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ACID PHOSPHATASE (ACP)

Continuous-spectrophotometric
SFBC

Instrument:
Principle of the method

SELECTRA-2

Acid phosphatase (ACP) catalyzes in acid medium the hydrolysis of the


phosphate group from -naphtyl phosphate. The -naphtol formed reacts with
a diazonium salt (Fast Red TR) originating a chromogen. The catalytic
concentration is determined from the rate of chromogen formation, measured
at 405 nm. Tartrate is used as a specific inhibitor of the prostatic fraction.

Samples

Reagent preparation
Working Reagent: Stopper the vial with the cap containing -naphtyl
phosphate and press the red button until the solute falls into the vial. Add 10
mL of Reagent A1 (Total ACP) or 10 mL of Reagent A2 (Non Prostatic ACP).
Cap and shake until dissolved. Stable for 10 days at 2-8C.

Performance characteristics

Serum.
Acid phosphatase is unstable in serum. In acidfied serum is stable for 6 days at 2-8C.

Linearity: up to 150 U/L.


Interferences: Hemolysis and bilirubin interfere.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Delay, min. Time

ACP
Kinetic
405 nm
U/L
0
0 U/L
150 U/L
(...)
3
1
*
(...)
No

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

0 U/L
10 U/L
0 U/L
10 U/L

Correlation Factor
Correlation Offset

1.000
0.000

ACP
No
25 mL
250 L
250 L

Linearity Limit
Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

10%
-0.050
3.000
-0.050
0.500
0.150
Yes
(...)
(...)

If the test is run without calibration enter


... Data entered by the operator
* assigned value of standard

FACTOR: 1480

20 L
10 L
289, 175 sec.

Version 0206

ALBUMIN

Spectrophotometric
BROMOCRESOL GREEN

Instrument:

SELECTRA-2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Albumin in the sample reacts with bromocresol green in acid medium forming a Reagent is ready to use.
coloured complex that can be measured by spectrophotometry.
Serum, plasma.
Stable for 6 days at 2-8C.

Linearity: up to 70 g/L.
Interferences: Hemoglobin (1 g/L) and bilirubin (25 mg/dL) interfere.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Incubation Time

Albumin
Endpoint
620 nm
g/L
1
0 g/L
70 g/L
(...)
3
1
*
(...)
No
Albumin
No
25 mL
270 L
250 L
4 L
3 L
11.5 min.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

35 g/L
50 g/L
35 g/L
50 g/L

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit

-0.100
3.000
-0.100
0.180

Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0207

ALKALINE PHOSPHATASE (ALP)

Continuous-spectrophotometric
DEA BUFFER

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Alkaline phosphatase (ALP) catalyzes in alkaline medium the transfer of the


phosphate group from 4-nitrophenylphosphate to diethanolamine (DEA),
liberating 4-nitrophenol. The catalytic concentration is determined from the rate
of 4-nitrophenol formation, measured at 405 nm.
Serum, plasma.
Alkaline phosphatase in serum or plasma is stable for 7 days at 2-8C.
Heparin may be used as anticoagulant

Working Reagent: Dissolve the powder of a Reagent B vial with 20 mL of the


Reagent A bottle (if 10x20 mL size) or dissolve the contents of a Reagent B
vial with the entire volume of a Reagent A bottle (if 5x100 mL size).
Stable for 2 months at 2-8C.
-

Linearity: up to 690 U/L.


Interferences: Fluoride, oxalate, citrate and EDTA as anticoagulants
interfere. Hemolysis interferes due to the alkaline phosphatase content in
red cells.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Delay, min. Time

ALP DEA
Kinetic
405 nm
U/L
0
0 U/L
690 U/L
(...)
3
1
*
(...)
No

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

90 U/L
280 U/L
90 U/L
280 U/L

Correlation Factor
Correlation Offset

1.000
0.000

ALP DEA
No
25 mL
250 L
250 L

Linearity Limit
Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

10%
-0.050
3.000
-0.050
0.950
0.150
Yes
(...)
(...)

If the test is run without calibration enter


... Data entered by the operator
* assigned value of standard

FACTOR: 2764

5 L
3 L
32, 175 sec.

Version 0012

ALKALINE PHOSPHATASE (ALP)

Continuous-spectrophotometric
AMP BUFFER (IFCC)

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Alkaline phosphatase (ALP) catalyzes in alkaline medium the transfer of the


phosphate group from 4-nitrophenylphosphate to 2-amino-2-methyl-1-propanol
(AMP), liberating 4-nitrophenol. The catalytic concentration is determined from
the rate of 4-nitrophenol formation, measured at 405 nm.
Serum, plasma.
Alkaline phosphatase in serum or plasma is stable for 7 days at 2-8C.
Heparin may be used as anticoagulant

Working Reagent: Dissolve the powder of a Reagent B vial with 20 mL of the


Reagent A bottle (if 10x20 mL size) or dissolve the contents of a Reagent B
vial with the entire volume of a Reagent A bottle (if 5x100 mL size).
Stable for 2 months at 2-8C.
-

Linearity: up to 1200 U/L.


Interferences: Fluoride, oxalate, citrate and EDTA as anticoagulants
interfere. Hemolysis interferes due to the alkaline phosphatase content in
red cells.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Delay, min. Time

ALP IFCC
Kinetic
405 nm
U/L
0
0 U/L
1200 U/L
(...)
3
1
*
(...)
No

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

26 U/L
117 U/L
26 U/L
117 U/L

Correlation Factor
Correlation Offset

1.000
0.000

ALP IFCC
No
25 mL
250 L
250 L

Linearity Limit
Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

10%
-0.050
3.000
-0.050
0.950
0.150
Yes
(...)
(...)

If the test is run without calibration enter


... Data entered by the operator
* assigned value of standard

FACTOR: 2764

5 L
3 L
32, 175 sec.

Version 0012

ALANINE AMINOTRANSFERASE (ALT)

Continuous-spectrophotometric
IFCC

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Alanine aminotransferase (ALT or GPT) catalyzes the transfer of the amino


group from alanine to 2-oxoglutarate, forming pyruvate and glutamate. The
catalytic concentration is determined from the rate of decrease of NADH,
measured at 340 nm, by means of the lactate dehydrogenase (LDH) coupled
reaction.
Serum.
Alanine aminotransferase in serum is stable for 7 days at 2-8C.

