 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
CHLORIDE - Code CL 0100 / 0500 CH LIQUID READY TO USE SINGLE REAGENT ROOM TEMPERATURE (2-30°C) UP TO DECLARED EXPIRATION ON REAGENT LABEL PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S SLOPE AVG REAG/DIL BEFORE 500 nm 0 mEq/l
ANALYSIS
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
NO NO NO NO
CALIBRATOR CAL-1:
CUP POS: 1 UTIL. DEF
REPLICATE: DEVIATION:
TRIPL. 6%
SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
H2O 2.00 NO
SAMPLE VOL:
CYCLE: DIL:
1 20.0 µl
CONTROL CS1 POS:
UTIL. DEF.
CYCLE:
1
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
3.0 µl
REAGENT VOL: 400 µl
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.1000 ∆A T1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 200 98 110
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST:
ENDPOINT CB LAST:
IUS.401.0.2
Directions for use
mEq/l mEq/l mEq/l mEq/l
10
Edition 2010-07-20
page 16 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
CHOLESTEROL FL - Codes CT F100 / F400 / 100F / 150F CH LIQUID READY TO USE SINGLE REAGENT REFRIGERATE AT 2-8°C UP TO DECLARED EXPIRATION ON REAGENT LABEL PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S SLOPE AVG REAG/DIL NO 500 nm 0 mg/dl
ANALYSIS
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0500 A 0.1600 A -0.0500 A 0.1000 A
CALIBRATOR CAL-1:
CUP POS: 1 UTIL. DEF
REPLICATE: DEVIATION:
TRIPL. 6%
SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
H2O 2.00 NO
SAMPLE VOL:
CYCLE: DIL:
1 20.0 µl
CONTROL CS1 POS:
UTIL. DEF.
CYCLE:
1
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
3.0 µl
REAGENT VOL: 250 µl
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.1000 ∆A T1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 700 140 200
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST:
ENDPOINT T1 LAST:
IUS.401.0.2
Directions for use
mg/dl mg/dl mg/dl mg/dl
12
Edition 2010-07-20
page 17 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation:
HDL-DIRECT FL - Code HD F080 / F245 / F400 CH REAGENT A - INSTALL AS “REAGENT” REAGENT B - INSTALL AS “START REAGENT 1” REFRIGERATE AT 2-8°C 60 DAYS ON BOARD
Storage: Stability:
PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S-SR1 SLOPE AVG REAG/DIL NO 600nm 0 mg/dl
ANALYSIS
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0500 A 0.1000 A -0.0500 A 0.0500 A
CALIBRATOR CAL-1:
CUP POS: 1 UTIL. DEF
REPLICATE: DEVIATION:
TRIPL. 6%
SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
H2O 2.00 NO
SAMPLE VOL:
CYCLE: DIL:
1 20.0 µl
CONTROL CS1 POS:
UTIL. DEF.
CYCLE:
1
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
3.0 µl
REAGENT VOL: 180 µl START REAGENT 1 VOL: 60 µl
CYCLE: DIL:
12 10.0 µl
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.3000 ∆A 2 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 220 35.3 79.5
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST:
ENDPOINT 10 LAST:
IUS.401.0.2
Directions for use
mg/dl mg/dl mg/dl mg/dl
24
Edition 2010-07-20
page 18 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation:
LDL-DIRECT FL - Code DL F080 CH REAGENT A - INSTALL AS “REAGENT” REAGENT B - INSTALL AS “START REAGENT 1” REFRIGERATE AT 2-8°C 30 DAYS ON BOARD
Storage: Stability:
PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S-SR1 SLOPE AVG REAG/DIL NO 600nm 0 mg/dl
ANALYSIS
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0500 A 0.1000 A -0.0500 A 0.0500 A
CALIBRATOR CAL-1:
CUP POS: 1 UTIL. DEF
REPLICATE: DEVIATION:
TRIPL. 6%
SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
H2O 2.00 NO
SAMPLE VOL:
CYCLE: DIL:
1 20.0 µl
CONTROL CS1 POS:
UTIL. DEF.
