LSP Enrollment Section on Data Submission Form

CDC Clinical Standardization Programs

Form Approved
OMB No. 0920-xxxx
Exp. Date xx/xx/201x

CDC Lipid Standardization Program (CDC LSP) Enrollment Form

Thank you for your interest in the Lipid Standardization Program. Please fill out the applicable fields in this form.

CONTACT INFORMATION

Laboratory ID (Assigned by CDC):

Laboratory and Director

Lab Name:
Director’s Title:
First Name:
Last Name:
E-mail:
Phone:
Zip Code:

Primary Laboratory Contact (send correspondence to)

Department:
Address 1:
Address 2:
City:
State:
Country:

Title:

Department:

First Name:

Address 1:

Last Name:
E-mail:
Phone:

Address 2:
City:
State:

Zip Code:

Country:

Ship Samples to (if different from primary laboratory contact)
Title:
First Name:
Last Name:
E-mail:
Phone:
Zip Code:

Department:
Address 1:
Address 2:
City:
State:
Country:

Billing Information (if different from primary laboratory contact)
Title:

Address 1:

First Name:

Address 2:

Last Name:
Phone:
Zip Code:

City:
State:
Country:

Signature
Director’s
Signature:

Date:

Return completed form to:
Centers for Disease Control and Prevention, Lipid Standardization Program (CDC LSP)
Email: [email protected]

Disclaimer

Information provided here will be shared with 3rd party shipping company.
If certified, laboratory and assay information will be listed on the CDC website (https://www.cdc.gov/labstandards/lsp_participants.html). If a
participant does not wish to be listed on the website, email [email protected].
CDC estimates the average public reporting burden for this collection of information as 70 minutes (25 minutes for enrollment
and 45 minutes for data return) per response, including the time for reviewing instructions, searching existing data/information
sources, gathering and maintaining the data/information needed, and completing and reviewing the collection of information. An
agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a
currently valid OMB Control Number. Send comments regarding this burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden to CDC/ATSDR Information Collection Review Office, 1600 Clifton
Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-xxxx).

Last Updated: 6/3/2020

CDC Clinical Standardization Programs
ANALYTES AND ASSAY INFORMATION

Select the analyte(s) you wish to enroll and provide assay information.

Analytes

□ Total Cholesterol (TC)
□ Total Glycerides (TG)
□ High-density Lipoprotein Cholesterol (HDL-C)
□ Apolipoprotein A1 (Apo A1) *
□ Apolipoprotein B (Apo B) *
(*Evaluation only)

Assay Information
Total Cholesterol (TC)
Method Principle

□ Chemical (600)
□ Enzymatic (601)
□ Other (specify): ______________________________________

Instrument Manufacturer and Model (select the code from Appendix 2 ─ specify if not listed)
Reagent Manufacturer (select the code from Appendix 3 ─ specify if not listed)

Reagent Name

Calibrator Manufacturer (select the code from Appendix 4 ─ specify if not listed)

Calibrator Name

Total Glycerides (TG)
Method Principle

□ Enzymatic (non-blanked) (602)
□ Enzymatic (with internal glycerol blank) (603)
□ Enzymatic (with separate glycerol blank) (604)
□ Other (specify): ______________________________________

Instrument Manufacturer and Model (select the code from Appendix 2 ─ specify if not listed)
Reagent Manufacturer (select the code from Appendix 3 ─ specify if not listed)

Reagent Name

Calibrator Manufacturer (select the code from Appendix 4 ─ specify if not listed)

Calibrator Name

Last Updated: 6/3/2020

CDC Clinical Standardization Programs
High-density Lipoprotein Cholesterol (HDL-C)
Method Principle

