Thermo Konelab 20-30-60 instructions

rev 418.1.4 - 2015-12-01

Chema Diagnostica
Via Campania 2/4
I-60030 Monsano | An Italy
T +39 0731 605064 | F +39 0731 605672
www.chema.com | mail@chema.com
 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Thermo Konelab 20-30-60 instructions

rev 418.1.4 - 2015-12-01

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.418.1.4 Directions for use Edition 2015-12-01 page 3 of 43

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: ALBUMIN - Code BC 0100 / 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 definition ALB test in use YES

test type Photometric Low High Units

Full name Albumin Test limit 0,01 g/dl
Online name
Result unit g/dl Initial absorb. 0,0 2,0 A

N. of decimals 1 Dilution limit * 6 g/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 15
Point/std 2 Rel. error % 3
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1

test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation
Reagent Volume (µl) Time (sec) λ1 (nm)
ALB BLANK 2 150 620

Volume (µl) λ2 (nm)
290 700

Disp. with. Disp. with λ2 weight

WATER WATER 1,0

Volume (µl) Volume (µl) Res. Net. Abs.

10 10 0

Diluent Meas. type

WATER Fixed timing

IUS.418.1.4 Directions for use Edition 2015-12-01 page 4 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: ALKALINE PHOSPHATASE DGKC FL - Codes AL F080 / F245 / F400 / F600 CH
Preparation: WORKING REAGENT PREPARATION AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 30 DAYS AT 2-8°C

Test definition ALP test in use YES

test type Photometric Low High Units

Full name ALK. Phosph. Test limit 7 U/L
Online name
Result unit U/L Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 3000 U/L

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters

calibration type NONE Factor 2757 bias 0

Bias corr. in use NO

test flow
Additional blank NONE
Antigen excess NO
Incubation Incubation
Reagent time (sec) Volume (µl) Time (sec) λ1 (nm) Curve type
ALP 180 4 120 405 LINEARCUT

Volume (µl) λ2 (nm) Nonlinearity
185 700

Disp. with. Disp. with resp.(mA/min)

EXTRA EXTRA 10

Volume (µl) Volume (µl) Time (sec)

15 10 120

Diluent Points&Inter.
WATER 7/18 sec

IUS.418.1.4 Directions for use Edition 2015-12-01 page 5 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: ALKALINE PHOSPHATASE IFCC FL - Codes AF F080 / F245 / F400 / F600 CH
Preparation: WORKING REAGENT PREPARATION AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 30 DAYS AT 2-8°C

Test definition ALP test in use YES

test type Photometric Low High Units

Full name ALK. Phosph. Test limit 0 U/L
Online name
Result unit U/L Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 3000 U/L

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters

calibration type NONE Factor 2757 bias 0

Bias corr. in use NO

test flow
Additional blank NONE
Antigen excess NO
Incubation Incubation
Reagent time (sec) Volume (µl) Time (sec) λ1 (nm) Curve type
ALP 180 4 120 405 LINEARCUT

Volume (µl) λ2 (nm) Nonlinearity
185 NONE

Disp. with. Disp. with resp.(mA/min)

EXTRA EXTRA 10

Volume (µl) Volume (µl) Time (sec)

15 10 120

Diluent Points&Inter.
WATER 7/18 sec

IUS.418.1.4 Directions for use Edition 2015-12-01 page 6 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

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

Test definition AMY test in use YES

test type Photometric Low High Units

Full name Amylase Test limit 0 U/L
Online name
Result unit U/L Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 3000 U/L

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters

calibration type NONE Factor 3178 bias 0

Bias corr. in use NO

test flow
Additional blank NONE
Antigen excess NO
Incubation Incubation
Reagent time (sec) Volume (µl) Time (sec) λ1 (nm) Curve type
AMY 180 5 120 405 LINEARCUT

Volume (µl) λ2 (nm) Nonlinearity
185 NONE

Disp. with. Disp. with resp.(mA/min)
EXTRA EXTRA 20

Volume (µl) Volume (µl) Time (sec)

15 10 120

Diluent Points&Inter.
WATER 7/18 sec

IUS.418.1.4 Directions for use Edition 2015-12-01 page 7 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: AMYLASE EPS FL - Codes EA F080 / F245 CH
Preparation: WORKING REAGENT PREPARATION AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 30 DAYS AT 2-8°C

Test definition AMY test in use YES

test type Photometric Low High Units

Full name Amylase Test limit 0 U/L
Online name
Result unit U/L Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 1500 U/L

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters

calibration type NONE Factor 3480 bias 0

Bias corr. in use NO

test flow
Additional blank NONE
Antigen excess NO
Incubation Incubation
Reagent time (sec) Volume (µl) Time (sec) λ1 (nm) Curve type
AMY 180 7 180 405 LINEARCUT

Volume (µl) λ2 (nm) Nonlinearity
200 NONE

Disp. with. Disp. with resp.(mA/min)
EXTRA EXTRA 20

Volume (µl) Volume (µl) Time (sec)

15 10 120

Diluent Points&Inter.
WATER 7/18 sec

IUS.418.1.4 Directions for use Edition 2015-12-01 page 8 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

