AssayChartMay04

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 Type

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)

Was

hes

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


Assay Type

Assay Range


Reagents Diluent


SP, LR, R (uL)

Probe 2 SP, LR

(uL)

Probe 3 SP, LR

(uL)

Was

hes

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


3


Assay Type

Assay Range


Reagents Diluent


SP, LR, R (uL)

Probe 2 SP, LR

(uL)

Probe 3 SP, LR

(uL)

Was

hes

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.


4


Assay Type

Assay Range


Reagents Diluent


SP, LR, R (uL)

Probe 2 SP, LR

(uL)

Probe 3 SP, LR

(uL)

Was

hes

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 B2M�S 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 Dil25 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.


5


Assay Type

Assay Range


Reagents Diluent


SP, LR, R (uL)

Probe 2 SP, LR

(uL)

Probe 3 SP, LR

(uL)

Was

hes

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 450 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


6


Assay Type

Assay Range


Reagents Diluent


SP, LR, R (uL)

Probe 2 SP, LR

(uL)

Probe 3 SP, LR

(uL)

Was

hes

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 Diluent30 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

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AssayChartMay04