Olympus AU 400 - 600 - 640 instructions

rev 422.0.7 - 2018-10-17

Chema Diagnostica
Via Campania 2/4
I-60030 Monsano | An Italy
T +39 0731 605064 | F +39 0731 605672
www.chema.com | [email protected]
 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Olympus AU 400 - 600 - 640 instructions

rev 422.0.7 - 2018-10-17

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.422.0.7 Directions for use Edition 2018-10-17 page 3 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: ALBUMIN - Codes BC 0100 / 0500 / 1000 / 1500 CH
Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT
Storage: REFRIGERATE (2-8°C)
Stability: AS INDICATED IN THE LABEL

TEST NAME: ALB

Sample: Volume 2 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 300 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelength: Pri. 600 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.5
Last L - 0.1 Last H 0.5
Measuring point 1: First 0 Last 15
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 0.1 H 6.0

Correlation factor:
A1 B0

Unit: g/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 4 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: ALKALINE PHOSPHATASE FL (IFCC) - Codes AF F080 / F245 / F400 / F600 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: ALP

Sample: Volume 7 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 280 ml Dilution 0 ml
R2 volume 70 ml Dilution 0 ml

Wavelength: Pri. 410 Sec. 700 Min OD Max OD

Method: RATE L -0.1 H 2.5

Reaction slope: + Reagent OD limit:

First L -0.1 First H 1.5
Last L -0.1 Last H 1.5
Measuring point 1: First 14 Last 27
Measuring point 2: First Last

Linearity: 15% Dynamic range:

No Lag Time: NO L5 H 3000

Correlation factor:
A1 B0

Unit: U/l

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 5 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: ALKALINE PHOSPHATASE (DGKC) FL - Codes AL F080 / F245 / F400 / F600 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: ALP

Sample: Volume 7 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 280 ml Dilution 0 ml
R2 volume 70 ml Dilution 0 ml

Wavelength: Pri. 410 Sec. 700 Min OD Max OD

Method: RATE L - 0.1 H 2.0

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 1.2
Last L - 0.1 Last H 1.2
Measuring point 1: First 14 Last 27
Measuring point 2: First Last

Linearity: 15% Dynamic range:

No Lag Time: NO L7 H 3000

Correlation factor:
A1 B0

Unit: U/l

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 6 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: AMYLASE FL - Codes AM F060 / F120 / F245 CH
Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: AMY

Sample: Volume 7 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 280 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelength: Pri. 410 Sec. 700 Min OD Max OD

Method: RATE L - 0.1 H 2.0

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.3
Last L - 0.1 Last H 0.3
Measuring point 1: First 7 Last 15
Measuring point 2: First Last

Linearity: 15% Dynamic range:

No Lag Time: NO L1 H 3000

Correlation factor:
A1 B0

Unit: U/l

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 7 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: AMYLASE EPS FL - Codes EA F080 / F245 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: AMY

Sample: Volume 10 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 240 ml Dilution 0 ml
R2 volume 60 ml Dilution 0 ml

Wavelength: Pri. 410 Sec. 700 Min OD Max OD

Method: RATE L - 0.1 H 2.0

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.3
Last L - 0.1 Last H 0.3
Measuring point 1: First 17 Last 27
Measuring point 2: First Last

Linearity: 15% Dynamic range:

No Lag Time: NO L2 H 2500

Correlation factor:
A1 B0

Unit: U/l

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 8 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: PANCREATIC ISOAMYLASE FL - Code PA F080 / F245 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: AMYP

Sample: Volume 5 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 200 ml Dilution 0 ml
R2 volume 50 ml Dilution 0 ml

Wavelength: Pri. 410 Sec. 700 Min OD Max OD

Method: RATE L - 0.1 H 2.0

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.3
Last L - 0.1 Last H 0.3
Measuring point 1: First 17 Last 27
Measuring point 2: First Last

Linearity: 20% Dynamic range:

No Lag Time: NO L2 H 2500

Correlation factor:
A1 B0

Unit: U/l

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 9 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: ASO FL - Codes AS 0050 / 0100 CH
Preparation: R1 - USE LIQUID READY TO USE REAGENT 1
R2 - USE LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: ASO

