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CY008

English
CYANExpert 130
Application Sheets

For a clear and precise diagnose

ISO 13485-2016
www.diagnostics.be • Belgium • Tel: ++ 32 15 67 67 68 • e-mail: cypress@diagnostics.be
Layout 20181024
CYANExpert 130

DIRECTIONS FOR USE


AUTOMATION

CYANExpert 130

CLINICAL CHEMISTRY

Version 20190624 - replaces all previous versions 1


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CYANExpert 130

Index

Page Test LIS


2 -amylase AAMY
3 Acid phosphatase total ACPt
4 Acid phosphatase (non) prostatic ACP(n)p
5 Albumin ALB
6 Alkaline phosphatase ALP
7 Alkaline phosphatase Liquid ALPL
8 Bilirubin Direct BILD
9 Bilirubin Total BILT
10 Calcium Arsenazo III CaAR
11 Chloride CL
12 Cholesterol CHOL
13 Cholesterol Liquid (new) CHOLLn
14 Cholesterol HDL direct NEW HDLd
15 Cholesterol LDL direct NEW LDLd
16 Creatine Kinase MB CKMB
17 Creatine Kinase MB Liquid CKMBL
18 Creatine Kinase NAC CKNAC
19 Creatine Kinase NAC Liquid CKNACL
20 Creatinine CRE
21 Glucose-6-phosphate dehydrogenase G6PDH
22 Glucose GLUC
24 Glucose Liquid GLUCL
25 Glucose Liquid NEW GLUCLn
26 -GT GGT
27 -GT Liquid GGTL
28 GOT/AST GOT
29 GOT/AST Liquid GOTL
30 GPT/ALT GPT
31 GPT/ALT Liquid GPTL
32 HbA1c HbA1c
33 Haemoglobin HGB
34 Iron IRON
35 TIBC TIBC
36 LDH LDH
37 LDH Liquid LDHL
38 Lipase LIPASE
39 Magnesium Xylidyl Blue MgXB
40 Phosphorus PHOSPH
41 Potassium Enzymatic POTenz
42 Sodium Enzymatic SODenz
43 Total Protein TP
44 Triglycerides TRIG
45 Triglycerides Liquid (new) TRIGLn
46 Urea UREA
47 Urea Liquid UREAL
48 Uric acid UA
49 Uric acid Liquid (new) UALn
50 BIB BIB
51 BIC BIC

Version 20190624 - replaces all previous versions 2


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CYANExpert 130

α-amylase
With CNPG3

PREPARATION AND STABILITY


Cod.HBE03. Reagent is ready to use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. After opening the reagent is stable for 60 days when properly capped
immediately after each opening and stored at 2°-8°C. The reagent should be discarded if turbidity or precipitation has occurred or
if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

These values are for serum or plasma samples. For urine samples; please check the insert for the values.
If less than 3 vials of reagent are used, it is recommended to place AMY1 in a 6 ml-reagent container, program it correctly in
Checks  Reagents Configuration.
LINEARITY
This method is linear up to 2200 U/l of α-amylase.
If the obtained results are greater than 2200 U/l, rerun is recommended using a 1/2 dilution.

Version 20190624 - replaces all previous versions 2

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CYANExpert 130

Acid phosphatase
TOTAL
Hillman method modif.

PREPARATION AND STABILITY


Cod.HBE01. R4 is ready to use. Dissolve one tablet R2 substrate in 2 ml of R1 buffer. Cap and mix gently to dissolve all the contents.
The stability of working reagent is 2 days at 2-8ºC or 6 hours at room temperature. Do not use the tablets if they appear to be
broken.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

If less than 6 mL of liquid reagent is prepared, it is recommended to place ACPW in a 6 ml-reagent container, program it correctly
in Checks  Reagents Configuration.

LINEARITY
This method is linear up to 150 U/L of Acid Phosphatase.
If the obtained results are greater than 150 U/l, rerun is recommended using a 1/2 dilution.
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CYANExpert 130

Acid phosphatase
(Non) Prostatic

PREPARATION
Cod.HBE01. Dissolve one tablet R2 substrate in 2 ml of R1 buffer. Then mix this solution (R1+R2) with R3 in the ratio: 1 ml R1+R2
with 10 μl R3. The stability of working reagent is 2 days at 2-8ºC or 6 hours at room temperature.

STABILITY - CALIBRATION & QUALITY CONTROL - LINEARITY


See ACPt

PROGRAM SETUP

If less than 6 mL of liquid reagent is prepared, it is recommended to place ACP3 in a 6 ml-reagent container, program it correctly
in Checks  Reagents Configuration.