CYCLE:
1
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
3.0 µl
REAGENT VOL: 180 µl START REAGENT 1 VOL: 60 µl
CYCLE: DIL:
12 10.0 µl
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.3000 ∆A 2 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 400 76 218
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST:
ENDPOINT 10 LAST:
IUS.401.0.2
Directions for use
mg/dl mg/dl mg/dl mg/dl
24
Edition 2010-07-20
page 19 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation:
CHOLINESTERASE FL (DGKC) - Codes CH F096 / F245 CH REAGENT A - INSTALL AS “REAGENT” REAGENT B - INSTALL AS “START REAGENT 1” REFRIGERATE AT 2-8°C UP TO DECLARED EXPIRATION ON REAGENT LABEL
Storage: Stability:
PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S-SR1 FACTOR REAG/DIL NO 405 nm 0 U/L
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
0.8000 A 2.0000 A -0.0100 A 0.0100 A
FACTOR:
99000
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR: SAMPLE VOL:
CONTROL
H2O 2.00 NO
CYCLE: DIL:
1 10.0 µl
REAGENT VOL: 230 µl
CYCLE:
1
START REAGENT 1: VOL: 38 µl
CYCLE: DIL:
4 10.0 µl
4.8 µl
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.1500 ∆A T1 DECREASE ON
CONVERS.
1.1000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 25000 5600 11200
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST: REACTION LIMIT:
KINETIC 7 LAST: NO
IUS.401.0.2
Directions for use
U/L U/L U/L U/L
10
Edition 2010-07-20
page 20 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
CK-NAC FL - Codes CK F060 / F120 / F245 CH AS INDICATED IN INSERT SHEET REFRIGERATE AT 2-8°C 30 DAYS PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S FACTOR REAG/DIL NO 340 nm 0 U/L
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0100 A 0.6000 A -0.0100 A 0.0100 A
FACTOR:
6878
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR: SAMPLE VOL:
CONTROL
H2O 2.00 NO
10.0 µl
REAGENT VOL: 240 µl
CYCLE: DIL:
1 10.0 µl
CYCLE:
1
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.3000 ∆A T1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 2000 24 204
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST: REACTION LIMIT: POINT:
KINETIC 6 LAST: 0.6000 ∆A T1
IUS.401.0.2
Directions for use
U/L U/L U/L U/L
12
Edition 2010-07-20
page 21 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
CK-MB FL - Code MB F060 / F120 CH AS INDICATED IN INSERT SHEET REFRIGERATE AT 2-8°C 14 DAYS PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S FACTOR REAG/DIL NO 340 nm 0 U/L
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0100 A 0.6000 A -0.0100 A 0.0100 A
FACTOR:
13750
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR: SAMPLE VOL:
CONTROL
H2O 2.00 NO
10.0 µl
REAGENT VOL: 240 µl
CYCLE: DIL:
1 10.0 µl
CYCLE:
1
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.3000 ∆A T1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0.0 1000.0 0.0 24.0
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST: REACTION LIMIT: POINT:
KINETIC 10 LAST: 0.6000 ∆A T1
IUS.401.0.2
Directions for use
U/L U/L U/L U/L
20
Edition 2010-07-20
page 22 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
COPPER - Code CU 0100 CH AS INDICATED IN INSERT SHEET DO NOT REFRIGERATE! 14 DAYS PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S SLOPE AVG REAG/DIL NO 600 nm 0 microg/dl
ANALYSIS
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0500 A 0.5000 A -0.0500 A 0.5000 A
CALIBRATOR CAL-1:
CUP POS: 1 UTIL. DEF
REPLICATE: DEVIATION:
TRIPL. 6%
SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
H2O 2.00 NO
SAMPLE VOL:
CYCLE: DIL:
1 20.0 µl
CONTROL CS1 POS:
UTIL. DEF.