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 definition AMYP test in use YES

test type Photometric Low High Units

Full name Pancreatic Amylase Test limit 0 U/L
Online name
Result unit U/L Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 2500 U/L

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters

calibration type NONE Factor 6280 bias 0

Bias corr. in use NO

test flow
Additional blank NONE
Antigen excess NO
Incubation Incubation Incubation
Reagent time (sec) Volume (µl) Time (sec) Reagent Time (sec) λ1 (nm) Curve type
P-AMY-1 180 4 180 P-AMY-2 120 405 LINEARCUT

Volume (µl) Volume (µl) λ2 (nm) Nonlinearity
160 40 NONE

Disp. with. Disp. with Disp. with resp.(mA/min)

EXTRA EXTRA EXTRA 20

Volume (µl) Volume (µl) Volume (µl) Time (sec)

10 10 10 180

Diluent Points&Inter.
WATER 7/18 sec

IUS.418.1.4 Directions for use Edition 2015-12-01 page 9 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: BICARBONATE FL - Codes 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 definition CO2 test in use YES

test type Photometric Low High Units

Full name BICARBONATE Test limit 0 mmol/l
Online name
Result unit mmol/l Initial absorb. 0,5 2,5 A

N. of decimals 1 Dilution limit * 50 mmol/l

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 15
Point/std 2 Rel. error % 0
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1

test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation
Reagent Volume (µl) Time (sec) λ1 (nm)
CO2 BLANK 2 120 405

Volume (µl) λ2 (nm)
200 700

Disp. with. Disp. with λ2 weight

WATER WATER 1,0

Volume (µl) Volume (µl) Res. Net. Abs.

10 10 0

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 10 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: BILIRUBIN TOTAL FL - Code DT F125 / F500 CH
Preparation: R1 - USE 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 definition T BIL test in use YES

test type Photometric Low High Units

Full name Total Bilirubin Test limit 0 mg/dl
Online name
Result unit mg/dl Initial absorb. 0,0 2,0 A

N. of decimals 1 Dilution limit * 20 mg/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 1 Abs. error (mA) 12
Point/std 2 Rel. error % 3
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1
test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation Incubation
Reagent Volume (µl) Time (sec) Reagent Time (sec) λ1 (nm)
T-BIL-1 10 180 BLANK T-BIL-2 300 510

Volume (µl) Volume (µl) λ2 (nm)
200 50 NONE

Disp. with. Disp. with Disp. with

WATER EXTRA WATER

Volume (µl) Volume (µl) Volume (µl)

10 10 10

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 11 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: BILIRUBIN DIRECT FL - Code DD F125 / F500 CH
Preparation: R1 - USE 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 definition D BIL test in use YES

test type Photometric Low High Units

Full name Direct Bilirubin Test limit 0 mg/dl
Online name
Result unit mg/dl Initial absorb. 0,0 2,0 A

N. of decimals 1 Dilution limit * 13 mg/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 1 Abs. error (mA) 12
Point/std 2 Rel. error % 3
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1
test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation Incubation
Reagent Volume (µl) Time (sec) Reagent Time (sec) λ1 (nm)
D-BIL-1 10 120 BLANK D-BIL-2 60 540

Volume (µl) Volume (µl) λ2 (nm)
200 50 NONE

Disp. with. Disp. with Disp. with

WATER EXTRA WATER

Volume (µl) Volume (µl) Volume (µl)

10 10 10

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 12 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: CALCIUM - Code CA 0305 / 0505 CH
Preparation: WORKING REAGENT PREPARATION AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 14 DAYS AT 2-8°C

Test definition CA test in use YES

test type Photometric Low High Units

Full name Calcium Test limit 0 mg/dl
Online name
Result unit mg/dl Initial absorb. 0,0 2,0 A

N. of decimals 2 Dilution limit * 20 mg/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 15
Point/std 2 Rel. error % 0
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1
test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation Incubation
Reagent Time (sec) Volume (µl) Time (sec) λ1 (nm)
CA 120 BLANK 4 120 575

Volume (µl) λ2 (nm)
225 700

Disp. with. Disp. with λ2 weight

WATER WATER 1,0

Volume (µl) Volume (µl) Res. Net. Abs.

15 15 0

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 13 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

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 definition CA test in use YES

test type Photometric Low High Units

Full name Calcium Test limit 0 mg/dl
Online name
Result unit mg/dl Initial absorb. 0,0 2,0 A

N. of decimals 2 Dilution limit * 20 mg/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 15
Point/std 2 Rel. error % 0
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1
test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation Incubation
Reagent Time (sec) Volume (µl) Time (sec) λ1 (nm)
CA 120 BLANK 2 120 660

Volume (µl) λ2 (nm)
185 700

Disp. with. Disp. with λ2 weight

WATER WATER 1,0

Volume (µl) Volume (µl) Res. Net. Abs.