NOTES
To obtain a value for prostatic acid phosphatase (ACPp), you can program a ratio in Parameters  Ratio: ACPp = ACPt – ACPnp.

Version 20190624 - replaces all previous versions 4

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CYANExpert 130

Albumin
Bromocresol Green

PREPARATION AND STABILITY


Cod.HB001. The reagent is ready to use.
All the components of the kit are stable at 2-25°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. Do not exceed the temperature of 25°C during storage. The reagent
should be a clear, yellow-green solution. The reagent should be discarded if turbidity or precipitation has occurred or if the blank
absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

LINEARITY
This method is linear up to 5.8 g/dl of Albumin.
If the obtained results are greater than 5.8 g/dl, rerun is recommended using a 1/2 dilution.

Version 20190624 - replaces all previous versions 5

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CYANExpert 130

Alkaline phosphatase
Method DGKC

PREPARATION AND STABILITY


Cod.HBE02. Dissolve one tablet R2 in 15 ml of buffer Reagent R1. Cap and mix gently to dissolve the contents. The stability of
working reagent is 5 days at room temperature (15-25°C) or 21 days at 2-8°C. Do not use the tablets if they appear to be broken.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

LINEARITY
This method is linear up to 1200 U/l of Alkaline Phosphatase.
If the obtained results are greater than 1200 U/l, rerun is recommended using a 1/10 dilution.

Version 20190624 - replaces all previous versions 6

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Alkaline phosphatase Liquid


Kinetic. Colorimetric. IFCC Liquid

PREPARATION AND STABILITY


Cod.HBE12. Reagents are ready to use
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. Do not freeze the reagents. The reagent should be discarded if turbidity
or precipitation has occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

LINEARITY
This method is linear up to 1400 U/l of Alkaline Phosphatase.
If the obtained results are greater than 1400 U/l, rerun is recommended using a 1/10 dilution.

Version 20190624 - replaces all previous versions 7

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CYANExpert 130

Bilirubin
DMSO - Direct

PREPARATION AND STABILITY


Cod HB0020 Bilirubin total and direct & Cod.HB0260 Bilirubin direct. Reagents are ready to use
All the components of the kit are stable at 2-25°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred, if color development has occurred in reagent N or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators. Use the value
indicated on the insert ‘with sample blank’. Program 3 replicates to be measured for the BILD calibration.

Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

Recommended to place BILN in a 6 ml-reagent container, indicate it correctly in Checks  Reagents Configuration.

LINEARITY
This method is linear up to 20 mg/dl of Bilirubin Direct.
If the obtained results are greater than 20 mg/dl, rerun is recommended using a 1/2 dilution.

Version 20190624 - replaces all previous versions 8

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CYANExpert 130

Bilirubin
DMSO - Total

PREPARATION AND STABILITY


Cod HB0020 Bilirubin total and direct & Cod.HB0270 Bilirubin total. Reagents are ready to use.
All the components of the kit are stable at 2-25°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred, if color development has occurred in reagent N or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators. Use the value
indicated on the insert ‘with sample blank’. Program 3 replicates to be measured for the BILT calibration.

Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

Recommended to place BILN in a 6 ml-reagent container, indicate it correctly in Checks  Reagents Configuration.

LINEARITY
This method is linear up to 20 mg/dl of Bilirubin Total.
If the obtained results are greater than 20 mg/dl, rerun is recommended using a 1/2 dilution.

Version 20190624 - replaces all previous versions 9

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CYANExpert 130

Calcium
Arsenazo III

PREPARATION AND STABILITY


Cod.HB0030. The reagent is ready for use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators. Program 3
replicates to be measured for the CaAR calibration:

Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

These values are for serum or plasma samples. For urine samples; please check the insert for the values.

LINEARITY
This method is linear up to 20 mg/dl of Calcium.
If the obtained results are greater than 20 mg/dl, rerun is recommended using a 1/2 dilution.

Version 20190624 - replaces all previous versions 10

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CYANExpert 130

Chloride
Thiocyanate

PREPARATION AND STABILITY


Cod.HB005. The reagent is ready for use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

These values are for serum or plasma samples. For urine, CSF or sweat samples; please check the insert for the values.

LINEARITY
This method is linear up to 190 mmol/l of chloride.
If the obtained results are greater than 190 mmol/l, rerun is recommended using a 1/2 dilution.