□ Homogeneous Direct (611)
□ Dextran Sulfate MW 50,000/Mg (605)
□ "Combined" Mn + Heparin (608)
□ Phosphotungstic acid/no ions (l:l) (612)
□ Dextran Sulfate MW 500,000/Mg (606)
□ 0.046 mol Mn + Heparin (609)
□ Phosphotungstate/Mg (613)
□ Dextran Sulfate Magnetic Separation (607)
□ 0.092 mol Mn + Heparin (610)
□ Polyethylene glycol (614)
□ Other (specify): ______________________________________
Instrument Manufacturer and Model (select the code from Appendix 2 ─ specify if not listed)
Reagent Manufacturer (select the code from Appendix 3 ─ specify if not listed)

Reagent Name

Calibrator Manufacturer (select the code from Appendix 4 ─ specify if not listed)

Calibrator Name

Apolipoprotein A1 (Apo A1)
Method Principle

□ Nephelometric (620)
□ Immunoturbidometric (621)
□ Other (specify): _____________________________________

Instrument Manufacturer and Model (select the code from Appendix 2 ─ specify if not listed)
Reagent Manufacturer (select the code from Appendix 3 ─ specify if not listed)

Reagent Name

Calibrator Manufacturer (select the code from Appendix 4 ─ specify if not listed)

Calibrator Name

Apolipoprotein B (Apo B)
Method Principle

□ Nephelometric (620)
□ Immunoturbidometric (621)
□ Other (specify): ______________________________________

Instrument Manufacturer and Model (select the code from Appendix 2 ─ specify if not listed)
Reagent Manufacturer (select the code from Appendix 3 ─ specify if not listed)

Reagent Name

Calibrator Manufacturer (select the code from Appendix 4 ─ specify if not listed)

Calibrator Name

Last Updated: 6/3/2020

CDC Clinical Standardization Programs
QUESTIONS ABOUT THE LABORATORY

Is your laboratory engaged in government funded research, clinical trials or studies involving
lipid metabolism or cardiovascular disease?
Is your laboratory engaged in non-government funded research, clinical trials, or studies
involving lipid metabolism or cardiovascular disease?
Is your laboratory a reference laboratory providing service to manufacturers of diagnostic
products or reference materials for measurement of lipids?
Is your laboratory a reference laboratory providing service to proficiency testing and external
quality control programs?
Is your laboratory engaged in research and development of analytical methods or reference
materials for the measurement of lipids?

□ Yes □ No
□ Yes □ No
□ Yes □ No
□ Yes □ No
□ Yes □ No

Last Updated: 6/3/2020

CDC Clinical Standardization Programs
APPENDIX: ASSAY INFORMATION CODES
1. Method Principle Code List
Code
600
601
602
603
604
605
606
607
608
609
610
611
612
613
614
615
616
617
618
620
620
621
621
622
624

Method
Chemical (Abell Kendall, etc.)
Enzymatic
Enzymatic (Non-Blanked)
Enzymatic (with internal Glycerol Blank)
Enzymatic (with separate Glycerol Blank)
Dextran Sulfate MW 50,000/Mg
Dextran Sulfate MW 500,000/Mg
Dextran Sulfate Magnetic Separation
Combined Mn + Heparin
0.046 mol Mn + Heparin
0.092 mol Mn + Heparin
Homogeneous Direct
Phosphotungstic acid/no ions (1:1)
Phosphotungstate/Mg
Polyethylene glycol
Dextran Sulfate MW 10,000/Mg
NMR
NMR
NMR
Nephelometric
Nephelometric
Immunoturbidometric
Immunoturbidometric
NMR
NMR

Analyte
TC
TC
TG
TG
TG
HDLC
HDLC
HDLC
HDLC
HDLC
HDLC
HDLC
HDLC
HDLC
HDLC
HDLC
TC
TG
HDLC
Apo A-I
Apo B
Apo A-I
Apo B
Apo B
Apo A-I

Last Updated: 6/3/2020

CDC Clinical Standardization Programs
2. Instrument Manufacturer and Model Code List
Code
64
700
701
702
703
704
705
706
708
714
715
716
717
718
719
720
721
724
725
726
727
728
731
732
735
736
737
738
739
740
741
742
743
744
745
746
747
748
749
750
751
752
753
754
755
756
757
758
759
760
761
762
763
764
765
766
767
768
769