MONO MODE.- Working Reagent: Pour the contents of the Reagent B into the
Reagent A bottle. Mix gently.
Stable for 2 months at 2-8C.
DUAL MODE.- Reagent 1: Use the Reagent A.
Reagent 2: Use the Reagent B.
-

Interferences: High pyruvate in the sample will consume NADH during the
delay time before measurements, reducing the linearity of the method.
Linearity: Up to 500 U/L.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Delay, min. Time
DUAL MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
R2 Bottle
Normal Volume
Rerun Volume
Predilution
Slope Blank
Delay, min. Time

ALT
Kinetic
340 nm
U/L
0
0 U/L
500 U/L
(...)
3
1
*
(...)
No

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

0 U/L
41 U/L
0 U/L
41 U/L

Correlation Factor
Correlation Offset

1.000
0.000

ALT
No
25 mL
250 L
250 L

Linearity Limit
Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

10%
0.800
2.500
0.800
2.200
0.150
Yes
(...)
(...)

Linearity Limit
Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

10%
0.800
2.500
0.800
2.200
0.100
Yes
(...)
(...)

If the test is run without calibration enter


... Data entered by the operator
* assigned value of standard

FACTOR: -3466

12 L
6 L
70, 176 sec.
ALT
No
25 mL
225 L
225 L
12 L
6 L
25 mL
25 L
25 L
No
No
77, 132 sec.

Version 0012

-AMYLASE

Continuous-spectrophotometric
DIRECT SUBSTRATE

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

-Amylase catalyzes the hydrolysis of 2-chloro-4-nitrophenyl-maltotrioside Reagent is ready to be used.


(CNP-G3) to 2-chloro-4-nitrophenol (CNP). The catalytic concentration is
determined from the rate of 2-chloro-4-nitrophenol formation, measured at 405
nm.
Serum, plasma, urine.
-Amylase in serum, plasma or urine is stable for 5 days at 2-8C.
Heparin may be used as anticoagulant

Linearity: up to 1300 U/L (serum) or 2600 U/L (urine).


Interferences: Fluoride, oxalate, citrate and EDTA as anticoagulants
interfere.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Delay, min. Time

AMYL DIRECT
Kinetic
405 nm
U/L
0
0 U/L
1300 U/L
(...)
3
1
*
(...)
No

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

0 U/L
60 U/L
0 U/L
60 U/L

Correlation Factor
Correlation Offset

1.000
0.000

AMYLASE DIR.
No
25 mL
250 L
250 L

Linearity Limit
Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

10%
-0.050
3.000
-0.050
0.250
0.150
Yes
(...)
(...)

If the test is run without calibration enter


... Data entered by the operator
* assigned value of standard

FACTOR: 3292

5 L
3 L
32, 175 sec.

Version 0012

-AMYLASE

Continuous-spectrophotometric
IFCC

Instrument:

SELECTRA-2

Principle of the method

Reagent preparation

-Amylase catalyzes the hydrolysis of 4-nitrophenyl-maltoheptaosideethylidene to smaller oligosacharides which are hydrolyzed by -glucosidase
liberating 4-nitrophenol. The catalytic concentration is determined from the rate
of 4-nitrophenol formation, measured at 405 nm.

Samples

Working Reagent: Pour the contents of the Reagent B into the Reagent A
bottle. Mix gently. Other volumes can be prepared in the proportion: 4 mL
Reagent A + 1 mL Reagent B.
Stable for 20 days at 2-8C.

Performance characteristics

Serum, plasma, urine.


-Amylase in serum or plasma is stable for 1 month at 2-8C. Use heparin or EDTA as anticoagulant.
-Amylase in urine is stable for 1 month at 2-8C if pH is adjusted to
approximately 7 before storage.

Linearity: up to 1300 U/L (serum) or 2600 U/L (urine).


Interferences: Lipemia (triglycerides 10 g/L) and blirubin (20 mg/dL) do
not interfere. Hemoglobin (10 g/L) interfere. Other drugs and substances
may interfere.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Delay, min. Time

AMYL
Kinetic
405 nm
U/L
0
0 U/L
1300 U/L
(...)
3
1
*
(...)
No

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

28 U/L
100 U/L
28 U/L
100 U/L

Correlation Factor
Correlation Offset

1.000
0.000

AMYLASE
No
25 mL
250 L
250 L

Linearity Limit
Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

10%
-0.100
3.000
-0.100
3.000
0.300
Yes
(...)
(...)

If the test is run without calibration enter


... Data entered by the operator
* assigned value of standard

FACTOR: 3042

8 L
6 L
129, 195 sec.

Version 0204

ASPARTATE AMINOTRANSFERASE (AST)

Continuous-spectrophotometric
IFCC

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Aspartate aminotransferase (AST or GOT) catalyzes the transfer of the amino


group from aspartate to 2-oxoglutarate, forming oxalacetate and glutamate.
The catalytic concentration is determined from the rate of decrease of NADH,
measured at 340 nm, by means of the malate dehydrogenase (MDH) coupled
reaction.
Serum.
Aspartate aminotransferase in serum is stable for 7 days at 2-8C.

MONO MODE.- Working Reagent: Pour the contents of the Reagent B into the
Reagent A bottle. Mix gently.
Stable for 2 months at 2-8C.
DUAL MODE.- Reagent 1: Use the Reagent A.
Reagent 2: Use the Reagent B.
-

Interferences: High pyruvate in the sample will consume NADH during the
delay time before measurements, reducing the linearity of the method.
Linearity: Up to 500 U/L.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Delay, min. Time
DUAL MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
R2 Bottle
Normal Volume
Rerun Volume
Predilution
Slope Blank
Delay, min. Time

AST
Kinetic
340 nm
U/L
0
0 U/L
500 U/L
(...)
3
1
*
(...)
No

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

0 U/L
42 U/L
0 U/L
42 U/L

Correlation Factor
Correlation Offset

1.000
0.000

AST
No
25 mL
250 L
250 L

Linearity Limit
Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

10%
0.800
2.500
0.800
2.200
0.150
Yes
(...)
(...)

Linearity Limit
Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

10%
0.800
2.500
0.800
2.200
0.100
Yes
(...)
(...)

If the test is run without calibration enter


... Data entered by the operator
* assigned value of standard

FACTOR: -3465

12 L
6 L
70, 176 sec.
AST
No
25 mL
225 L
225 L
12 L
6 L
25 mL
25 L
25 L
No
No
77, 132 sec.

Version 0012

TOTAL BILIRUBIN

Spectrophotometric
DIAZOTIZED SULFANILIC

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Total bilirubin in the sample reacts with diazotized sulfanilic in acid medium Working Reagent: Transfer the contents of one Reagent B vial into a Reagent
forming a coloured complex that can be measured by spectrophotometry. Both A-T bottle. Mix thoroughly.
direct (conjugated with glucuronate) and indirect (unconjugated) bilirubin Stable for 20 days at 2-8C.
couple with diazo in the presence of cetrimide. The terms direct and total
refer to the reaction characteristics of serum bilirubin in the absence or
presence of solubilizing (accelerating) reagents, and are only approximately
equivalent to the conjugated and unconjugated fractions.
Serum.
Stable for 20 days at 2-8 C and protected from light.