Version 20190624 - replaces all previous versions 11

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CYANExpert 130

Cholesterol
Enzymatic CHOD-POD

PREPARATION AND STABILITY


Cod.HB006. Dissolve the contents of one bottle R2 Enzymes into the contents of one bottle R1 Buffer. Cap and mix gently to
dissolve all the contents. This working reagent is stable 4 months at 2–8°C or 40 days at room temperature when stored in a dark
bottle.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

LINEARITY
This method is linear up to 900 mg/dl of Cholesterol.
If the obtained results are greater than 900 mg/dl, rerun is recommended using a 1/2 dilution.

Version 20190624 - replaces all previous versions 12

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CYANExpert 130

Cholesterol Liquid
Enzymatic CHOD-POD

PREPARATION AND STABILITY


Cod.HBL010. (new formulation and programming from lot 00451)
The reagent is ready to use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

LINEARITY
This method is linear up to 1000 mg/dL of Cholesterol.
If the obtained results are greater than 1000 mg/dL, rerun is recommended using a 1/2 dilution.

Version 20190624 - replaces all previous versions 13

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CYANExpert 130

Cholesterol HDL Direct


Enzymatic colorimetric

PREPARATION AND STABILITY


Cod.HBL011. R1 and R2 are ready to use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified. The reagents are light sensitive. Do not
leave bottles open. Keep containers tightly closed and prevent contamination during their use. Do not freeze the reagents.
Once opened they are stable for 60 days at 2-8°C. The reagents should be a clear solution. If turbidity or precipitation has occurred,
the reagent should be discarded.

CALIBRATION & QUALITY CONTROL


Use the HDL/LDL direct calibrator (HBC11) for calibration. The concentration is lot specific and given on the label of the calibrator.
Control sera are recommended to monitor the performance of assay procedures. Use the HDL/LDL Direct control set (HBC10).
Insert the values mentioned on the labels in Parameters  Controls. Prepare and measure these controls the same as samples. If
the control values are found outside the defined range, mentioned on the labels of the control vials, check the instrument, reagents
and calibration for problems.

PROGRAM SETUP

LINEARITY
This method is linear up to 184.8 mg/dL of HDL Cholesterol.
If the obtained results are greater than 184.8 mg/dL, rerun is recommended using a 1/2 dilution.

Version 20190624 - replaces all previous versions 14

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CYANExpert 130

Cholesterol LDL Direct


Enzymatic colorimetric

PREPARATION AND STABILITY


Cod.HBL012. R1 and R2 are ready to use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified. The reagents are light sensitive. Do not
leave bottles open. Keep containers tightly closed and prevent contamination during their use. Do not freeze the reagents.
Once opened they are stable for 60 days at 2-8°C. The reagents should be a clear solution. If turbidity or precipitation has occurred,
the reagent should be discarded.

CALIBRATION & QUALITY CONTROL


Use the HDL/LDL direct calibrator (HBC11) for calibration. The concentration is lot specific and given on the label of the calibrator.
Control sera are recommended to monitor the performance of assay procedures. Use the HDL/LDL Direct control set (HBC10).
Insert the values mentioned on the labels in Parameters  Controls. Prepare and measure these controls the same as samples. If
the control values are found outside the defined range, mentioned on the labels of the control vials, check the instrument, reagents
and calibration for problems.

PROGRAM SETUP

LINEARITY
This method is linear up to 250 mg/dL of LDL Cholesterol.
If the obtained results are greater than 250 mg/dL, rerun is recommended using a 1/2 dilution.

Version 20190624 - replaces all previous versions 15

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CYANExpert 130

Creatine kinase - MB
Immunoinhibition. Kinetic UV

PREPARATION AND STABILITY


Cod.HBE10. Dissolve one tablet R2 in 2,5 ml buffer R1. The working reagent is stable for 8 days at 2-8ºC or 24 hours at room
temperature (15-25°C). Do not use tablets that appear to be broken. Control: Dissolve the contents in 2 ml of distilled water. Cap
vial and mix gently to dissolve the contents. Stability: 8 hours at room temperature, 5 days at 2-8°C or 1 month at –20°C. Bring at
room temperature for 30 min before use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Calibration by means of a factor (8255).
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use the CK control included in the kit. Insert the range
mentioned on the vial in Parameters  Controls.

PROGRAM SETUP

LINEARITY
This method is linear up to 1000 U/l of CK-NAC (CK-MB is between 6 and 25% of total CK activity).
If the obtained results are greater than 1000 U/l for CK-NAC, rerun is recommended using a 1/2 dilution.