CYCLE:
1
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
20.0 µl
REAGENT VOL: 280 µl
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.1000 ∆A T1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 500 70 140
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST:
ENDPOINT CB LAST:
IUS.401.0.2
Directions for use
microg/dl microg/dl microg/dl microg/dl
10
Edition 2010-07-20
page 23 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
CREATININE - Code CR 0500 / 1000 / 1500 CH AS INDICATED IN INSERT SHEET ROOM TEMPERATURE (2-30°C) 14 DAYS PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S SLOPE AVG REAG/DIL NO 500 nm 2 mg/dl
ANALYSIS
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.1000 A 0.3500 A -0.0300 A 0.0300 A
CALIBRATOR CAL-1:
CUP POS: 1 UTIL. DEF
REPLICATE: DEVIATION:
TRIPL. 6%
SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
H2O 2.00 NO
SAMPLE VOL:
CYCLE: DIL:
1 20.0 µl
CONTROL CS1 POS:
UTIL. DEF.
CYCLE:
1
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
15.0 µl
REAGENT VOL: 250 µl
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.3500 ∆A T1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0.00 20.0 0.70 1.20
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST:
ENDPOINT 2 LAST:
IUS.401.0.2
Directions for use
mg/dl mg/dl mg/dl mg/dl
3
Edition 2010-07-20
page 24 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
GAMMA-GT FL - Codes GT F080 / F245 / F400 / F600 CH AS INDICATED IN INSERT SHEET REFRIGERATE AT 2-8°C 60 DAYS PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S FACTOR REAG/DIL NO 405 nm 0 U/L
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0700 A 0.8000 A -0.0100 A 0.0200 A
FACTOR:
2130
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR: SAMPLE VOL:
CONTROL
H2O 5.00 NO
25.0 µl
REAGENT VOL: 240 µl
CYCLE: DIL:
1 10.0 µl
CYCLE:
1
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
CALCULATION SAMPLE
LIMIT:
NO
REAC. DIRECTION: CHECK:
INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 800 0 50
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST: REACTION LIMIT: POINT:
KINETIC 4 LAST: 0.4300 ∆A T1
IUS.401.0.2
Directions for use
U/L U/L U/L U/L
8
Edition 2010-07-20
page 25 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
GLUCOSE FL - Codes GL F400 / 100F / 150F CH LIQUID READY TO USE SINGLE REAGENT REFRIGERATE AT 2-8°C UP TO DECLARED EXPIRATION ON REAGENT LABEL PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S SLOPE AVG REAG/DIL NO 500 nm 0 mg/dl
ANALYSIS
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0500 A 0.2000 A -0.0500 A 0.2000 A
CALIBRATOR CAL-1:
CUP POS: 1 UTIL. DEF
REPLICATE: DEVIATION:
TRIPL. 6%
SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
H2O 2.00 NO
SAMPLE VOL:
CYCLE: DIL:
1 20.0 µl
CONTROL CS1 POS:
UTIL. DEF.
CYCLE:
1
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
3.0 µl
REAGENT VOL: 250 µl
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.1000 ∆A T1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 500 70 105
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST:
ENDPOINT CB LAST:
IUS.401.0.2
Directions for use
mg/dl mg/dl mg/dl mg/dl
15
Edition 2010-07-20
page 26 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
GLUCOSE UV FL - Code GL F601 CH AS INDICATED IN INSERT SHEET REFRIGERATE AT 2-8°C 60 DAYS PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S SLOPE AVG REAG/DIL NO 340 nm 0 mg/dl
ANALYSIS
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0500 A 0.2000 A -0.0500 A 0.2000 A
CALIBRATOR CAL-1:
CUP POS: 1 UTIL. DEF
REPLICATE: DEVIATION:
TRIPL. 6%
SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
H2O 2.00 NO
SAMPLE VOL:
CYCLE: DIL:
1 20.0 µl
CONTROL CS1 POS:
UTIL. DEF.
