Biotecnica BT 2000/3000 plus instructions

rev 423.0.2 - 2010-08-01

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

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Biotecnica BT 2000/3000 plus instructions

rev 423.0.2 - 2010-08-01
Warning!
These programs should be used only as guideline.
To check the reagent correct setting on the
instrument, use only good quality control sera
and work accordingly to with good laboratory
practice. Instrumental factor must be checked.
Chema Diagnostica will not be responsible for
instrumental bad programming.

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 3 of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:


Storage:

Stability:

Biotecnica BT 2000/3000 plus

ACID PHOSPHATASE (TOTAL) - Codes AC 0120 TC
POWDER SINGLE REAGENT.
FOLLOW PREPARATION PROGRAM INDICATED IN INSERT SHEET.
REFRIGERATE AT 2-8C
10 DAYS
PROGRAM

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

HILLMAN
KINETIC
LINEAR
405/700
INCREASE
300
0
(INACTIVE)
300
0
300
UI/L

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

ACP TOTAL
30
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
INITIAL ABS
(mABS)
FINAL ABS
(mABS)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:
:
:

2.00
75
1000
2000
500
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 9.00
0.00 / 0.00
0.00 / 0.00

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
INCUBATION TIME
(SEC)
DELAY TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

1
1
INACTIVE
EVERY RUN
300
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 4 of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:


Storage:

Stability:

Biotecnica BT 2000/3000 plus

ACID PHOSPHATASE (NON PROSTATIC) - Codes AC 0120 TC
POWDER SINGLE REAGENT. FOLLOW PREPARATION PROGRAM INDICATED IN INSERT
SHEET. ADD THE RIGHT QUANTITY OF L-TARTRATE.
REFRIGERATE AT 2-8C
10 DAYS

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

HILLMAN
KINETIC
LINEAR
405/700
INCREASE
300
0
(INACTIVE)
300
0
300
UI/L

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

ACP TOTAL
30
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
INITIAL ABS
(mABS)
FINAL ABS
(mABS)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:
:
:

2.00
75
1000
2000
500
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
INCUBATION TIME
(SEC)
DELAY TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

1
1
INACTIVE
EVERY RUN
300
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 5 of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Biotecnica BT 2000/3000 plus

Application:
Preparation:
Storage:
Stability:

ALBUMIN - Codes BC 0100/ 0500 / 1000 / 1500 CH

LIQUID READY TO USE SINGLE REAGENT
ROOM TEMPERATURE (2-30C)
UP TO DECLARED EXPIRATION ON REAGENT LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

BCG
END POINT
LINEAR
630/NO
INCREASE
450
0
(INACTIVE)
0
180
10
g/dl

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

ALBUMIN
3
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
6
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

4.20 / 5.50
3.70 / 5.30
0.00 / 0.00

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

2
2
INACTIVE
EVERY RUN
1000
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 6 of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

ALKALINE PHOSPHATASE FL (DGKC) - Codes AL F080 / F245 / F400 / F600 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

DGKC
KINETIC
LINEAR
405/700
INCREASE
320
80
(INACTIVE)
30/90
0
90
UI/L

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

ALP DGKC
8
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
INITIAL ABS
(mABS)
FINAL ABS
(mABS)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:
:
:

2.00
3000
1500
2500
500
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0 / 270
0 / 240
0/0

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
INCUBATION TIME
(SEC)
DELAY TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

1/1
1
INACTIVE
EVERY RUN
1200
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:

1.00

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 7 of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

ALKALINE PHOSPHATASE FL (IFCC) - Codes AF F080 / F245 / F400 / F600 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

IFCC
KINETIC
LINEAR
405/700
INCREASE
320
80
(INACTIVE)
30/90
0
90
UI/L

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

ALP IFCC
8
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
INITIAL ABS
(mABS)
FINAL ABS
(mABS)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:
:
:

2.00
3000
1500
2500
500
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

35 / 104
40 / 129
0/0

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
INCUBATION TIME
(SEC)
DELAY TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

1/1
1
INACTIVE
EVERY RUN
1200
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:

1.00

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 8 of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Biotecnica BT 2000/3000 plus

Application:
Preparation:
Storage:
Stability:

AMYLASE FL - Codes AM F060 / F120 / F245 CH

LIQUID READY TO USE SINGLE REAGENT
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

