GBCL3 Assay Format Survey on Current Recommendations

Background: GBC L3 Assay Format Team is currently drafting best practices for various assay formats for bioanalytical work (see attached slide deck). This survey is constructed to solicit bioanalytical community’s input in this area to help make the team’s recommendation reflect the best practices.

Instructions:

  • Please complete the survey from Sept 9thto Sept 30th , 2012 and send your results back to L3 GBC team at
  • Please work with your colleagues to submit one response representing your organization’s feedback whenever possible to minimize duplications.
  • Please select the best choice for each question unless being instructed otherwise. In addition, please note that the feedback should reflect your organization’s preferred practice on regulated bioanalytical work rather than research/non-regulated work. You may add comments to further elaborate your answer in the comment area.

Organization/group name: .

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  1. Do you use any of the following plaforms for PK, Immunogenicity, PD assays (please check all apply)?

PK Assay / Immunogenicity Assay / PD Assay
ELISA
MSD
Gyros
Erenna
Alphalisa
Delfia
Biacore
Luminex
Cellular Assay
  1. Would you perform singulate analysis with any of these platforms if the percentage of CV on the signal value was equal to or less than 5%?
  2. No __
  3. Yes __
  4. Yes with only selected assay formats ______
  1. Would you perform singulate analysis if the %CV on the signal value was:
  2. Equal or less than 1% __
  3. Equal or less than 3% __
  4. Equal or less than 5% __
  5. Equal or less than 10% __
  6. None of the above __
  1. For assay platforms that run samples in series such as Gyros, RIA, Biacore, Erenna, how would you define a run?
  2. A run is defined by one CD or sample plate __
  3. A run is defined by multiple CDs or samples plates that are done continuously __
  4. None of the above __
  1. How would you set-up your calibrators (Cs) and QCs in a run with assay platforms that run samples in series such as Gyros, RIA, Biacore, Erenna?
  2. Cs at the beginning of the run and QCs interspersed throughout the run __
  3. Cs plus two QC sets spread over one CD or one sample plate throughout the run __
  4. None of the above __
  1. For assay platforms that run samples in series such as Gyros, RIA, Biacore, Erenna, what would you do if there is a partial run failure because of one or more QC sets fails?
  2. Reject the run and re-run all samples __
  3. Identify the last passing QC set prior to the first failed one, and accept samples before that last passing QC set; re-run remaining samples regardless of performance of later QC sets __
  4. Accept samples bracketed by any twopassing QC sets withall QC sets in between passed; onlyre-run samples bracketed by two passing QC sets but with failed QC sets interspersed among samples __
  5. None of the above __
  1. To validate assay transfer from one platform to another, are you in favor of comparing (please check all that apply):
  2. Spiked samples __
  3. Real study sample __
  4. Pooled study samples __
  5. None of the above __
  1. How many samples should be run in order to validate assay transfer from one platform to another?
  2. 0-20 __
  3. 20-50 __
  4. 50-100 __
  5. None of the above __
  1. If you are running an assay in multiplex, do you used it mainly for (check all that apply):
  2. PK assay __
  3. Immunogenicity assay __
  4. PD assay __
  5. None of the above __
  1. If you are running an assay in multiplex, for validation, would you:
  2. Validate each analyte separately __
  3. Validate each analyte while combined in a cocktail mix __
  4. None of the above __
  1. If a multiplex assay fails to analyze all analytes within a sample, would you
  2. Re-run all the samples and report all available results even though it means that some analytes from a same sample may have two sets of values __
  3. Re-run the samples and report only the missing results of the analyte in question, while masking the other results __
  4. Run only the analyte that was missing as a single analysis, in which case a validated single assay needs to be established before the run __
  5. None of the above __
  1. If you detect a carry over effect, do you:
  2. Optimize the assay conditions to ensure that carry over effect is eliminated in a validated assay __
  3. Determine the extent of carry over during validation and calculate this into the sample concentration estimations, with the assumption that the amount of carry-over leads to a consistent non-specific signal, one that can be quantitated and subtract out __
  4. None of the above __
  1. To transfer an assay onto a new platform using the same reagents, do you ( please choose all that apply):
  2. Re-validate the assay __
  3. Perform a partial validation for any characteristics that could potentially change between the platforms __
  4. Keep number of standards and QCs the same, but adjust the dilution factor between standards to cover the full dynamic range __
  5. Test study samples on the two platforms to obtain pre-defined comparable results __
  6. Test spiked samples on the two platforms to obtain pre-defined comparable results __
  7. Test BOTH study and spiked samples on the two platforms to obtain pre-defined comparable results __
  8. None of the above __
  1. For a dynamic range that extends over 2 logs, do you do any of the following (choose all that apply):
  2. Add more calibrators on the curve __
  3. Add more standards and QCs during validation __
  4. Concentrate standards around the ends of the standard curve with fewer in the middle or linear portion of the curve __
  5. Nothing different than an assay that expands over 2 logs or less __
  6. None of the above __
  1. Please provide additional comments on assay formats that are of value to share with the bioanalytical community:

Thank you very much for taking the survey!

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