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Assay Chart May 2004

076D0003-04 Rev. A, 2004-05 ACS:180 Assay Chart (based on version 1.0.BP TDef) Page of 6 1

The information in this chart is based on Version 1.0.BP Test Definitions.
Assay availability depends on regulatory status in each country.

Reagent Probes Calibrator
Assay
T
y
p
e

Assay
Range
Ancillary Reagent,
Wash, Conditioning
Reagents
Diluent
Sample
Vol
(uL)
Probe 1
SP, LR, R
(uL)
Probe 2
SP, LR
(uL)
Probe 3
SP, LR
(uL)
W
a
s
h
e
s

ID
Vol
(mL)
Recon
Stability
(days)
Ratio Range
Cal
Interval
(days)
Comments

THYROID



aTG C 10 -500 U/mL ---
Onboard
aTG Dil
40 100 LR 200 SP --- 2 1
1
liq
--- 0.200 0.500 14
aTGxWHO C TBD --- --- 40 100 LR 200 SP --- 2 1
1
liq
--- TBD 14
aTPO C 10 1300 U/mL ---
Onboard
aTPO Dil
30 100 LR 200 SP --- 2 O
1
liq
---
0.006
0.106
14
Do not run in random access with ACS:180
Testosterone assay
aTPOxWHO C TBD --- --- 30 100 LR 200 SP --- 2 O
1
liq
--- TBD 14
FrT4 C 0.1 - 12 ng/dL --- --- 25
450 SP
100 LR
--- --- 1 A 5 28 0.200-0.400 7
FT3 C 0.2 - 20 pg/mL --- --- 50 100 LR --- 450 SP 1 A 5 28 0.030-0.300 28 Sequential One Antibody Procedure
T3 C 0.2 - 8 ng/mL
Rel Rgt
100 tests/5 mL
Manual
T3
Diluent
50
300 SP
100 LR
--- --- 1 A 5 28 0.150-0.700 7 Releasing Agent onboard stability is 8 hours.
T4 C 0.5 - 30 ug/dL
Rel Rgt
100 tests/5 mL
Manual
T4
Diluent
25
250 SP
100 LR
--- --- 1 A 5 28 0.100-0.550 15 Releasing Agent onboard stability is 8 hours.
TSH S
0.011 - 150
uIU/mL
(OPTIONAL)
Wash Rgt.#1
25 tests/5 mL
Onboard
Multi-Dil
1

200
225 SP
50 LR
--- --- 2 B 5 28 75 - 1100 28
Use of Reagent Wash 1 at the discretion of
user.
Large sample volume.
TSH3 S
0.004 - 150
uIU/mL
Wash Rgt #1
25 tests/5 mL
Onboard
Multi-Dil
1
200 100 LR 225 SP --- 2 TSH-3 2 28 300.0-1200.0 28 Calibrator onboard stability is 4 hours.
TUP C --- --- --- 20 ---
450 SP
100 LR
--- 1 A 5 28 --- 28
iPTH
S
1.5 - 1900 pg/mL
Wash Rgt #3
20 tests/5mL
Onboard
Multi-Dil
11
200 50 LR --- 200 SP 2 iPTH 1 4 hrs
8.3 30.5
14


076D0003-04 Rev. A, 2004-05 ACS:180 Assay Chart (based on version 1.0.BP TDef) Page of 6

2



Reagent Probes Calibrator
Assay
T
y
p
e

Assay
Range
Ancillary Reagent,
Wash, Conditioning
Reagents
Diluent
Sample
Vol
(uL)
Probe 1
SP, LR, R
(uL)
Probe 2
SP, LR
(uL)
Probe 3
SP, LR
(uL)
W
a
s
h
e
s

ID
Vol
(mL)
Recon
Stability
(days)
Ratio Range
Cal
Interval
(days)
Comments



REPRODUCTIVE
ESTRAD6 C 10 - 1000 pg/mL
Antibody Reagent
50 tests/2.5 mL.
Onboard
Multi-Dil
9
50 ---
250 SP
50 LR
--- 1 E2-6 2 28 0.120-0.250 14
Special handling required. See package
insert.
ESTRA6II C 10 1000 pg/mL
Antibody Reagent
50 tests/2.5 mL.
Onboard
Multi-Dil
9
50 ---
250 SP
50 LR
--- 1 6 2 28 0.120-0.250 14
Special handling required. See package
insert.
FSH S 0.3 - 200 mIU/mL ---
Onboard
Multi-Dil
1
100 50 LR --- 225 SP 2 B 5 28 10.00-125.00 14
LH2 S 0.07 - 200 IU/mL ---
Onboard
Multi-Dil
1
50 100 LR --- 400 SP 2 B 5 28 20.00-70.00 28
PRGE C 0.11 - 60 ng/mL
Rel Rgt
50 tests/5 mL
Wash Rgt #2
20 tests/5 mL
Onboard
Multi-Dil
3
20 100 LR 200 SP --- 2 E 2 14 0.100-0.250 7
PROLACT S 0.3 -200 ng/mL ---
Onboard
Multi-Dil
1
25 100 LR --- 450 SP 2 B 5 28 10.00-50.00 28
TESTOST C 10 - 1500 ng/dL
Rel Rgt
100 tests/5 mL
Wash Rgt #2
20 tests/5 mL
Manual
Multi-Dil 3
15 ---
300 SP
50 LR
--- 2 E 2 14 0.280-0.500 7
THCG S 2 - 1000 mIU/mL
Wash Rgt #1
25 tests/5 mL
Onboard
ThCG Dil
50
450 SP
100 LR
--- --- 2 B 5 28 10.00-60.00 28