CYCLE:
1
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
3.0 µl
REAGENT VOL: 250 µl
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.1000 ∆A T1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 700 70 105
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST:
ENDPOINT CB LAST:
IUS.401.0.2
Directions for use
mg/dl mg/dl mg/dl mg/dl
15
Edition 2010-07-20
page 27 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
GOT/AST FL - Codes GO F080 / F245 / F400 / F600 CH AS INDICATED IN INSERT SHEET REFRIGERATE AT 2-8°C 30 DAYS PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S FACTOR REAG/DIL NO 340 nm 0 U/L
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
0.4000 A 1.6000 A -0.2000 A 0.2000 A
FACTOR:
2910
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR: SAMPLE VOL:
CONTROL
H2O 5.00 NO
25.0 µl
REAGENT VOL: 240 µl
CYCLE: DIL:
1 10.0 µl
CYCLE:
1
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
CALCULATION SAMPLE
LIMIT:
NO
REAC. DIRECTION: CHECK:
DECREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 440 0 35
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST: REACTION LIMIT: POINT:
KINETIC 4 LAST: 0.2000 ∆A T1
IUS.401.0.2
Directions for use
U/L U/L U/L U/L
8
Edition 2010-07-20
page 28 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
GPT/ALT FL - Codes GP F080 / F245 / F400 / F600 CH AS INDICATED IN INSERT SHEET REFRIGERATE AT 2-8°C 30 DAYS PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S FACTOR REAG/DIL NO 340 nm 0 U/L
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
0.4000 A 1.6000 A -0.2000 A 0.2000 A
FACTOR:
2910
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR: SAMPLE VOL:
CONTROL
H2O 5.00 NO
25.0 µl
REAGENT VOL: 240 µl
CYCLE: DIL:
1 10.0 µl
CYCLE:
1
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
CALCULATION SAMPLE
LIMIT:
NO
REAC. DIRECTION: CHECK:
DECREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 440 0 45
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST: REACTION LIMIT: POINT:
KINETIC 4 LAST: 0.2000 ∆A T1
IUS.401.0.2
Directions for use
U/L U/L U/L U/L
8
Edition 2010-07-20
page 29 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation:
IRON FZ - Code FE F245 / F400 CH REAGENT A - INSTALL AS “REAGENT” REAGENT B - MIX AS INDICATED IN INSERT SHEET. INSTALL AS “START REAGENT 1” REFRIGERATE AT 2-8°C UP TO DECLARED EXPIRATION ON REAGENT LABEL
Storage: Stability:
PROGRAM CALIBRATION
GENERAL
MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S-SR1 SLOPE AVG REAG/DIL NO 550nm 0 µg/dl
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
H2O 2.00 NO
SAMPLE VOL:
CYCLE: DIL:
1 20.0 µl
CYCLE:
1
50.0 µl
REAGENT VOL: 200 µl
CYCLE: DIL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0500 A 0.1000 A -0.0500 A 0.0500 A
CALIBRATOR CAL-1:
CUP POS: 1 UTIL. DEF
REPLICATE: DEVIATION:
TRIPL. 6%
CONTROL
START REAGENT 1 VOL: 50 µl
CALIB. INTERVAL:
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
12 20.0 µl
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.3000 ∆A 11 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 1000 59 158
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST:
ENDPOINT 11 LAST:
IUS.401.0.2
Directions for use
mg/dl mg/dl mg/dl mg/dl
15
Edition 2010-07-20
page 30 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
LDH FL - Codes LD F060 / F120 / F245 CH AS INDICATED IN INSERT SHEET REFRIGERATE AT 2-8°C 30 DAYS PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S FACTOR REAG/DIL NO 340 nm 0 U/L
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
0.3000 A 1.0000 A -0.2000 A 0.2000 A
FACTOR:
26715
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR: SAMPLE VOL:
CONTROL
H2O 2.00 NO
3.0 µl
REAGENT VOL: 280 µl
CYCLE: DIL:
1 20.0 µl
CYCLE:
1
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
CALCULATION
SAMPLE
LIMIT: POINT:
0.2000 ∆A T1
REAC. DIRECTION: CHECK:
DECREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 4000 225 450
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST: REACTION LIMIT: POINT:
KINETIC 3 LAST: 0.2000 ∆A T1
IUS.401.0.2
Directions for use
U/L U/L U/L U/L
7
Edition 2010-07-20
page 31 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation:
LIPASE FL - Code LP F060 CH REAGENT A - INSTALL AS “REAGENT” REAGENT B - INSTALL AS “START REAGENT 1” REFRIGERATE AT 2-8°C
Storage:
PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S-SR1 SLOPE AVG REAG/DIL BEFORE 550 nm 1 U/L
