Assay Summary Tables: For Use With The Access Family of Immunoassay Systems

Assay Summary Tables
Assay Summary Tables

For use with the Access Family of Immunoassay Systems
This document is only appropriate for use outside the U.S.A.
February 2016
Revisions have been made to the Assay Summary Tables document based on the improved menu of assays
available for use on the Access Family of Immunoassay Systems.
The summary tables contain frequently referenced information for assays run on the Access systems, grouped
by assay type (Adrenal/Pituitary, Allergy, Anemia, Blood Virus, Bone Metabolism, Cardiac, Diabetes,
Infectious Disease, Inflammation, Reproductive, Thyroid, Tumor Markers, and RUO assays). The summary
information is taken from the assay Instructions For Use (IFU) documents and other Access system
documentation. For a more thorough description of an assay and its performance characteristics, refer to its IFU.
NOTE
An assay may not be available for use on all systems. In addition, the assays that are available in your
country are dependent on the status of regulatory submissions. Contact your Beckman Coulter
representative if you have questions about the availability of particular assays.
Keep the Assay Summary Tables document where it is most convenient for your laboratory.
Table of Description of Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Contents Updating Your Document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Contact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Adrenal/Pituitary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Allergy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Anemia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Blood Virus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Bone Metabolism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Cardiac. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Infectious Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Reproductive. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Thyroid. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Tumor Markers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Research Use Only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
© 2016 Beckman Coulter, Inc. All rights reserved. Page 1 of 46

P/N 2016-2155 2/2016
Access Immunoassay Systems Assay Summary Tables
Description of The Assay Summary Tables document has been updated to include TSH (3rd IS)
Changes information.
Information for all assays included in the Assay Summary Tables document has been
reviewed and updated to correspond to the current versions of the assay Instructions
for Use.
Updating Your Discard all previous versions of the Assay Summary Tables document,
Document P/N 387968A-K and B63375B, and replace with this version, P/N 2016-2155.
Contact If you have any questions about this information, or for technical assistance regarding
the Access Family of Immunoassay Systems, contact Beckman Coulter.
• In Canada, contact Beckman Coulter Technical Support by phone at
1-800-854-3633, or online at www.beckmancoulter.com. Before using online
support the first time, you will need to register online.
• Outside Canada, contact your local Beckman Coulter representative.
NOTE
Be prepared to provide your system ID.

P/N 2016-2155 2/2016
Adrenal/Pituitary
Cortisol
Adrenal/Pituitary
Test Name / LIS Code: Cortisol / Cort
Access & DxI/DxC
Test Number 119
Remisol Code A10
Catalog #s
Reagent 33600
Calibrator 33605
QC NA
Diluent* 33606 (S0)
Assay Type 1-Step Competitive
Minutes to 1st Result ~30
Reportable Range ~0.4–60 μg/dL (11-1655 nmol/L)
SI Units Conversion Factor μg/dL x 27.59
Sample Dilution if OVR 1/2
Analytical Sensitivity 0.4 μg/dL (11 nmol/L)
Expected Values** See IFU
Days Stable: Curve 28
Days Stable: Open Pack 14
Expected Total Imprecision < 12% at ~ 5 μg/dL (138nmol/L)
< 10% at > 5 μg/dL
Sample Pickup 25 μL
Sample Type Serum, Urine, Plasma (H, E)
Sample Avoid Turbidity, particulate matter,
multiple freeze/thaws
Sample Max. Time at:
RT 8 hours
2–8°C 48 hours
-20°C Undetermined
Sample Max. Thaws 1
Calibrator:
Levels, Form 6 @ 1 x 4 mL liquid
Storage, Stability 2–10°C until exp.
Primary Standard USP
QC NA
NOTES:
* For some assays, S0 Calibrator is available for separate purchase. If no S0 Calibrator part number is noted,
you must use the S0 Calibrator from the calibrator set.
** Not all expected values range subgroups may be listed. Refer to the reagent IFU document for more
information.
• The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
• Always refer to the reagent IFU document for complete product information.

P/N 2016-2155 2/2016
All ergy
Total IgE
Allergy
Test Name / LIS Code: TotIgE / IgE
Access & DxI/DxC
Test Number 123
Remisol Code A51
Catalog #s
Reagent 35000
Calibrator 35005
QC NA
Diluent* S0 (35006)
Assay Type 2-Step Sandwich
Reportable Range ~0.25–3,000 IU/mL
(0.6–7200 μg/L)
SI Units Conversion Factor IU/mL x 2.4
Sample Dilution if OVR 1/10
Analytical Sensitivity 0.25 IU/mL (0.6 μg/L)
Expected Values** 1.31–165.3 IU/mL
Expected Total Imprecision < 10%
Sample Type Serum, Plasma (H, E)
Sample Avoid Heat inactivation
RT 8 hours
2–8°C 48 hours
-20°C Undetermined
Sample Max. Thaws 1
Calibrator:
Levels, Form S0 @1 x 6 mL liquid
S1 - S6 @ 1 x 4 mL liquid
Primary Standard WHO 2nd IRP (75/502)
QC NA
NOTES:
information.

P/N 2016-2155 2/2016
Anemi a
EPO Ferritin,
EPO–Diluted*** Diluted Ferritin,
Ferritin–Diluted***
Anemia
EPO EPO–Diluted Ferritin/Dil. Fer Ferritin–Diluted
Test Name/LIS Code: EPO / EPO dEPO / dEPO Ferritin / Ferr d-Fer / d-Fer
Access & DxI/DxC Dil-Fer / dFer
Test Number 209 11209 125 11125
218 (Dil-Fer)
Remisol Code A81 A160 A19 A146
A83 (Dil-Fer)
Catalog #s
Reagent A16364 33020
Calibrator A16365 33025
QC NA NA
Diluent* S0, Samp. Dil. A (81908) S0, Samp. Dil. A (81908), or Wash Buffer II
Diluent Pack (Dilutions/Pack) A79783 (90) A79784 (102)
Assay Type 2-Site Sandwich 2-Site Sandwich
Minutes to 1st Result ~45 ~30
Reportable Range • ~0.6–750 mIU/mL (EPO) • ~0.2–1500 ng/mL (μg/L) (Ferritin)
• ~637–4500 mIU/mL (dEPO) • 1300 – ~15,000 ng/mL (μg/L) (Dil-Fer)
• ~1275–7500 ng/mL (μg/L)(d-Fer)
SI Units Conversion Factor 1 1
Sample Dilution if OVR 1/6 or 1/11 1/6 Onboard 1/5 1/5 Onboard
Analytical Sensitivity ≤ 0.6 mIU/mL 0.2 ng/mL (μg/L)
Expected Values** 2.59–18.50 mIU/mL F: 11.0–306.8 ng/mL (μg/L)
M: 23.9–336.2 ng/mL (μg/L)
Days Stable: Curve 28 28
Days Stable: Open Pack 28 28
Expected Total Imprecision ≤ 10% at > 3 mIU/mL < 10%
< 20% (Dil-Fer)
Sample Pickup 85 μL 61 μL 10 μL 66 μL
Sample Type Serum, Plasma (H) Serum, Plasma (H)
Sample Avoid Glass tube storage Gross hemolysis
RT 8 hours 8 hours
2–8×C 24 hours 48 hours
-20×C Undetermined Undetermined
Sample Max. Thaws 3 1
Calibrator:
Levels, Form S0 1 x 10 mL liquid 6 @ 1 x 4.0 mL, liquid
S1–S5 1 x 2.5 mL liquid
Storage, Stability 2–10°C until exp. or 90 days 2–10°C until exp.
after initial use
Primary Standard WHO 2nd IRP 67/343 WHO 3rd IS 94/572
QC NA NA
NOTES:
information.
*** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.

P/N 2016-2155 2/2016
Folate
RBC Folate
Folate–Diluted***
Anemia
Traceable to WHO International Standard 03/178
Folate Folate–Diluted RBC Folate
Test Name/LIS Code: FOLW/ FOLW dFOLW/dFOLW RBCW/ RBCW
Access & DxI/DxC
Test Number 156 11156 157
Remisol Code A170 A172 A171
Catalog #s
Reagent A98032
Calibrator A98033
QC N/A
Diluent* S0 (A99250) Folate, or Wash Buffer II;
Lysing Reagent - RBC Folate (A14206)
Diluent Pack (Dilutions/Pack) A79784 (174)
Assay Type 2 -Step Competitive
(Online serum pretreatment; offline RBC pretreatment)
Reportable Range • ~1.0–24.8 ng/mL (2.27 – 56.2 nmol/L) (FOLW)
• ~21–50 ng/mL (~47.6 – 112.4 nmol/L) (dFOLW)
SI Units Conversion Factor ng/mL x 2.266
Sample Dilution if OVR 1/2 1/2 Onboard 1/2
Analytical Sensitivity < 0.80 ng/mL (< 1.81 nmol/L)
Days Stable: Curve 28 days
Days Stable: Open Pack 14 days
Expected Total Imprecision ≤ 15% at > 2.0 ng/mL
≤ 0.3 ng/mL SD at ≤ 2.0 ng/mL
Sample Pickup 55 μL 155 μL Manual 1/21 predil.
Sample Type Fasting Serum, Plasma (H) Whole Blood (E, H)
Sample Avoid Exposure to light, hemolysis
RT Refrig. ASAP 1.5 hrs. (hemolysate)
2–8°C 8 hours 4 hrs. (whole blood)
-20°C 6 months See IFU (hemolysate)
Sample Max. Thaws 1
Calibrator:
Levels, Form 6 @ 1 x 4 mL, liquid
Storage, Stability -20°C or colder until exp. / 2–10°C for 90 days
Max. Thaw 1x
Primary Standard WHO IS 03/178
QC NA
Levels, Form:
Storage, Stability:
NOTES:
information.