Version 20190624 - replaces all previous versions 16

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CYANExpert 130

Creatinine kinase - MB Liquid


Immunoinhibition. Kinetic UV

PREPARATION AND STABILITY


Cod.HBEL05. R1 and R2 are ready for use.
Control: Dissolve the contents in 2 ml of distilled water. Cap vial and mix gently to dissolve the contents. Stability: 12 hours at room
temperature (15-25°C), 7 days at 2-8°C or 1 month at –20°C. Bring at room temperature for 30 min before use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Calibration by means of a factor (8255).
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use the CK control included in the kit. Insert the range
mentioned on the vial in Parameters  Controls.

PROGRAM SETUP

Recommended to place MBL2 in a 6 ml-reagent container, indicate it correctly in Checks  Reagents Configuration.

LINEARITY
This method is linear up to 318 U/l of CK-MB.
If the obtained results are greater than 318 U/l for CK-NAC, rerun is recommended using a 1/10 dilution.

Version 20190624 - replaces all previous versions 17

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CYANExpert 130

Creatine kinase - NAC


Kinetic UV. NAC Activated

PREPARATION AND STABILITY


Cod.HBE04. Dissolve one tablet R2 in 2,5 ml of buffer Reagent R1. The stability of working reagent is 10 days at 2-8°C or 3 days at
room temperature (15-25°C). Do not use the tablets if they appear to be broken.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02 sera. CK-
NAC/CK-MB control (HBC08) is also available. Insert the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

LINEARITY
This method is linear up to 1300 U/l of CK-NAC.
If the obtained results are greater than 1300 U/l for CK-NAC, rerun is recommended using a 1/10 dilution.

Version 20190624 - replaces all previous versions 18

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CYANExpert 130

Creatinine kinase - NAC Liquid


Kinetic UV. NAC Activated

PREPARATION AND STABILITY


Cod.HBEL03. R1 and R2 are ready for use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. CK-
NAC/CK-MB control (HBC08) is also available. Insert the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

Recommended to place NAC2 in a 6 ml-reagent container, indicate it correctly in Checks  Reagents Configuration.

LINEARITY
This method is linear up to 2000 U/L of CK-NAC.
If the obtained results are greater than 2000 U/l for CK-NAC, rerun is recommended using a 1/10 dilution.

Version 20190624 - replaces all previous versions 19

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CYANExpert 130

Creatinine
Jaffé

PREPARATION AND STABILITY


Cod.HB0080. ATTENTION: Place Reagent 2 on first position and Reagent 1 on second position.
All the components of the kit are stable at 2-25°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

Place Reagent 2 on first position and Reagent 1 on second position.


These values are for serum or plasma samples. For urine samples; please check the insert for the values.

LINEARITY
This method is linear up to 15 mg/dl of Creatinine.
If the obtained results are greater than 15 mg/dl, rerun is recommended using a 1/2 dilution.

Version 20190624 - replaces all previous versions 20

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G6-PDH
U.V. Enzymatic

PREPARATION AND STABILITY


Cod.HBE11. R1 and R4 are ready to use. Reconstitute the content of R2 and R3 with 2 ml of distilled water each. After opening, R1
and R4 are stable until the expiration date specified on the label at 2-8°C and the reconstituted R2 and R3 are stable for 4 weeks at
2-8ºC and, when stored tightly closed, protected from light and contaminations are prevented during their use.
CALIBRATION & QUALITY CONTROL
Calibration by means of a factor.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use the 2 levels of G6-PDH controls (HBC09). Insert the range
mentioned on the vials in Parameters  Controls.

ERYTHROCYTES
To determine G6-PDH a hemolysate must be prepared for each sample as well as for controls HBC09. This hemolysate must be
positioned on the analyzer.
- Wash 0,2 ml of blood with 2 ml of 0.9% NaCl (saline) solution.
- Centrifuge after each wash for 10 min at around 3000 rpm.
- Repeat 3 times.
- Suspend the washed and centrifuged erythrocytes in 0,5 ml of R4 and let stand for 15 min at +4°C and then centrifuge again.
- Use the supernatant in the assay within 2 hours.

PROGRAM SETUP

Recommended to place GPD2&GPD3 in 6 ml-reagent containers, indicate it correctly in Checks  Reagents Configuration. These
values are for erythrocytes (U/L).
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To obtain a value for G6-PDH in U/g HGB, program and use the following ratio:

LINEARITY
This method is linear up to 4303 U/l of G6-PDH.
If the obtained results are greater than 4303 U/l, rerun is recommended using a 1/10 dilution.