Linearity: Up to 15 mg/dL.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Incubation Time

Bilirubin
Endpoint
546 nm
mg/dL
2
0 mg/dL
15 mg/dL
(...)
3
1
*
(...)
No
T-BILIRUBIN
No
25 mL
250 L
250 L
25 L
15 L
11.5 min.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

0.00 mg/dL
1.10 mg/dL
0.00 mg/dL
1.10 mg/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit

-0.100
3.000
-0.100
0.150

Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0012

CALCIUM

Spectrophotometric
ARSENAZO III

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Calcium in the sample reacts with arsenazo III forming a coloured complex that Reagent is ready to be used.
can be measured by spectrophotometry.
Serum, heparinized plasma, urine.
Calcium in serum or plasma is stable for 10 days at 2-8 C.
Anticoagulants other than heparin should not be used.

Linearity: Up to 18 mg/dL.
Interferences: Hemoglobin (1.5 g/L), bilirubin (20 mg/dL), magnesium (10
mg/dL) and phosphate (20 mg/dL) do not interfere.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Incubation Time

Calcium
Endpoint
620 nm
mg/dL
2
0 mg/dL
18 mg/dL
(...)
3
1
*
(...)
No
CALCIUM
No
25 mL
300 L
300 L
4 L
2 L
11.5 min.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

9.0 mg/dL
10.7 mg/dL
9.0 mg/dL
10.7 mg/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit

-0.100
3.000
-0.100
2.000

Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0012

CALCIUM

Spectrophotometric
METHYLTHYMOL BLUE

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Calcium in the sample reacts with methylthymol blue in alkaline medium Working Reagent: Mix equal volumes of Reagent A and Reagent B. Mix
forming a coloured complex that can be measured by spectrophotometry. thoroughly.
Hydroxyquinoline is included in the reagent to remove magnesium interference. Stable for 2 days at 2-8C.
Serum, heparinized plasma, urine.
Calcium in serum or plasma is stable for 10 days at 2-8 C.
Anticoagulants other than heparin should not be used.

Linearity: Up to 15 mg/dL.
Interferences: Hemoglobin (1.5 g/L), bilirubin (20 mg/dL), magnesium (10
mg/dL) and phosphate (20 mg/dL) do not interfere.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Incubation Time

Calcium
Endpoint
620 nm
mg/dL
2
0 mg/dL
15 mg/dL
(...)
3
1
*
(...)
No
CALCIUM
No
25 mL
300 L
300 L
3 L
2 L
11.5 min.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

9.0 mg/dL
10.7 mg/dL
9.0 mg/dL
10.7 mg/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit

-0.100
3.000
-0.100
0.700

Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0012

CHOLINESTERASE

Continuous-spectrophotometric
BENZOYLCHOLINE

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Cholinesterase (CHE) catalyzes the hydrolysis of benzoylcholine to choline and


benzoic acid. The catalytic concentration is determined from the rate of
quinoneimine formation, measured at 500 nm, by means of the choline and
peroxidase coupled reactions.
Serum, heparinized plasma or EDTA plasma.
Cholinesterase in serum or plasma is stable for 7 days at 2-8C.

Working Reagent: Reconstitute the contents of a Reagent B vial with 3 mL (if


20x3 mL size), 15 mL (if 10x15 mL size) or 50 mL (if 4x50 mL size) of Reagent
A. Swirl gently.
Stable for 10 days at 2-8C.
-

Linearity: up to 6500 U/L.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Delay, min. Time

Cholinesterase
Kinetic
505 nm
U/L
0
0 U/L
6500 U/L
(...)
3
1
*
(...)
No

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

2150 U/L
4950 U/L

Correlation Factor
Correlation Offset

1.000
0.000

Cholinesterase
No
25 mL
300 L
250 L

Linearity Limit
Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

10%
-0.050
3.000
-0.050
0.950
0.150
Yes
(...)
(...)

If the test is run without calibration enter


... Data entered by the operator
* assigned value of standard

FACTOR: 28000

2 L
2 L
188, 175 sec.

Version 0203

CHOLESTEROL

Enzymatic-spectrophotometric
CHOLESTEROL OXIDASE/PEROXIDASE

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Free and esterified cholesterol in the sample originates, by means of some Reagent is ready to be used
coupled reactions, a coloured complex that can be measured by
spectrophotometry.
Serum or plasma.
Stable for 7 days at 2-8C.
Heparin, EDTA, oxalate and fluoride may be used as anticoagulants.

Interferences: Hemoglobin (3 g/L), ascorbic acid (0.3 mmol/L) and


bilirubin (0.25 mmol/L) interfere. Lipemia does not affect results.
Linearity: Up to 1000 mg/dL.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Incubation Time

Cholesterol
Endpoint
505 nm
mg/dL
0
0 mg/dL
1000 mg/dL
(...)
3
1
*
(...)
No
Cholesterol
No
25 mL
300 L
300 L
3 L
2 L
11.5 min.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

123 mg/dL
270 mg/dL
123 mg/dL
243 mg/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit

-0.100
3.000
-0.100
0.150

Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0012

CREATINE KINASE (CK)

Continuous-spectrophotometric
IFCC

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Creatine kinase (CK) catalyzes the phosphorylation of ADP, in the presence of Working Reagent: Empty the contents of a Reagent B bottle into a Reagent A
creatine phosphate, to form ATP and creatine. The catalytic concentration is bottle. Swirl gently.
determined from the rate of NADPH formation, measured at 340 nm, by means Stable for 15 days at 2-8C.
of the hexokinase (HK) and glucose-6-phosphate coupled reactions.
Serum.
Creatine kinase in serum is stable for 7 days at 2-8C.

Linearity: up to 730 U/L.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Delay, min. Time

CK
Kinetic
340 nm
U/L
0
0 U/L
730 U/L
(...)
3
1
*
(...)
No

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

38 U/L
174 U/L
26 U/L
140 U/L

Correlation Factor
Correlation Offset

1.000
0.000

CK
No
25 mL
250 L
250 L

Linearity Limit
Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

10%
-0.050
3.000
-0.050
0.500
0.150
Yes
(...)
(...)