P/N 2016-2155 2/2016
Intrinsic Factor Ab sTfR

sTfR–Diluted***
Anemia
sTfR sTfR–Diluted
Test Name / LIS Code: IFAb / IFAb sTfR / sTfR dsTfR / dsTfR
Access & DxI/DxC
Catalog #s
Reagent 387992 A32493
Calibrator 387993 A32494
QC 387999 B11056 (QC1) & B11057 (QC2 & QC3)
Diluent* NA S0 or Wash Buffer II
Diluent Pack (Dilutions/Pack) NA A79784 (70)
Assay Type 2 -Step Competitive 2 -Step Sandwich
Reportable Range NA See IFU ~128-1200
nmol/L (9.4-88.6
mg/L)
SI Units Conversion Factor NA nmol/L x 0.0738
Sample Dilution if OVR NA 1/8 or 1/15 1/8 Onboard
Analytical Sensitivity NA 0.05 nmol/L
Expected Values** See IFU See IFU
Expected Total Imprecision <10% ≤ 8% CVs at > 9nmol/L
≤ 0.72 nmol/L SD at ≤ 9nmol/L
Sample Pickup 55 μL 25 μL 55 μL
Sample Avoid Hemolysis, Plasma (E), None
Patients receiving B12
injections in the past week
RT 8 hours 8 hours
2–8°C 48 hours 7 days
-20°C Undetermined Undetermined
Calibrator:
Levels, Form 1 @ 2 x 4.0 mL, liquid S0 @ 1 x 4mL
S1-S5 @ 1 x 2.5 mL
Storage, Stability 2–10°C until exp. or 56 days Unopened: 2–10°C until exp.
after initial use Opened: 90 days @ 2-10°C
Primary Standard Internal Internal
QC
Levels, Form: 2 @ 3 x 4.0 mL liquid QC1 @ 2 x 2.5 mL
QC2 and QC3 @ 2 x 2.5 mL / Level
Storage, Stability: Unopened: 2–10°C until exp. Unopened: -20°C until exp.
Opened: 2–10°C for 56 days (thaw only 1x)
Opened: 90 days @ 2–10°C
NOTES:
information.

P/N 2016-2155 2/2016
Vitamin B12
Vitamin B12–Diluted***
Anemia
Vitamin B12 Vitamin B12–Diluted
Test Name / LIS Code: VitB12 / B12 dB12 / dB12
Access & DxI/DxC
Test Number 190 11190
Remisol Code A60 A161
Catalog #s
Reagent 33000
Calibrator 33005
QC NA
Diluent* S0 (33006) or Samp. Dil. A (81908)
Assay Type 2 -Step Competitive
(Online sample pretreatment)
st
Minutes to 1 Result ~35
Reportable Range • ~50–1500 pg/mL (37–1107 pmol/L) (VitB12)
• ~1275–7500 pg/mL (941–5533 pmol/L) (dB12)
SI Units Conversion Factor pg/mL x 0.7378
Sample Dilution if OVR 1/5 1/5 Onboard
Analytical Sensitivity 50 pg/mL (37 pmol/L)
Expected Values** 180–914 pg/mL
(133–675 pmol/L)
Expected Total Imprecision See IFU
Sample Pickup 45 μL 66 μL
Sample Type Serum, Plasma (H)
Sample Avoid Hemolysis
RT 8 hours
2–8°C 24 hours
-20°C Undetermined
Sample Max. Thaws 1
Calibrator:
Levels, Form 6 @ 1 x 4.0 mL, liquid
Primary Standard Internal
QC NA
Levels, Form:
Storage, Stability:
NOTES:
information.

P/N 2016-2155 2/2016
Bl ood Virus
HAV Ab
Blood Virus
Test Name / LIS Code: HAVAb / HAVAb
Access & DxI/DxC
Test Number 140
Remisol Code A26
Catalog #s
Reagent 34200
Calibrator 34205
QC 34209
Diluent* Wash Buffer II
Assay Type 2-Step Competitive
Reportable Range • 0.0–80 mIU/mL
See IFU
SI Units Conversion Factor NA
Sample Dilution if OVR 1/11, 1/101, or 1/1001
Analytical Sensitivity NA
Sample Type Serum, Plasma (H, E, oxalate, citrate)
Sample Avoid NA
RT 8 hours
2–8°C 48 hours
-20°C Undetermined
Sample Max. Thaws 3
Calibrator:
Levels, Form 5 @ 1 x 2.0 mL liquid
Primary Standard WHO Ref. Preparation
QC
Levels, Form: 2 @ 3 x 3.5 mL liquid
Storage, Stability: 2–10°C until exp.
NOTES:
information.

P/N 2016-2155 2/2016
HAV IgM HBc Ab
Blood Virus
Test Name / LIS Code: HAV-IgM / HAV-M HBc-Ab / HBcAb
Access & DxI/DxC
Test Number 141 143
Catalog #s
Reagent 34210 34240
Calibrator 34215 34245
QC 34219 34249
Diluent* NA NA
Assay Type 2-Step Sandwich 1-Step Sandwich
Reportable Range Reactive / Non reactive Reactive / Non reactive
See IFU
SI Units Conversion Factor NA NA
Sample Dilution if OVR NA NA
Analytical Sensitivity NA NA
Expected Total Imprecision See IFU < 10% with Reactive Samples
Sample Type Serum, Plasma (H, E, citrate) Serum, Plasma (H, E, citrate)
Sample Avoid NA Hemolysis, turbidity,
heat-inactivated
RT 8 hours 8 hours
2–8°C 48 hours 48 hours
Calibrator:
Levels, Form 2 @ 1 x 1.0 mL liquid 2 @ 1 x 1.0 mL liquid
Storage, Stability 2–10°C until exp. 2–10°C until exp.
QC
Levels, Form: 2 @ 3 x 2.5 mL liquid 2 @ 3 x 2.0 mL liquid
Storage, Stability: Unopened: 2–10°C until exp. Unopened: 2–10°C until exp.
Opened: 30 days Opened: 30 days
NOTES:
information.

P/N 2016-2155 2/2016
HBc IgM HBs Ab
Blood Virus
Test Name / LIS Code: HBc-IgM / HBc-M HBAb3 / HBAb3
Access & DxI/DxC
Test Number 142 247
Catalog #s
Reagent 34250 A24296
QC 34259 A24298
Diluent* NA Negative human serum
Reportable Range Reactive / Non reactive 0– ~750 mIU/mL
See IFU
Sample Dilution if OVR NA See IFU
Analytical Sensitivity NA • 1.87 mIU/mL with
WHO 1st IRP (W1042;
17-2-77)
• 0.81 mIU/mL with
SFTS Panel (02/08.02.22C)
Expected Total Imprecision < 10% with Reactive Samples ≤ 10% with Reactive Samples
Sample Type Serum, Plasma (H, E, citrate) Serum, Plasma (Na or Li H)
Sample Avoid Hemolysis, turbidity, Microbial contamination;
heat-inactivated Turbid samples - See IFU
RT 8 hours 8 hours
Thawed samples, or those
stored > 8 hours -See IFU for
processing information
Calibrator:
Storage, Stability 2–10°C until exp. Unopened: 2–10°C until exp.
Opened: 90 days @ 2-10°C
Primary Standard Internal WHO 1st IRP (W1042,
Lot no. 17-2-77)
QC
NOTES:
information.

P/N 2016-2155 2/2016
HBs Ag
HBs Ag Confirmatory
Blood Virus
Test Name / LIS Code: HBsAgV3 / HBsAg HBsBkV3 / HBsBk &
Access & DxI/DxC HBsCtV3 / HBsCt
Test Number 223 239 & 238
Remisol Code A98 A99 & A100
Catalog #s
Reagent A24291 A24295
Calibrator A24292 A24292
QC A24294 A24294
Diluent* NA Wash Buffer II
Assay Type 1-Step Sandwich 1-Step Sequential
Reportable Range Reactive / Confirmed /
Non reactive Non confirmed
See IFU See IFU
Sample Dilution if OVR See IFU See IFU
Analytical Sensitivity ≤ 0.1 ng/mL NA
(with French SFTS
2005 panel)
Expected Total Imprecision ≤ 10% with ≤ 10% with
Reactive Samples Reactive Samples
Sample Pickup 110 μL 2 x 110 μL
Sample Type Serum, Plasma (E, citrate, H, ACD)
Sample Avoid Turbidity, particulate matter, fibrin
RT 8 hours
2–8°C 4 days
-20°C Undetermined
Sample Max. Thaws 5
Calibrator:
Levels, Form 2 @ 1 x 2.7 mL/vial
Storage, Stability 2–10°C until exp. or 90 days after
initial use
QC
Levels, Form: 2 @ 3 x 4.0 mL liquid
Storage, Stability: Unopened: 2–10°C or -20°C until exp.
Opened: 2–10°C 56 days
NOTES:
information.