15 15 0

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 14 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: CHLORIDE - Code CL 0100 / 0500 CH
Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT
Storage: ROOM TEMPERATURE (15-30°C)
Stability: AS INDICATED IN THE LABEL

Test definition CHLOR test in use YES

test type Photometric Low High Units

Full name Chloride Test limit 0 mEq/l
Online name
Result unit mEq/l Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 200 mEq/l

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 15
Point/std 2 Rel. error % 5
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1

test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation
Reagent Volume (µl) Time (sec) λ1 (nm)
CHLOR BLANK 2 600 460

Volume (µl) λ2 (nm)
350 700

Disp. with. Disp. with λ2 weight

WATER WATER 1,0

Volume (µl) Volume (µl) Res. Net. Abs.

10 10 0

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 15 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

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 definition CHOL test in use YES

test type Photometric Low High Units

Full name Cholesterol Test limit 0 mg/dl
Online name
Result unit mg/dl Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 700 mg/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 10
Point/std 2 Rel. error % 5
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1

test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation
Reagent Volume (µl) Time (sec) λ1 (nm)
CHOL BLANK 2 300 510

Volume (µl) λ2 (nm)
200 700

Disp. with. Disp. with λ2 weight
WATER WATER 1,0

Volume (µl) Volume (µl) Res. Net. Abs.

20 20 0

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 16 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

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
CALIBRATOR - RECONSTITUTE AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 60 DAYS OPEN BOTTLES - CALIBRATOR: AS INDICATED IN INSERT SHEET

Test definition HDL-C test in use YES

test type Photometric Low High Units

Full name HDL direct Test limit 0 mg/dl
Online name
Result unit mg/dl Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 220 mg/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 12
Point/std 2 Rel. error % 3
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
HDL CAL
test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation Incubation
Reagent Volume (µl) Time (sec) Reagent Time (sec) λ1 (nm)
HDL-C-1 3 300 BLANK HDL-C-2 300 600

Volume (µl) Volume (µl) λ2 (nm)
270 90 700

Disp. with. Disp. with Disp. with λ2 weight

WATER EXTRA WATER 1,0

Volume (µl) Volume (µl) Volume (µl) Res. Net. Abs.

10 10 20 0

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 17 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

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
CALIBRATOR - RECONSTITUTE AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 60 DAYS OPEN BOTTLES - CALIBRATOR: AS INDICATED IN INSERT SHEET

Test definition LDL-C test in use YES

test type Photometric Low High Units

Full name LDL direct Test limit 0 mg/dl
Online name
Result unit mg/dl Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 400 mg/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 12
Point/std 2 Rel. error % 3
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
LDL CAL
test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation Incubation
Reagent Volume (µl) Time (sec) Reagent Time (sec) λ1 (nm)
LDL-C-1 3 300 BLANK LDL-C-2 300 600

Volume (µl) Volume (µl) λ2 (nm)
270 90 700

Disp. with. Disp. with Disp. with λ2 weight

WATER EXTRA WATER 1,0

Volume (µl) Volume (µl) Volume (µl) Res. Net. Abs.

10 10 10 0

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 18 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: CHOLINESTERASE FL (DGKC) - Codes CH F096 / F245 CH
Preparation: WORKING REAGENT PREPARATION AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 30 DAYS AT 2-8°C

Test definition CHE test in use YES

test type Photometric Low High Units

Full name Cholinesterase Test limit 0 U/L
Online name
Result unit U/L Initial absorb. 0,8 2,0 A

N. of decimals 0 Dilution limit * 25000 U/L

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters

calibration type NONE Factor 65800 bias 0

Bias corr. in use NO

test flow
Additional blank NONE
Antigen excess NO
Incubation Incubation
Reagent time (sec) Volume (µl) Time (sec) λ1 (nm) Curve type
CHE 180 4 90 405 LINEARCUT

Volume (µl) λ2 (nm) Nonlinearity
230 NONE

Disp. with. Disp. with resp.(mA/min)

EXTRA EXTRA 20

Volume (µl) Volume (µl) Time (sec)

10 10 90

Diluent Points&Inter.
WATER 7/18 sec

IUS.418.1.4 Directions for use Edition 2015-12-01 page 19 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: CK-NAC FL - Codes CK F060 / F120 / F245 CH
Preparation: WORKING REAGENT PREPARATION AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 30 DAYS AT 2-8°C

Test definition CK test in use YES

test type Photometric Low High Units

Full name Creatine kinase Test limit 0 U/L
Online name
Result unit U/L Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 2000 U/L

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters

calibration type NONE Factor 4127 bias 0

Bias corr. in use NO

test flow
Additional blank NONE
Antigen excess NO
Incubation Incubation
Reagent time (sec) Volume (µl) Time (sec) λ1 (nm) Curve type
CK 180 8 120 340 LINEARCUT

Volume (µl) λ2 (nm) Nonlinearity
190 NONE

Disp. with. Disp. with resp.(mA/min)
EXTRA EXTRA 20

Volume (µl) Volume (µl) Time (sec)

10 10 120

Diluent Points&Inter.
WATER 7/18 sec

IUS.418.1.4 Directions for use Edition 2015-12-01 page 20 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: CK-MB FL - Code MB F060 / F120 CH
Preparation: WORKING REAGENT PREPARATION AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 10 DAYS AT 2-8°C