Manufacturer
Other (Distributor Name)
Abbott
Abbott
Abbott
Abbott
Abbott
Bayer ADVIA
Bayer ADVIA
Bayer Technicon
Chiron
CIBA Corning
Dade Behring
Dade Behring
Dade Behring
Gilford Instruments
IL Monarch
Manual Spectrophotometric
Olympus
Olympus
Olympus
Olympus
Ortho-Vitros Chemistry Systems
Ortho-Vitros Chemistry Systems
Roche Cobas
Roche / BM / Hitachi
Roche / BM / Hitachi
Roche / BM / Hitachi
Roche / BM / Hitachi
Roche / BM / Hitachi
Roche / BM / Hitachi
Roche / BM / Hitachi
Roche / BM / Hitachi
Roche / BM / Hitachi
Roche / BM / Hitachi
Roche Modular
Schapparelli
Vital Scientific
Wako
ATAC
Roche / BM / Hitachi
Bio Mek
Bio Rad
Molecular Devices
Beckman
Optima
Alfa Wasserman
Olympus
Polymedco
Thermo Clinical Labsystem
Molecular Devices
Bayer
Abbott
Beckman
Abbott
Olympus
Alfa Wassermann
Ortho Clinical Diagnostics
Cholestech
Molecular Devices

Instrument Model
Any Model
Aeroset
Axsym
IMX
Spectrum
VP
1650
IMS
Axon
550 Express
550 Express
Dimension
Paramax
Stratus II
Any Model
Any Model
Any Model
AU 5000
AU 5200
Demand
Reply
250
950
E 170
704
705
717
736
747
902
911
912
914
917
D&P
Ace
Any Model
Any Model
8000
7020
2000
Any Model
Thermo Max
LX20
909
NExCT
AU 5400
Poly-Chem System
Konelab 20
SpectroMax 250
ADVIA 1650
CI 8200
DXC 600
Architect C8000
AU 2700
ACE
Vitros 5,1 FS
LDX System
Versamax

Code
770
771
772
773
774
775
776
777
778
779
780
781
782
783
784
785
786
787
789
790
791
792
793
794
795
796
797
707A
707B
709A
709B
709C
709D
710A
710B
710C
711A
711B
712A
712B
712C
713A
713B
713C
722A
722B
722C
723A
723B
729A
729B
729C
730A
730B
733A
733B
734A
734B

Manufacturer
Bio-Tek Instruments
Dade Behring
Roche Cobas
Beckman Coulter
Bio-Tek Instruments, Inc.
Hitachi
Siemens
Ortho Clinical Diagnostics
Siemens
AMS Diagnostics
Siemens
Roche
Siemens (Dade)
Beckman
Roche
Abbott
Beckman
Roche
Mindray
Ortho Clinical Diagnostics
Roche
Beckman Coulter
Hitachi
Roche
Hitachi
LabCorp
Bruker
Bayer Technicon
Bayer Technicon
Bayer Technicon
Bayer Technicon
Bayer Technicon
Bayer Technicon
Beckman
Beckman
Beckman
Beckman
Beckman
Beckman
Beckman
Beckman
Beckman
Beckman
Beckman
Olympus
Olympus
Olympus
Olympus
Olympus
Ortho-Vitros Chemistry Systems
Ortho-Vitros Chemistry Systems
Ortho-Vitros Chemistry Systems
Ortho-Vitros Chemistry Systems
Ortho-Vitros Chemistry Systems
Roche Cobas
Roche Cobas
Roche Cobas
Roche Cobas

Instrument Model
ELx808 IU
BN II
6000
DxC 800
Ceres UV 900HDi
7060
ADVIA 1800
Vitros 5600
ADVIA 2400
Liasys 300
Dimension Vista 1500
Cobas c311
BN Prospec
AU480
Cobas 8000
Architect ci16200
AU 5800
Cobas c111
BS-120
Vitros 4600
Integra 400 Plus
AU680
7600
Cobas c501
Labospect 008AS
Vantera
NMR AVANCE IVDr
AAI
AAII
RA-500
1000
2000 Opera
XT
Astra 4
Astra 8
Ideal
CX4
CX5
4CE
5CE
CX7
DU-30
DU-6
UV-35
AU 400
AU 600
AU 640
AU 1000
AU 800
700
700
750 XRC
500
550 XRC
Integra 400
Integra 700
Fara
Mira