If the test is run without calibration enter


... Data entered by the operator
* assigned value of standard

FACTOR: 3465

12 L
6 L
188, 175 sec.

Version 0101

CREATININE

Kinetic-spectrophotometric
ALKALINE PICRATE

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Creatinine in the sample reacts with picrate in alkaline medium forming a Reagent 1: Use the Reagent A.
coloured complex. The complex formation rate is measured in a short period to Reagent 2: Use the Reagent B.
avoid interferences.
Serum, plasma, urine.
Creatinine in serum or plasma is stable for 24 hours at 2-8C.
Heparin, EDTA, oxalate and fluoride may be used as anticoagulants.

Interferences: Hemoglobin (0.1 g/L), bilirubin (10 mg/dL), protein and


ketonic bodies do not interfere.
Linearity: Up to 20 mg/dL (serum or plasma).

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
DUAL MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
R2 Bottle
Normal Volume
Rerun Volume
Predilution
Slope Blank
Point one, two

Creatinine
Twopoint
505 nm
mg/dL
1
0 mg/dL
20 mg/dL
(...)
3
1
*
(...)
No
Creatinine
No
25 mL
190 L
190 L
25 L
12 L
25 mL
65 L
65 L
No
No
24, 103 sec.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

0.6 mg/dL
1.1 mg/dL
0.5 mg/dL
0.9 mg/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

-0.100
3.000
-0.100
0.350
0.100
Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0012

GAMMA-GLUTAMYLTRANSFERASE ( -GT)

Continuous-spectrophotometric
IFCC

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Gamma-glutamyltansferase ( -GT) catalyzes the transfer of the -glutamyl Working Reagent: Pour the contents of the Reagent B into the Reagent A
group from -glutamyl-3-carboxy-4-nitroanilide to glycylglycine, liberating 3- bottle. Mix gently.
carboxy-4-nitroaniline. The catalytic concentration is determined from the rate Stable for 2 months at 2-8 C.
of 3-carboxy-4-nitroaniline formation.
Serum.
Gamma-glutamyltransferase in serum is stable for 5 days at 2-8 C.

Linearity: up to 300 U/L.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Delay, min. Time

GGT
Kinetic
405 nm
U/L
0
0 U/L
300 U/L
(...)
3
1
*
(...)
No

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

15 U/L
86 U/L
10 U/L
40 U/L

Correlation Factor
Correlation Offset

1.000
0.000

GGT
No
25 mL
250 L
250 L

Linearity Limit
Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

10%
-0.050
3.000
-0.050
0.900
0.150
Yes
(...)
(...)

If the test is run without calibration enter


... Data entered by the operator
* assigned value of standard

FACTOR: 1111

25 L
12 L
32, 175 sec.

Version 0207

GLUCOSE

Enzymatic-spectrophotometric
GLUCOSE OXIDASE/PEROXIDASE

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Glucose in the sample originates, by means of some coupled reactions, a Reagent is ready to be used
coloured complex that can be measured by spectrophotometry.
Serum or plasma.
Stable for 7 days at 2-8C.
Heparin, EDTA, oxalate and fluoride may be used as anticoagulants.

Interferences: Hemoglobin (0.3 g/L), ascorbic acid (10 mg/dL) and


bilirubin (15 mg/dL) interfere. Moderate lipemia does not affect the
results.
Linearity: Up to 500 mg/dL.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Incubation Time

Glucose
Endpoint
505 nm
mg/dL
0
0 mg/dL
500 mg/dL
(...)
3
1
*
(...)
No
Glucose
No
25 mL
300 L
300 L
3 L
2 L
11.5 min.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

76 mg/dL
110 mg/dL
76 mg/dL
110 mg/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit

-0.100
3.000
-0.100
0.150

Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0012

HDL CHOLESTEROL

Precipitation/Enzymatic-spectrophotometric
PHOSPHOTUNGSTATE/Mg 2+-CHOLESTEROL OXIDASE/PEROXIDASE

Instrument:

SELECTRA-2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Very low density lipoproteins (VLDL) and low density lipoproteins (LDL) in the Reagent B is ready to be used.
sample precipitate with phosphotungstate and magnesium ions. The
supernatant contains high density lipoproteins (HDL). The HDL cholesterol is
then spectrophotometrically measured by means of some coupled reactions.
Serum or plasma. Stable for 7 days at 2-8C.
Heparin, EDTA, oxalate and fluoride may be used as anticoagulants.
Precipitation Procedure:
1.
Pipette into labelled centrifuge tubes:
Sample
0.2 mL
Reagent A
0.5 mL
2.
Mix thoroughly and let stand for 10 minutes at room temperature.
3.
Centrifuge at a minimum of 4000 r.p.m. for 10 minutes.
4.
Carefully collect the supernatant.

Linearity: up to 200 mg/dL.


Interferences: Hemoglobin (1 g/L), bilirubin (10 mg/d/L) and acid ascorbic
(0.1 mmol/L) interfere.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Incubation Time

HDL-C
Endpoint
505 nm
mg/dL
0
0 mg/dL
200 mg/dL
(...)
3
1
*
(...)
No
HDL-C
No
25 mL
260 L
260 L
13 L
2 L
11.5 min.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

30 mg/dL
60 mg/dL
40 mg/dL
70 mg/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit

-0.100
3.000
-0.100
0.200

Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0206

IRON

Spectrophotometric
CHROMAZUROL B

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Ferric ions in the sample react with chromazurol B and Reagent is ready to be used
cetyltrimethylamoniumbromide (CTAB) forming a coloured complex that can be
measured by spectrophotometry.
Serum or heparinized plasma.
Stable for 7 days at 2-8C.

Interferences: Do not use hemolyzed sera.


Linearity: Up to 500 g/dL.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Incubation Time

Iron
Endpoint
620 nm
g/dL
0
0 g/dL
500 g/dL
(...)
3
1
*
(...)
No
Iron
No
25 mL
250 L
250 L
12 L
12 L
11.5 min.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

70 g/dL
155 g/dL
55 g/dL
140 g/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

-0.100
3.000
-0.100
3.000
0.100
No
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0012

IRON

Spectrophotometric
FERROZINE

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Transferrin-bound ferric ions in the sample are released by guanidinium and Working Reagent: Transfer the contents of one Reagent B vial into a Reagent
reduced to ferrous by means of hydroxylamine. Ferrous ions react with A bottle. Mix thoroughly.
ferrozine forming a coloured complex that can be measured by Stable for 6 months at 2-8C.
spectrophotometry.
Serum or heparinized plasma.
Stable for 7 days at 2-8C.

Interferences: Do not use hemolyzed sera.