Test definition CK-MB test in use YES

test type Photometric Low High Units

Full name CK-MB Test limit 0 U/L

Result unit U/L Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 2000 U/L

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters

calibration type NONE Factor 8254 bias 0

Bias corr. in use NO

test flow
Additional blank NONE
Antigen excess NO
Incubation Incubation
Reagent time (sec) Volume (µl) Time (sec) λ1 (nm) Curve type
MB 120 8 300 340 LINEARCUT

Volume (µl) λ2 (nm) Nonlinearity
190 NONE 10

Disp. with. Disp. with resp.(mA/min)

EXTRA EXTRA 20

Volume (µl) Volume (µl) Time (sec)

10 10 240

Diluent Points&Inter.
WATER 9/27 sec

IUS.418.1.4 Directions for use Edition 2015-12-01 page 21 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: COPPER - Code CU 0100 CH
Preparation: R1 - MIX REAGENT A + REAGENT B AS INDICATED IN INSERT SHEET
Storage: DO NOT REFRIGERATE ! REAGENT COULD CONDENSATE!
Stability: 2 WEEKS

Test definition CU test in use YES

test type Photometric Low High Units

Full name Copper Test limit 0 µg/dl
Online name
Result unit µg/dl Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 500 µg/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 10
Point/std 2 Rel. error % 5
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CHEM CAL

test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation
Reagent Volume (µl) Time (sec) λ1 (nm)
CU BLANK 20 300 575

Volume (µl) λ2 (nm)
300 700

Disp. with. Disp. with λ2 weight

WATER WATER 1,0

Volume (µl) Volume (µl) Res. Net. Abs.

10 10 0

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 22 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: CREATININE - Code CR 0500 / 1000 CH
Preparation: WORKING REAGENT PREPARATION AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 10 DAYS AT 2-8°C

Test definition CREA test in use YES

test type Photometric Low High Units

Full name Creatinine Test limit 0 mg/dl
Online name
Result unit mg/dl Initial absorb. 0,0 2,0 A

N. of decimals 1 Dilution limit * 20 mg/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 5
Point/std 2 Rel. error % 5
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1
test flow
Additional blank NONE
Antigen excess NO
Incubation Incubation
Reagent time (sec) Volume (µl) Time (sec) λ1 (nm) Curve type
CREA 180 20 60 510 NONLINEAR

Volume (µl) λ2 (nm) Nonlinearity
190 NONE

Disp. with. Disp. with resp.(mA/min)
EXTRA EXTRA 20

Volume (µl) Volume (µl) Time (sec)

10 10 60

Diluent Points&Inter.
WATER 12/4.5 sec

IUS.418.1.4 Directions for use Edition 2015-12-01 page 23 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: CREATININE-E FL- Code CE F125 / F375 / 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 LABE

Test definition CREAE test in use YES

test type Photometric Low High Units

Full name Creatinine Test limit 0 mg/dl
Online name
Result unit mg/dl Initial absorb. 0,0 2,0 A

N. of decimals 1 Dilution limit * 50 mg/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 12
Point/std 2 Rel. error % 3
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL
test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation Incubation
Reagent Volume (µl) Time (sec) Reagent Time (sec) λ1 (nm)
CREAE-1 4 300 BLANK CREAE-2 300 540

Volume (µl) Volume (µl) λ2 (nm)
200 50 700

Disp. with. Disp. with Disp. with λ2 weight
WATER EXTRA WATER 1,0

Volume (µl) Volume (µl) Volume (µl) Res. Net. Abs.

20 10 20 0

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 24 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: CRP FL - Code RP 0090 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 definition CRP test in use YES

test type Photometric Low High Units

Full name C-Reactive Protein Test limit 0 mg/l
Online name
Result unit mg/l Initial absorb. 0,0 2,0 A

N. of decimals 2 Dilution limit * 2600 mg/l

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma
calibration parameters
calibration type NON LINEAR Bias corr. in use NO
Repeat time (d) 14 Abs. error (mA) 12
Point/std 6 Rel. error % 3
Acceptance AUTOMATIC
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1
CAL 2
CAL 3
CAL 4
CAL 5
test flow
Additional blank YES
Antigen excess NO
Incubation Incubation
Reagent Volume (µl) Time (sec) Reagent Time (sec) λ1 (nm)
CRP-1 11 300 BLANK CRP-2 300 340

Volume (µl) Volume (µl) λ2 (nm)
200 25 NONE

Disp. with. Disp. with Disp. with

WATER WATER WATER

Volume (µl) Volume (µl) Volume (µl)

10 10 10

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 25 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: GAMMA-GT FL - Codes GT F080 / F245 / F400 / F600 CH
Preparation: WORKING REAGENT PREPARATION AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 30 DAYS AT 2-8°C

Test definition GGT test in use YES

test type Photometric Low High Units

Full name Gamma GT Test limit 0 U/L
Online name
Result unit U/L Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 800 U/L