P/N 2016-2155 2/2016
Access HCV Ab Plus* Access HIV combo*
Blood Virus
Test Name / LIS Code: HCVPLUS / HCVAb HIVco / HIVco
Access & DxI/DxC
Test Number 148 262
Catalog #s
QC 34339 A59430 (Neg, HIV-1 Ab, HIV-1 Ag)
Diluent NA NA
Assay Type Indirect 2-Step 2-Step Sandwich
Reportable Range Reactive / Non reactive Reactive / Non reactive
See IFU See IFU
Sample Dilution if OVR NA NA
Analytical Sensitivity See IFU <2 IU/mL to HIV-1 p24 Ag
Expected Values See IFU See IFU
Expected Total Imprecision <10% <10%
Sample Type Serum, Plasma (EDTA, citrate, H) Serum, Plasma (Li H)
Sample Avoid NA Particulate matter
RT 8 hours 24 hours
Thawed Samples - See IFU for Thawed Samples - See IFU for
processing information processing information
Calibrator:
Levels, Form 2 @ 1 x 1 mL liquid 2 @ 1 x 1.7 mL liquid
Opened: 2–10°C 120 days
QC:
Levels, Form: 2 @ 3 x 2.5 mL liquid 3 @ 2 x 4.4 mL, liquid
Opened: 2–10°C 30 days Opened: 2–10°C 120 days
*Available through partnership with Bio-Rad. Bio-Rad and the Bio-Rad logo are registered
trademarks of Bio-Rad Laboratories, Inc.
NOTES:
• The contents of this page are under the control of Bio-Rad.
P/N 2016-2155 2/2016

13
Bon e Metabol ism
Ultrasensitive hGH Ostase

Ultrasensitive hGH–Diluted*** Ostase–Diluted***
Bone Metabolism
Ultrasensitive hGH Ultrasensitive hGH–Diluted Ostase Ostase–Diluted
Test Name / LIS Code: hGH2 / hGH2 dhGH2 / dhGH2 Ostase / Ostas dOst / dOst
Access & DxI/DxC
Test Number 232 11232 153 11153
Catalog #s
Reagent 33580 37300
QC NA 37309
Diluent* S0 or Samp. Dil. A (81908) Sample Dil. A (81908)
Reportable Range • ~0.002–35 ng/mL (μg/L) (hGH2) • 0.1 – ~120 μg/L (Ostase)
• ~34–70 ng/mL (μg/L) (dhGH2) • ~102–360 μg/L (dOst)
SI Units Conversion Factor 1 NA
Sample Dilution if OVR 1/2 1/2 Onboard 1/3, 1/5, or 1/10 1/3 Onboard
Analytical Sensitivity 0.002 ng/mL 0.1 μg/L
Expected Values** F: 0.010–3.607 ng/mL Males: ≤ 20.1 μg/L
M: 0.003–0.971 ng/mL Females:
Premen.: ≤ 14.3 μg/L
Post men.: ≤ 22.4 μg/L
Expected Total Imprecision < 20% at ~0.007 ng/mL See IFU
< 10% at 0.007–0.07 ng/mL
< 8% at > 0.07 ng/mL
Sample Type Serum, Plasma (H) Serum, Plasma (Na or Li H)
Sample Avoid NA Turbidity
RT 8 hours 24 hours
-20°C Undetermined NA
2 months @ -70°C
Sample Max. Thaws 2 Undetermined
Calibrator:
Levels, Form 6 @ 1 x 2.0 mL lyophilized 6 @ 1 x 2.5 mL liquid
(Reconst. 2 mos. at 2–10°C)
Primary Standard WHO 2nd IS 98/574 Internal
QC NA
Levels, Form: 2 @ 1 x 4 mL liquid
Storage, Stability: 2–10°C until exp.
NOTES:
information.

P/N 2016-2155 2/2016
Intact PTH
Intact PTH–Diluted***
Bone Metabolism
Intact PTH Intact PTH–Diluted
Test Name / LIS Code: PTH / PTH (routine) dPTH / dPTH(routine)
Access & DxI/DxC PTHIO / PTHIO (intraoperative) dPTHi / dPTHi (intraoperative)
Test Number 214 (PTH) 11214 (dPTH)
215 (PTHIO) 11215 (dPTHi)
Remisol Code A85 (PTH) A134 (dPTH)
A86 (PTHIO) A135 (dPTHi)
Catalog #s
Reagent A16972
Calibrator A16953
QC NA
Diluent* Sample Dil. A (81908)
Minutes to 1st Result ~30 (PTH)
~15 (PTHIO)
Reportable Range • 1 – ~3500 pg/mL (0.1 – 371 pmol/L) (PTH)
• 6 – ~3500 pg/mL (0.6 – 371 pmol/L) (PTHIO)
• ~2975 – 35,000 pg/mL (316 – 3714 pmol/L) (dPTH & dPTHi)
Analytical Sensitivity • PTH: 1 pg/mL (0.1 pmol/L)
(<4 pg/mL functional) (< 0.4 pmol/L)
• PTHIO: 6 pg/mL (0.6 pmol/L)
(<8 pg/mL functional) (< 0.8 pmol/L)
Expected Values** 12 – 88 pg/mL (1.3 – 9.3 pmol/L)
Expected Total Imprecision ≤ 8% above 12 pg/mL (1.3 pmol/L)(PTH/dPTH)
≤ 12% above 12 pg/mL (1.3 pmol/L)(PTHIO/dPTHi)
Sample Type Serum, Plasma (H, E)
Sample Avoid Lipemic, hemolysis
Sample Max. Time at: Serum Plasma (H,E)
RT 4 hours 8 hours
-20°C 6 months 6 months
Sample Max. Thaws 3

Calibrator:
Levels, Form 6 @ 1 x 1 mL lyophilized
2 x 4 mL reconstitution buffer
Storage, Stability Lyophilized Calibrators and reconstitution buffer: 2–10°C until
exp. Reconstituted: 2 hours @ 18 – 25°C; 10 hours @ 2 – 10°C
Primary Standard WHO 79/500
QC NA
Levels, Form:
Storage, Stability:
NOTES:
information.

P/N 2016-2155 2/2016
25(OH) Vitamin D Total 25(OH) Vitamin D Total

For use on Access 2 and For use on UniCel DxI 600 and 800, and
UniCel DxC 600i UniCel DxC 880i, 860i, 680i, and 660i
Bone Metabolism Integrated Workstations
Test Name / LIS Code: VitdA / VitdA VitdD / VitdD

Access & DxI/DxC
Test Number 272 271
Catalog #s
Reagent B24838 A98856
Calibrator B24839 A98857
QC NA NA
Diluent* Do not dilute Do not dilute
Assay Type Two-step competitive
Minutes to 1st Result 39
Reportable Range 2.0 - 167 ng/mL (5.0 - 418 nmol/L) 2.00 - 210 ng/mL (5.0 - 525 nmol/L)
SI Units Conversion Factor 2.5
Sample Dilution if OVR NA
Analytical Sensitivity • LoB ≤ 1.50 ng/mL (3.75 nmol/L) • LoB ≤ 1.50 ng/mL (3.75 nmol/L)
• LoD ≤ 2.0 ng/mL (5.0 nmol/L) • LoD ≤ 2.00 ng/mL (5.0 nmol/L)
• LoQ ≤ 6.0 ng/mL (15.0 nmol/L) (20% CV) • LoQ ≤ 6.0 ng/mL (15.0 nmol/L) (20% CV)
Expected Total Imprecision ≤ 10.0% CV for samples > 15.0 ng/mL (37.5 nmol/L) and
Total SD ≤ 1.5 ng/mL (3.8 nmol/L) at concentrations ≤ 15.0 ng/mL
Sample Type Serum, Plasma (LiH)
Sample Avoid lipemic or hemolyzed
RT 72 hours
2–10°C 7 days
-20°C 1 year
Sample Max. Thaws 3
Calibrator:
Levels, Form 6 @ 1 x 1.4 mL
Storage, Stability -15 to -30°C until exp. or

56 days at 2–10°C (do not refreeze)
Primary Standard NIST-Ghent ID-LC-MS/MS RMP
QC NA
Levels, Form:
Storage, Stability:
NOTES:
information.

P/N 2016-2155 2/2016
Cardi ac
AccuTnI+3 AccuTnI+3
For use on Access 2 and For use on UniCel DxI 600 and 800,
Cardiac UniCel DxC 600i and
UniCel DxC 880i, 860i, 680i, and 660i
Integrated Workstations
Test Name / LIS Code: TnIA2/TnIA2 TnIDx/TnIDx
Access & DxI/DxC
Test Number 154 288
Catalog #s
QC NA NA
Assay Type 2-Site Sandwich
Reportable Range See IFU
SI Units Conversion Factor 1
Analytical Sensitivity See IFU
Expected Total Imprecision ≤ 8% for samples > 0.075 ng/mL and
Total SD ≤ 0.006 ng/mL (μg/L) at concentrations ≤ 0.075 ng/mL (μg/L)
Sample Type Recommended: Serum, Plasma (LiH)
Acceptable: Serum, Pl (H,E)
(Plasma-E outside US only)
Sample types not interchangeable - See IFU
RT 2 hours
2–8°C 24 hours
-20°C 6 months
Sample Max. Thaws 1 (avoid water bath)
Calibrator:
Levels, Form S0 - S1 @ 1 x 1.5 mL liquid
S2 - S5 @ 1 x 1.0 mL liquid
Storage, Stability Unopened: -20°C until exp.
Opened: 2-10°C for 60 days
QC N/A
Levels, Form:
Storage, Stability:
NOTES:
information.