Sample: Volume 3 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 240 ml Dilution 0 ml
R2 volume 60 ml Dilution 0 ml

Wavelenght: Pri. 540 Sec. - Min OD Max OD

Method: END L 0.1 H 2.5

Reaction slope: + Reagent OD limit:

First L -2 First H 2.5
Last L -2 First H 2.5
Measuring point 1: First 12 Last 18
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L3 H 850

Correlation factor:
A1 B0

Unit: IU/ml Decimals: 1

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 10 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: BICARBONATE FL - Code BR F060 / F245 / F400 CH
Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: CO2

Sample: Volume 3 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 300 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelength: Pri. 410 Sec. 520 Min OD Max OD

Method: FIXED L 0.1 H 2.5

Reaction slope: - Reagent OD limit:

First L - 2.0 First H 2.5
Last L - 2.0 Last H 2.5
Measuring point 1: First 3 Last 17
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L1 H 50

Correlation factor:
A1 B0

Unit: mmol/l

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 11 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: BILIRUBIN TOTAL FL - Code DT F125 / F500 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: BILT

Sample: Volume 10 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 200 ml Dilution 0 ml
R2 volume 50 ml Dilution 0 ml

Wavelength: Pri. 520 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.8
Last L - 0.1 Last H 0.8
Measuring point 1: First 0 Last 27
Measuring point 2: First 0 Last 10

Linearity: Dynamic range:

No Lag Time: L 0.05 H 20

Correlation factor:
A1 B0

Unit: mg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 12 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: BILIRUBIN DIRECT FL - Code DD F125 / F500 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: BILD

Sample: Volume 10 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 200 ml Dilution 0 ml
R2 volume 50 ml Dilution 0 ml

Wavelength: Pri. 540 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.5
Last L - 0.1 Last H 0.5
Measuring point 1: First 0 Last 27
Measuring point 2: First 0 Last 10

Linearity: Dynamic range:

No Lag Time: L 0.05 H 13

Correlation factor:
A1 B0

Unit: mg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 13 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: CALCIUM - Code CA 0305 / 0505 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: CA

Sample: Volume 5 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 150 ml Dilution 0 ml
R2 volume 150 ml Dilution 0 ml

Wavelength: Pri. 570 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 1.2
Last L - 0.1 Last H 1.2
Measuring point 1: First 0 Last 25
Measuring point 2: First Last 10

Linearity: Dynamic range:

No Lag Time: L 0.1 H 20

Correlation factor:
A1 B0

Unit: mg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 14 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: CALCIUM ASX - Code CA 0100 / 0500 CH
Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT
Storage: ROOM TEMPERATURE OR REFRIGERATE (2-30°C)
Stability: AS INDICATED IN THE LABEL

TEST NAME: CA

Sample: Volume 3 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 300 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelength: Pri. 660 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 2.0
Last L - 0.1 Last H 2.0
Measuring point 1: First 0 Last 15
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 0.2 H 20

Correlation factor:
A1 B0

Unit: mg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 15 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: CHOLESTEROL FL - Codes CT F100 / F400 / 100F / 150F CH
Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: CHOL

Sample: Volume 3 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 300 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelength: Pri. 520 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.5
Last L - 0.1 Last H 0.5
Measuring point 1: First 0 Last 17
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L1 H 700

Correlation factor:
A1 B0

Unit: mg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 16 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: HDL direct FL- Code HD F080 / F245 / F400 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: 60 DAYS OPEN BOTTLES

TEST NAME: HDLC

Sample: Volume 3 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 270 ml Dilution 0 ml
R2 volume 90 ml Dilution 0 ml

Wavelength: Pri. 600 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.3
Last L - 0.1 Last H 0.3
Measuring point 1: First 0 Last 27
Measuring point 2: First 0 Last 10

Linearity: Dynamic range:

No Lag Time: L1 H 220

Correlation factor:
A1 B0

Unit: mg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 17 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: LDL direct FL- Code DL F080 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: 60 DAYS OPEN BOTTLES