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters

calibration type NONE Factor 1200 bias 0

Bias corr. in use NO

test flow
Additional blank NONE
Antigen excess NO
Incubation Incubation
Reagent time (sec) Volume (µl) Time (sec) λ1 (nm) Curve type
GGT 180 20 120 405 LINEARCUT

Volume (µl) λ2 (nm) Nonlinearity
180 NONE

Disp. with. Disp. with resp.(mA/min)
EXTRA EXTRA 20

Volume (µl) Volume (µl) Time (sec)

20 10 120

Diluent Points&Inter.
WATER 7/18 sec

IUS.418.1.4 Directions for use Edition 2015-12-01 page 26 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

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 definition GLUC test in use YES

test type Photometric Low High Units

Full name GLUC GOD-POD Test limit 0 mg/dl
Online name
Result unit mg/dl Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 500 mg/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 15
Point/std 2 Rel. error % 0
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1

test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation
Reagent Volume (µl) Time (sec) λ1 (nm)
GLUC BLANK 2 600 510

Volume (µl) λ2 (nm)
200 700

Disp. with. Disp. with λ2 weight

WATER WATER 1,0

Volume (µl) Volume (µl) Res. Net. Abs.

20 20 0

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 27 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: GLUCOSE UV FL - Code GL F601 CH
Preparation: WORKING REAGENT PREPARATION AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 30 DAYS AT 2-8°C

Test definition GLU-HK test in use YES

test type Photometric Low High Units

Full name GLUC HK Test limit 0 mg/dl
Online name
Result unit mg/dl Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 700 mg/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 10
Point/std 2 Rel. error % 5
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1

test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation
Reagent Volume (µl) Time (sec) λ1 (nm)
GLU-HK BLANK 2 300 340

Volume (µl) λ2 (nm)
200 700

Disp. with. Disp. with λ2 weight
WATER WATER 1,0

Volume (µl) Volume (µl) Res. Net. Abs.

20 20 0

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 28 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: GOT/AST FL - Codes GO F080 / F245 / F400 / F600 CH
Preparation: WORKING REAGENT PREPARATION AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 30 DAYS AT 2-8°C

Test definition GOT test in use YES

test type Photometric Low High Units

Full name GOT - AST Test limit 0 U/L
Online name
Result unit U/L Initial absorb. 0,8 2,0 A

N. of decimals 0 Dilution limit * 440 U/L

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters

calibration type NONE Factor -1746 bias 0

Bias corr. in use NO

test flow
Additional blank NONE
Antigen excess NO
Incubation Incubation
Reagent time (sec) Volume (µl) Time (sec) λ1 (nm) Curve type
GOT 180 20 120 340 LINEARCUT

Volume (µl) λ2 (nm) Nonlinearity
190 NONE

Disp. with. Disp. with resp.(mA/min)

EXTRA EXTRA 20

Volume (µl) Volume (µl) Time (sec)

20 10 180

Diluent Points&Inter.
WATER 9/27 sec

IUS.418.1.4 Directions for use Edition 2015-12-01 page 29 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: GPT/ALT FL - Codes GP F080 / F245 / F400 / F600 CH
Preparation: WORKING REAGENT PREPARATION AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 30 DAYS AT 2-8°C

Test definition GPT test in use YES

test type Photometric Low High Units

Full name GPT - ALT Test limit 0 U/L
Online name
Result unit U/L Initial absorb. 0,8 2,0 A

N. of decimals 0 Dilution limit * 440 U/L

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters

calibration type NONE Factor -1746 bias 0

Bias corr. in use NO

test flow
Additional blank NONE
Antigen excess NO
Incubation Incubation
Reagent time (sec) Volume (µl) Time (sec) λ1 (nm) Curve type
GPT 180 200 120 340 LINEARCUT

Volume (µl) λ2 (nm) Nonlinearity
190 NONE

Disp. with. Disp. with resp.(mA/min)

EXTRA EXTRA 20

Volume (µl) Volume (µl) Time (sec)

20 10 180

Diluent Points&Inter.
WATER 9/27 sec

IUS.418.1.4 Directions for use Edition 2015-12-01 page 30 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: IgA FL - Code GA 0050 / 0100 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 definition IGA test in use YES

test type Photometric Low High Units

Full name IgA Test limit 0 g/l
Online name
Result unit g/l Initial absorb. 0,0 2,0 A

N. of decimals 2 Dilution limit * 38 g/l

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma
calibration parameters
calibration type NON LINEAR Bias corr. in use NO
Repeat time (d) 14 Abs. error (mA) 12
Point/std 6 Rel. error % 3
Acceptance AUTOMATIC
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1
CAL 2
CAL 3
CAL 4
CAL 5
test flow
Additional blank YES
Antigen excess NO
Incubation Incubation
Reagent Volume (µl) Time (sec) Reagent Time (sec) λ1 (nm)
IGA-1 2 300 BLANK IGA-2 300 600

Volume (µl) Volume (µl) λ2 (nm)
240 60 NONE

Disp. with. Disp. with Disp. with

WATER WATER WATER

Volume (µl) Volume (µl) Volume (µl)