Linearity: Up to 1000 g/dL.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Incubation Time

Iron Ferrozine
Endpoint
546 nm
g/dL
0
0 g/dL
1000 g/dL
(...)
3
1
*
(...)
No
Iron Ferrozine
Yes
25 mL
220 L
220 L
30 L
15 L
11.5 min.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

70 g/dL
155 g/dL
55 g/dL
140 g/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit

-0.100
3.000
-0.100
0.150

Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0012

LACTATE DEHYDROGENASE (LD/LDH)

Continuous-spectrophotometric
PYRUVATE

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Lactate dehydrognase (LD or LDH) catalyzes the reduction of pyruvate by Working Reagent: Pour the contents of the Reagent B into the Reagent A
NADH, to form lactate and NAD+. The catalytic concentration is determined bottle. Mix gently.
from the rate of decrease of NADH, measured at 340 nm.
Stable for 2 months at 2-8C.
Serum or plasma.
Lactate dehydrogenase in serum or plasma is stable for 24 hours at 2-8C.
Heparin may be used as anticoagulant.

Interferences: Hemolysis interferes due


dehydrogenase concentration in red cells.
Linearity: Up to 1500 U/L.

to

the

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Delay, min. Time

LDH
Kinetic
340 nm
U/L
0
0 U/L
1200 U/L
(...)
3
1
*
(...)
No

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

207 U/L
414 U/L
207 U/L
414 U/L

Correlation Factor
Correlation Offset

1.000
0.000

LDH
No
25 mL
250 L
250 L

Linearity Limit
Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

10%
-0.050
3.000
-0.050
2.000
0.150
Yes
(...)
(...)

If the test is run without calibration enter


... Data entered by the operator
* assigned value of standard

FACTOR: -8095

5 L
3 L
32, 175 sec.

Version 0203

high

lactate

LDL CHOLESTEROL

Precipitation/Enzymatic-spectrophotometric
POLIVINYL SULPHATE-CHOLESTEROL OXIDASE/PEROXIDASE

Instrument:

SELECTRA-2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Sample preparation

Low density lipoproteins (LDL) in the sample precipitate with polivinyl sulphate. Reagent is ready to be used.
The supernatant contains low density lipoproteins (LDL). LDL cholesterol
concentration is calculated by substracting cholestrol values in serum from
supernatant values after being precipitated. The LDL cholesterol is then
spectrophotometrically measured by means of some coupled reactions.
Serum. Stable for 24 hours at 2-8C.
Precipitation:
1.- Pipette into labelled centrifuge tubes: 0.2 mL Sample + 0.1 mL Reagent B
2.- Mix thoroughly and let stand for 15 minutes at room temperature
3.- Centrifuge at a minimum of 4000 r.p.m. for 15 minutes
4.- Carefully collect the supernatant

Linearity: up to 500 mg/dL.


Interferences: Hemoglobin (1 g/L), bilirubin (10 mg/d/L) and acid ascorbic
(0.1 mmol/L) interfere.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Incubation Time

LDL-Cholesterol
Endpoint
505 nm
mg/dL
0
0 mg/dL
500 mg/dL
(...)
3
1
*
(...)
No
LDL-Cholesterol
No
25 mL
300 L
300 L
6 L
3 L
11.5 min.

Prozone Check
Ref. Male Low
Ref. Male High
Ref. Female Low
Ref. Female High

No
150 mg/dL
150 mg/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit

-0.100
3.000
-0.100
0.150

Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0206

MAGNESIUM
Spectrophotometric
CALMAGITE

Instrument:

SELECTRA-2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Magnesium in the sample reacts with calmagite in alkaline medium forming a Reagent is ready to be used.
coloured complex that can be measured by spectrophotometry. EGTA is
included in the reagent to remove calcium interference.
Serum, heparinized plasma.
Magnesium in serum or plasma is stable for 10 days at 2-8C.
Anticoagulants other than heparin should not be used.

Interferences: Hemoglobin (1.5 g/L), calcium (20 mg/dL) and bilirubin (20
mg/dL) do not interfere.
Linearity: Up to 4 mg/dL.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Incubation Time

MAGNESIUM
Endpoint
505 nm
mg/dL
1
0.0 mg/dL
4.0 mg/dL
(...)
3
1
*
(...)
No
MAGNESIUM
No
25 mL
250 L
250 L
3 L
2 L
11.5 min.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

1.8 mg/dL
2.1 mg/dL
1.8 mg/dL
2.1 mg/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit

-0.100
3.000
-0.100
0.700

Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0109

PHOSPHORUS

Spectrophotometric
PHOSPHOMOLYBDATE/UV

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Inorganic phosphorus in the sample reacts with molybdate in acid medium Working Reagent: Mix 35 mL Reagent A + 15 mL Reagent B. Mix thoroughly.
forming a phosphomolybdate complex that can be measured by Stable for 12 months at 15-30C.
spectrophotometry.
Serum, plasma, urine.
Phosphorus in serum or plasma is stable for 7 days at 2-8C. EDTA and fluoride may be used as anticoagulants.

Interferences: Do not use hemolyzed sera.


Linearity: Up to 20 mg/dL.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Incubation Time

Phosphorus
Endpoint
340 nm
mg/dL
2
0 mg/dL
20 mg/dL
(...)
3
1
*
(...)
No
Phosphorus
Yes
25 mL
300 L
300 L
3 L
2 L
11.5 min.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

2.70 mg/dL
4.50 mg/dL
2.70 mg/dL
4.50 mg/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit

-0.100
3.000
-0.100
0.500

Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0012

PROTEIN

Spectrophotometric
BIURET

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Protein in the sample reacts with copper (II) ion in alkaline medium forming a Reagent is ready to be used.
coloured complex that can be measured by spectrophotometry.
Serum, heparinized plasma.
Stable for 8 days at 2-8C.
Anticoagulants other than heparin should not be used.

Interferences: Hemoglobin (0.2 g/L) and bilirubin (15 mg/dL) interfere.


Moderate lipemia does not affect the results.
Linearity: Up to 150 g/L.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Incubation Time

Protein
Endpoint
546 nm
g/L
1
0 g/L
150 g/L
(...)
3
1
*
(...)
No
Protein
No
25 mL
250 L
250 L
5 L
3 L
11.5 min.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

65 g/L
80 g/L
65 g/L
80 g/L

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit

-0.100
3.000
-0.100
0.180

Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0012

PROTEIN (URINE)

Spectrophotometric
PYROGALLOL RED

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Protein in the sample reacts with pyrogallol red and molybdate in acid medium Reagent is ready to be used.
forming a coloured complex that can be measured by spectrophotometry.
Urine, cerebrospinal fluid.
Stable for 8 days at 2-8C.