TEST NAME: LDLC

Sample: Volume 3 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 270 ml Dilution 0 ml
R2 volume 90 ml Dilution 0 ml

Wavelength: Pri. 600 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.3
Last L - 0.1 Last H 0.3
Measuring point 1: First 0 Last 27
Measuring point 2: First 0 Last 10

Linearity: Dynamic range:

No Lag Time: L1 H 400

Correlation factor:
A1 B0

Unit: mg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 18 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: CHOLINESTERASE FL (DGKC) - Codes CH F096 / F245 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: CHE

Sample: Volume 5 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 250 ml Dilution 0 ml
R2 volume 50 ml Dilution 0 ml

Wavelength: Pri. 410 Sec. 700 Min OD Max OD

Method: RATE L 0.4 H 2.5

Reaction slope: - Reagent OD limit:

First L 1.1 First H 2.2
Last L 1.1 Last H 2.2
Measuring point 1: First 17 Last 23
Measuring point 2: First Last

Linearity: 15% Dynamic range:

No Lag Time: NO L 400 H 25000

Correlation factor:
A1 B0

Unit: U/l

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 19 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: CK-NAC FL - Codes CK F060 / F120 / F245 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: CK

Sample: Volume 10 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 200 ml Dilution 0 ml
R2 volume 50 ml Dilution 0 ml

Wavelength: Pri. 340 Sec. 700 Min OD Max OD

Method: RATE L -0.1 H 2.0

Reaction slope: + Reagent OD limit:

First L -0.1 First H 0.5
Last L -0.1 Last H 0.5
Measuring point 1: First 18 Last 26
Measuring point 2: First Last

Linearity: 15% Dynamic range:

No Lag Time: NO L1 H 2000

Correlation factor:
A1 B0

Unit: U/l

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 20 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: CK-MB FL - Codes MB F060 / F120 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: CKMB

Sample: Volume 10 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 200 ml Dilution 0 ml
R2 volume 50 ml Dilution 0 ml

Wavelength: Pri. 340 Sec. 540 Min OD Max OD

Method: RATE L -0.1 H 2.0

Reaction slope: + Reagent OD limit:

First L -0.1 First H 0.5
Last L -0.1 Last H 0.5
Measuring point 1: First 18 Last 26
Measuring point 2: First Last

Linearity: 15% Dynamic range:

No Lag Time: NO L2 H 2000

Correlation factor:
A1 B0

Unit: U/l

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 21 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: COPPER - Code CU 0100 CH
Preparation: R1 - MIX REAGENT 1 + REAGENT 2 AS INDICATED IN INSERT SHEET
Storage: ROOM TEMPERATURE - DO NOT REFRIGERATE IF POSSIBLE
Stability: 2 WEEKS

TEST NAME: CU

Sample: Volume 20 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 300 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelength: Pri. 600 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.5
Last L - 0.1 Last H 0.5
Measuring point 1: First 0 Last 27
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L4 H 500

Correlation factor:
A1 B0

Unit: microg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 22 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: CREATININE - Code CR 0500 / 1000 / 1500 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: ROOM TEMPERATURE OR REFRIGERATE (2-30°C)
Stability: AS INDICATED IN THE LABEL

TEST NAME: CREA

Sample: Volume 25 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 125 ml Dilution 0 ml
R2 volume 125 ml Dilution 0 ml

Wavelength: Pri. 520 Sec. 570 Min OD Max OD

Method: FIXED L - 0.1 H 2.5

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.5
Last L - 0.1 Last H 0.5
Measuring point 1: First 14 Last 18
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 0.2 H 20

Correlation factor:
A1 B -0.3

Unit: mg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 23 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: CREATININE-E FL - Codes CE F125 / F375 / F600 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: CRENZ

Sample: Volume 5 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 240 ml Dilution 0 ml
R2 volume 60 ml Dilution 0 ml

Wavelength: Pri. 540 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.3
Last L - 0.1 Last H 0.3
Measuring point 1: First 0 Last 27
Measuring point 2: First 0 Last 10

Linearity: Dynamic range:

No Lag Time: L1 H 50

Correlation factor:
A1 B0

Unit: mg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 24 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: CRP FL - Code RP 0090 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: CRP

Sample: Volume 11 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 200 ml Dilution 0 ml
R2 volume 25 ml Dilution 0 ml

Wavelength: Pri. 340 Sec. Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.3
Last L - 0.1 Last H 0.3
Measuring point 1: First 0 Last 27
Measuring point 2: First 0 Last 10

Linearity: Dynamic range:

No Lag Time: L1 H 200

Correlation factor:
A1 B0

Unit: mg/l

Calibration type: 5AB Formula: POLYGONAL

IUS.422.0.7 Directions for use Edition 2018-10-17 page 25 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: ETHANOL FL - Codes EH F060 / F245
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: ETOH

Sample: Volume 10 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 200 ml Dilution 0 ml
R2 volume 50 ml Dilution 0 ml

Wavelength: Pri. 340 Sec. 700 Min OD Max OD

Method: RATE L -0.1 H 2.0

Reaction slope: + Reagent OD limit:

First L -0.1 First H 1.0
Last L -0.1 Last H 1.0
Measuring point 1: First 15 Last 20
Measuring point 2: First Last

Linearity: 15% Dynamic range:

No Lag Time: NO L3 H 600

Correlation factor:
A1 B0

Unit: mg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 26 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: GAMMA-GT FL - Codes GT F080 / F245 / F400 / F600 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: GGT

Sample: Volume 25 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 200 ml Dilution 0 ml
R2 volume 50 ml Dilution 0 ml

Wavelength: Pri. 410 Sec. 700 Min OD Max OD

Method: RATE L -0.1 H 2.0

Reaction slope: + Reagent OD limit:

First L -0.1 First H 1.5
Last L -0.1 Last H 1.5
Measuring point 1: First 16 Last 27
Measuring point 2: First Last

Linearity: 15% Dynamic range:

No Lag Time: NO L2 H 800

Correlation factor:
A1 B0

Unit: U/l

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 27 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: GLUCOSE FL - Codes GL F400 / 100F / 150F CH
Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: GLUC

Sample: Volume 3 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 300 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelength: Pri. 520 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.5
Last L - 0.1 Last H 0.5
Measuring point 1: First 0 Last 27
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L1 H 500

Correlation factor:
A1 B0

Unit: mg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 28 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: GLUCOSE UV FL - Code GL F601 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: GLUC

Sample: Volume 3 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 240 ml Dilution 0 ml
R2 volume 60 ml Dilution 0 ml

Wavelength: Pri. 340 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.5
Last L - 0.1 Last H 0.5
Measuring point 1: First 0 Last 27
Measuring point 2: First Last 10

Linearity: Dynamic range:

No Lag Time: L1 H 700

Correlation factor:
A1 B0

Unit: mg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 29 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: GOT/AST FL - Codes GO F080 / F245 / F400 / F600 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: GOT

Sample: Volume 25 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 200 ml Dilution 0 ml
R2 volume 50 ml Dilution 0 ml

Wavelength: Pri. 340 Sec. 700 Min OD Max OD

Method: RATE L 0.7 H 2.5

Reaction slope: - Reagent OD limit:

First L 1.0 First H 2.5
Last L 1.0 Last H 2.5
Measuring point 1: First 14 Last 23
Measuring point 2: First Last

Linearity: 15% Dynamic range:

No Lag Time: L2 H 440

Correlation factor:
A1 B0

Unit: U/l

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 30 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: GPT/ALT FL - Codes GP F060 / F245 / F400 / F600 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: GPT

Sample: Volume 25 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 200 ml Dilution 0 ml
R2 volume 50 ml Dilution 0 ml

Wavelength: Pri. 340 Sec. 700 Min OD Max OD

Method: RATE L 0.7 H 2.5

Reaction slope: - Reagent OD limit:

First L 1.0 First H 2.5
Last L 1.0 Last H 2.5
Measuring point 1: First 14 Last 23
Measuring point 2: First Last

Linearity: 15% Dynamic range:

No Lag Time: L2 H 440

Correlation factor:
A1 B0

Unit: U/l

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 31 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: HbA1c - Codes HC 0040 / 0080 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: HBA1C