CNPG3
KINETIC
LINEAR
405/700
INCREASE
320
0
(INACTIVE)
90
0
120
UI/L
UI/L
1
1
INACTIVE
EVERY RUN
1200
100

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

AMYLASE
8
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
INITIAL ABS
(mABS)
FINAL ABS
(mABS)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:
:
:

5.00
3000
1500
2500
500
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0 / 96
0 / 96
0 / 96

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
INCUBATION TIME
(SEC)
DELAY TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

AMYLASE
8
5.00

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:

1.00
3000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0 / 480
0 / 480
0 / 480

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 9 of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

AMYLASE EPS FL - Codes EA F080 / F245 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

IFCC
KINETIC
LINEAR
405/700
INCREASE
320
80
(INACTIVE)
30/120
0
120
UI/L
UI/L
1/2
1
INACTIVE
EVERY RUN
1200
100

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

AMYLASE EPS
12
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
INITIAL ABS
(mABS)
FINAL ABS
(mABS)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:
:
:

5.00
1500
1500
2500
500
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

28 / 100
28 / 100
28 / 100

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
INCUBATION TIME
(SEC)
DELAY TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

AMYLASE EPS
12
5.00

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:

1.00
1500
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0 / 460
0 / 460
0 / 460

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 10

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

PANCREATIC ISOAMYLASE FL - Code PA F080 / F245 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

IFCC
KINETIC
LINEAR
405/700
INCREASE
320
80
(INACTIVE)
300/120
0
180
UI/L
UI/L
1/2
1
INACTIVE
EVERY RUN
1200
100

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

ISOAMYLASE
8
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
INITIAL ABS
(mABS)
FINAL ABS
(mABS)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:
:
:

2.00
2500
1500
2500
500
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

13 / 53
13 / 53
13 / 53

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
INCUBATION TIME
(SEC)
DELAY TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

ISOAMYLASE
8
2.00

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:

1.00
2500
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0 / 350
0 / 350
0 / 350

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 11

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Biotecnica BT 2000/3000 plus

Application:
Preparation:
Storage:
Stability:

BICARBONATE FL - Code BR F060 / F245 / F400 CH

LIQUID REAGENT READY TO USE
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

PEPC
END POINT
LINEAR
405 / 700
INCREASE
300
0
(INACTIVE)
0
180
10
mEq/l

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

BICARBONATE
3
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
50
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

22 / 29
22 / 29
20 / 28

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

2
2
INACTIVE
EVERY RUN
1000
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 12

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

TOTAL BILIRUBIN FL - Code DT F125 / F500 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

DCA
SAMPLE BLANK A
LINEAR
510 / 700
INCREASE
320
80
(INACTIVE)
0
180/300
10
mg/dl

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

BILIRUBIN TOTAL
20
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

5.00
20
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.20 / 1.00
0.20 / 1.00
0.20 / 1.00

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

2/2
2
INACTIVE
EVERY RUN
2000
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 13

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

DIRECT BILIRUBIN FL - Code DD F125 / F500 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

DCA
SAMPLE BLANK A
LINEAR
546 / 700
INCREASE
320
80
(INACTIVE)
0
180/300
10
mg/dl

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

BILIRUBIN DIRECT
20
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
13
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.20
0.00 / 0.20
0.00 / 0.20

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

2/2
2
INACTIVE
EVERY RUN
2000
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 14

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

CALCIUM - Code CA 0305 / 0505 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

OCP
END POINT
LINEAR
578 / 700
INCREASE
200
200
(ACTIVE)
240
0/120
10
mg/dl
mg/dl
1/2
2
INACTIVE
EVERY RUN
2000
100

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

CALCIUM
7
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
20
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

8.60 / 10.30
8.60 / 10.30
0.00 / 0.00

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

CALCIUM
7
2.00

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00
20
INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 15

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Biotecnica BT 2000/3000 plus

Application:
Preparation:
Storage:
Stability:

CALCIUM ASX - Code CA 0100 / 0500 CH

LIQUID REAGENT READY TO USE
ROOM TEMPERATURE (2-30C)
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

ARSENAZO
END POINT
LINEAR
630 / NO
INCREASE
300
0
(INACTIVE)
0
300
10
mg/dl
mg/dl
1
1
INACTIVE
EVERY RUN
2000
100

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

CALCIUM
3
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
20
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