Linearity: Up to 4 g/L.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Incubation Time

Protein-Urine
Endpoint
620 nm
g/L
2
0.00 g/L
4.00 g/L
(...)
3
1
*
(...)
No
Protein-Urine
No
25 mL
250 L
250 L
5 L
3 L
11.5 min.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

0.05 g/L
0.14 g/L
0.05 g/L
0.14 g/L

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit

-0.100
3.000
-0.100
0.180

Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0012

TRIGLYCERIDES

Enzymatic-spectrophotometric
GLYCEROL PHOSPHATE OXIDASE/PEROXIDASE

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Triglycerides in the sample originates, by means of some coupled reactions, a Reagent is ready to be used
coloured complex that can be measured by spectrophotometry.
Serum or plasma.
Stable for 5 days at 2-8C.
Heparin, EDTA, oxalate and fluoride may be used as anticoagulants.

Interferences: Hemoglobin (3 g/L), ascorbic acid (0.3 mmol/L) and


bilirubin (0.25 mmol/L) interfere. Lipemia does not affect results.
Linearity: Up to 600 mg/dL.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Incubation Time

Triglycerides
Endpoint
505 nm
mg/dL
0
0 mg/dL
600 mg/dL
(...)
3
1
*
(...)
No
Triglycerides
No
25 mL
300 L
300 L
3 L
2 L
11.5 min.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

60 mg/dL
150 mg/dL
60 mg/dL
150 mg/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit

-0.100
3.000
-0.100
0.200

Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0012

UREA/BUN

Enzymatic-spectrophotometric
COLOR

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Urine in the sample originates, by means of some coupled reactions, a Reagent 1: Transfer the contents of one Reagent A2 vial into a Reagent A1
coloured complex that can be measured by spectrophotometry.
bottle. Mix thoroughly. Stable for 2 months at 2-8C.
Reagent 2: Use the Reagent B.
Serum, plasma, urine. Stable for 7 days at 2-8C.
Heparin is recommended as anticoagulant.

Interferences: Ammonium salts of the anticoagulants interfere.


Linearity: Up to 300 mg/dL.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
DUAL MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
R2 Bottle
Normal Volume
Rerun Volume
Incubation Time

Urea Color
Endpoint
620 nm
mg/dL
0
0 mg/dL
300 mg/dL
(...)
3
1
*
(...)
No
Urea Color
No
25 mL
220 L
220 L
2 L
1 L
25 mL
180 L
180 L
6.5 min.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

10 mg/dL
50 mg/dL
10 mg/dL
50 mg/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit

-0.100
3.000
-0.100
0.200

Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0012

UREA/BUN

Enzymatic-spectrophotometric
ULTRAVIOLET

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Urea in the sample consumes, by means of some coupled reactions, NADH Reagent 1: Use the Reagent A.
that can be measured by spectrophotometry.
Reagent 2: Use the Reagent B.
Serum, plasma, urine.
Stable for 7 days at 2-8C.
Heparin is recommended as anticoagulant.

Interferences: Ammonium salts of the anticoagulants interfere.


Linearity: Up to 300 mg/dL.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Delay, min. Time
DUAL MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
R2 Bottle
Normal Volume
Rerun Volume
Predilution
Slope Blank
Delay, min. Time

Urea
Twopoint
340 nm
mg/dL
0
0 U/L
300 U/L
(...)
3
1
*
(...)
No
Urea
No
25 mL
300 L
250 L
2 L
2 L
32, 70 sec.
Urea
No
25 mL
270 L
250 L
2 L
2 L
25 mL
30 L
30 L
No
No
24, 77 sec.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

10 mg/dL
50 mg/dL
10 mg/dL
50 mg/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

-0.100
3.000
-0.100
2.000
0.100
Yes
(...)
(...)

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

-0.100
3.000
-0.100
2.000
0.100
Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0012

URIC ACID

Enzymatic-spectrophotometric
URICASE/PEROXIDASE

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Uric acid in the sample originates, by means of some coupled reactions, a Reagent is ready to be used.
coloured complex that can be measured by spectrophotometry.
Serum, heparinized plasma.
Magnesium in serum or plasma is stable for 10 days at 2-8C.
Anticoagulants other than heparin should not be used.

Interferences: Hemoglobin (1 g/L), ascorbic acid (0.3 mmol/L) and


bilirubin (15 mg/dL) do not interfere. Lipemia may affect the results
Linearity: Up to 25 mg/dL.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Incubation Time

Uric acid
Endpoint
505 nm
mg/dL
1
0 mg/dL
25 mg/dL
(...)
3
1
*
(...)
No
Uric acid
No
25 mL
250 L
250 L
6 L
3 L
11.5 min.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

3.4 mg/dL
7.0 mg/dL
2.4 mg/dL
5.7 mg/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit

-0.100
3.000
-0.100
0.200

Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0012

ANTI-STREPTOLYSIN O (ASO)

Turbidimetry
LATEX

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Anti-streptolysin O (ASO) causes agglutination of the latex particles coated Working Reagent: Pour the contents of a Latex vial into a Diluent bottle. Mix
with streptolysin O. The agglutination of the latex particles is proportional to the thoroughly.
ASO concentration and can be measured by turbidimetry.
Stable for 20 days at 2-8C.
Serum.
Stable for 7 days at 2-8 C.
Hemolyzed or lipemic samples are not suitable for testing..

Linearity: Up to 800 IU/mL.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Point one, two

ASO
Twopoint
546 nm
IU/mL
0
0 IU/mL
800 IU/mL
(...)
3
1
*
(...)
No
ASO
No
25 mL
300 L
300 L
3 L
2 L
12, 110 sec.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

0 IU/mL
200 IU/mL
0 IU/mL
200 IU/mL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

-0.050
3.000
-0.050
0.900
0.150
Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0012

COMPLEMENT COMPONENT C3
Turbidimetry

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Complement component C3 precipitates in the presence of anti-human C3 Reagent 1: Use the Reagent A.
antibodies. The originated turbidity is proportional to the C3 concentration and Reagent 2: Use the Reagent B.
can be measured by turbidimetry.
Serum or plasma treated with heparin or EDTA.
Stable 2 days at 2-8 C.
Hemolyzed or lipemic samples are not suitable for testing.