P/N 2016-2155 2/2016
AccuTnI
This product is being replaced world wide with AccuTnI+3 as
registrations are obtained. AccuTnI will be discontinued,
please check with your local Beckman Coulter
Representative for product availability.
Cardiac
Test Name / LIS Code:
Access & DxI/DxC TropI / TropI
Test Number 275
Remisol Code A115
Catalog #s
Reagent A78803
Calibrator 33345
QC NA
Diluent* NA
Reportable Range ~0.01–100 ng/mL (μg/L)
Analytical Sensitivity 0.01 ng/mL
Expected Values** URL: 0.04 ng/mL (99 ptl.)
AMI cutoff: 0.50 ng/mL (Serum, Plasma-LiH)
Sample Type Recommended: Plasma (LiH)
Acceptable: Serum, Pl (H,E)
(Plasma-E outside US only)
Sample types not interchangeable - See IFU
RT 2 hours
2–8°C 24 hours
-20°C 6 months
Calibrator:
Storage, Stability Unopened: -20°C until exp.
QC N/A
Levels, Form:
Storage, Stability:
NOTES:
information.

P/N 2016-2155 2/2016
CK-MB
CK-MB–Diluted***
Cardiac
CK-MB CK-MB–Diluted
Test Name / LIS Code: CK-MB / CK-MB dCKMB / dCKMB
Access & DxI/DxC
Catalog #s
Reagent 386371
Calibrator 386372
QC NA
Diluent* Samp. Dil. A (81908)
Reportable Range • ~0.1–300 ng/mL (μg/L) (CK-MB)
• ~255–600 ng/mL (μg/L) (dCKMB)
Analytical Sensitivity < 0.1 ng/mL
Expected Values** 0.6–6.3 ng/mL (Serum, Plasma-LiH)
0.5-5.0 ng/mL (Plasma-E)
Expected Total Imprecision < 8% across range
Sample Type Recommended: Plasma-LiH
Acceptable: Serum, Plasma-E
Sample types not interchangeable - See
IFU
Sample Avoid Lipemic, hemolysis, icterus, turbidity,
fibrin, or particulate matter
RT 8 hours
2–8°C 48 hours
-20°C Undetermined
Calibrator:
Storage, Stability Unopened: 2–10°C until exp.
Primary Standard AACC/IFCC Intl. Ref. Mtl.
QC NA
Levels, Form:
Storage, Stability:
NOTES:
information.

P/N 2016-2155 2/2016
Digoxin Myoglobin
Digoxin–Diluted*** Myoglobin–Diluted***
Cardiac
Digoxin Digoxin–Diluted Myoglobin Myoglobin–Diluted
Test Name / LIS Code: Dig / Dig- dDig / dDig MYO / MYO dMYO / dMYO
Access & DxI/DxC
Test Number 117 11117 162 11162
Catalog #s
Reagent 33710 973243
QC NA NA
Diluent* S0 (33716), Samp. Dil. A (81908) Samp. Dil. A (81908)
Assay Type 1-Step Competitive 1-Step Sandwich
Reportable Range • ~0.20–6.0 ng/mL (0.3–7.7 nmol/L) (Dig) • ~1-4000 ng/mL (μg/L) (MYO)
• ~5.1–12 ng/mL (6.5–15.4 nmol/L) (dDig) • ~3400–40,000 ng/mL (μg/L) (dMYO)
SI Units Conversion Factor ng/mL x 1.281 1
Sample Dilution if OVR 1/2 1/2 Onboard 1/10 1/10 Onboard
Analytical Sensitivity 0.2 ng/mL (0.3 nmol/L) < 1 ng/mL
Expected Total Imprecision ≤ 10% ≤ 10%
Sample Pickup 55 μL 155 μL 20 µL 50 µL
Sample Type Serum Recommended: Plasma (LiH)
Acceptable: Serum, Plasma (H, E)
Sample types not interchangeable -
See IFU
Sample Avoid See IFU Lipemia, hemolysis
RT 8 hours 8 hours
Calibrator:
Storage, Stability 2–10°C until exp. Unopened: -20°C until exp.
Primary Standard USP Internal
QC NA NA
NOTES:
information.

P/N 2016-2155 2/2016
Diabetes
Ultrasensitive Insulin
Ultrasensitive Insulin–Diluted***
Diabetes
Ultrasensitive Ultrasensitive
Insulin Insulin–Diluted
Test Name / LIS Code: Insulin / Insul dIns / dIns
Access & DxI/DxC
Catalog #s
Reagent 33410
Calibrator 33415
QC NA
Diluent* S0 or Samp. Dil. A (81908)
Reportable Range • ~0.03–300 μIU/mL (0.21–2100 pmol/L) (Insulin)
• ~255–3000 μIU/mL (1785–21,000 pmol/L)(dIns)
SI Units Conversion Factor μIU/mL x 7.0
Analytical Sensitivity 0.03 μIU/mL (0.21 pmol/L)
Expected Values** 1.9–23 μIU/mL (13.0 – 161 pmol/L)
Sample Type Serum, Plasma (E)
Sample types not interchangeable -see IFU
Sample Avoid Hemolysis
RT 8 hours
2–8°C 24 hours
-20°C Undetermined
Sample Max. Thaws 1
Calibrator:
Levels, Form 6 @ 1 x 2 mL lyophilized
Storage, Stability Lyophilized: 2–10°C until exp.
Reconst: -20°C until exp.; Max. Thaws: 3x
Primary Standard WHO 1st IRP (66/304)
QC NA
NOTES:
information.

P/N 2016-2155 2/2016
In fectious Disease
CMV IgG CMV IgM
Infectious Disease
Test Name / LIS Code CMV-G / CMV-G CMV-M / CMV-M
Test Number 242 254
Catalog #s
QC A40704 A40707
Diluent* Wash buffer II N/A
Reportable Range 0– ~400 AU/mL Reactive / Equivocal /
See IFU Non-reactive
See IFU
SI Units Conversion Factor NA N/A
Sample Dilution if OVR See IFU N/A
Analytical Sensitivity See IFU N/A
Expected Total Imprecision < 20% (For samples > 7 AU/mL) See IFU
Sample Type Serum, Plasma (E, H) Serum, Plasma (E, H)
Sample Avoid Lipemic, icteric, hemolyzed Lipemic, icteric, hemolyzed
RT 8 hours 8 hours
2–8°C 5 days 5 days
Calibrator:
Storage, Stability Unopened: 2–10°C until exp. Unopened: 2–10°C until exp.
Opened: 2–10°C 90 days Opened: 2–10°C 90 days
QC
NOTES:
information.

P/N 2016-2155 2/2016
Rubella IgG Rubella IgM
Infectious Disease
Test Name / LIS Code: Rub-IgG / Rub-G MRub / MRub
Access & DxI/DxC
Test Number 102 233
Catalog #s
QC 34439 34449
Diluent* S0 NA
Reportable Range ~10–500 IU/mL 0– ~60 AU/mL
See IFU See IFU
Sample Dilution if OVR 1/10 NA
Analytical Sensitivity NA NA
Expected Total Imprecision See IFU < 15% (reactive samples)
Sample Type Serum Serum
Sample Avoid NA Hemolysis, turbidity,
heat treated, fibrin
RT 8 hours 8 hours
Calibrator:
Primary Standard WHO 2nd ISP for Anti-Rubella Serum Internal
QC
Opened: See IFU Opened: 2–10°C for 30 days
NOTES:
information.

P/N 2016-2155 2/2016
Toxo IgG Toxo IgM II
Infectious Disease
Test Name / LIS Code: GToxo / GToxo IgM-Toxo / Tox-M
Access & DxI/DxC
Test Number 228 112
Catalog #s
QC A31590 34479
Diluent* S0 Do not dilute
Reportable Range 0– ~450 IU/mL Reactive / Equivocal / Non-reactive
See IFU See IFU
Sample Dilution if OVR See IFU NA
Analytical Sensitivity See IFU NA
Expected Total Imprecision < 20% (for samples > 3.2 IU/mL) < 20% (positive samples, within run)
Sample Type Serum Serum, Plasma (E, C, H)
Sample Avoid Heat treated NA
RT 8 hours 8 hours
2–8°C 4 days 48 hours
Calibrator:
Storage, Stability Unopened: 2–10°C until exp. 2–10°C until exp.
Primary Standard WHO 3rd IS (TOXM) Internal
QC
Opened: 2-10°C for 90 days Opened: 30 days
NOTES:
information.