Sample: Volume 6 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 150 ml Dilution 0 ml
R2 volume 50 ml Dilution 0 ml

Wavelength: Pri. 660 Sec. 800 Min OD Max OD

Method: FIXED1 L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 1.5
Last L - 0.1 Last H 1.5
Measuring point 1: First 14 Last 27
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L0 H 15

Correlation factor:
A1 B0

Unit: %

Calibration type: 5AB Formula: SPLINE

IUS.422.0.7 Directions for use Edition 2018-10-17 page 32 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: IgA FL - Codes GA 0050 / 0100 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: IGA

Sample: Volume 2 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 240 ml Dilution 0 ml
R2 volume 60 ml Dilution 0 ml

Wavelength: Pri. 600 Sec. Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 1.5
Last L - 0.1 Last H 1.5
Measuring point 1: First 0 Last 27
Measuring point 2: First 0 Last 10

Linearity: Dynamic range:

No Lag Time: L1 H6

Correlation factor:
A1 B0

Unit: g/l

Calibration type: 5AB Formula: POLYGONAL

IUS.422.0.7 Directions for use Edition 2018-10-17 page 33 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: IgG FL - Codes GG 0050 / 0100 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: IGG

Sample: Volume 3 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 240 ml Dilution 0 ml
R2 volume 60 ml Dilution 0 ml

Wavelength: Pri. 600 Sec. Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 1.5
Last L - 0.1 Last H 1.5
Measuring point 1: First 0 Last 27
Measuring point 2: First 0 Last 10

Linearity: Dynamic range:

No Lag Time: L1 H 30

Correlation factor:
A1 B0

Unit: g/l

Calibration type: 5AB Formula: POLYGONAL

IUS.422.0.7 Directions for use Edition 2018-10-17 page 34 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: IgM FL - Code GM 0050 / 0100 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: IGM

Sample: Volume 3 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 240 ml Dilution 0 ml
R2 volume 60 ml Dilution 0 ml

Wavelength: Pri. 340 Sec. Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 1.5
Last L - 0.1 Last H 1.5
Measuring point 1: First 0 Last 27
Measuring point 2: First 0 Last 10

Linearity: Dynamic range:

No Lag Time: L1 H 3.5

Correlation factor:
A1 B0

Unit: g/l

Calibration type: 5AB Formula: POLYGONAL

IUS.422.0.7 Directions for use Edition 2018-10-17 page 35 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: IRON FZ - Codes FE F245 / F400 CH
Preparation: R1 - INSTALL REAGENT 1 AFTER PREPARATION
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: FE

Sample: Volume 40 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 160 ml Dilution 0 ml
R2 volume 40 ml Dilution 0 ml

Wavelength: Pri. 570 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.5
Last L - 0.1 Last H 0.5
Measuring point 1: First 0 Last 27
Measuring point 2: First 0 Last 10

Linearity: Dynamic range:

No Lag Time: L 25 H 1000

Correlation factor:
A1 B0

Unit: microg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 36 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: LDH FL - Codes LD F060 / F120 / F245 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: LDH

Sample: Volume 2 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 200 ml Dilution 0 ml
R2 volume 50 ml Dilution 0 ml

Wavelength: Pri. 340 Sec. 700 Min OD Max OD

Method: RATE L 0.7 H 2.5

Reaction slope: - Reagent OD limit:

First L 1.0 First H 2.5
Last L 1.0 Last H 2.5
Measuring point 1: First 16 Last 27
Measuring point 2: First Last

Linearity: 15% Dynamic range:

No Lag Time: L 30 H 4000

Correlation factor:
A1 B0

Unit: U/l

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 37 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: LIPASE FL - Code LP F080 / F125 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: LIP

Sample: Volume 4 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 200 ml Dilution 0 ml
R2 volume 50 ml Dilution 0 ml

Wavelength: Pri. 570 Sec. 700 Min OD Max OD

Method: RATE L -0.1 H 2.5

Reaction slope: + Reagent OD limit:

First L -0.1 First H 1
Last L -0.1 Last H 1
Measuring point 1: First 16 Last 24
Measuring point 2: First Last

Linearity: 15% Method linearity:

No Lag Time: NO L1 H 300

Correlation factor:
A1 B0

Unit: U/l

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 38 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: MAGNESIUM - Codes MG 0200 / 0500 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: ROOM TEMPERATURE OR REFRIGERATE (2-30°C)
Stability: AS INDICATED IN THE LABEL

TEST NAME: MG

Sample: Volume 3 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 150 ml Dilution 0 ml
R2 volume 150 ml Dilution 0 ml

Wavelength: Pri. 520 Sec. Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L 0.3 First H 2.0
Last L 0.3 Last H 2.0
Measuring point 1: First 0 Last 27
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 0.1 H8

Correlation factor:
A1 B0

Unit: mEq/l

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 39 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: MAGNESIUM XL - Codes MX 0300 / 0500 CH
Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: MG

Sample: Volume 3 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 300 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelength: Pri. 540 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L 0.3 First H 2.0
Last L 0.3 Last H 2.0
Measuring point 1: First 0 Last 16
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 0.3 H6

Correlation factor:
A1 B0

Unit: mEq/l

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 40 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: MICROALBUMIN FL - Codes MA 0050 / 0100 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: MALB

Sample: Volume 12 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 200 ml Dilution 0 ml
R2 volume 50 ml Dilution 0 ml

Wavelenght: Pri. 340 Sec. none Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 1.5
Last L - 0.1 First H 1.5
Measuring point 1: First 0 Last 27
Measuring point 2: First 0 Last 10

Linearity: Dynamic range:

No Lag Time: L1 H 320

Correlation factor:
A1 B0

Unit: mg/l Decimals: 1

Calibration type: 5AB Formula: Polygonal

IUS.422.0.7 Directions for use Edition 2018-10-17 page 41 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: PHOSPHORUS - Code PH 0100 / 0500 CH
Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN INSERT SHEET

TEST NAME: PHOS

Sample: Volume 3 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 300 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelength: Pri. 340 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 1
Last L - 0.1 Last H 1
Measuring point 1: First 0 Last 17
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 0.4 H 20

Correlation factor:
A1 B0

Unit: mg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 42 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: PROTEINS HS - Code HS 0100 / 0500 CH
Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT
Storage: ROOM TEMPERATURE OR REFRIGERATE (2-30°C)
Stability: AS INDICATED IN THE LABEL

TEST NAME: HS

Sample: Volume 2 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 350 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelength: Pri. 600 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.5
Last L - 0.1 Last H 0.5
Measuring point 1: First 0 Last 27
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 0.3 H 500

Correlation factor:
A1 B0

Unit: mg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 43 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: RHEUMATOID FACTOR FL - Codes RF 0050 / 0100 CH
Preparation: R1 - USE LIQUID READY TO USE REAGENT 1
R2 - USE LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: RF

Sample: Volume 3 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 240 ml Dilution 0 ml
R2 volume 60 ml Dilution 0 ml

Wavelenght: Pri. 660 Sec. - Min OD Max OD

Method: END L 0.1 H 2.5

Reaction slope: + Reagent OD limit:

First L -2 First H 2.5
Last L -2 First H 2.5
Measuring point 1: First 0 Last 17
Measuring point 2: First 0 Last 10

Linearity: Dynamic range:

No Lag Time: L7 H 150

Correlation factor:
A1 B0

Unit: IU/ml Decimals: 1

Calibration type: 5AB Formula: POLYGONAL

IUS.422.0.7 Directions for use Edition 2018-10-17 page 44 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: TOTAL PROTEINS - Codes TP 0500 / 1000 / 1500 CH
Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT
Storage: ROOM TEMPERATURE OR REFRIGERATE (2-30°C)
Stability: AS INDICATED IN THE LABEL

TEST NAME: TP

Sample: Volume 3 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 300 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelength: Pri. 540 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.5
Last L - 0.1 Last H 0.5
Measuring point 1: First 0 Last 27
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 0.1 H 12