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH: CALIBRATOR CAL-1:
NO NO NO NO CUP POS: DEF UTIL. DEF
H2O 2.00 NO
REPLICATE: DEVIATION:
TRIPL. 10%
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
CONTROL SAMPLE VOL:
CYCLE: DIL:
2.5 µl
REAGENT VOL: 240 µl
CYCLE:
START REAGENT 1: VOL: 60 µl
CYCLE: DIL:
1 15.0 µl
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
1
4 10.0 µl
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.5000 ∆A 1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 250 0 63
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST: REACTION LIMIT:
KINETIC 6 LAST: NO
IUS.401.0.2
Directions for use
U/L U/L U/L U/L
10
Edition 2010-07-20
page 32 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage:
MAGNESIUM - Code MG 0200 / 0500 CH AS INDICATED IN INSERT SHEET REFRIGERATE AT 2-8°C (STABLE 90 days) ROOM TEMPERATURE 15-30°C (STABLE 30 days) PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: AFTER TESTS: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S SLOPE AVG REAG/DIL SELECT CHOL TRIG ALP 500nm 2 mEq/l
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0500 A 0.5000 A -0.0500 A 0.5000 A
CALIBRATOR CAL-1:
CUP POS: 1 UTIL. DEF
H2O NO NO
REPLICATE: DEVIATION:
TRIPL. 5%
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
CONTROL SAMPLE VOL:
CYCLE: DIL:
3.0 µl
REAGENT VOL: 280 µl
CYCLE:
1 20.0 µl
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
1
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.1000 ∆A T1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0.00 8.00 1.30 2.10
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST:
ENDPOINT CB LAST:
IUS.401.0.2
Directions for use
mEq/l mEq/l mEq/l mEq/l
4
Edition 2010-07-20
page 33 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
MAGNESIUM XL - Code MX 0300 / 0500 CH LIQUID READY TO USE SINGLE REAGENT REFRIGERATE AT 2-8°C UP TO DECLARED EXPIRATION ON REAGENT LABEL PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: AFTER TESTS: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S SLOPE AVG REAG/DIL SELECT CHOL TRIG ALP 550 nm 2 mEq/l
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0500 A 0.5000 A -0.0500 A 0.5000 A
CALIBRATOR CAL-1:
CUP POS: 1 UTIL. DEF
H2O NO NO
REPLICATE: DEVIATION:
TRIPL. 5%
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
CONTROL SAMPLE VOL:
CYCLE: DIL:
3.0 µl
REAGENT VOL: 300 µl
CYCLE:
1 20.0 µl
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
1
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.1000 ∆A T1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0.00 6.00 1.30 2.10
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST:
ENDPOINT CB LAST:
IUS.401.0.2
Directions for use
mEq/l mEq/l mEq/l mEq/l
12
Edition 2010-07-20
page 34 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
PHOSPHORUS - Code PH 0100 / 0500 CH LIQUID READY TO USE SINGLE REAGENT REFRIGERATE AT 2-8°C UP TO DECLARED EXPIRATION ON REAGENT LABEL PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: AFTER TESTS: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S SLOPE AVG REAG/DIL SELECT LDH - URIC - GLUC 340 nm 2 mg/dl
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0500 A 0.5000 A -0.0500 A 0.5000 A
CALIBRATOR CAL-1:
CUP POS: 1 UTIL. DEF
H2O 2.00 NO
REPLICATE: DEVIATION:
TRIPL. 6%
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
CONTROL SAMPLE VOL:
CYCLE: DIL:
3.0 µl
REAGENT VOL: 250 µl
CYCLE:
1 20.0 µl
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
1
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.2000 ∆A T1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0.0 20.0 2.5 4.5
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST:
ENDPOINT CB LAST:
IUS.401.0.2
Directions for use
mg/dl mg/dl mg/dl mg/dl
12
Edition 2010-07-20
page 35 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
PROTEINS HS - Code HS 0100 / 0500 CH LIQUID READY TO USE SINGLE REAGENT ROOM TEMPERATURE (2-30°C) UP TO DECLARED EXPIRATION ON REAGENT LABEL PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S SLOPE AVG REAG/DIL NO 600 nm 0 mg/dl
ANALYSIS
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
NO NO NO NO
CALIBRATOR CAL-1:
CUP POS: 1 UTIL. DEF
REPLICATE: DEVIATION:
TRIPL. 10%
SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
H2O 2.00 NO
SAMPLE VOL:
CYCLE: DIL:
1 20.0 µl
CONTROL CS1 POS:
UTIL. DEF.