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Glucose
Enzymatic. GOD-POD

PREPARATION AND STABILITY


Cod. HB009 & HB010. Dissolve the contents of one bottle R2 Enzymes in one bottle R1 buffer. This working reagent (GLUW) is stable
1 month after constitution at 2-8°C or 7 days at room temperature (15-25°C).
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.
CALIBRATION & QUALITY CONTROL
Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators. Program 3
replicates to be measured for the GLUC calibration:

Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

These values are for serum or plasma samples. For CSF samples; please check the insert for the values.
LINEARITY
This method is linear up to 500 mg/dl of glucose.
If the obtained results are greater than 500 mg/dl, rerun is recommended using a 1/2 dilution.
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Glucose Liquid
Enzymatic. GOD-POD

PREPARATION AND STABILITY


Cod. HBL04 & HBL04A. The reagent is ready for use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

These values are for serum or plasma samples. For CSF samples; please check the insert for the values.

LINEARITY
This method is linear up to 600 mg/dl of glucose.
If the obtained results are greater than 600 mg/dl, rerun is recommended using a 1/2 dilution.

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New formulation Glucose Liquid


starting from lot GL-00731 Enzymatic. GOD-POD

PREPARATION AND STABILITY


Cod. HBL04 & HBL04A. The reagent is ready for use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

LINEARITY
This method is linear up to 460 mg/dl of glucose.
If the obtained results are greater than 460 mg/dl, rerun is recommended using a 1/2 dilution.

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γ-GT
Carboxy substrate

PREPARATION AND STABILITY


Cod.HBE05. Dissolve one tablet of R2 Substrate into one 15ml R1 Buffer. Cap and mix gently to dissolve all the contents. This
working reagent is stable 21 days at 2-8°C or 5 days at room temperature. Do not use the tablets if they appear to be broken.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

LINEARITY
This method is linear up to 375 U/l of γGT.
If the obtained results are greater than 375 U/l, rerun is recommended using a 1/10 dilution.

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γ-GT Liquid
Carboxy substrate

PREPARATION AND STABILITY


Cod.HBEL06 & HBEL061. GGT Reagent 1 and Reagent 2 are ready for use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

Recommended to place GGT2 in a 6 ml-reagent container, indicate it correctly in Checks  Reagents Configuration.

LINEARITY
This method is linear up to 300 U/l of γGT.
If the obtained results are greater than 300 U/l, rerun is recommended using a 1/10 dilution.

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GOT/AST
IFCC optimized

PREPARATION AND STABILITY


Cod.HBE06. Dissolve one tablet of R2 Substrate in 15 ml of R1 Buffer. Cap and mix gently to dissolve all the contents. This working
reagent is stable 72 hours at 15-25°C or 21 days at 2-8°C. Do not use the tablets if they appear to be broken.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

LINEARITY
This method is linear up to 360 U/l of GOT (ast).
If the obtained results are greater than 360 U/l, rerun is recommended using a 1/10 dilution.

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GOT/AST Liquid
IFCC optimized

PREPARATION AND STABILITY


Cod.HBEL010. R1 and R2 are ready for use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUPP

Recommended to place G0T2 in a 6 ml-reagent container, indicate it correctly in Checks  Reagents Configuration.

LINEARITY
This method is linear up to 260 U/L of GOT (ast).
If the obtained results are greater than 260 U/l, rerun is recommended using a 1/10 dilution.

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GPT/ALT
IFCC optimized

PREPARATION AND STABILITY


Cod.HBE07. Dissolve one tablet of R2 Substrate in 15 ml of R1 Buffer. Cap and mix gently to dissolve all the contents. This working
reagent is stable 72 hours at 15-25°C or 21 days at 2-8°C. Do not use the tablets if they appear to be broken.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

LINEARITY
This method is linear up to 400 U/L of GPT (alt).
If the obtained results are greater than 400 U/l, rerun is recommended using a 1/10 dilution.

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GPT/ALT Liquid
IFCC optimized

PREPARATION AND STABILITY


Cod.HBEL020. R1 and R2 are ready for use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

Recommended to place GPT2 in a 6 ml-reagent container, indicate it correctly in Checks  Reagents Configuration.

LINEARITY
This method is linear up to 260 U/L of GPT (alt).
If the obtained results are greater than 260 U/l, rerun is recommended using a 1/10 dilution.

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HbA1c
Turbidimetric

PREPARATION AND STABILITY


Cod.HT001. R 1, R2 and R 3 are ready to use. Mix gently before use.
All the components of the kit are stable until the expiration date on the label when stored tightly closed at 2-8ºC and
contaminations are prevented during their use. The reagent should be discarded if turbidity or precipitation has occurred. Reagent
1 and 2 are stable for at least one month after opening stored at 2-8°C.

CALIBRATION & QUALITY CONTROL


Use the HbA1c-calibrator (HT001S). Pay attention: program a 5-point calibration with a saline solution (9 g/L NaCl) or distilled water
as Calibrator 1 (Ref.1 = 0.001). For Ref.2–Ref.5 , program the value mentioned on the vials in Parameters  Calibrators.

Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use the HbA1c-control set (HT001C). Insert the range
mentioned on the vial in Parameters  Controls.

HEMOLYSIS
To determine HbA1c, a hemolysate must be prepared for each sample as well as for Calibrator HT001S (Level 2 to 4) and Control
HT001C. Hemolysate must be positioned on the analyzer.
- Dispense 1 mL of Reagent 3 into labeled test tubes (glass or plastic). Also provide test tubes for Calibrator and Control.
- Add 20 μL of well mixed whole blood (sample, calibrator, control). Mix.
- Allow to stand for 5 minutes or until complete lysis is evident. Hemolysates may be stored up to 10 days at 2-8°C.
PROGRAM SETUP

LINEARITY
This method is linear up to 16% of HbA1c. If the obtained results are higher, rerun is recommended using a 1/2 dilution.
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Haemoglobin
Colorimetric

PREPARATION AND STABILITY


Cod.HB011. Working reagent: 4,9 ml distilled water + 2 drops of reagent, or 245 ml distilled water + 5 ml of reagent and mix. The
working reagent (HGBW) is stable for 2 months at 2 –8°C, protected from the sunlight.
All the components of the kit and the hemoglobin calibrator (HBS02) are stable at 2-8°C up to the date of expiration as specified,
when stored tightly closed, protected from light and contaminations prevented during their use. The reagent should be discarded
if turbidity or precipitation has occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the Haemoglobin calibrator (HBS02). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems.

PROGRAM SETUP

LINEARITY
This method is linear up to 20 g/dl of Haemoglobin.
If the obtained results are greater than 20 g/dl, rerun is recommended using a 1/2 dilution.

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Iron
Ferrozine

PREPARATION AND STABILITY


Cod.HB012. R3 (FER3) is ready to use. Add the contents of one tube R2 reductant to the contents of one bottle R1 buffer. Cap and
mix gently to dissolve all the contents. This working reagent (FERW) is stable for 3 months at 2-8°C or 1 month at room temperature
(15-25°C).
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.
CALIBRATION & QUALITY CONTROL
Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators. Program 3
replicates to be measured for the IRON calibration:

Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.
PROGRAM SETUP

Recommended to place FER3 in a 6 ml-reagent container, indicate it correctly in Checks  Reagents Configuration.

LINEARITY
This method is linear up to 1000 μg/dl of iron.
If the obtained results are greater than 1000 μ/dl, rerun is recommended using a 1/2 dilution.
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TIBC
Saturation and precipitation

PREPARATION AND STABILITY


Cod.HB017. The reagents are ready to use. Cod.HB012. see Iron
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert for TIBC in Parameters  Calibrators. Program
3 replicates to be measured for the TIBC calibration:

Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

Recommended to place FER3 in a 6 ml-reagent container, indicate it correctly in Checks  Reagents Configuration.

LINEARITY
This method is linear up to 1000 μg/dl of iron.
If the obtained results are greater than 1000 μ/dl, rerun is recommended using a 1/2 dilution.

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LDH
Optimized

PREPARATION AND STABILITY


Cod.HBE08. Dissolve one tablet R2 into 3 ml of buffer Reagent R.1. Cap and mix gently to dissolve the contents. The stability of this
working reagent is 2 days at 2-8°C or 12 hours at room temperature (15-25°C). Do not use the tablets if they appear to be broken.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

LINEARITY
This method is linear up to 1500 U/L of LDH.
If the obtained results are greater than 1500 U/L, rerun is recommended using a 1/10 dilution.

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LDH Liquid
Optimized

PREPARATION AND STABILITY


Cod.HBEL04 & HBEL041. R1 and R2 are ready for use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

Recommended to place LDH2 in a 6 ml-reagent container, indicate it correctly in Checks  Reagents Configuration.

LINEARITY
This method is linear up to 1600 U/L of LDH.
If the obtained results are greater than 1600 U/L, rerun is recommended using a 1/10 dilution.