8.6 / 10.3
8.6 / 10.3
0/0

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

CALCIUM
3
2.00

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00
20
INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 16

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Biotecnica BT 2000/3000 plus

Application:
Preparation:
Storage:
Stability:

CHLORIDE - Code CL 0100 / 0500 CH

LIQUID READY TO USE SINGLE REAGENT
ROOM TEMPERATURE (2-30C)
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

THIOCYANATE
END POINT
LINEAR
480 / 700
INCREASE
400
0
(INACTIVE)
0
300
10
mEq/l
mEq/l
2
2
INACTIVE
EVERY RUN
1500
100

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

CHLORIDE
2
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
200
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

98 / 110
98 / 110
98 / 110

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

CHLORIDE
2
2.00

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00
200
INACTIVE
1500
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 17

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Biotecnica BT 2000/3000 plus

Application:
Preparation:
Storage:
Stability:

CHOLESTEROL FL - Codes CT F100 / F400 / 100F / 150F CH

LIQUID READY TO USE SINGLE REAGENT
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

CHOD-PAP
END POINT
LINEAR
510 / 700
INCREASE
300
0
(INACTIVE)
0
300
10
mg/dl

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

CHOLESTEROL
3
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
700
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

140 / 200
140 / 200
140 /200

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

1
1
INACTIVE
EVERY RUN
2000
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 18

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

HDL-DIRECT FL - Code HD F080 / F245 / F400 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

SEL INHIBITION
SAMPLE BLANK A
LINEAR
578 / 700
INCREASE
300
100
(INACTIVE)
0
300/300
10
mg/dl

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

HDL-C
4
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
220
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

35.30 / 79.50
42.00 / 88.00
0.00 / 0.00

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

1/1
1
INACTIVE
EVERY RUN
2000
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 19

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

LDL-DIRECT FL - Code DL F080 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

SEL INHIBITION
SAMPLE BLANK A
LINEAR
578 / 700
INCREASE
300
100
(INACTIVE)
0
300/300
10
mg/dl

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

LDL-C
4
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
400
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

76 / 218
76 / 218
0.00 / 0.00

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

1/1
1
INACTIVE
EVERY RUN
2000
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 20

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

CHOLINESTERASE FL (DGKC) - Codes CH F096 / F245 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

DGKC
KINETIC
LINEAR
405/700
DECREASE
250
50
(ACTIVE)
90
0/90
90
UI/L

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

CHE
5
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
INITIAL ABS
(mABS)
FINAL ABS
(mABS)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:
:
:

2.00
440
2500
500
400
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

5600 / 11200
4200 / 10800
0.00 / 0.00

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
INCUBATION TIME
(SEC)
DELAY TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

2/2
2
INACTIVE
EVERY RUN
800
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:

1.00

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 21

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

CK-NAC FL - Codes CK F060 / F120 / F245 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

IFCC
KINETIC
LINEAR
340/700
INCREASE
300
75
(INACTIVE)
30/120
0
150
UI/L

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

CK-NAC
15
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
INITIAL ABS
(mABS)
FINAL ABS
(mABS)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:
:
:

5.00
2000
1200
2500
500
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

24 / 204
24 / 173
0/0

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
INCUBATION TIME
(SEC)
DELAY TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

2/2
2
INACTIVE
EVERY RUN
1200
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION:
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:

1.00

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 22

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

CK-MB FL - Code MB F060 / F120 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

IFCC
KINETIC
LINEAR
340/700
INCREASE
300
75
(INACTIVE)
300/120
0
300
UI/L

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

CK-MB
15
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
INITIAL ABS
(mABS)
FINAL ABS
(mABS)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:
:
:

2.00
2000
1200
2500
500
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0 / 24
0 / 24
0/0

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
INCUBATION TIME
(SEC)
DELAY TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

2/2
2
INACTIVE
EVERY RUN
1200
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:

1.00

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 23

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Biotecnica BT 2000/3000 plus

Application:
Preparation:
Storage:
Stability:

COPPER - Code CU 0100 CH

AS INDICATED IN INSERT SHEET
KEEP AT ROOM TEMP (MANDATORY!)
14 DAYS
PROGRAM

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

DI-BR-P
END POINT
LINEAR
578 / 700
INCREASE
300
0
(INACTIVE)
0
300
10
ug/dl
ug/dl
1
1
INACTIVE
EVERY RUN
2000
100

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

COPPER
20
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
500
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