076D0003-04 Rev. A, 2004-05 ACS:180 Assay Chart (based on version 1.0.BP TDef) Page of 6

3

Reagent Probes Calibrator
Assay
T
y
p
e

Assay
Range
Ancillary Reagent,
Wash, Conditioning
Reagents
Diluent
Sample
Vol
(uL)
Probe 1
SP, LR, R
(uL)
Probe 2
SP, LR
(uL)
Probe 3
SP, LR
(uL)
W
a
s
h
e
s

ID
Vol
(mL)
Recon
Stability
(days)
Ratio Range
Cal
Interval
(days)
Comments


ANEMIA

FERRITIN S 0.5 - 1650 ng/mL ---
Onboard
Multi-Dil 1
25
450 SP
100 LR
--- --- 2 C 5 28 35.00-125.00 28
FolateBA C 0.25 24 ng/mL
Rel Rgt/DTT
50 tests/3 mL
Onboard
Folate Dil
130
200 SP
100 R
--- 100 LR 1 Folate 3 7 0.100-0.700 7
Special handling required. See package
insert.
Rel Rgt/DTT = 1:2 with 108 hour onboard
stability.
Ascorbic Acid needed for RBC Folate
determination.
VB12 C 30 - 2000 pg/mL
Rel Rgt/DTT
30 tests/4 mL
Onboard
VB12-Dil
100 200 SP --- 200 LR 1 C 5 28 0.150-0.57 28
DTT/Rel=1:40 with 8 hour onboard stability.
Protect controls from light.


CARDIOVASCULAR

BNP S TBD
Wash Reagent 4
30 tests/5mL
Onboard
Multi-Dil 1
100 100 LR --- 200 SP 2 38 2 5 77 369 42
Calibrator onboard stability is 8 hours.
Sample Tube Type is EDTA plasma in plastic
tube.
CKMB S 0.65 500 ng/mL ---
Onboard
CKMB Dil
100 50 LR --- 225 SP 2 CK 2 14 4.00-15.00 7 Serum samples only recommended.
CKMBII S 0.18 - 300 ng/mL ---
Onboard
CKMB Dil
100 50 LR --- 225 SP 2 CK 2 14 4.00-15.00 7
Serial specimens should either be all serum
or all plasma.
cTnI S 0.07 - 50.0 ng/mL ---
Onboard
cTnI Dil
100 100 LR 200 SP --- 2 U 2 1 25.00-200.00 28
Serial specimens should either be all serum
or all plasma.
Calibrator onboard stability is 4 hours.
HCY
C
0 65 umol/L
Reducing reagent
500 tests/10 mL
Onboard
HCY
Diluent
20 50E 250 SP 100 LR 2 88 2 liq. ---
0.01 0.24
28
MYO S 3.0 - 1000 ng/mL ---
Onboard
MYO Dil
10 100 LR 200 SP --- 2 U 2 1 3.0-15.0 28
Serial specimens should either be all serum
or all plasma.
076D0003-04 Rev. A, 2004-05 ACS:180 Assay Chart (based on version 1.0.BP TDef) Page of 6

4

Reagent Probes Calibrator
Assay
T
y
p
e

Assay
Range
Ancillary Reagent,
Wash, Conditioning
Reagents
Diluent
Sample
Vol
(uL)
Probe 1
SP, LR, R
(uL)
Probe 2
SP, LR
(uL)
Probe 3
SP, LR
(uL)
W
a
s
h
e
s

