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pdfCDC
Clinical Standardization Programs
Form Approved
OMB No. 0920-xxxx
Exp. Date xx/xx/201x
2019 CDC Accuracy-Based Monitoring Programs (CDC AMP) Enrollment Form
Lab ID (assigned by CDC)
LABORATORY AND DIRECTOR:
Enter number of kits required (each kit includes 0.4 mL aliquots)
Total Testosterone in male (TTM) [Total Testosterone > 100 ng/dL] 0
Total Testosterone in female (TTF) [Total Testosterone < 100 ng/dL] 0
Total 25-hydroxyvitamin D (VD) 0
Lab Name:
Director’s Title:
First Name:
Last Name:
E-mail:
Phone:
Zip Code:
Department:
Address 1:
Address 2:
City:
State:
Country:
Title:
First Name:
Last Name:
E-mail:
Phone:
Zip Code:
Department:
Address 1:
Address 2:
City:
State:
Country:
Title:
First Name:
Last Name:
E-mail:
Phone:
Zip Code:
Department:
Address 1:
Address 2:
City:
State:
Country:
Title:
First Name:
Last Name:
Phone:
Zip Code:
Address 1:
Address 2:
City:
State:
Country:
PRIMARY LABORATORY CONTACT (send correspondence to):
Kit(s)
Kit(s)
Kit(s)
SHIP SAMPLES TO (if different from primary laboratory contact):
BILLING INFORMATION (if different from primary laboratory contact):
SHIPPING INFORMATION
FedEx Account No.:
VAT/Tax ID:
SIGNATURE
Laboratory
Director’s
Signature:
Date:
SUBMIT ELECTRONIC COPIES TO
Centers for Disease Control and Prevention (CDC)
Clinical Standardization Programs
Email: [email protected]
*Disclaimer-Information provided here will be shared with 3rd party shipping company
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).
Version 1.0.0
Assay Characteristics Form for Total Testosterone in Females (TTF) and Total Testosterone in Males (TTM) Data Form
Fill all applicable white fields in sections 1 ‐ 6
Analyte:
Matrix:
Total Testosterone in Females
Serum
4. Instrument/Assay Description
Description
Laboratory's Assay Identifier (CLIA code etc.)
Choose Methodology Category:
if other:
1. Participant Information
Primary Contact (First and Last):
Company/Institution:
Telephone Number:
Email:
CDC Lab ID (provided by CDC):
Mass Spectrometry (MS)
Immunoassay (IA)
1
1
ATFXXX
1
2. Pool Series Information
Other Instrument Details (if applicable):
Pool Series (PS):
Year and Quarter:
PS148
2019 Q1
3. Notes/Comments
Volume of Serum Used Per Analysis (uL):
Analysis Time Per Sample (min):
Units used to report results:
Limit of Detection (ng/dL):
Reportable Range Min (ng/dL):
Reportable Range Max (ng/dL):
Single or Multi‐Analyte Method:
if Multi‐Analyte Method, list other analytes included:
5. Calibrators (one level per row)
Manufacturer:
if other:
Level
Name
1
Lot Number
Concentration (ng/dL)
Name
Lot Number
1
2
3
4
5
6
7
8
9
10
11
12
6. Reagents
Manufacturer
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
**If Manufacturer Not Listed, Please Specify Below**
ng/dL
1
Other
Data Submission Form for Total Testosterone in Females (TTF) and Total Testosterone in Males (TTM) Data Form
Fill all applicable white fields in sections 1 ‐ 2
Lab ID:
ATFXXX
1. Sample Results (in ng/dL and 3 significant digits)
Sample Order
Week
Vial ID
1
2
3
4
5
6
7
8
9
10
11
12
Week 1
Week 2
Week 3
Week 4
Week 5
Week 6
Week 7
Week 8
Week 9
Week 10
Week 11
Week 12
1354684
1354685
1354686
1354687
1354688
1354689
1354690
1354691
1354692
1354693
1354694
1354695
Date of Analysis
mm
dd
yyyy
Results (ng/dL) with 3 significant digits
Run 1
NR
Run 2
NR
*Comments/Error Message & Explanation
1.00
1.00
1.00
1.00
2. Comments
Not Reported (NR) Legend
Code
Description
QNS
| File Type | application/pdf |
| Author | Sugahara, Otoe (CDC/ONDIEH/NCEH) |
| File Modified | 2022-08-19 |
| File Created | 2019-04-17 |