P/N 2016-2155 2/2016
In fl am m ati on
IL-6
IL-6–Diluted***
Inflammation
IL-6 IL-6–Diluted
Test Name / LIS Code: IL-6 / IL-6 dIL-6 / dIL-6
Access & DxI/DxC
Catalog #s
Reagent A16369
Calibrator A16370
QC A16371
Diluent* S0 or Samp. Dil. A (81908)
Reportable Range • ~0.5 – 1500 pg/mL (0.054 – 160 IU/mL)(IL-6)
• ~1275–4500 pg/mL
(136.43 – 481.50 IU/mL) (dIL-6)
Analytical Sensitivity 0.5 pg/mL (0.054 IU/mL)
Expected Values** 22 – 73 years: <6.4 pg/mL
Expected Total Imprecision <12% at > 2.0 pg/mL
Sample Avoid lipemic, hemolyzed
RT 8 hours
2–8°C 48 hours
-20°C Undetermined
Sample Max. Thaws 1
Calibrator:
Levels, Form S0 @ 1 x 4mL
S1-S5 @ 1 x 2.5 mL
QC
Storage, Stability -20°C until exp.
14 days @ 2-10°C
NOTES:
information.

P/N 2016-2155 2/2016
Reproducti ve
Alpha-fetoprotein,
Diluted Alpha-fetoprotein,
Alpha-fetoprotein–Diluted***
Reproductive
AFP Dil-AFP AFP–Diluted
Test Name / LIS Code: AFP / AFP Dil-AFP / dAFP d-AFP / d-AFP
Access & DxI/DxC
Catalog #s 100 test kit: 300 test kit:
Reagent (OUS only) (Worldwide)
QC 33215 Included in 33211
Diluent* NA NA
Diluent Pack (Dilutions/Pack) 33216 or Wash Buffer II 33216 or Wash Buffer II
A79784 (132) A79784 (132)
Reportable Range • ~0.5–3000 ng/mL (~0.41–2478 IU/mL) (AFP)
• 2700– ~51,000 ng/mL
(2230–~42,126 IU/mL)(Dil-AFP)
• 2550–303,000 ng/mL
(2107–250,413 IU/mL)(d-AFP)
SI Units Conversion Factor ng/mL x 0.826
Sample Dilution if OVR 1/101: Serum 1/11 1/101
1/11: Amniotic Onboard
Fluid
See IFU for more information.
Analytical Sensitivity 0.50 ng/mL
Sample Type 100 test kit: Serum
300 test kit: Serum, Amniotic Fluid
Sample Avoid Repeated freezing and thawing
RT 8 hours
2–8°C 48 hours
-20°C Undetermined
Sample Max. Thaws 1
Calibrator:
Primary Standard WHO 1st IS (72/225)

QC NA
Levels, Form
Storage, Stability
NOTES:
information.

P/N 2016-2155 2/2016
AMH Total βhCG (5th IS),

Diluted Total βhCG (5th IS)
Total βhCG–Diluted (5th IS)***
Reproductive
Total
Total βhCG Dil-Total
AMH AMH-Diluted βhCG–Diluted
(5th IS) βhCG (5 IS)
th
(5th IS)
Test Name / LIS Code: AMH / AMH dAMH / dAMH HCG5 / HCG5d / d-CG5 /
Access & DxI/DxC HCG5 HCG5d d-CG5
Test Number 293 11293 273 274 11273
Remisol Code A183 A184 A178 A179 A180
Catalog #s
Reagent B13127 A85264
Calibrator B13128 B11754
QC B13129 NA
Diluent* Samp. Dil. A (81908) Wash Buffer II
Assay Type One-Step Sandwich 2-Step Sequential Sandwich
Reportable Range • ~0.02 - 24 ng/mL [0.14 - 171 • See IFU (HCG5)
pmol/L] (AMH) • 1,050 – ~270,000 mIU/mL (HCG5d)
• ~20 - 240 ng/mL [146 - 1714 • 1,050 – ~270,000 mIU/mL (d-CG5)
pmol/L] (dAMH)
SI Units Conversion Factor 7.14 1
Sample Dilution if OVR 1/16 or 1/10 1/10 Onboard 1/200 1/200
Onboard
Analytical Sensitivity LoB: ≤ 0.01 ng/mL (≤ 0.07 pmol/L) LoB and LoD: ≤ 0.5 mIU/mL
LoD: ≤ 0.02 ng/mL (≤ 0.14 pmol/L) 20% LoQ: ≤ 0.6 mIU/mL
LoQ: ≤ 0.08 ng/mL (≤ 0.57 pmol/L)
Expected Total Imprecision ≤ 10.0% CV @ ≥ 0.16 ng/mL ≤ 10.0% CV @ > 3.9 mIU/mL
SD ≤ 0.032 ng/mL@ < 0.16 ng/mL ≤ 0.39 mIU/mL (1 SD) @ ≤ 3.9 mIU/mL
Sample Pickup 25 μL 50 μL 25 μL 6 μL 20 μL
Sample Type Serum, Plasma (LiH) Serum, Plasma (LiH)
Sample Avoid Lipemic or Hemolyzed NA
RT 24 hours 8 hours
2–8°C 6 days 48 hours
-20°C 60 days 6 months
Calibrator:
Levels, Form 6 @ 1 x 2.0 mL lyophilized 6 @ 1 x 4.0 mL liquid
Storage, Stability 2-10°C until exp. -20°C or colder until exp.

Reconst: 90 days @ 2–10°C Re-freeze between uses. Thaw at RT.
Stable 120 days @ -20°C or colder after 1st use
Primary Standard Internal WHO 5th IS (07/364)
QC NA
Levels, Form 3 @ 2 x 2.0 mL, lyophilized
Storage, Stability 2-10°C until exp.
Reconst: 2 days @ 2-10°C or
60 days @ -15 to -30°C (thaw ≤ 3x)
NOTES:
information.

P/N 2016-2155 2/2016
Total βhCG, DHEA-S

Diluted Total βhCG DHEA-S–Diluted***
Total βhCG–Diluted***
Reproductive
Dil-Total Total
Total βhCG DHEA-S DHEA-S–Diluted
βhCG βhCG–Diluted
Test Name / LIS Code: TBhCG2 / Dil-hCG2 / d-ThCG / DHE-S / DHE-S dDHES / dDHES
Access & DxI/DxC TBhCG DlhCG d-hCG
Test Number 151 152 11151 235 11235
Catalog #s
QC NA NA
Diluent* Wash Buffer II Normal Saline or Wash Buffer II
Assay Type 1-Step Sandwich 1-Step Competitive
Reportable Range • ~0.5 – 1000 mIU/mL (TBhCG2) • ~2-1000 μg/dL (0.05 - 27.14 μmol/L) (DHE-S)
• 1,000 – 200,000 mIU/mL (Dil-hCG2) • ~850–10,000 μg/dL
• ~800–200,000 mIU/mL (d-ThCG) (~23.07 - 271.4 μmol/L)(dDHES)
SI Units Conversion Factor 1 μg/dL x 0.02714
Sample Dilution if OVR 1/200 1/200 1/10 1/10 Onboard
Onboard
Analytical Sensitivity 0.5 mIU/mL < 2 μg/dL (< 0.05 μmol/L)
Expected Values** M: < 0.5 – 2.67 mIU/mL, See IFU
Non-pregnant F: < 0.5 – 2.90 mIU/mL
Expected Total Imprecision < 10% ≤ 10% (for samples ≥ 20 μg/dL)
Sample Type Serum, Plasma (H) Serum, Plasma (Li. H, Na H, E)
Sample Avoid NA NA
RT 8 hours 8 hours
-20°C 6 months Undetermined
Calibrator:
Levels, Form 6 @ 1 x 4 mL liquid 6 @ 1 x 2.0 mL liquid
Storage, Stability -20°C or colder until exp. 2–10°C until exp. or
Re-freeze between uses. Thaw at RT. 28 days after initial use
Primary Standard WHO 3rd IS (75/537) Internal
QC NA NA
NOTES:
information.

P/N 2016-2155 2/2016
Estradiol Unconjugated
Estriol
Reproductive
Test Name / LIS Code: E2 / E2 uE3 / uE3
Access & DxI/DxC
Test Number 243 126
Catalog #s
Reagent 33540 33570
QC NA NA
Diluent* S0 (33546) S0
Assay Type 2-Step Competitive 1-Step Competitive
Reportable Range ~20–4800 pg/mL ~0.017–6.9 ng/mL
(73–17,621 pmol/L) (0.059–24.0 nmol/L)
SI Units Conversion Factor pg/mL x 3.671 ng/mL x 3.467
Sample Dilution if OVR 1/2 1/2 or 1/3
Analytical Sensitivity 20 pg/mL (73 pmol/L) 0.017 ng/mL
Expected Values** See IFU TBD by laboratory
Expected Total Imprecision • ≤ 12% at concentrations See IFU
≥ 120 pg/mL
• For Imprecision
< 120 pg/mL, see IFU
Sample Type Serum, Plasma (H) Serum
Sample Avoid NA NA
RT 8 hours 8 hours
Calibrator:
Levels, Form S0 @ 1 x 4.0 mL liquid S0 @ 1 x 4.0 mL liquid
S1–S5 @ 1 x 2.5 mL liquid S1–S6 @ 1 x 2.5 mL liquid
Primary Standard ID/GC-MS GC-MS
QC NA NA
NOTES:
information.