10 10 10

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 31 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: IgG FL - Code GG 0050 / 0100 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 definition IGG test in use YES

test type Photometric Low High Units

Full name IgG Test limit 0 g/l
Online name
Result unit g/l Initial absorb. 0,0 2,0 A

N. of decimals 2 Dilution limit * 180 g/l

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma
calibration parameters
calibration type NON LINEAR Bias corr. in use NO
Repeat time (d) 14 Abs. error (mA) 12
Point/std 6 Rel. error % 3
Acceptance AUTOMATIC
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1
CAL 2
CAL 3
CAL 4
CAL 5
test flow
Additional blank YES
Antigen excess NO
Incubation Incubation
Reagent Volume (µl) Time (sec) Reagent Time (sec) λ1 (nm)
IGG-1 3 300 BLANK IGG-2 300 600

Volume (µl) Volume (µl) λ2 (nm)
240 60 NONE

Disp. with. Disp. with Disp. with

WATER WATER WATER

Volume (µl) Volume (µl) Volume (µl)

10 10 10

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 32 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: IgM FL - Code GM 0050 / 0100 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 definition IGM test in use YES

test type Photometric Low High Units

Full name IgM Test limit 0 g/l
Online name
Result unit g/l Initial absorb. 0,0 2,0 A

N. of decimals 2 Dilution limit * 30 g/l

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma
calibration parameters
calibration type NON LINEAR Bias corr. in use NO
Repeat time (d) 14 Abs. error (mA) 12
Point/std 6 Rel. error % 3
Acceptance AUTOMATIC
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1
CAL 2
CAL 3
CAL 4
CAL 5
test flow
Additional blank YES
Antigen excess NO
Incubation Incubation
Reagent Volume (µl) Time (sec) Reagent Time (sec) λ1 (nm)
IGM-1 3 300 BLANK IGM-2 300 340

Volume (µl) Volume (µl) λ2 (nm)
240 60 NONE

Disp. with. Disp. with Disp. with

WATER WATER WATER

Volume (µl) Volume (µl) Volume (µl)

10 10 10

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 33 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: IRON FZ - Codes FE F245 / F400 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A
R2 - INSTALL REAGENT B (PREPARATION AS PER INSERT SHEET)
Storage: REFRIGERATE AT 2-8°C
Stability: AS INDICATED IN THE LABEL

Test definition IRON-F test in use YES

test type Photometric Low High Units

Full name Iron FZ Test limit 0 µg/dl
Online name
Result unit µg/dl Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 1000 µg/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 12
Point/std 2 Rel. error % 5
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1
test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation Incubation
Reagent Volume (µl) Time (sec) Reagent Time (sec) λ1 (nm)
IRON-F-1 40 240 BLANK IRON-F-2 300 575

Volume (µl) Volume (µl) λ2 (nm)
160 40 NONE

Disp. with. Disp. with Disp. with

WATER EXTRA WATER

Volume (µl) Volume (µl) Volume (µl)

10 10 10

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 34 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: IRON CRX - Code FE 0100 / 0500 CH
Preparation: R1 - LIQUID READY TO USE SINGLE REAGENT
Storage: ROOM TEMPERATURE (15-30°C) - AVOID REFRIGERATION
Stability: AS INDICATED IN THE LABEL

Test definition IRON-C test in use YES

test type Photometric Low High Units

Full name Iron CRX Test limit 0 µg/dl
Online name
Result unit µg/dl Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 500 µg/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 15
Point/std 2 Rel. error % 5
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1

test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation
Reagent Volume (µl) Time (sec) λ1 (nm)
IRON-C BLANK 10 120 620

Volume (µl) λ2 (nm)
250 700

Disp. with. Disp. with λ2 weight

WATER WATER 1,0

Volume (µl) Volume (µl) Res. Net. Abs.

10 10 0

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 35 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: LDH FL - Codes LD F060 / F120 / F245 CH
Preparation: WORKING REAGENT PREPARATION AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 30 DAYS AT 2-8°C

Test definition LDH test in use YES

test type Photometric Low High Units

Full name LDH-P Test limit 0 U/L
Online name
Result unit U/L Initial absorb. 0,8 2,0 A

N. of decimals 0 Dilution limit * 4000 U/L

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters

calibration type NONE Factor -16030 bias 0

Bias corr. in use NO

test flow
Additional blank NONE
Antigen excess NO
Incubation Incubation
Reagent time (sec) Volume (µl) Time (sec) λ1 (nm) Curve type
LDH 180 2 120 340 LINEARCUT

Volume (µl) λ2 (nm) Nonlinearity
190 NONE

Disp. with. Disp. with resp.(mA/min)
EXTRA EXTRA 20

Volume (µl) Volume (µl) Time (sec)

10 10 120

Diluent Points&Inter.
WATER 7/18 sec

IUS.418.1.4 Directions for use Edition 2015-12-01 page 36 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: LIPASE FL- Code LP F060 CH
Preparation: R1 - INSTALL LIQUID READY TO USE REAGENT A
R2 - INSTALL LIQUID READY TO USE REAGENT B
CALIBRATOR - RECONSTITUTE AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 60 DAYS OPEN BOTTLES - CALIBRATOR: AS INDICATED IN INSERT SHEET

