OLYMPUS AU 400/600/640 Manual

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 Olympus AU 400 - 600 - 640 instructions
rev 422.0.2 - 2010-08-01

Chema Diagnostica
Via Campania 2/4
I-60030 Monsano | An Italy
T +39 0731 605064 | F +39 0731 605672
www.chema.com | [email protected]

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This Manual: http://www.manuallib.com/file/2605920
 Chema Diagnostica - Guidelines for automatic analyzers - Olympus AU 400 - 600 - 640

Olympus AU 400 - 600 - 640 instructions

rev 422.0.2 - 2010-08-01

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.422.0.2 Directions for use Edition 2010-08-01 page 3 of 41

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

Analyzer: Olympus AU 400 - 600 - 640

Application: ACID PHOSPHATASE - Codes AC 0120 TC
Preparation: POWDER SINGLE REAGENT. FOLLOW PREPARATION PROGRAM INDICATED IN INSERT
SHEET. INSTALL AS R1
Storage: REFRIGERATE AT 2-8°C

TEST NAME: ACP

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

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

Wavelenght: Pri. 410 Sec. 800 Min OD Max OD

Method: RATE L - 0.1 H 2.5

Reaction slope: + Reagent OD limit:

First L - 0.1 First H 0.3
Last L - 0.1 First H 0.3
Measuring point 1: First 12 Last 27
Measuring point 2: First Last

Linearity: 20% Dynamic range:

No Lag Time: NO L 1 H 60

Correlation factor:
A 1 B0

On-board stability period: 30

Unit: U/L

Factor: 853

IUS.422.0.2 Directions for use Edition 2010-08-01 page 4 of 41

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 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 295 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelenght: Pri. 600 Sec. 800 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 First H 0.5
Measuring point 1: First 0 Last 4
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: YES L 0.1 H 6.0

Correlation factor:
A 1 B0

On-board stability period: 90

Unit: g/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 5 of 41

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 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 A
R2 - INSTALL LIQUID READY TO USE REAGENT B
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: ALP

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

Wavelenght: Pri. 410 Sec. 480 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 First H 1.5
Measuring point 1: First 13 Last 19
Measuring point 2: First Last

Linearity: 20% Dynamic range:

No Lag Time: NO L 5 H 3000

Correlation factor:
A 1 B0

On-board stability period: 60

Unit: U/L

Factor: 2757

IUS.422.0.2 Directions for use Edition 2010-08-01 page 6 of 41

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 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 A
R2 - INSTALL LIQUID READY TO USE REAGENT B
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: ALP

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

Wavelenght: Pri. 410 Sec. 480 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 First H 1.2
Measuring point 1: First 20 Last 24
Measuring point 2: First Last

Linearity: 20% Dynamic range:

No Lag Time: NO L 7 H 3000

Correlation factor:
A 1 B0

On-board stability period: 30

Unit: U/L

Factor: 2757

IUS.422.0.2 Directions for use Edition 2010-08-01 page 7 of 41

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 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 6 ml Dilution 0 ml Pre-dilution Rate: 1

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

Wavelenght: Pri. 410 Sec. 480 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 First H 0.3
Measuring point 1: First 5 Last 10
Measuring point 2: First Last

Linearity: 20% Dynamic range:

No Lag Time: NO L 10 H 3000

Correlation factor:
A 1 B0

On-board stability period: 30

Unit: U/L

Factor: 3178

IUS.422.0.2 Directions for use Edition 2010-08-01 page 8 of 41

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 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 A
R2 - INSTALL LIQUID READY TO USE REAGENT B
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: AMY

Sample: Volume 8 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 192 ml Dilution 0 ml
R2 volume 48 ml Dilution 0 ml

Wavelenght: Pri. 410 Sec. 480 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 First H 0.3
Measuring point 1: First 20 Last 27
Measuring point 2: First Last

Linearity: 20% Dynamic range:

No Lag Time: NO L 6 H 1500

Correlation factor:
A 1 B0

On-board stability period: 30

Unit: U/L

Factor: 3480

IUS.422.0.2 Directions for use Edition 2010-08-01 page 9 of 41

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 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 A
R2 - INSTALL LIQUID READY TO USE REAGENT B
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

Wavelenght: Pri. 410 Sec. 480 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 First H 0.3
Measuring point 1: First 20 Last 27
Measuring point 2: First Last

Linearity: 20% Dynamic range:

No Lag Time: NO L 2 H 2500

Correlation factor:
A 1 B0

On-board stability period: 30

Unit: U/L

Factor: 3480

IUS.422.0.2 Directions for use Edition 2010-08-01 page 10

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 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 2.5 ml Dilution 0 ml Pre-dilution Rate: 1

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

Wavelenght: Pri. 410 Sec. 480 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 First H 2.5
Measuring point 1: First 1 Last 9
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 1 H 50

Correlation factor:
A 1 B0

On-board stability period: 30

Unit: mmol/L

IUS.422.0.2 Directions for use Edition 2010-08-01 page 11

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 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 A
R2 - INSTALL LIQUID READY TO USE REAGENT B
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

Wavelenght: Pri. 520 Sec. 800 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 First H 0.5
Measuring point 1: First Last 27
Measuring point 2: First Last 10

Linearity: Dynamic range:

No Lag Time: L 0.05 H 20

Correlation factor:
A 1 B0

On-board stability period: 60

Unit: mg/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 12

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 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 A
R2 - INSTALL LIQUID READY TO USE REAGENT B
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

Wavelenght: Pri. 540 Sec. 660 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 First H 0.5
Measuring point 1: First Last 27
Measuring point 2: First Last 10

Linearity: Dynamic range:

No Lag Time: L 0.05 H 20

Correlation factor:
A 1 B0

On-board stability period: 60

Unit: mg/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 13

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 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 B
R2 - INSTALL LIQUID READY TO USE REAGENT A
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 145 ml Dilution 0 ml
R2 volume 145 ml Dilution 0 ml

Wavelenght: Pri. 570 Sec. 660 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 First H 1.2
Measuring point 1: First Last 27
Measuring point 2: First Last 10

Linearity: Dynamic range:

No Lag Time: L 0.1 H 20

Correlation factor:
A 1 B0

On-board stability period: 30

Unit: mg/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 14

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 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 295 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelenght: 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 First H 2.0
Measuring point 1: First Last 10
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 0.2 H 20

Correlation factor:
A 1 B0

On-board stability period: 90

Unit: mg/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 15

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 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 295 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelenght: 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 First H 0.5
Measuring point 1: First Last 27
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 1 H 700

Correlation factor:
A 1 B0

On-board stability period: 60

Unit: mg/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 16

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 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 A
R2 - INSTALL LIQUID READY TO USE REAGENT B
Storage: REFRIGERATE AT 2-8°C
Stability: 60 DAYS OPEN BOTTLES

TEST NAME: HDLC

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

Reagents: R1 volume 180 ml Dilution 0 ml
R2 volume 60 ml Dilution 0 ml

Wavelenght: 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 First H 0.3
Measuring point 1: First 0 Last 27
Measuring point 2: First 0 Last 10

Linearity: Dynamic range:

No Lag Time: L 1 H 220

Correlation factor:
A 1 B0

On-board stability period: 60

Unit: mg/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 17

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 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 A
R2 - INSTALL LIQUID READY TO USE REAGENT B
Storage: REFRIGERATE AT 2-8°C
Stability: 60 DAYS OPEN BOTTLES

TEST NAME: LDLC

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

Reagents: R1 volume 180 ml Dilution 0 ml
R2 volume 60 ml Dilution 0 ml

Wavelenght: 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 First H 0.3
Measuring point 1: First 0 Last 27
Measuring point 2: First 0 Last 10

Linearity: Dynamic range:

No Lag Time: L 1 H 400

Correlation factor:
A 1 B0

On-board stability period: 60

Unit: mg/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 18

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

Analyzer: Olympus AU 400 - 600 - 640

Application: CHOLINESTERASE FL (DGKC) - Codes CH F080 / F245 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A
R2 - INSTALL LIQUID READY TO USE REAGENT B
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: CHE

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

Reagents: R1 volume 200 ml Dilution 0 ml
R2 volume 40 ml Dilution 0 ml

Wavelenght: Pri. 410 Sec. 480 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 First H 2.2
Measuring point 1: First 16 Last 20
Measuring point 2: First Last

Linearity: 20% Dynamic range:

No Lag Time: NO L 0.4 H 25*

Correlation factor:
A 1 B0

On-board stability period: 30

Unit: U/L

Factor: 66*

* NOTE: results in kU/L

IUS.422.0.2 Directions for use Edition 2010-08-01 page 19

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 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 A
R2 - INSTALL LIQUID READY TO USE REAGENT B
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

Wavelenght: Pri. 340 Sec. 660 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 First H 0.5
Measuring point 1: First 21 Last 27
Measuring point 2: First Last