P/N 2016-2155 2/2016
hFSH hLH
hFSH–Diluted*** hLH–Diluted***
Reproductive
hFSH hFSH–Diluted hLH hLH–Diluted
Test Name / LIS Code: hFSH / hFSH dhFSH / dhFSH hLH / hLH dhLH / dhLH
Access & DxI/DxC
Test Number 115 11115 116 11116
Catalog #s
Reagent 33520 33510
QC NA NA
Diluent* S0 or Samp. Dil. A (81908) S0 or Samp. Dil. A (81908)
Reportable Range • ~0.2–200 mIU/mL (IU/L) (hFSH) • ~0.2–250 mIU/mL (IU/L) (hLH)
• ~170–400 mIU/mL (IU/L) (dhFSH) • ~213–500 mIU/mL (IU/L) (dhLH)
Analytical Sensitivity 0.2 mIU/mL 0.2 mIU/mL
Expected Total Imprecision < 10% < 10%
Sample Avoid NA NA
RT 8 hours 8 hours
-20°C 3 months 6 months
Calibrator:
Levels, Form 6 @ 1 x 4 mL liquid 6 @ 1 x 4 mL liquid
Primary Standard WHO 2nd IRP (78/549) WHO 2nd IRP (80/552)
QC NA NA
NOTES:
information.

P/N 2016-2155 2/2016
Inhibin A PAPP-A
Inhibin A–Diluted*** PAPP-A–Diluted***
Reproductive
Inhibin A Inhibin A–Diluted PAPP-A PAPP-A Diluted
Test Name / LIS Code: InhibinA / InhbA dInhA / dInhA PAPPA / PAPPA dPAPA / dPAPA
Access & DxI/DxC
Test Number 237 11237 270 11270
Catalog #s
QC A36100 A48573
Diluent* Samp. Dil. A 81908 Wash Buffer II
Reportable Range • ~1 – 1500 pg/mL (InhibinA) • ~1 – 5000 ng/mL (PAPPA)
• ~1275 – 4500 pg/mL • ~4250–10,000 ng/mL (dPAPA)
(~50.8 - 179.3 IU/mL)(dInhA)
SI Units Conversion Factor pg/mL ÷ 25.1 NA
Sample Dilution if OVR 1/3 or 1/11 1/3 Onboard 1/2 or 1/10 1/2 Onboard
Analytical Sensitivity < 1 pg/mL < 1 ng/mL
Expected Total Imprecision ≤ 8% at > 30 pg/mL ≤ 8% at > 10 ng/mL
Sample Type Serum, Plasma (H, E) Serum
Sample Avoid Lipemic, hemolyzed Lipemic, hemolyzed
RT 8 hours 8 hours
Calibrator:
Storage, Stability 2–8°C until exp. -20°C or colder until exp.
Open: 28 days @ 2–8°C Opened: -20°C or colder (thaw up to 3x)
or 28 days @ 2–10°C
QC:
Levels, Form 3 @ 2 x 2.5 mL, liquid 3 @ 2 x 2.5 mL, liquid
Open: 28 days @ 2–8°C Opened: -20°C or colder (thaw up to 3x)
or 28 days @ 2–10°C
NOTES:
information.

P/N 2016-2155 2/2016
Progesterone Prolactin
Prolactin–Diluted***
Reproductive
Prolactin Prolactin–Diluted
Test Name / LIS Code: Prog / Prog PRL / PRL dPRL / dPRL
Access & DxI/DxC
Catalog #s
Reagent 33550 33530
QC NA NA
Diluent* S0 (33556) S0 or Samp. Dil. A (81908)
Reportable Range ~0.10 – 40 ng/mL • ~0.25 – 200 ng/mL (μg/L) (PRL)
(0.32–127.2 nmol/L) • ~170 – 2000 ng/mL (μg/L) (dPRL)
SI Units Conversion Factor ng/mL x 3.18 1 ng/mL = 1 μg/L
1 μg/L x 21.2 = mIU/L
Sample Dilution if OVR 1/3 1/10 1/10 Onboard
Analytical Sensitivity 0.10 ng/mL 0.25 ng/mL
(0.32 nmol/L)
Expected Total Imprecision See IFU < 10%
Sample Type Serum Serum, Plasma (H)
Sample Avoid Gross lipemia, gel tube storage NA
RT 8 hours 8 hours
Calibrator:
Levels, Form S0 @ 1 x 4.0 mL liquid S0 @ 1 x 4.0 mL liquid
S1 – S5 @ 1 x 2.5 mL liquid S1 – S5 @ 1 x 2.5 mL liquid
Storage, Stability -20°C until exp. -20°C until exp.
2–10°C for 3 months Return to -20 after each use.
Thaw at RT ≤ 5x
Primary Standard USP WHO 3rd IS (84/500)
QC:
Levels, Form NA NA
Storage, Stability
NOTES:
information.

P/N 2016-2155 2/2016
SHBG Testosterone
SHBG–Diluted***
Reproductive
SHBG SHBG–Diluted
Test Name / LIS Code: SHBG / SHBG dSHBG / dSHBG Testo / Testo
Access & DxI/DxC
Catalog #s
QC A48619 NA
Diluent* Wash Buffer II S0
Diluent Pack (Dilutions/Pack) A79784 (60) NA
Assay Type 2-Step Sandwich 1-Step Competitive
Reportable Range • 0.33 – ~200 nmol/L (SHBG) ~0.1 – 16 ng/mL
• ~170 – 2000 nmol/L (dSHBG) (0.35 – 55.5 nmol/L)
SI Units Conversion Factor 1 ng/mL x 3.47
Sample Dilution if OVR 1/10 1/10 Onboard 1/2
Analytical Sensitivity Limit of Blank (Analytical Sensitivity): 0.1 ng/mL
0.017 nmol/L
Limit of Detection: 0.33 nmol/L
Expected Values** See IFU M-S: 1.75 – 7.81 ng/mL
M-P: 1.68 – 7.58 ng/mL
F-S: < 0.1 – 0.75 ng/mL
F-P: < 0.1 – 0.9 ng/mL
Expected Total Imprecision < 7% at > 2nmol/L ≤ 20% at 0.5 ng/mL
< 10% from 2-10 ng/mL
Sample Avoid Lipemic or hemolyzed samples, E Plasma
Plasma (E)
RT 8 hours 8 hours
2–8°C 7 days (serum), 5 days (plasma (H)) 48 hours
-20°C 2 months Undetermined
Sample Max. Thaws 3 (serum), 2 (plasma (H)) 2
Calibrator:
Levels, Form 6 @ 1x 1.0 mL lyoph. 6 @ 1 x 2.5 mL liquid
Storage, Stability 2-8°C until exp. 2–10°C until exp.
Reconst: 28 days at 2-8°C
Primary Standard WHO 95/560 USP
QC:
Levels, Form 2 @ 3 x 2mL, lyoph. NA
2-8°C until exp.
Storage, Stability Reconst: 28 days at 2-8°C
NOTES:
information.

P/N 2016-2155 2/2016
Thy roi d
Free T3 Free T4
Thyroid
Test Name / LIS Code: FT3 / FT3 FRT4 / FRT4
Access & DxI/DxC
Test Number 212 226
Catalog #s
QC NA NA
Reportable Range ~0.88–30 pg/mL ~0.25–6.0 ng/dL
(1.4–46 pmol/L) (3.2–77.2 pmol/L)
SI Units Conversion Factor pg/mL x 1.536 ng/dL x 12.87
Sample Dilution if OVR Do not dilute Do not dilute
Analytical Sensitivity 0.88 pg/mL 0.25 ng/dL
(1.4 pmol/L) (3.2 pmol/L)
Expected Values** 2.5–3.9 pg/mL 0.61–1.12 ng/dL
(3.8–6.0 pmol/L) (7.9–14.4 pmol/L)
Expected Total Imprecision See IFU See IFU
Sample Avoid NA NA
RT 8 hours 8 hours
Calibrator:
Opened: 2–10°C 4 months Refreeze within 2 hours;
Max. thaws: 5x
QC NA NA
NOTES:
information.

P/N 2016-2155 2/2016
Total T3 Total T4
Thyroid
Test Name / LIS Code: TotT3 / TotT3 TotT4 / TotT4
Access & DxI/DxC
Test Number 166 134
Catalog #s
Reagent 33830 33800
QC NA NA
Diluent* S0 NA
Reportable Range ~0.1–8.0 ng/mL ~0.5–30.0 μg/dL
(0.2–12.3 nmol/L) (6.4–386 nmol/L)
SI Units Conversion Factor ng/mL x 1.536 μg/dL x 12.87
Sample Dilution if OVR 1/2 NA
Analytical Sensitivity 0.1 ng/mL 0.50 μg/dL
(0.2 nmol/L) (6.4 nmol/L)
Expected Values** 0.87–1.78 ng/mL 6.09–12.23 μg/dL
(1.34–2.73 nmol/L) (78.38–157.4 nmol/L)
Expected Total Imprecision <10% < 10%
Sample Avoid NA Pregnant women
RT 8 hours 8 hours
Calibrator:
Storage, Stability 2–10°C until exp. -15°C or colder until exp.,
Max. thaws: 5x
2–10°C for 6 hours
Primary Standard USP USP
QC NA NA
NOTES:
information.