CYCLE:
1
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
2.5 µl
REAGENT VOL: 300 µl
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.3500 ∆A T1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 500 28 141
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST:
ENDPOINT T1 LAST:
IUS.401.0.2
Directions for use
mg/dl mg/dl mg/dl mg/dl
12
Edition 2010-07-20
page 36 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
PROTEINS (TOTAL) - Codes TP 0100 / 0500 / 1000 / 1500 CH LIQUID READY TO USE SINGLE REAGENT ROOM TEMPERATURE (2-30°C) UP TO DECLARED EXPIRATION ON REAGENT LABEL PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S SLOPE AVG REAG/DIL NO 550 nm 1 g/dl
ANALYSIS
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0100 A 0.5000 A -0.0100 A 0.5000 A
CALIBRATOR CAL-1:
CUP POS: 1 UTIL. DEF
REPLICATE: DEVIATION:
TRIPL. 6%
SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
H2O 2.00 NO
SAMPLE VOL:
CYCLE: DIL:
1 20.0 µl
CONTROL CS1 POS:
UTIL. DEF.
CYCLE:
1
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
3.0 µl
REAGENT VOL: 280 µl
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.3500 ∆A T1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0.0 12.0 6.30 8.30
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST:
ENDPOINT CB LAST:
IUS.401.0.2
Directions for use
g/dl g/dl g/dl g/dl
12
Edition 2010-07-20
page 37 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
TRIGLYCERIDES FL - Codes TR F100 / F400 / 100F / 150F CH LIQUID READY TO USE SINGLE REAGENT REFRIGERATE AT 2-8°C UP TO DECLARED EXPIRATION ON REAGENT LABEL PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S SLOPE AVG REAG/DIL NO 500 nm 0 mg/dl
ANALYSIS
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0500 A 0.1800 A -0.0500 A 0.1800 A
CALIBRATOR CAL-1:
CUP POS: 1 UTIL. DEF
REPLICATE: DEVIATION:
TRIPL. 6%
SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
H2O 2.00 NO
SAMPLE VOL:
CYCLE: DIL:
1 20.0 µl
CONTROL CS1 POS:
UTIL. DEF.