Test definition LIP test in use YES

test type Photometric Low High Units

Full name Lipase Test limit 0 U/L
Online name
Result unit U/L Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 300 U/L

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 12
Point/std 2 Rel. error % 5
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
HDL CAL

test flow
Additional blank NONE
Antigen excess NO
Incubation Incubation Incubation
Reagent time (sec) Volume (µl) Time (sec) Reagent Time (sec) λ1 (nm) Curve type
LIP-1 120 4 300 LIP-2 120 575 LINEARCUT

Volume (µl) Volume (µl) λ2 (nm) Nonlinearity
200 50 NONE

Disp. with. Disp. with Disp. with resp.(mA/min)

EXTRA EXTRA EXTRA 20

Volume (µl) Volume (µl) Volume (µl) Time (sec)

10 10 10 180

Diluent Points&Inter.
WATER 7/18 sec

IUS.418.1.4 Directions for use Edition 2015-12-01 page 37 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: MAGNESIUM - Codes MG 0200 / 0500 CH
Preparation: WORKING REAGENT PREPARATION AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 30 DAYS AT 2-8°C

Test definition MG test in use YES

test type Photometric Low High Units

Full name Magnesium Test limit 0 mEq/l
Online name
Result unit mEq/l Initial absorb. 0,0 2,0 A

N. of decimals 1 Dilution limit * mEq/l

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 10
Point/std 2 Rel. error % 5
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1

test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation
Reagent Volume (µl) Time (sec) λ1 (nm)
MG BLANK 2 90 510

Volume (µl) λ2 (nm)
200 700

Disp. with. Disp. with λ2 weight

WATER WATER 1,0

Volume (µl) Volume (µl) Res. Net. Abs.

10 10 0

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 38 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

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 definition MG test in use YES

test type Photometric Low High Units

Full name Magnesium Test limit 0 mEq/l
Online name
Result unit mEq/l Initial absorb. 0,0 2,0 A

N. of decimals 1 Dilution limit * 6 mEq/l

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 10
Point/std 2 Rel. error % 5
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1

test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation
Reagent Volume (µl) Time (sec) λ1 (nm)
MX BLANK 2 90 540

Volume (µl) λ2 (nm)
200 700

Disp. with. Disp. with λ2 weight

WATER WATER 1,0

Volume (µl) Volume (µl) Res. Net. Abs.

10 10 0

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 39 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

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

Test definition PH test in use YES

test type Photometric Low High Units

Full name Phosphorus Test limit 0 mg/dl
Online name
Result unit mg/dl Initial absorb. 0,0 2,0 A

N. of decimals 1 Dilution limit * 20 mg/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 10
Point/std 2 Rel. error % 5
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1

test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation
Reagent Volume (µl) Time (sec) λ1 (nm)
PH BLANK 2 300 340

Volume (µl) λ2 (nm)
200 700

Disp. with. Disp. with λ2 weight

WATER WATER 1,0

Volume (µl) Volume (µl) Res. Net. Abs.

10 10 0

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 40 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

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 definition HSP test in use YES

test type Photometric Low High Units

Full name HS Proteins Test limit 0 mg/dl
Online name
Result unit mg/dl Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 500 mg/dl

Acceptance AUTOMATIC Secondary dil. 0 10

Dilution 1+ 0 Correction factor 1.00

Sample type urine Bias correction 0.00

CSF

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 10
Point/std 2 Rel. error % 5
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1

test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation
Reagent Volume (µl) Time (sec) λ1 (nm)
HSP BLANK 2 300 600

Volume (µl) λ2 (nm)
300 700

Disp. with. Disp. with λ2 weight

WATER WATER 1,0

Volume (µl) Volume (µl) Res. Net. Abs.

8 8 0

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 41 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: TOTAL PROTEINS - Codes TP 0100 / 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 definition TP test in use YES

test type Photometric Low High Units

Full name Total proteins Test limit 0 g/dl
Online name
Result unit g/dl Initial absorb. 0,0 2,0 A

N. of decimals 1 Dilution limit * 12 g/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 10
Point/std 2 Rel. error % 5
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1

test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation
Reagent Volume (µl) Time (sec) λ1 (nm)
TP BLANK 2 600 540

Volume (µl) λ2 (nm)
200 700

Disp. with. Disp. with λ2 weight

WATER WATER 1,0

Volume (µl) Volume (µl) Res. Net. Abs.