70 / 140
80 / 155
80 /190

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

COPPER
50
1.00

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00
500
INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 24

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

CREATININE - Code CR 0500 / 1000 / 1500 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

JAFFE
KINETIC
LINEAR
510/700
INCREASE
200
200
(ACTIVE)
60
0/90
60
mg/dl
mg/dl
2/2
2
INACTIVE
EVERY RUN
2000
100

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

CREATININE
25
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
INITIAL ABS
(mABS)
FINAL ABS
(mABS)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:
:
:

5.00
20
1500
2500
500
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.70 / 1.20
0.60 / 1.10
0/0

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
INCUBATION TIME
(SEC)
DELAY TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

CREATININE
25
50.00

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:

1.00
20
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 25

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

GAMMA-GT FL - Codes GT F080 / F245 / F400 / F600 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

SZASZ
KINETIC
LINEAR
405/700
INCREASE
240
60
(INACTIVE)
30/90
0
120
UI/L

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

GAMMA-GT
30
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
INITIAL ABS
(mABS)
FINAL ABS
(mABS)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:
:
:

2.00
800
1500
2500
500
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0 / 50
0 / 30
0/0

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
INCUBATION TIME
(SEC)
DELAY TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

1/1
1
INACTIVE
EVERY RUN
1200
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:

1.00

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 26

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Biotecnica BT 2000/3000 plus

Application:
Preparation:
Storage:
Stability:

GLUCOSE FL - Codes GL F400 / 100F / 150F CH

LIQUID READY TO USE SINGLE REAGENT
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

GOD-PAP
END POINT
LINEAR
510 / 700
INCREASE
300
0
(INACTIVE)
0
300
10
mg/dl
mg/dl
2
2
INACTIVE
EVERY RUN
2000
100

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

GLUCOSE
3
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
500
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

70 / 105
70 / 105
70 / 105

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

GLUCOSE
3
1.00

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00
500
INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0 / 30
0 / 30
0 / 30

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 27

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

GLUCOSE UV FL - Code GL F601 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

GOD-PAP
END POINT
LINEAR
340 / 700
INCREASE
320
80
(ACTIVE)
300
0/120
10
mg/dl
mg/dl
1/1
1
INACTIVE
EVERY RUN
2000
100

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

GLUCOSE
4
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
700
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

70 / 105
70 / 105
70 / 105

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

GLUCOSE
4
1.00

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00
700
INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0 / 30
0 / 30
0 / 30

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 28

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

GOT/AST FL - Codes GO F080 / F245 / F400 / F600 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

IFCC
KINETIC
LINEAR
340/700
DECREASE
240
60
(INACTIVE)
60/120
0
120
UI/L

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

GOT/AST
30
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
INITIAL ABS
(mABS)
FINAL ABS
(mABS)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:
:
:

2.00
440
2500
500
400
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0 / 35
0 / 31
0.00 / 0.00

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
INCUBATION TIME
(SEC)
DELAY TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

2/1
2
INACTIVE
EVERY RUN
800
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:

1.00

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 29

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

GPT/ALT FL - Codes GP F245 / F400 / F600 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

IFCC
KINETIC
LINEAR
340/700
DECREASE
240
60
(INACTIVE)
60/120
0
120
UI/L

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

GPT/ALT
30
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
INITIAL ABS
(mABS)
FINAL ABS
(mABS)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:
:
:

2.00
440
2500
500
400
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0 / 45
0 / 34
0.00 / 0.00

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
INCUBATION TIME
(SEC)
DELAY TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

2/1
2
INACTIVE
EVERY RUN
800
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:

1.00

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 30

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

IRON FZ - Code FE F245 / F400 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B (READ PREPARATION IN MANUAL INSERT SHEET)
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

FERROZINE
SAMPLE BLANK A
LINEAR
578 / 700
INCREASE
300
75
(INACTIVE)
0
300/300
10
ug/dl

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

IRON
75
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
1000
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

59 / 158
37 / 145
0.00 / 0.20

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

2/2
2
INACTIVE
EVERY RUN
2000
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 31

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

LDH FL - Codes LD F060 / F120 / F245 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

DGKC
KINETIC
LINEAR
340/700
DECREASE
320
80
(INACTIVE)
60/90
0
120
UI/L

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

LDH
8
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
INITIAL ABS
(mABS)
FINAL ABS
(mABS)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:
:
:

5.00
2000
2500
500
400
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

225 / 450
225 / 450
0.00 / 0.00

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
INCUBATION TIME
(SEC)
DELAY TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

2/1
2
INACTIVE
EVERY RUN
800
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:

1.00

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 32

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

LIPASE FL - Code LP F060 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

DMRR
KINETIC
LINEAR
578/700
INCREASE
300
75
(ACTIVE)
120
0/120
120
UI/L

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

LIPASE
6
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
INITIAL ABS
(mABS)
FINAL ABS
(mABS)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:
:
:

2.00
800
1500
2500
500
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0 / 60
0 / 60
0/0

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
INCUBATION TIME
(SEC)
DELAY TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

2/2
2
INACTIVE
EVERY RUN
1200
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:

1.00

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 33

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

MAGNESIUM - Code MG 0200 / 0500 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

CALMAGITE
END POINT
LINEAR
510 / 700
INCREASE
200
200
(ACTIVE)
240
0/120
10
mEq/l
mEq/l
2/2
2
INACTIVE
EVERY RUN
2000
100

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

MAGNESIUM
4
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
8
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

1.30 / 2.10
1.30 / 2.10
1.38 / 1.74

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

MAGNESIUM
4
2.00

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00
8
INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 34

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Biotecnica BT 2000/3000 plus

Application:
Preparation:
Storage:
Stability:

MAGNESIUM XL - Code MX 0300 / 0500 CH

LIQUID REAGENT READY TO USE
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

XYL BLUE
END POINT
LINEAR
546 / 700
INCREASE
300
0
(ACTIVE)
0
240
10
mEq/l
mEq/l
2
2
INACTIVE
EVERY RUN
2000
100

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

MAGNESIUM
3
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
6
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

1.30 / 2.10
1.30 / 2.10
1.38 / 1.74

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

MAGNESIUM
3
2.00

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00
6
INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 35

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Biotecnica BT 2000/3000 plus

Application:
Preparation:
Storage:
Stability:

PHOSPHORUS - Code PH 0100 / 0500 CH

LIQUID READY TO USE SINGLE REAGENT
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

MOLIBD UV
END POINT
LINEAR
340/700
INCREASE
300
0
(INACTIVE)
0
300
10
mg/dl
mg/dl
2
2
INACTIVE
EVERY RUN
1500
100

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

PHOSPHORUS
3
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
20
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

2.50 / 4.50
2.50 / 4.50
4.00 / 7.00

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

PHOSPHORUS
3
20.00

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00
20
INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 36

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Biotecnica BT 2000/3000 plus

Application:
Preparation:
Storage:
Stability:

PROTEINS (TOTAL) - Codes TP 0100 / 0500 / 1000 / 1500 CH

LIQUID READY TO USE SINGLE REAGENT
ROOM TEMPERATURE (2-30C)
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

BIURET
END POINT
LINEAR
546/700
INCREASE
300
0
(INACTIVE)
0
300
10
g/dl

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

TOT PROTEINS
3
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
12
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

6.30 / 8.30
6.00 / 7.80
0.00 / 0.00

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

2
2
INACTIVE
EVERY RUN
1000
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 37

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Biotecnica BT 2000/3000 plus

Application:
Preparation:
Storage:
Stability:

PROTEINS HS - Code HS 0100 / 0500 CH

LIQUID READY TO USE SINGLE REAGENT
ROOM TEMPERATURE (2-30C)
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

PR
END POINT
LINEAR
578/700
INCREASE
400
0
(INACTIVE)
0
300
10
mg/dl
1
1
INACTIVE
EVERY RUN
1500
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

PROTEINS HS
2
1.00

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

5.00
500
INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

- SERUM NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

0.00

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

IUS.423.0.2

1.00

0.000
0.000
ACTIVE
INACTIVE

Directions for use

Edition 2010-08-01

page 38

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Biotecnica BT 2000/3000 plus

Application:
Preparation:
Storage:
Stability:

TRIGLYCERIDES FL - Codes TR F100 / F400 / 100F / 150F CH

LIQUID READY TO USE SINGLE REAGENT
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

GPO-PAP
END POINT
LINEAR
510 / 700
INCREASE
300
0
(INACTIVE)
0
300
10
mg/dl

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

TRIGLYCERIDES
3
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
1000
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0 / 200
0 / 200
0 /200