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Lipase
Enzymatic colorimetric / Liquid

PREPARATION AND STABILITY


Cod.HBE09. Reagent 1 & 2: Ready to use. Stability after opening 90 days at 2-8°C. R2: Mix gently before use (note 1 on insert).
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. R1 should be discarded if turbidity or precipitation has occurred or if
the blank absorbance is out of range. R2 is a turbid orange-colored micro-emulsion, discard if turning red.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators. Program 3
replicates to be measured for the LIPASE calibration:

Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

Recommended to place LIP2 in a 6 ml-reagent container, indicate it correctly in Checks  Reagents Configuration.
LINEARITY
This method is linear up to 250 U/l of Lipase. If the obtained results are greater than 250 U/l, rerun is recommended using a 1/10
dilution.
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Magnesium Xylidyl Blue


Xylidyl Blue-EGTA

PREPARATION AND STABILITY


Cod. HB0320. The reagent is ready for use
All the components of the kit are stable at 2-25°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators. Program 3
replicates to be measured for the MgXB calibration:

Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

These values are for serum or plasma samples. For urine samples; please check the insert for the values.
LINEARITY
This method is linear up to 6.6 mg/dl of magnesium.
If the obtained results are greater than 5 mg/dl, rerun is recommended using a 1/2 dilution.
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Phosphorus
U.V

PREPARATION AND STABILITY


Cod.HB014. The reagent is ready for use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators. Program 3
replicates to be measured for the PHOSPH calibration:
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

These values are for serum or plasma samples. For urine samples; please check the insert for the values.

LINEARITY
This method is linear up to 35 mg/dl of phosphorus.
If the obtained results are greater than 35 mg/dl, rerun is recommended using a 1/2 dilution.

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Potassium Enzymatic
U.V. Enzymatic

PREPARATION AND STABILITY


Cod.HB0330. All reagents are ready for use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed (immediately
close after use!), protected from light and contaminations prevented during their use. Do not freeze the reagents. The above
conditions are valid if the vials are opened just only for the time to take the reagent, closed immediately with their cap and stored
at the indicated storage temperature.
CALIBRATION & QUALITY CONTROL
Use the standards includes in kit. Pay attention: program a 2-point calibration. Program the reference values mentioned on the
vials of the standards in Parameters  Calibrators. Program 2-3 replicates to be measured for the POTenz calibration:

Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

Recommended to place POT2 in a 6 ml-reagent container, indicate it correctly in Checks  Reagents Configuration.

LINEARITY
This method is linear up to 8 mmol/l of potassium. If the obtained results are greater than 8 mmol/l, rerun is recommended using
a 1/2 dilution.
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Sodium Enzymatic
Colorimetric test. Enzymatic

PREPARATION AND STABILITY


Cod.HB0340. All reagents are ready for use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed (immediately
close after use!), protected from light and contaminations prevented during their use. Do not freeze the reagents. The above
conditions are valid if the vials are opened just only for the time to take the reagent, closed immediately with their cap and stored
at the indicated storage temperature.
CALIBRATION & QUALITY CONTROL
Use the standards includes in kit. Pay attention: program a 2-point calibration. Insert the reference values mentioned on the vials
of the standards in Parameters  Calibrators. Program 2-3 replicates to be measured for the SODenz calibration:

Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.
PROGRAM SETUP

LINEARITY
This method is linear up to 180 mmol/l of sodium.
If the obtained results are greater than 180 mmol/l, rerun is recommended using a 1/2 dilution.
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Total protein
Biuret

PREPARATION AND STABILITY


Cod.HB0190 and HB019. The reagent is ready for use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed (immediately
close after use!), protected from light and contaminations prevented during their use. The reagent should be discarded if turbidity
or precipitation has occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

LINEARITY
This method is linear up to 15 g/dl of Total Proteins.
If the obtained results are greater than 15 g/dl, rerun is recommended using a 1/2 dilution.

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Triglycerides
Enzymatic-POD

PREPARATION AND STABILITY


Cod.HB021. Dissolve the contents of one bottle R2 Enzymes into the contents of one bottle R1 Buffer. Cap and mix gently to
dissolve the contents. This working reagent is stable 42 days at 2-8°C or 1 week at room temperature (15-25°C).
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

LINEARITY
This method is linear up to 1200 mg/dl of triglycerides.
If the obtained results are greater than 1200 mg/dl, rerun is recommended using a 1/2 dilution.

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Triglycerides Liquid
Enzymatic-POD

PREPARATION AND STABILITY


Cod.HBL060. All the reagents are ready to use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

LINEARITY
This method is linear up to 1000 mg/dl of triglycerides.
If the obtained results are greater than 1000 mg/dl, rerun is recommended using a 1/2 dilution.

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CYANExpert 130

Urea
Berthelot

PREPARATION AND STABILITY


Cod.HB022 & HB029. Dissolve the content of one bottle R3 Enzymes into one bottle R1 Buffer. Cap and mix gently to dissolve the
contents. This working solution is stable 4 weeks at 2-8°C or 1 week at room temperature (15-25°C). The R.2 is ready for use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

These values are for serum or plasma samples. For urine samples; please check the insert for the values.