ID
Vol
(mL)
Recon
Stability
(days)
Ratio Range
Cal
Interval
(days)
Comments



ONCOLOGY
AFP S 0.9 - 1000 ng/mL
AFP Wash Rgt
25 tests/5 mL
Manual
Multi-Dil 2
10
250 SP
50 LR
--- --- 2 D 2 28 8.00-35.00 7
Do not run in random access with ACS:180
BR assay.
B2MS C 0.3 38 mg/L ---
Onboard
B2MS Dil
10
180 SP
50 LR
--- --- 1 4 B2M-S 2 4 hrs --- 7
B2MU
C
45 2000 ug/L
B2M-U Stabilizer
(Anc. Rgt.)
150 tests/5 mL
Onboard
B2M-U Dil
100
180 SP
50 LR
--- --- 1 5 B2M-U 2 4 hrs
0.14 0.33
7
B2MGS C --- ---
Onboard
B2M-U Dil
20 50 LR 180 SP --- 1 4 B2M-S 2 4 hrs
0.07 0.25
7
B2MGU C ---
B2M-U Stabilizer
(Anc. Rgt.)
150 tests/5 mL
Onboard
B2M-U Dil
100
180 SP
50 LR
--- --- 1
5
B2M-U
2 4 hrs
0.14 0.33
7
BR C 3.5 - 450 U/mL
BR pretreatment
reagent
225 tests/5 mL
Onboard
Multi-Dil 1
25
250 SP
50 LR
--- --- 2 G 2 28 0.10-0.30 7
BR1 C --- ---
Onboard
Multi-Dil 1
25
250 SP
50 LR
--- --- 2 G 2 28 0.150-0.250 5
C199 S 2 500 U/L ---
Onboard
CA19-9 Dil
75
450 SP
100 LR
--- --- 2 9 2 14 0.20-38.80 28
CA199
S
2 - 500 U/L ---
Manual
CA 19-9 Dil
25
250 SP
50 LR
--- --- 2 9 2
Recon
each
day
0.20 38.8
4 Reconstitute on the day of use.
CEA S 0.5 - 100ng/mL
Wash Rgt #1
25 tests/5 mL
Onboard
CEA-Dil
50
250 SP
50 LR
--- --- 2 D 2 28 5.00-25.00 14
cPSA
S
0.03 - 100 ng/mL
cPSA pretreatment
500 tests/5 mL
Onboard
Multi-Dil 2
36
250 SP
100 LR
--- --- 2 Y 2 21
108 596
21
Pretreatment reagent stability is 8 hours at
room temperature.
FPSARUO S 0.1 20 ng/mL --- --- 50
250 SP
100 LR
--- --- 2 fPSA
Recon
before
each
run
5.00-20.00
8
hrs

OV S 1.7 1000 U/mL ---
Onboard
Multi-Dil 8
50
250 SP
50 LR
--- --- 2 X 2 7 15.00-35.00 14
ONCOLOGY continued on next page.
076D0003-04 Rev. A, 2004-05 ACS:180 Assay Chart (based on version 1.0.BP TDef) Page of 6

5

Reagent Probes Calibrator
Assay
T
y
p
e

Assay
Range
Ancillary Reagent,
Wash, Conditioning
Reagents
Diluent
Sample
Vol
(uL)
Probe 1
SP, LR, R
(uL)
Probe 2
SP, LR
(uL)
Probe 3
SP, LR
(uL)
W
a
s
h
e
s

ID
Vol
(mL)
Recon
Stability
(days)
Ratio Range
Cal
Interval
(days)
Comments



ONCOLOGY continued
PSA S --- --- 35
250 SP
100 LR
--- --- 2 Q 2 21 77.00-750.00 21
PSA2 S 0.06 135 ng/mL ---
Onboard
Multi-Dil 2
100
250 SP
50 LR
--- --- 2 D 2 28 20.00-175.00 28