The measurement interval depends on concentration of the highest


standard.
Due to the zone effect, falsely low values will be obtained when C3 is
present in the sample at a concentration higher than 600 mg/dL.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
DUAL MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
R2 Bottle
Normal Volume
Rerun Volume
Predilution
Slope Blank
Point one, two

Complement C3
Twopoint
340 nm
mg/dL
0
0 mg/dL
600 mg/dL
(...)
2
5
*
(...)
No
Complement C3
No
25 mL
220 L
220 L
3 L
3 L
5 mL
50 L
50 L
No
No
-3, 236 sec.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

90 mg/dL
180 mg/dL
90 mg/dL
180 mg/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

-0.050
3.000
-0.050
3.000
0.000
Yes
(...)
(...)
1.00

... Data entered by the operator


* assigned value of standard
Version 0109

COMPLEMENT COMPONENT C4
Turbidimetry

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Complement component C4 precipitates in the presence of anti-human C4 Reagent 1: Use the Reagent A.
antibodies. The originated turbidity is proportional to the C4 concentration and Reagent 2: Use the Reagent B.
can be measured by turbidimetry.
Serum or plasma treated with heparin or EDTA.
Stable 2 days at 2-8 C.
Hemolyzed or lipemic samples are not suitable for testing.

The measurement interval depends on concentration of the highest


standard.
Due to the zone effect, falsely low values will be obtained when C4 is
present in the sample at a concentration higher than 150 mg/dL.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
DUAL MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
R2 Bottle
Normal Volume
Rerun Volume
Predilution
Slope Blank
Point one, two

Complement C4
Twopoint
340 nm
mg/dL
0
0 mg/dL
150 mg/dL
(...)
2
5
*
(...)
No
Complement C4
No
25 mL
220 L
220 L
9 L
4 L
5 mL
50 L
50 L
No
No
-3, 236 sec.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

10 mg/dL
40 mg/dL
10 mg/dL
40 mg/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

-0.050
3.000
-0.050
3.000
0.000
Yes
(...)
(...)
1.00

... Data entered by the operator


* assigned value of standard
Version 0102

C-REACTIVE PROTEIN (CRP)

Turbidimetry
LATEX

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Serum C-reactive protein (CRP) causes agglutination of the latex particles Working Reagent: Pour the contents of a Latex vial into a Diluent bottle. Mix
coated with anti-human C-reactive protein. The agglutination of the latex thoroughly.
particles is proportional to the CRP concentration and can be measured by Stable for 20 days at 2-8C.
turbidimetry.
Serum.
Stable for 7 days at 2-8 C.
Hemolyzed or lipemic samples are not suitable for testing..

Linearity: Up to 150 mg/L.


Interferences: Rheumatoid factors, up to 200 IU/mL, do not interfere.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Point one, two

CRP
Twopoint
546 nm
mg/L
0
0 mg/L
150 mg/L
(...)
3
1
*
(...)
No
CRP
No
25 mL
398 L
398 L
2 L
1 L
12, 110 sec.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

0 mg/L
6 mg/L
0 mg/L
6 mg/L

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

-0.050
3.000
-0.050
0.900
2.000
Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0012

C-REACTIVE PROTEIN-hs (CRP-hs)


Turbidimetry
LATEX-HIGH SENSITIVITY

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Serum C-reactive protein (CRP) causes agglutination of the latex particles Working Reagent: Pour the contents of a Reagent B vial into a Reagent A
coated with anti-human C-reactive protein. The agglutination of the latex bottle. Mix thoroughly.
particles is proportional to the CRP concentration and can be measured by Stable for 20 days at 2-8C.
turbidimetry.
Serum.
Stable for 7 days at 2-8 C.

Measurement: 0.06-15 mg/L.


Interferences: Hemoglobin (10 g/L) and lipemia (triglycerides 10 g/L) do
not interfere. Bilirubin (>10 mg/dL) and rheumatoid factors (>75 IU/mL)
may interfere.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Point one, two

CRP-hs
Twopoint
546 nm
mg/L
1
0 mg/L
15 mg/L
(...)
3
1
*
(...)
No
CRP-hs
No
25 mL
225 L
225 L
3 L
2 L
12, 304 sec.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

0 mg/L
5 mg/L
0 mg/L
5 mg/L

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

-0.050
3.000
1.000
1.700
2.000
Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0203

IMMUNOGLOBULIN A (IgA)
Turbidimetry

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Immunoglobulin A precipitates in the presence of anti-human immunoglobulin Reagent 1: Use the Reagent A.
A antibodies. The originated turbidity is proportional to the immunoglobulin A Reagent 2: Use the Reagent B.
concentration and can be measured by turbidimetry.
Use the Working Reagent if MONO MODE.
Serum or plasma treated with heparin or EDTA.
Stable for 7 days at 2-8 C.
Hemolyzed or lipemic samples are not suitable for testing.

The measurement interval depends on concentration of the highest


standard.
Due to the zone effect, falsely low values will be obtained when IgA is
present in the sample at a concentration higher than 1300 mg/dL.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
DUAL MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
R2 Bottle
Normal Volume
Rerun Volume
Predilution
Slope Blank
Point one, two

Ig A
Twopoint
620 nm
mg/dL
0
0 mg/dL
1300 mg/dL
(...)
2
5
*
(...)
No
Ig A
No
25 mL
220 L
220 L
3 L
2 L
5 mL
50 L
50 L
No
No
-3, 236 sec.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

70 mg/dL
400 mg/dL
70 mg/dL
400 mg/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

-0.050
3.000
-0.050
3.000
0.000
Yes
(...)
(...)
1.00

... Data entered by the operator


* assigned value of standard
Version 0110

IMMUNOGLOBULIN G (IgG)
Turbidimetry

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Immunoglobulin G precipitates in the presence of anti-human immunoglobulin Reagent 1: Use the Reagent A.
G antibodies. The originated turbidity is proportional to the immunoglobulin G Reagent 2: Use the Reagent B.
concentration and can be measured by turbidimetry.
Use the Working Reagent if MONO MODE.
Serum or plasma treated with heparin or EDTA.
Stable for 7 days at 2-8 C.
Hemolyzed or lipemic samples are not suitable for testing.

The measurement interval depends on concentration of the highest


standard.
Due to the zone effect, falsely low values will be obtained when IgG is
present in the sample at a concentration higher than 8000 mg/dL.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
DUAL MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
R2 Bottle
Normal Volume
Rerun Volume
Predilution
Slope Blank
Point one, two
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Point one, two

Ig G
Twopoint
620 nm
mg/dL
0
0 mg/dL
8000 mg/dL
(...)
2
5
*
(...)
No
Ig G
No
25 mL
220 L
220 L
2 L
2 L
5 mL
50 L
50 L
No
No
-3, 236 sec.
Ig G
No
25 mL
250 L
250 L
5 L
5 L
12, 70 sec.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

700 mg/dL
1600 mg/dL
700 mg/dL
1600 mg/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

-0.050
3.000
-0.050
3.000
0.000
Yes
(...)
(...)
1.00

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit

0.000
3.000
0.000
3.000
0.100
Yes
(...)