LINEARITY
This method is linear up to 225 mg/dl of Urea.
If the obtained results are greater than 225 mg/dl, rerun is recommended using a 1/2 dilution.

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Urea Liquid
Urease

PREPARATION AND STABILITY


Cod.HBL03. R1 and R2 are ready for use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.
CALIBRATION & QUALITY CONTROL
Use the human serum calibrator (HBC03). Insert the reference value mentioned on the insert in Parameters  Calibrators. Program
3 replicates to be measured for the UREAL calibration:

Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.
PROGRAM SETUP

Recommended to place URL2 in a 6 ml-reagent container, indicate it correctly in Checks  Reagents Configuration.
These values are for serum or plasma samples. For urine samples; please check the insert for the values.
LINEARITY
This method is linear up to 400 mg/dl of Urea.
If the obtained results are greater than 400 mg/dl, rerun is recommended using a 1/2 dilution.
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Uric acid
Uricase-POD

PREPARATION AND STABILITY


Cod.HB023 & HB024 Dissolve the contents of one bottle R2 to the contents of one bottle buffer solution R1. Cap and mix gently to
dissolve the contents. This working reagent is stable for 1 month at 2-8°C or 10 days at room temperature.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

These values are for serum or plasma samples. For urine samples; please check the insert for the values.

LINEARITY
This method is linear up to 40 mg/dl of Uric acid.
If the obtained results are greater than 40 mg/dl, rerun is recommended using a 1/2 dilution.

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Uric acid Liquid


Uricase-POD

PREPARATION AND STABILITY


Cod.HBL020. R1 and R2 are ready for use.
All the components of the kit are stable at 2-8°C up to the date of expiration as specified, when stored tightly closed, protected
from light and contaminations prevented during their use. The reagent should be discarded if turbidity or precipitation has
occurred or if the blank absorbance is out of range.

CALIBRATION & QUALITY CONTROL


Use the human serum calibrator (HBC03). Insert the value mentioned on the insert in Parameters  Calibrators.
Control sera are recommended to monitor the performance of assay procedures. If control values are found outside the defined
range, check the instrument, reagents and calibrator for problems. Use normal and pathological human (HBC01, HBC02) sera. Insert
the range mentioned on the inserts in Parameters  Controls.

PROGRAM SETUP

These values are for serum or plasma samples. For urine samples; please check the insert for the values.

LINEARITY
This method is linear up to 25 mg/dl of Uric acid.
If the obtained results are greater than 25 mg/dl, rerun is recommended using a 1/2 dilution.

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BIB

PREPARATION AND STABILITY


Use Potassium Dichromate K2Cr2O7 at 0.04 g/L as reagent and samples. Prepare the solution and use the same day.
See service manual 4.3.11 for more information.

PROGRAM SETUP

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BIC

PREPARATION AND STABILITY


Use Rinse working solution as reagent and Potassium Dichromate K2Cr2O7 at 4 g/L as samples. Prepare the solution and use the
same day.
See service manual 4.3.11 for more information.

PROGRAM SETUP

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Adjustments compared to version 20171123


1. Cholesterol Liquid
a. Sample volume: 3μL
b. Incubation time: 460 sec
2. Cholesterol HDL Direct  NEW
3. Cholesterol LDL Direct  NEW
4. Cholesterol Liquid old formulation (CHOLL)  Discontinued, now use method CHOLLn
5. Triglycerides Liquid old formulation (TRIGL)  Discontinued, now use method TRIGLn
6. GOT(L) + GPT(L)
a. Reaction Fit: 0.990

Adjustments compared to version 20180305


1. Albumin  HB0010 (1L format) discontinued, use HB001
2. Cholesterol LDL (HB028)  Discontinued, now use method LDLd
3. Cholesterol LDL direct (HBL012)
a. Reference ranges
4. HbA1c (HT001)
a. End point limit: 0.0500
5. Triglycerides (HB021)
a. Linearity limit: 1200 mg/dL
6. BIB + BIC
a. Reagent volume: 297 μL
7. Lipid control (HBC07) discontinued, now use only HBC01 & HBC02 for CHOL, CHOLLn, TRIG, TRIGLn

Adjustments compared to the previous version 20181119


1. Glucose Liquid (HBL04/HBL04A)  New improved formulation
Starting from lot GL-00731, use GLUCLn method

Adjustments compared to the previous version 20190401


1. Glucose Liquid (HBL04/HBL04A) starting from lot GL-00731 (GLUCLn)
a. End point limit: 0.0030 abs
b. Incubation time: 512 sec

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