Lorem Ipsum
First Name
Last Name
Business Number
Business Email
Do you perform LDT (assays)?
Yes
No
What PCR instruments are in use for LDT assays?
CFX96™ Real-Time PCR Detection System (Bio-Rad)
CFX96™ Dx System (Bio-Rad)
CFX96™ Opus (Bio-Rad)
CFX96 Touch™ Real-Time PCR Detection System (Bio-Rad)
What extraction instruments are in use for LDT?
STARlet
Kingfisher
Other
Are your PCR instruments owned or acquired by rental or lease or other contract?
Owned
Rental
Leased
Other Contract
If yes, how long is the agreement?
1
2
3
4
5
6
7
8
9
10
Describe your agreement, please.
Are the LDT instruments under a service agreement?
Yes
No
How often do you make a change in your LDT assays (switch to a new LDT)?
How many new LDTs do you bring up annually?
When validating a new LDT, where do you get samples ?
Other Labs
Save from our Patients
Purchase
What are the challenges to validating a new LDT ?
Getting clinical samples
Getting analytical samples (validation panel)
Developing the LDT test protocols (v&v)
Running the Validation Testing
Determining the Number of Clinical Samples to Run
Writing the report (or assessment)
Finding information that guides the overall work to be performed
Other
Comments