... Data entered by the operator


* assigned value of standard
Version 0109

IMMUNOGLOBULIN M (IgM)

Turbidimetry

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Immunoglobulin M precipitates in the presence of anti-human immunoglobulin Reagent 1: Use the Reagent A.
M antibodies. The originated turbidity is proportional to the immunoglobulin M Reagent 2: Use the Reagent B.
concentration and can be measured by turbidimetry.
Serum or plasma treated with heparin or EDTA.
Stable for 7 days at 2-8 C.
Hemolyzed or lipemic samples are not suitable for testing.

The measurement interval depends on concentration of the highest


standard.
Due to the zone effect, falsely low values will be obtained when IgM is
present in the sample at a concentration higher than 600 mg/dL.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
DUAL MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
R2 Bottle
Normal Volume
Rerun Volume
Predilution
Slope Blank
Point one, two

Ig M
Twopoint
340 nm
mg/dL
0
0 mg/dL
600 mg/dL
(...)
2
5
*
(...)
No
Ig M
No
25 mL
220 L
220 L
5 L
3 L
5 mL
50 L
50 L
No
No
-3, 236 sec.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

40 mg/dL
230 mg/dL
40 mg/dL
230 mg/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

-0.050
3.000
-0.050
3.000
0.000
Yes
(...)
(...)
1.00

... Data entered by the operator


* assigned value of standard
Version 0102

ALBUMIN (URINE)

Turbidimetry
LATEX

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Albumin in the urine sample causes agglutination of the latex particles coated Working Reagent: Pour the contents of a Latex vial into a Diluent bottle. Mix
with anti-human albumin. The agglutination of the particles is proportional to thoroughly. Stable for 8 hours at 2-8C.
the albumin concentration and can be measured by turbidimetry.
Urine.
Stable for 7 days at 2-8 C.
Urine should be centrifugated befor analysis.

Linearity: Up to 130 mg/L.


The zone effect will cause to obtain falsely low values when albumin is
present in the sample at a concentration higher than 1000 mg/L.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
MONO MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
Point one, two

Albumin (Urine)
Twopoint
546 nm
mg/L
0
0 mg/L
130 mg/L
(...)
3
1
*
(...)
No
Albumin (Urine)
No
25 mL
300 L
300 L
2 L
1 L
12, 110 sec.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

0 mg/L
15 mg/L
0 mg/L
15 mg/L

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

-0.050
3.000
-0.050
0.900
0.200
Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0012

RHEUMATOID FACTORS (RF)

Turbidimetry
LATEX

Linear calibration

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Rheumatoif factors (RF) cause agglutination of the latex particles coated with Reagent 1: Use the Diluent.
human gamma-globulin. The agglutination of the latex particles is proportional Reagent 2: Use the Latex.
to the RF concentration and can be measured by turbidimetry.
Serum.
Stable for 7 days at 2-8 C.
Hemolyzed or lipemic samples are not suitable for testing..

Linearity: Up to 120 IU/mL.


This method has not zone effect up to 800 IU/mL.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
DUAL MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
R2 Bottle
Normal Volume
Rerun Volume
Predilution
Slope Blank
Point one, two

RF
Twopoint
620 nm
IU/mL
1
0 IU/mL
120 IU/mL
(...)
2
1
*
(...)
No
RF
No
25 mL
350 L
270 L
3 L
2 L
25 mL
40 L
30 L
No
No
-3, 120 sec.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

0 IU/mL
20 IU/mL
0 IU/mL
20 IU/mL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

-0.050
3.000
-0.050
3.000
2.000
Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0012

RHEUMATOID FACTORS (RF)

Turbidimetry
LATEX

Non linear calibration

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Rheumatoif factors (RF) cause agglutination of the latex particles coated with Reagent 1: Use the Diluent.
human gamma-globulin. The agglutination of the latex particles is proportional Reagent 2: Use the Latex.
to the RF concentration and can be measured by turbidimetry.
Serum.
Stable for 7 days at 2-8 C.
Hemolyzed or lipemic samples are not suitable for testing..

Linearity: Up to highest value of standard.


This method has not zone effect up to 800 IU/mL.

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
DUAL MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
R2 Bottle
Normal Volume
Rerun Volume
Predilution
Slope Blank
Point one, two

RF
Twopoint
620 nm
IU/mL
1
0 IU/mL
... IU/mL
(...)
2
5
*
(...)
No
RF
No
25 mL
350 L
270 L
3 L
2 L
25 mL
40 L
30 L
No
No
-3, 120 sec.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

0 IU/mL
20 IU/mL
0 IU/mL
20 IU/mL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

-0.050
3.000
-0.050
3.000
2.000
Yes
(...)
(...)

... Data entered by the operator


* assigned value of standard
Version 0106

TRANSFERRIN
Turbidimetry

Instrument:

SELECTRA 2

Principle of the method

Reagent preparation

Samples

Performance characteristics

Transferrin precipitates in the presence of anti-human transferrin antibodies. Reagent 1: Use the Reagent A.
The originated turbidity is proportional to the transferrin concentration and can Reagent 2: Use the Reagent B.
be measured by turbidimetry.
Serum or plasma treated with heparin or EDTA.
Stable for 7 days at 2-8C.

Interferences: Hemoglobin (10 g/L), bilirubin (20 mg/dL) and Rheumatoid


factors (300 UI/mL) do not interfere. Lipemia does not affect the results (5
g/L).

Instrument settings
Name
Mode
Wavelength
Units
Decimals
Low Concentration
High Concentration
Calibrator Name
Repeat
Number
Concentration
Interval
Cut-off
DUAL MODE
Name
Sample Blank
R1 Bottle
Normal Volume
Rerun Volume
Sample
Normal Volume
Rerun Volume
R2 Bottle
Normal Volume
Rerun Volume
Predilution
Slope Blank
Point one, two

Transferrin
Twopoint
340 nm
mg/dL
0
0 mg/dL
... mg/dL
(...)
2
5
*
(...)
No
Transferrin
No
25 mL
220 L
220 L
2 L
4 L
5 mL
50 L
50 L
No
No
-3, 236 sec.

Prozone Check

No

Ref. Male Low


Ref. Male High
Ref. Female Low
Ref. Female High

200 mg/dL
360 mg/dL
200 mg/dL
360 mg/dL

Correlation Factor
Correlation Offset

1.000
0.000

Low Absorbance
High Absorbance
R. Abs. Low Limit
R. Abs. High Limit
R. Abs. Deviation
Reagent Blank
Cal. Low Limit
Cal. High Limit
Factor

-0.050
3.000
-0.050
3.000
0.000
Yes
(...)
(...)
1.00

... Data entered by the operator


* assigned value of standard
Version 0105

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