THERAPEUTIC DRUG MONITORING

CARB C 0.25 - 18.0 ug/mL ---
Onboard
Multi-Dil 5
15
400 SP
100 LR
--- --- 2 Z 5 28 0.180-0.360 28
DIGITOXN C 1.5 - 80 ng/mL ---
Onboard
Multi-Dil 5
10 50 LR 250 SP --- 2 Z 5 28 0.350-0.600 21
DIGOXIN C 0.1 - 5.0 ng/mL ---
Manual
Multi-Dil 4
50 50 LR --- 250 SP 2 B 5 28 0.250-0.700 7
GENT C 0.17 - 12 ug/mL
Wash Rgt 3
20 tests/5 mL
Uses Conditioning
Reagents for Reagent
Probe 1
Onboard
Multi-Dil 7
15
400 SP
100 LR
--- --- 2 Gent 2 28 0.200-0.500 28
PHENOB C 0.40 - 80 ug/mL
Rel Rgt
100 tests/5 mL
Manual
Multi-Dil 5
10 400 SP --- 50 LR 2 PHN B
2
liq.
--- 0.120-0.300 28
PHENY C 0.5 - 40 ug/mL ---
Onboard
Multi-Dil 5
10
400 SP
100 LR
--- --- 2 PHTN
2
liq.
Exp. 0.100-0.400 28
THEO C 0.3 - 40 ug/mL ---
Onboard
Multi-Dil 3
20
450 SP
100 LR
--- --- 2 A 5 28 0.150-0.500 7
SP/LR onboard stability is 32 hours.
Do not run in random access with CKMBII,
Digoxin, Estradiol, LH2, PROG, T4, TSH-3,
and BR.
THEO2 C 0.5 40 ug/mL ---
Onboard
Multi-Dil 3
20
450 SP
100 LR
--- --- 2 A 5 28 0.15 - 0.35 14
TOBR C 0.18 - 13 ug/mL
Wash Reagent 3
20 tests/5 ml
Onboard
Multi-Dil 5
50
400 SP
100 LR
--- --- 2 Z 5 28 0.07 - 0.63 14
SP/LR onboard stability is 32 hours.
Do not run in random access with ACS:180
AFP assay.
Wash 3 onboard stability is 8 hours.
VALP C 1 - 150 ug/mL ---
Onboard
Multi-Dil 5
25
300 SP
100 LR
--- --- 1 Z 5 28 0.07 - 0.48 14
Solid Phase and Lite Reagent must
be stored protected from light at 4 -
8C
VANCO C 0.67 - 90 ug/mL ---
Onboard
Multi-Dil 7
40
400 SP
100 LR
--- --- 2 Vanco 2 7 0.050-0.140 28
076D0003-04 Rev. A, 2004-05 ACS:180 Assay Chart (based on version 1.0.BP TDef) Page of 6

6

Reagent Probes Calibrator
Assay
T
y
p
e

Assay
Range
Ancillary Reagent,
Wash, Conditioning
Reagents
Diluent
Sample
Vol
(uL)
Probe 1
SP, LR, R
(uL)
Probe 2
SP, LR
(uL)
Probe 3
SP, LR
(uL)
W
a
s
h
e
s

ID
Vol
(mL)
Recon
Stability
(days)
Ratio Range
Cal
Interval
(days)
Comments


OTHER
CORTISOL C 0.2 - 75 ug/dL ---
Onboard
Multi-Dil
3
20 ---
250 SP
50 LR
--- 2 E 2 14 0.11-0.35 7
Urine Cortisol should not be run in random
access with other ACS:180 assays except for
ACS:180 serum Cortisol.
Onboard stability for SP/LR is 32 hours.
CpS
S
0.05 - 30 ng/mL ---
Onboard
Multi-Dil
10
50
250 SP
100 LR
--- --- 2 67
1
liq
---
40.9 143
14
DPD C 5.0 nM - 350 nM ---
Onboard
DPD Dil
20 100 LR 180 SP --- 1 DPD 2 28 0.200-0.500 4
Urine for specimen. Centrifuge urine
samples before use. Calibrate every 4 days
or after 8 cumulative hours.
IGE S 1.5 - 3000 IU/mL ---
Onboard
IgE Diluent
30
450 SP
100 LR
--- --- 2 B 5 28 10.00-125.00 7
Do not run in random access with ACS:180
BR assay.
IRI S 0.1 - 300 mU/L ---
Onboard
IRI Dil
25 50 LR --- 250 SP 2 66
1
liq
--- 4.38 129 14


Footnotes:

C and S denote competitive or sandwich assays.

Number of tests per 5 mL is based on an average 5 mL sample cup volume.

SP, LR, R denote Solid Phase, Lite Reagent, Releasing Reagent

To identify the acceptability of the calibration curve, determine if the ratio is acceptable and
then compare control values to expected values. If controls are out of range, prepare fresh
reagents, calibrators, and controls, perform routine cleaning, and then recalibrate the tests.

Primary reagent cumulative 40 hours stability at room temperature unless otherwise noted.

Refer to package insert for specifics on assay principle, specimen collection and handling,
reagent information including preparation, calibrating the assay, quality control, assay
procedure and notes, limitations, expected values, performance characteristics, technical
assistance and references.

Calibrator U reconstituted stability is 1 day stored refrigerated and 60 days frozen at less
than or equal to -20 degrees C.

Currently available outside the United States only.

The information in this chart is updated to Version 1.0.BP Test Definitions and is correct at the
time of printing. However, Bayer HealthCare continues to improve products, and reserves the
right to change specifications, equipment, and maintenance procedures at any time without
notice. For current information, refer to the package insert.

Not all assays may be available in your area, contact your local technical support provider or
distributor for availability.



ACS:180 is a trademark of Bayer HealthCare LLC.
! 2004 Bayer HealthCare LLC. All rights reserved.
Bayer HealthCare LLC., Tarrytown, New York 10591-5097 USA