CYCLE:
1
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
3.0 µl
REAGENT VOL: 280 µl
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.1000 ∆A T1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 1000 0 200
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST:
ENDPOINT CB LAST:
IUS.401.0.2
Directions for use
mg/dl mg/dl mg/dl mg/dl
13
Edition 2010-07-20
page 38 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
UREA UV FL - Codes AZ F080 / F245 / F400 / F600 CH AS INDICATED IN INSERT SHEET REFRIGERATE AT 2-8°C 60 DAYS PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: AFTER TESTS: IRON WAVELENGHT: DECIMAL POSITION: UNIT: mg/dl
ABSORB R-S SLOPE AVG REAG/DIL SELECT 340 nm 1
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
0.4000 A 1.4000 A -0.0300 A 0.1000 A
CALIBRATOR CAL-1:
CUP POS: 1 UTIL. DEF
REPLICATE: DEVIATION:
TRIPL. 6%
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
H2O 2.00 NO
CONTROL SAMPLE VOL:
CYCLE: DIL:
3.0 µl
REAGENT VOL: 280 µl
CYCLE:
1 20.0 µl
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
1
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.1000 ∆A T1 DECREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0.0 300.0 10.0 50.0
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST:
ENDPOINT 3 LAST:
IUS.401.0.2
Directions for use
mg/dl mg/dl mg/dl mg/dl
5
Edition 2010-07-20
page 39 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation: Storage: Stability:
URIC ACID T FL - Code AU F402 CH AS INDICATED IN INSERT SHEET REFRIGERATE AT 2-8°C 90 DAYS PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S SLOPE AVG REAG/DIL NO 550 nm 2 mg/dl
ANALYSIS
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH:
-0.0500 A 0.1600 A -0.0500 A 0.1000 A
CALIBRATOR CAL-1:
CUP POS: 1 UTIL. DEF
REPLICATE: DEVIATION:
TRIPL. 6%
SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
H2O 2.00 NO
SAMPLE VOL:
CYCLE: DIL:
1 20.0 µl
CONTROL CS1 POS:
UTIL. DEF.
CYCLE:
1
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
8.0 µl
REAGENT VOL: 250 µl
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.1000 ∆A T1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0.00 25.00 3.50 7.20
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST:
ENDPOINT CB LAST:
IUS.401.0.2
Directions for use
mg/dl mg/dl mg/dl mg/dl
16
Edition 2010-07-20
page 40 of 42
Chema Diagnostica - Guidelines for automatic analyzers - Roche Cobas Mira
Analyzer:
Cobas Mira
Application: Preparation:
URIC ACID AOX FL - Code AX F100 / F250 / F060 CH REAGENT A - INSTALL AS “REAGENT” REAGENT B - INSTALL AS “START REAGENT 1” REFRIGERATE AT 2-8°C
Storage:
PROGRAM CALIBRATION
GENERAL MEASUREMENT MODE: REACTION MODE: CALIBRATION MODE: REAGENT BLANK: CLEANER: WAVELENGHT: DECIMAL POSITION: UNIT:
ABSORB R-S-SR1 SLOPE AVG REAG/DIL NO 550 nm 2 mg/dl
CALIB. INTERVAL:
ON REQUEST
REAGENT BLANK REAG. RANGE LOW: HIGH: BLANK RANGE LOW: HIGH: CALIBRATOR CAL-1:
NO NO NO NO CUP POS: DEF UTIL. DEF
H2O 2.00 NO
REPLICATE: DEVIATION:
TRIPL. 3%
ANALYSIS SAMPLE DIL. NAME: POST. DIL. FACTOR: CONC. FACTOR:
CONTROL SAMPLE VOL:
CYCLE: DIL:
10.0 µl
REAGENT VOL: 190 µl
CYCLE:
START REAGENT 1: VOL: 50 µl
CYCLE: DIL:
1 10.0 µl
CS1 POS:
UTIL. DEF.
CS2 POS:
UTIL. DEF.
CS3 POS:
UTIL. DEF.
1
13 5.0 µl
CALCULATION
SAMPLE
LIMIT: POINT: REAC. DIRECTION: CHECK:
0.5000 ∆A 1 INCREASE ON
CONVERS.
1.0000 0.0000
FACTOR: OFFSET:
TEST RANGE LOW: HIGH: NORM. RANGE LOW: HIGH:
0 35 3.5 7.2
NUMBER OF STEPS:
1
CALC. STEP A: READINGS FIRST: REACTION LIMIT:
ENDPOINT 10 LAST: NO
IUS.401.0.2
Directions for use
mg/dl mg/dl mg/dl mg/dl
25
Edition 2010-07-20
page 41 of 42