Correlation factor:
A1 B0

Unit: g/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 45 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: TRANSFERRIN FL - Codes TF 0050 / 0100 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: TRF

Sample: Volume 2 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 240 ml Dilution 0 ml
R2 volume 60 ml Dilution 0 ml

Wavelength: Pri. 520 Sec. Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 1.5
Last L - 0.1 Last H 1.5
Measuring point 1: First 0 Last 27
Measuring point 2: First 0 Last 10

Linearity: Dynamic range:

No Lag Time: L1 H 8.5

Correlation factor:
A1 B0

Unit: g/l

Calibration type: 5AB Formula: POLYGONAL

IUS.422.0.7 Directions for use Edition 2018-10-17 page 46 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: TRIGLYCERIDES FL - Code TR F100 / F400 / 100F / 150F CH
Preparation: R1 - LIQUID READY TO USE SINGLE RAGENT
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: TRIG

Sample: Volume 3 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 300 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelength: Pri. 540 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 1.5
Last L - 0.1 Last H 1.5
Measuring point 1: First 0 Last 17
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L1 H 1000

Correlation factor:
A1 B0

Unit: mg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 47 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: UREA UV FL - Codes AZ F080 / F245 / F400 / F600 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: UREA

Sample: Volume 3 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 240 ml Dilution 0 ml
R2 volume 60 ml Dilution 0 ml

Wavelength: Pri. 340 Sec. 700 Min OD Max OD

Method: RATE L 1.0 H 2.5

Reaction slope: - Reagent OD limit:

First L 1.2 First H 2.5
Last L 1.2 Last H 2.5
Measuring point 1: First 13 Last 17
Measuring point 2: First Last

Linearity: 15% Dynamic range:

No Lag Time: L1 H 300

Correlation factor:
A1 B0

Unit: mg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 48 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: UREA COLOR FL - Codes UC F400 / 100F CH
Preparation: R1 - MIX REAGENT R1A + REAGENT R1B AS INDICATED IN INSERT SHEET
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: UCOL

Sample: Volume 2 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 200 ml Dilution 0 ml
R2 volume 200 ml Dilution 0 ml

Wavelength: Pri. 600 Sec. Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 1.5
Last L - 0.1 Last H 1.5
Measuring point 1: First 0 Last 27
Measuring point 2: First 0 Last 10

Linearity: Dynamic range:

No Lag Time: L3 H 300

Correlation factor:
A1 B0

Unit: mg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 49 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: URIC ACID T FL - Code AU F402 CH
Preparation: R1 - MIX REAGENT 1 + REAGENT 2 AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 90 DAYS

TEST NAME: UA

Sample: Volume 6 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 240 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelength: Pri. 540 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.5
Last L - 0.1 Last H 0.5
Measuring point 1: First 0 Last 17
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 0.2 H 30

Correlation factor:
A1 B0

Unit: mg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 50 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: URIC ACID AOX FL - Codes AX F100 / F250 / F600 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT 1
R2 - INSTALL LIQUID READY TO USE REAGENT 2
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: AOX

Sample: Volume 10 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 200 ml Dilution 0 ml
R2 volume 50 ml Dilution 0 ml

Wavelength: Pri. 540 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.5
Last L - 0.1 Last H 0.5
Measuring point 1: First 0 Last 27
Measuring point 2: First 0 Last 10

Linearity: Dynamic range:

No Lag Time: L 0.1 H 35

Correlation factor:
A1 B0

Unit: mg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 51 of 52

 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Analyzer: Olympus AU 400 - 600 - 640

Application: ZINC - Code ZN 0125 CH
Preparation: R1 - MIX REAGENT 1 + REAGENT 2 AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 2 WEEKS

TEST NAME: ZN

Sample: Volume 12 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 240 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelength: Pri. 570 Sec. 700 Min OD Max OD

Method: END L H

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.8
Last L - 0.1 Last H 0.8
Measuring point 1: First 0 Last 27
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L5 H 1000

Correlation factor:
A1 B0

Unit: microg/dl

Calibration type: AB Formula: Y=AX+B

IUS.422.0.7 Directions for use Edition 2018-10-17 page 52 of 52