Linearity: 20% Dynamic range:

No Lag Time: NO L 1 H 1000

Correlation factor:
A 1 B0

On-board stability period: 30

Unit: U/L

Factor: 4127

IUS.422.0.2 Directions for use Edition 2010-08-01 page 20

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 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 A
R2 - INSTALL LIQUID READY TO USE REAGENT B
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

Wavelenght: Pri. 340 Sec. 660 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 First H 0.5
Measuring point 1: First 21 Last 27
Measuring point 2: First Last

Linearity: 20% Dynamic range:

No Lag Time: NO L 2 H 1000

Correlation factor:
A 1 B0

On-board stability period: 30

Unit: U/L

Factor: 8254

IUS.422.0.2 Directions for use Edition 2010-08-01 page 21

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 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 A + REAGENT B 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 295 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelenght: 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 First H 0.5
Measuring point 1: First Last 27
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 4 H 500

Correlation factor:
A 1 B0

On-board stability period: 10

Unit: microg/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 22

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 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 B
R2 - INSTALL LIQUID READY TO USE REAGENT A
Storage: ROOM TEMPERATURE OR REFRIGERATE (2-30°C)
Stability: AS INDICATED IN THE LABEL

TEST NAME: CREA

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

Reagents: R1 volume 145 ml Dilution 0 ml
R2 volume 145 ml Dilution 0 ml

Wavelenght: Pri. 520 Sec. 800 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 First H 0.5
Measuring point 1: First 20 Last 24
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 0.2 H 20

Correlation factor:
A 1 B0

On-board stability period: 14

Unit: mg/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 23

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 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 A
R2 - INSTALL LIQUID READY TO USE REAGENT B
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

Wavelenght: Pri. 410 Sec. 480 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 First H 1.5
Measuring point 1: First 14 Last 23
Measuring point 2: First Last

Linearity: 20% Dynamic range:

No Lag Time: NO L 2 H 800

Correlation factor:
A 1 B0

On-board stability period: 60

Unit: U/L

Factor: 1571

IUS.422.0.2 Directions for use Edition 2010-08-01 page 24

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 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 295 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelenght: 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 First H 0.5
Measuring point 1: First Last 27
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 1 H 500

Correlation factor:
A 1 B0

On-board stability period: 60

Unit: mg/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 25

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 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 A
R2 - INSTALL LIQUID READY TO USE REAGENT B
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: GLUC

Sample: Volume 2.5 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. 380 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 First H 0.5
Measuring point 1: First Last 27
Measuring point 2: First Last 10

Linearity: Dynamic range:

No Lag Time: L 1 H 700

Correlation factor:
A 1 B0

On-board stability period: 60

Unit: mg/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 26

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 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 A
R2 - INSTALL LIQUID READY TO USE REAGENT B
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

Wavelenght: Pri. 340 Sec. 660 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 First H 2.5
Measuring point 1: First 14 Last 27
Measuring point 2: First Last

Linearity: 20% Dynamic range:

No Lag Time: YES L 2 H 440

Correlation factor:
A 1 B0

On-board stability period: 60

Unit: U/L

Factor: 1746

IUS.422.0.2 Directions for use Edition 2010-08-01 page 27

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 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 A
R2 - INSTALL LIQUID READY TO USE REAGENT B
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

Wavelenght: Pri. 340 Sec. 660 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 First H 2.5
Measuring point 1: First 14 Last 27
Measuring point 2: First Last

Linearity: 20% Dynamic range:

No Lag Time: YES L 2 H 440

Correlation factor:
A 1 B0

On-board stability period: 60

Unit: U/L

Factor: 1746

IUS.422.0.2 Directions for use Edition 2010-08-01 page 28

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 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 A AFTER PREPARATION
R2 - INSTALL LIQUID READY TO USE REAGENT B
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: FE

Sample: Volume 50 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. 570 Sec. 800 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 First H 0.3
Measuring point 1: First 0 Last 12
Measuring point 2: First 0 Last 10

Linearity: Dynamic range:

No Lag Time: L 25 H 1000

Correlation factor:
A 1 B0

On-board stability period: 30

Unit: microg/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 29

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 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 A
R2 - INSTALL LIQUID READY TO USE REAGENT B
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: LDH

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

Wavelenght: Pri. 340 Sec. 380 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 First H 2.5
Measuring point 1: First 12 Last 27
Measuring point 2: First Last

Linearity: 20% Dynamic range:

No Lag Time: YES L 30 H 2000

Correlation factor:
A 1 B0

On-board stability period: 30

Unit: U/L

Factor: 8015

IUS.422.0.2 Directions for use Edition 2010-08-01 page 30

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

Analyzer: Olympus AU 400 - 600 - 640

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

TEST NAME: ALP

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

Wavelenght: Pri. 570 Sec. 800 Min OD Max OD

Method: RATE L -0.1 H 2.5

Reaction slope: + Reagent OD limit:

First L -0.1 First H 0.8
Last L -0.1 First H 0.8
Measuring point 1: First 13 Last 19
Measuring point 2: First Last

Linearity: 20% Dynamic range:

No Lag Time: NO L 3 H 300

Correlation factor:
A 1 B0

On-board stability period: 60

Unit: U/L

IUS.422.0.2 Directions for use Edition 2010-08-01 page 31

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 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 B
R2 - INSTALL LIQUID READY TO USE REAGENT A
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 145 ml Dilution 0 ml
R2 volume 145 ml Dilution 0 ml

Wavelenght: Pri. 520 Sec. 800 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 First H 2.0
Measuring point 1: First Last 27
Measuring point 2: First Last 10

Linearity: Dynamic range:

No Lag Time: L 0.1 H8

Correlation factor:
A 1 B0

On-board stability period: 14

Unit: mEq/l

IUS.422.0.2 Directions for use Edition 2010-08-01 page 32

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 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 295 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelenght: Pri. 520 Sec. 800 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 First H 2.0
Measuring point 1: First Last 27
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 0.3 H6

Correlation factor:
A 1 B0

On-board stability period: 14

Unit: mEq/l

IUS.422.0.2 Directions for use Edition 2010-08-01 page 33

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 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 295 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelenght: Pri. 340 Sec. 380 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 First H 0.5
Measuring point 1: First Last 27
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 0.4 H 20

Correlation factor:
A 1 B0

On-board stability period: 90

Unit: mg/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 34

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 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 295 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelenght: Pri. 600 Sec. 800 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 First H 0.5
Measuring point 1: First Last 27
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 0.3 H 500

Correlation factor:
A 1 B0

On-board stability period: 90

Unit: mg/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 35

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 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 295 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelenght: 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 First H 0.5
Measuring point 1: First Last 27
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 0.1 H 12

Correlation factor:
A 1 B0

On-board stability period: 30

Unit: g/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 36

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 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 295 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelenght: 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 First H 0.5
Measuring point 1: First Last 27
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 1 H 1000

Correlation factor:
A 1 B0

On-board stability period: 60

Unit: mg/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 37

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 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 A
R2 - INSTALL LIQUID READY TO USE REAGENT B
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 200 ml Dilution 0 ml
R2 volume 50 ml Dilution 0 ml

Wavelenght: Pri. 340 Sec. 660 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 First H 2.5
Measuring point 1: First 12 Last 18
Measuring point 2: First Last

Linearity: 25% Dynamic range:

No Lag Time: YES L 1 H 300

Correlation factor:
A 1 B0

On-board stability period: 60

Unit: mg/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 38

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 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 A + REAGENT B AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 90 DAYS

TEST NAME: UA

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

Reagents: R1 volume 295 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelenght: 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 First H 0.5
Measuring point 1: First Last 27
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 0.2 H 25

Correlation factor:
A 1 B0

On-board stability period: 90

Unit: mg/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 39

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 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 A
R2 - INSTALL LIQUID READY TO USE REAGENT B
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

TEST NAME: UA

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

Wavelenght: 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 First H 0.5
Measuring point 1: First Last 27
Measuring point 2: First Last 10

Linearity: Dynamic range:

No Lag Time: L 0.1 H 35

Correlation factor:
A 1 B0

On-board stability period: 90

Unit: mg/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 40

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 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 A + REAGENT B AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 2 WEEKS

TEST NAME: ZN

Sample: Volume 15 ml Dilution 0 ml Pre-dilution Rate: 1

Reagents: R1 volume 295 ml Dilution 0 ml
R2 volume 0 ml Dilution 0 ml

Wavelenght: Pri. 570 Sec. 800 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 First H 0.8
Measuring point 1: First Last 27
Measuring point 2: First Last

Linearity: Dynamic range:

No Lag Time: L 5 H 1000

Correlation factor:
A 1 B0

On-board stability period: 10

Unit: microg/dl

IUS.422.0.2 Directions for use Edition 2010-08-01 page 41

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