10 10 0

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 42 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: TRANSFERRIN FL - Code TF 0050 CH / 0100 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 definition TRF test in use YES

test type Photometric Low High Units

Full name Transferrin Test limit 0 g/l
Online name
Result unit g/l Initial absorb. 0,0 2,0 A

N. of decimals 2 Dilution limit * 40 g/l

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma
calibration parameters
calibration type NON LINEAR Bias corr. in use NO
Repeat time (d) 14 Abs. error (mA) 12
Point/std 6 Rel. error % 3
Acceptance AUTOMATIC
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1
CAL 2
CAL 3
CAL 4
CAL 5
test flow
Additional blank YES
Antigen excess NO
Incubation Incubation
Reagent Volume (µl) Time (sec) Reagent Time (sec) λ1 (nm)
TRF-1 2 300 BLANK TRF-2 300 510

Volume (µl) Volume (µl) λ2 (nm)
240 60 NONE

Disp. with. Disp. with Disp. with

WATER WATER WATER

Volume (µl) Volume (µl) Volume (µl)

10 10 10

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 43 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: TRIGLYCERIDES FL - Codes TR 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 definition TRIG test in use YES

test type Photometric Low High Units

Full name Triglycerides Test limit 0 mg/dl
Online name
Result unit mg/dl Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 1000 mg/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 10
Point/std 2 Rel. error % 5
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1

test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation
Reagent Volume (µl) Time (sec) λ1 (nm)
TRIG BLANK 2 300 540

Volume (µl) λ2 (nm)
200 700

Disp. with. Disp. with λ2 weight

WATER WATER 1,0

Volume (µl) Volume (µl) Res. Net. Abs.

20 20 0

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 44 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

Application: UREA UV FL - Codes AZ F080 / F245 / F400 / F600 CH
Preparation: WORKING REAGENT PREPARATION AS INDICATED IN INSERT SHEET
Storage: REFRIGERATE AT 2-8°C
Stability: 30 DAYS AT 2-8°C

Test definition UREA test in use YES

test type Photometric Low High Units

Full name Urea Test limit 0 mg/dl
Online name
Result unit mg/dl Initial absorb. 0,8 2,2 A

N. of decimals 0 Dilution limit * 300 mg/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 7
Point/std 2 Rel. error % 10
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1
test flow
Additional blank NONE
Antigen excess NO
Incubation Incubation
Reagent time (sec) Volume (µl) Time (sec) λ1 (nm) Curve type
UREA 180 2 30 340 NONLINEAR

Volume (µl) λ2 (nm) Nonlinearity
180 NONE

Disp. with. Disp. with resp.(mA/min)
EXTRA EXTRA 20

Volume (µl) Volume (µl) Time (sec)

20 10 60

Diluent Points&Inter.
WATER 12/4.5 sec

IUS.418.1.4 Directions for use Edition 2015-12-01 page 45 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

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 definition URIC test in use YES

test type Photometric Low High Units

Full name Uric acid Test limit 0 mg/dl
Online name
Result unit mg/dl Initial absorb. 0,0 2,0 A

N. of decimals 1 Dilution limit * 30 mg/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 10
Point/std 2 Rel. error % 5
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1

test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation
Reagent Volume (µl) Time (sec) λ1 (nm)
URIC BLANK 5 300 540

Volume (µl) λ2 (nm)
200 700

Disp. with. Disp. with λ2 weight

WATER WATER 1,0

Volume (µl) Volume (µl) Res. Net. Abs.

20 20 0

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 46 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

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

Test definition URIC test in use YES

test type Photometric Low High Units

Full name AU AOX Test limit 0 35 mg/dl
Online name
Result unit mg/dl Initial absorb. 0,0 2,0 A

N. of decimals 1 Dilution limit * 25 µg/dl

Acceptance AUTOMATIC Secondary dil. 0 2

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 12
Point/std 2 Rel. error % 5
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CAL 1
test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation Incubation
Reagent Volume (µl) Time (sec) Reagent Time (sec) λ1 (nm)
URIC-1 10 240 BLANK URIC-2 300 540

Volume (µl) Volume (µl) λ2 (nm)
200 50 700

Disp. with. Disp. with Disp. with
WATER EXTRA WATER

Volume (µl) Volume (µl) Volume (µl)

10 10 10

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 47 of 49

 Chema Diagnostica - Guidelines for automatic analyzers - Thermo Konelab

Analyzer: Thermo Konelab 20 - 30 - 60

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 definition ZN test in use YES

test type Photometric Low High Units

Full name Zinc Test limit 0 µg/dl
Online name
Result unit µg/dl Initial absorb. 0,0 2,0 A

N. of decimals 0 Dilution limit * 1000 µg/dl

Acceptance AUTOMATIC Secondary dil. 0

Dilution 1+ 0 Correction factor 1.00

Sample type serum Bias correction 0.00

plasma

calibration parameters
calibration type LINEAR Bias corr. in use NO
Repeat time (d) 0 Abs. error (mA) 10
Point/std 2 Rel. error % 5
Acceptance MANUAL
Response limit
Type of standard SEPARATE Min. *
Std. ID WATER Max *
CHEM CAL

test flow
Additional blank MEASUREMENT
Antigen excess NO
Incubation
Reagent Volume (µl) Time (sec) λ1 (nm)
ZN BLANK 10 300 575

Volume (µl) λ2 (nm)
200 700

Disp. with. Disp. with λ2 weight

WATER WATER 1,0

Volume (µl) Volume (µl) Res. Net. Abs.

10 10 0

Diluent Meas. type

WATER NORMAL

IUS.418.1.4 Directions for use Edition 2015-12-01 page 48 of 49