P/N 2016-2155 2/2016
HYPERsensitive hTSH Fast hTSH

HYPERsensitive hTSH–Diluted*** Fast hTSH–Diluted***
Thyroid
HYPERsensitive
HYPERsensitive hTSH Fast hTSH Fast hTSH–Diluted
hTSH–Diluted
Test Name / LIS Code: TSH / TSH dTSH / dTSH fTSH2 / fTSH2 dfTSH / dfTSH
Access & DxI/DxC
Test Number 183 11183 246 11246
Catalog #s
Reagent 33820 33820
QC NA NA
Diluent* S0 or Samp. Dil. A (81908) S0 or Samp. Dil. A (81908)
Reportable Range • 0.015– ~100 μIU/mL (mIU/L) (TSH) • 0.03 – ~100 μIU/mL (mIU/L) (fTSH2)
(incorporates functional sensitivity for lower (incorporates functional sensitivity for
limit of detection) lower limit of detection)
• ~85 – 500 μIU/mL (mIU/L) (dTSH) • ~85 – 500 μIU/mL (mIU/L) (dfTSH)
Analytical Sensitivity 0.003 μIU/mL 0.01 μIU/mL
0.015 μIU/mL functional 0.03 μIU/mL functional
Expected Values** 0.34–5.60 μIU/mL 0.34–5.60 μIU/mL
Expected Total Imprecision See IFU See IFU
Sample Avoid Severe hemolysis Severe hemolysis
RT 8 hours 8 hours
Calibrator:
Primary Standard WHO 2nd IRP (80/558) WHO 2nd IRP (80/558)
QC NA NA
NOTES:
information.

P/N 2016-2155 2/2016
Thyroglobulin Thyroglobulin Antibody II
Thyroid
Version 2
Test Name / LIS Code: Tg / TgAg Tg2 / Tg2 Tg-Ab / Tg-Ab
Access & DxI/DxC
Catalog #s
QC NA NA
Diluent* 33866 NA
Reportable Range ~0.1–500 ng/mL ~0.9–2500 IU/mL
Sample Dilution if OVR 1/5 or 1/10 NA
Analytical Sensitivity 0.1 ng/mL Limit of Blank (Analytical Sensitivity):
0.9 IU/mL
Limit of Detection: 0.9 IU/mL
Expected Values** 1.59–50.03 ng/mL < 4.0 IU/mL
Expected Total Imprecision < 10% @ > 1 ng/mL < 10% @ ≥ 15 IU/mL
<1.5 IU/mL SD @ <15 IU/mL
Sample Type Serum, Plasma (H) Serum, Plasma (H,E)
Sample Avoid NA NA
RT 8 hours 8 hours
Calibrator:
Levels, Form 6 @ 1 x 2.0 mL lyoph. 1 x 4.0 mL liquid (S0)
5 @ 1 x 2.5 mL liquid (S1-S5)
Reconst: 4 mos. at 2–10°C
Primary Standard BCR CRM 457 Tg Std. WHO 65/93
QC NA NA
NOTES:
information.

P/N 2016-2155 2/2016
Thyroid Uptake TPO Antibody

TPO Antibody–Diluted***
Thyroid
TPO Antibody TPO Antibody–Diluted
Test Name / LIS Code: TU / TU- TPOAb / TPOAb dTPO / dTPO
Access & DxI/DxC
Catalog #s
QC NA NA
Diluent* Do not dilute Samp. Dil. A 81908
Reportable Range NA • ~0.25 - 1000 IU/mL (TPOAb)
• ~850–10,000 IU/mL (dTPO)
SI Units Conversion Factor % x 0.01 NA
Sample Dilution if OVR NA 1/10 or 1/100 1/10 Onboard
Analytical Sensitivity NA 0.25 IU/mL
Expected Values** 32.0–48.4% < 9 IU/mL
Expected Total Imprecision See IFU ≤ 12%
Sample Type Serum, Plasma (H) Serum, Plasma (Li-H, E)
Sample Avoid NA NA
RT 8 hours 8 hours
-20°C Undetermined 2 months
Calibrator:
Levels, Form 1 @ 6 x 1.0 mL lyoph. 6 @ 1 x 2.0 mL liquid
Reconst: 1 mo. at -20°C Opened: 120 days at 2–10°C
or 2 wks at 2–10°C
Primary Standard Internal WHO 66/387
QC NA NA
NOTES:
information.

P/N 2016-2155 2/2016
TSH (3rd IS)

Diluted TSH (3rd IS)
Thyroid
TSH (3rd IS) Diluted TSH (3rd IS)
Test Name / LIS Code: TSH3 / TSH3 TSH3d / TSH3d
Access & DxI/DxC
Test Number 277 278
Catalog #s
Reagent B63284
Calibrator B63285
QC NA
Diluent* Wash Buffer II
Diluent Pack (Dilutions/Pack) N/A
Minutes to 1st Result ~ 26
Reportable Range • 0.005 - ~ 50.0 μIU/mL (TSH3)
• 37.5 - ~ 500 mIU/mL (TSH3d)
Sample Dilution if OVR 1/10 1/10 Dilution Assay
Analytical Sensitivity • LoB: < 0.005 μIU/mL
• LoD: ≤ 0.005 μIU/mL
• LoQ: ≤ 0.01 μIU/mL (10% between run CV)
Expected Total Imprecision CV ≤ 10% @ > 0.02 µIU/mL
SD ≤ 0.0029 µIU/mL @ ≤ 0.02 µIU/mL
Sample Pickup 55 µL 50 µL
Sample Type Serum, Plasma (Li-H)
Sample Avoid lipemic or hemolyzed
RT 18 hours
2–8°C 7 days
-20°C or colder 90 days
Sample Max. Thaws 2
Calibrator:
Stable 90 days @ 2-10°C after opening
Primary Standard WHO 3rd IS (81/565)
QC N/A
NOTES:
information.

P/N 2016-2155 2/2016
Tum or Markers
Alpha-fetoprotein, BR Monitor
Diluted Alpha-fetoprotein, BR Monitor–Diluted***
Alpha-fetoprotein–Diluted*** (CA 15-3 Antigen)
Tumor Markers
AFP Dil-AFP AFP–Diluted BR Monitor BR Monitor–Diluted
Test Name / LIS Code: AFP / AFP Dil-AFP / dAFP d-AFP / d-AFP BR15-3Ag / BR153 dBRAg / dBRAg
Access & DxI/DxC
Test Number 180 208 11180 193 11193
Catalog #s 100 test kit: 300 test kit:
(OUS only) (Worldwide)
Reagent 33210 33211 387620
Calibrator 33215 Included in 33211 387647
QC NA NA NA
Diluent* 33216 or Wash Buffer II 33216 or Wash Buffer II Samp. Dil. A 81908
Diluent Pack (Dilutions/Pack) A79784 (132) A79784 (132) A79783 (60)
Reportable Range • ~0.5–3000 ng/mL (~0.41–2478 IU/mL) (AFP) • ~0.5–1000 U/mL (BR15-3Ag)
• 2700– ~51,000 ng/mL • ~850–10,000 U/mL (dBRAg)
(2230–~42,126 IU/mL)(Dil-AFP)
• 2550–303,000 ng/mL
(2107–250,413 IU/mL)(d-AFP)
SI Units Conversion Factor ng/mL x 0.826 NA
Sample Dilution if OVR 1/101: Serum 1/11 1/101 1/10 1/10 Onboard
1/11: Amniotic Onboard
Fluid
See IFU for more information.
Analytical Sensitivity 0.50 ng/mL < 0.5 U/mL
Expected Total Imprecision See IFU ≤ 10% (15–500 U/mL)
≤ 12% (> 500 U/mL)
Sample Type 100 test kit: Serum Serum, Plasma (H)
300 test kit: Serum, Amniotic Fluid
Sample Avoid Repeated freezing and thawing Hemolysis or lipemic
RT 8 hours 8 hours
Calibrator:
Storage, Stability 2–10°C until exp. 2–10°C until exp. or
90 days after initial use
Primary Standard WHO 1st IS (72/225) Internal
QC NA Not Available
Levels, Form
Storage, Stability
NOTES:
information.

P/N 2016-2155 2/2016
CEA GI Monitor
GI Monitor–Diluted***
(CA 19-9 Antigen)
Tumor Markers
GI Monitor GI Monitor–Diluted
Test Name / LIS Code: CEA2 / CEA2 GI19-9Ag / GI199 dGIAg / dGIAg
Access & DxI/DxC
Catalog #s
Reagent 33200 387687
QC 33209 NA
Diluent* 33206 Samp. Dil. A 81908
Reportable Range ~0.1–1000 ng/mL • ~0.8–2000 U/mL (GI19-9Ag)
• ~1700–20,000 U/mL (dGIAg)
Sample Dilution if OVR 1/10 1/10 1/10 Onboard
Analytical Sensitivity 0.1 ng/mL 0.8 U/mL
Expected Total Imprecision See IFU <10%
Sample Type Serum Serum, Plasma (H)
Sample Avoid NA hemolysis, lipemic
RT 8 hours 8 hours
Sample Max. Thaws Undetermined 1
Calibrator:
Levels, Form 6 @ 1 x 2.5 mL liquid 6 @ 1x2.5 mL
Storage, Stability 2–10°C until exp. -20°C until exp.
2–10°C See IFU
QC NA
NOTES:
information.