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

1
1
INACTIVE
EVERY RUN
2000
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

1.00

INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 39

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

UREA UV FL - Codes AZ F080 / F245 / F400 / F600 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

UREASE UV
KINETIC
LINEAR
340/700
DECREASE
320
80
(ACTIVE)
90
0/90
90
mg/dl
mg/dl
1/1
1
INACTIVE
EVERY RUN
900
100

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

UREA
4
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
INITIAL ABS
(mABS)
FINAL ABS
(mABS)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:
:
:

5.00
300
2500
500
400
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

10 / 50
10 / 50
0.00 / 0.00

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
INCUBATION TIME
(SEC)
DELAY TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

UREA
4
50.00

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:

1.00
300
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 40

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:


Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

URIC ACID T FL - Code AU F402 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

URICASE-PAP
END POINT
LINEAR
546 / 700
INCREASE
360
40
(INACTIVE)
300
0/90
10
mg/dl
mg/dl
2
2
INACTIVE
EVERY RUN
2000
100

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

URIC ACID
15
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
20
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

3.50 / 7.20
2.60 / 6.00
0.00 / 0.00

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
INCUBATION TIME
(SEC)
DELAY TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

URIC ACID
15
10.00

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00
20
INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 41

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Application:

Preparation:



Storage:

Stability:

Biotecnica BT 2000/3000 plus

URIC ACID AOX FL - Code AX F100 / F250 / F600 CH
REAGENT # 1 - USE REAGENT A
REAGENT # 2 - USE REAGENT B
REFRIGERATE AT 2-8C
UNTIL EXPIRATION DATE ON LABEL

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

URICASE-PAP-AOX
SAMPLE BLANK A
LINEAR
546 / 700
INCREASE
300
75
(INACTIVE)
0
180/300
10
mg/dl
mg/dl
2/2
2
INACTIVE
EVERY RUN
2000
100

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

URIC ACID
15
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
35
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

3.50 / 7.20
2.60 / 6.00
0.00 / 0.20

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

URIC ACID
15
10.00

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00
35
INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 42

of 43

Chema Diagnostica - Guidelines for automatic analyzers - Biotecnica BT 2000/3000 plus

Analyzer:

Biotecnica BT 2000/3000 plus

Application:
Preparation:
Storage:
Stability:

ZINC - Code ZN 0125 CH

PREPARE MIXED REAGENT AS INDICATED IN INSERT SHEET
REFRIGERATE AT 2-8C
14 DAYS

TEST METHODOLOGY

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

N-PAPS
END POINT
LINEAR
578 / 700
INCREASE
300
0
(INACTIVE)
0
300
10
g/dl

NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

ZINC
15
1.00

DILUTION:
FACTOR
TEST LIMIT (CONC)
MAX ABS DELTA
(mABS)
CHECK PROZONE
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

2.00
1000
2000
INACTIVE
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

70 / 150
70 / 150
70 /150

METHOD
KIND OF PROCESS
FILTERS
REACTION DIRECTION
REAGENT #1
REAGENT #2
SAMPLE STARTER
DELAY TIME
(SEC)
INCUBATION TIME
(SEC)
READING TIME
(SEC)
UNIT SERUM
UNIT URINE
NUMBER OF NEEDLE WASHES
NUMBER OF CUVETTE WASHES
DYNAMIC BLANK
REAGENT BLANK
REAGENT LIMIT
(mABS)
CURVE ACCEPTANCE
(%)

1
1
INACTIVE
EVERY RUN
2000
100

- URINE NAME
SAMPLE
(l)
PRE-DILUTION

:
:
:

ZINC
15
1.00

DILUTION
FACTOR
TEST LIMIT (CONC)
CHECK PROZONE
MAX ABS DELTA
(mABS)
INSTRUMENTAL FACTOR
SHIFT
RE-RUN HYPERACTIVE
RE-RUN PATHOLOGICAL

:
:
:
:
:
:
:
:

1.00
1000
INACTIVE
2000
0.000
0.000
ACTIVE
INACTIVE

NORMAL RANGE:
MALE:
FEMALE:
CHILD

:
:
:

0.00 / 0.00
0.00 / 0.00
0.00 / 0.00

- SERUM -

IUS.423.0.2

Directions for use

Edition 2010-08-01

page 43

of 43