Last Updated: 6/3/2020

CDC Clinical Standardization Programs
3. Reagent Manufacturer Code List
Code
800
801
802
803
804
805
806
808
810
811
812
813
814
815
816
817
818
819
820
821
822
824
825
826
827
829
830
831
832
833
835
836
837
838
839
840
841
842
843
844
845
846
847
848
849
850

Reagent Manufacturer
Abbott
American Monitor Corporation
Bayer HealthCare
Beckman
CIBA Corning
Dade Behring
Daiichi
Diagnostic Chemical Limited
Equal Diagnostics
Fisher
Genzyme
In-House
International Reagents Corporation
Kokusai
Kyowa Medex Company, Ltd.
Olympus
Ortho Clinical Diagnostic
Pointe Scientific
Roche
Raichem
Schiapparelli
Sigma
Wako Pure Chemical Industries, Ltd.
Warnick & Company
Bioengineering Company
RANDOX
Vital Diagnostics
Thermo Clinical Lab Systems
Polymedco
Trace
Trinity Biotech
Denka Seiken Company, Ltd.
Nittobo Medical Company, Ltd.
Serotec Company
Alfa Wassermann
Cholestech
Instrumentation Laboratory (IL Test)
Kamiya
Bacton Assay
Orion Diagnostica
Siemens
AMS Diagnostics
CHEMELEX
Sun Diagnostics, LLC
DiaSys Diagnostic Systems
Bruker Plasma Buffer

Last Updated: 6/3/2020

CDC Clinical Standardization Programs
4. Calibrator Manufacturer Code List
Calibrator
Manufacturer
Code
ListCode
100
900
901
902
903
904
905
906
907
908
910
911
912
913
914
915
916
917
918
919
920
921
922
924
925
926
927
929
930
931
932
933
935
936
937
938
939
940
941
942
943
944
945
946
947
948
949
950
951
952
953
954
955
956

Calibrator Manufacturer
Other (Add manufacturer to comments)
Abbott
American Monitor Corporation
Bayer HealthCare
Beckman
CIBA Corning
Dade Behring
Daiichi
Warnick & Company
Diagnostic Chemical Limited
Equal Diagnostics
Fisher
Genzyme
In-House
International Reagents Corporation
Kokusai
Kyowa Medex Company, Ltd.
Olympus
Ortho Clinical Diagnostic
Pointe Scientific
Roche
Raichem
Schiapparelli
Sigma
Wako Pure Chemical Industries, Ltd.
Instrumentation Laboratory (IL Test)
Bioengineering Company
RANDOX
Vital Diagnostics
Thermo Clinical Lab Systems
Polymedco
Trace
Trinity Biotech
Denka Seiken Company, Ltd.
Nittobo Medical Company, Ltd.
Serotec Company
Pacific Biometrics
Alfa Wasserman
Solomon Park Research Laboratory
Zhongshan Company
CEQAL
STANBIO
Bio-Rad
Streck
Thermo Electron Corporation
Kamiya
Bacton Assay
Orion Diagnostica
Siemens
AMS Diagnostics
Alere LDX Calibrator
CHEMELEX
Bruker NMR IVDr
Sekisui

Last Updated: 6/3/2020

LSP PS 148 Interim Data Submission Form
Laboratory ID
Analyte

Not Selected

Method Principle Code

Not Selected

Reagent Manufacturer Code

Not Selected

Unit of Measure

Not Selected

Run

Sample ID

Result 1

Result 2

Run Date

Reagent Lot

Calibrator Lot

Calibrator Manufacturer

1

Not Selected

2

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3

Not Selected

4

Not Selected

5

Not Selected

6

Not Selected

7

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8

Not Selected

9

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10

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11

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12

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