P/N 2016-2155 2/2016
Hybritech PSA
Hybritech PSA–Diluted***
Hybritech WHO
Tumor Markers Calibration Calibration
PSA PSA–Diluted PSA PSA–Diluted
Test Name / LIS Code: PSA-Hyb / PSA dPSA / dPSA PSA-WHO / PSA-W dPSAW / dPSAW
Access & DxI/DxC
Test Number 170 11170 231 11231
Catalog #s
Reagent 37200
Calibrator 37205
QC 37209
Diluent* 37206 or Wash Buffer II
Reportable Range • ~0.008–150 ng/mL (PSA-Hyb) • ~0.008–121 ng/mL (PSA-WHO)
• ~127.5–1500 ng/mL (dPSA) • ~110.5–1210 ng/mL (dPSAW)
Sample Dilution if OVR 1/5 or 1/10 1/10 Onboard 1/5 or 1/10 1/10 Onboard
Analytical Sensitivity <0.008 ng/mL
Expected Values** 0–4 ng/mL 0–3.1 ng/mL
Sample Type Serum
Sample Avoid Collection after prostatic manipulation; hemolysis, turbidity
RT 3 hours
2–8°C 24 hours
-20°C 5 months
Sample Max. Thaws See IFU
Calibrator:
QC
NOTES:
information.

P/N 2016-2155 2/2016
Hybritech free PSA
Tumor Markers
Hybritech Calibration WHO Calibration
Test Name / LIS Code: freePSA / fPSA fPSA-WHO / fPSAW
Access & DxI/DxC
Test Number 169 230
Catalog #s
Reagent 37210
Calibrator 37215
QC 37219
Diluent* S0
Reportable Range ~0.005–20 ng/mL ~0.005–16 ng/mL
Sample Dilution if OVR 1/5 or 1/10
Analytical Sensitivity <0.005 ng/mL
Expected Total Imprecision <7%
Sample Type Serum
Sample Avoid Collection after prostatic manipulation; hemolysis,
turbidity
RT 3 hours
2–8°C 24 hours
-20°C 5 months
Sample Max. Thaws See IFU
Calibrator:
Levels, Form S0 @ 1x 5 mL, S1-S5 @ 1x 2.5 mL; liquid
QC
NOTES:
information.

P/N 2016-2155 2/2016
Hybritech p2PSA
&
phi
Tumor Markers
p2PSA phi-HYB phi-WHO
Test Name / LIS Code: p2PSA / p2PSA phi-HYB / NA phi-WHO / NA
Access & DxI/DxC
Test Number 146 NA NA
Catalog #s
Reagent A49752
Calibrator A49753
QC A56934
Diluent* NA
Reportable Range ~ 0.50–5,000 pg/mL
Analytical Sensitivity LoB 0.50 pg/mL (analytical)
LoQ 3.23 pg/mL (functional)
Expected Total Imprecision <20% at 3.23-10 pg/mL
≤10% at ≥10 pg/mL.
Sample Pickup 50 µL
Sample Type Serum
Sample Avoid Collection after prostatic manipulation;
hemolysis, turbidity
RT 3 hours (from time of blood draw)
2–8°C 24 hours
-20°C 5 months
(store at -70°C if >5 months)
Sample Max. Thaws 2
Calibrator:
2–10°C See IFU
QC
2–10°C See IFU
NOTES:
information.

P/N 2016-2155 2/2016
OV Monitor
OV Monitor–Diluted***
Tumor Markers
OV Monitor OV Monitor–Diluted
Test Name / LIS Code: OV125Ag / OV125 dOVAg / dOVAg
Access & DxI/DxC
Catalog #s
Reagent 386357
Calibrator 386358
QC NA
Diluent* Samp. Dil. A (81908)
Reportable Range • ~ 0.5–5,000 U/mL (OV125Ag)
• ~4250–100,000 U/mL (dOVAg)
Sample Dilution if OVR 1/10 or 1/20 1/20 Onboard
Analytical Sensitivity 0.5 U/mL
Expected Total Imprecision <10% across range
Sample Pickup 25 µL
Sample Type Serum, Plasma-H
Sample Avoid NA
RT 8 hours
2–8°C 48 hours
-20°C Undetermined
Sample Max. Thaws 1
Calibrator:
Storage, Stability 2-10°C until exp.
QC NA
Levels, Form
Storage, Stability
NOTES:
information.

P/N 2016-2155 2/2016
Research Use Onl y
Research IL-6 RUO

Use IL-6 RUO–Diluted**
Only
IL-6 RUO IL-6 RUO–Diluted

Test Name / LIS Code: IL-6RUO / IL6RU dILRU / dILRU
Access & DxI/DxC
Catalog #s
Reagent A30945
Calibrator A30944
QC A30946
Diluent* S0 or Sample Dil. A (81908)
Reportable Range • NA
Analytical Sensitivity NA
Expected Total Imprecision NA
Sample Avoid lipemic, hemolyzed
RT 8 hours
2–8°C 48 hours
-20°C Undetermined
Sample Max. Thaws 1
Calibrator:
Levels, Form S0 @ 1 x 4mL
S1-S5 @ 1 x 2.5 mL
Primary Standard NA
QC
14 days @ 2-10°C
NOTE:
** Available only on stand-alone UniCel DxI and UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems.
Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein
are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries.
Hybritech is a trademark of Hybritech Incorporated, a subsidiary of Beckman Coulter, Inc.

P/N 2016-2155 2/2016

Assay Summary Tables: For Use With The Access Family of Immunoassay Systems

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Assay Summary Tables: For Use With The Access Family of Immunoassay Systems

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Assay Summary Tables

Assay Summary Tables

Table of Description of Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

© 2016 Beckman Coulter, Inc. All rights reserved. Page 1 of 46

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Intrinsic Factor Ab sTfR

© 2016 Beckman Coulter, Inc. All rights reserved. Page 7 of 46

© 2016 Beckman Coulter, Inc. All rights reserved. Page 8 of 46

© 2016 Beckman Coulter, Inc. All rights reserved. Page 9 of 46

HAV IgM HBc Ab

© 2016 Beckman Coulter, Inc. All rights reserved. Page 10 of 46

HBc IgM HBs Ab

© 2016 Beckman Coulter, Inc. All rights reserved. Page 11 of 46

© 2016 Beckman Coulter, Inc. All rights reserved. Page 12 of 46

Access HCV Ab Plus* Access HIV combo*

P/N 2016-2155 2/2016

Bon e Metabol ism

Ultrasensitive hGH Ostase

© 2016 Beckman Coulter, Inc. All rights reserved. Page 14 of 46

Sample Max. Thaws 3

© 2016 Beckman Coulter, Inc. All rights reserved. Page 15 of 46

25(OH) Vitamin D Total 25(OH) Vitamin D Total

Test Name / LIS Code: VitdA / VitdA VitdD / VitdD

Storage, Stability -15 to -30°C until exp. or

© 2016 Beckman Coulter, Inc. All rights reserved. Page 16 of 46

© 2016 Beckman Coulter, Inc. All rights reserved. Page 17 of 46

© 2016 Beckman Coulter, Inc. All rights reserved. Page 18 of 46

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© 2016 Beckman Coulter, Inc. All rights reserved. Page 21 of 46

CMV IgG CMV IgM

© 2016 Beckman Coulter, Inc. All rights reserved. Page 22 of 46

Rubella IgG Rubella IgM

© 2016 Beckman Coulter, Inc. All rights reserved. Page 23 of 46

Toxo IgG Toxo IgM II

© 2016 Beckman Coulter, Inc. All rights reserved. Page 24 of 46

© 2016 Beckman Coulter, Inc. All rights reserved. Page 25 of 46

Storage, Stability 2–10°C until exp.

Primary Standard WHO 1st IS (72/225)

© 2016 Beckman Coulter, Inc. All rights reserved. Page 26 of 46

AMH Total βhCG (5th IS),

Storage, Stability 2-10°C until exp. -20°C or colder until exp.

© 2016 Beckman Coulter, Inc. All rights reserved. Page 27 of 46

Total βhCG, DHEA-S

© 2016 Beckman Coulter, Inc. All rights reserved. Page 28 of 46

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© 2016 Beckman Coulter, Inc. All rights reserved. Page 32 of 46

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© 2016 Beckman Coulter, Inc. All rights reserved. Page 35 of 46

HYPERsensitive hTSH Fast hTSH

© 2016 Beckman Coulter, Inc. All rights reserved. Page 36 of 46

Thyroglobulin Thyroglobulin Antibody II

© 2016 Beckman Coulter, Inc. All rights reserved. Page 37 of 46

Thyroid Uptake TPO Antibody

© 2016 Beckman Coulter, Inc. All rights reserved. Page 38 of 46

TSH (3rd IS)