Flow Cytometry P30

1. LB document MITEST/CD: Rows 7-8 (CDISC-1823 to 1826)
2. Status of request for new Variable in lab to house CD markers
3. Team Working Document – What is the status?
4. Do we want to keep this meeting or merge with lab meeting?

1. Completed
2.  The IHC group (Ellie Schatz is running this team) will be requesting this new variable for both LB and MI domain. Craig will follow up with Ellie about status of this request – this variable needs to be requested for both LB and MI.
3. Batch 1: Team wanted to start with peripheral cells and normal cells commonly assessed by immunophenotyping – done in P29.
   Batch 2: Abnormal/Cancer cells and relative counts of normal cells. – do with P30.
   Still to do for future batches: Bone marrow and progenitor cells; known sub-classes/sub-types of more general cell types. Note: progenitor cells may be lower priority, though Anna may have an AZ opinion. Sue’s company also does progenitor cells via immunophenotyping. Therefore, keep on list for batch 3.
4. Keep this as a standing, separate meeting for 2017. Erin to create folder on portal and create an attendance file

1. P29 public review requests in Lab  P29
2. Wintrachange Agenda items
3. New term requests? 

 1. Completed

Didn't get to 2 and 3.

1. Wintrachange agenda
2. P29 public review requests in lab P29
3. New term requests
4. Craig Database items

1. Completed

2. Completed all except CT-95

Didn't get to 3, 4.

1. CT-95 – P29 public review
2. New Term requests
3. Craig Database Items

1. Craig - Discuss possibility on holding off on publishing these terms in P29: Regarding immunophenotyping, I’m also inclined to recommend to the subteam that we hold off on publishing the terms.  Although I think the terms we’ve come up with so far are fine, I’m running into some issues when trying to use our implementation plan for the more complex terms (recall we started with the simple ones).  

This is leading me to believe that the team needs to discuss potential solutions for these more complicated test names (both short-term and long-term) which involve numerous modifiers and subsets that have no name other than a portion of the marker string. So far, it seems we’ve only developed a partial modeling solution, so are not yet ready to provide a complete recommendation on implementation.  As well, with a more complete solution in hand, our CT subteam will be able to continue its work of expanding the test name codelist beyond the simple terms we’ve already identified.

There is a solution for the difficulties, but we need to discuss the various options to try to find the best one for the domain model.  The central question is how much information do we want to cram into the test name?

Audrey Walker also shared strong reservations towards publishing out this set of CT until more difficult issues are also resolved.

Sue Use case; First test –

T Lymphocytes is the test code

Antigen Marker string is CD3+CD8+CD4-

Result is expressed as a percentage of total T lymphocytes

I can’t use the test code/name of TLYCE - T-Lymphocytes because this is a relative count

What code would you anticipate we would be using?

TLYCTLYC – T-Lymphocytes (CD3+CD8+CD4-) as a percent of total T cells? 

Since the Antigen string which describes the T-cells being counted is in the SUPPQUAL field, how else will we describe the relative cell counts?

Team decision: (Craig, Sue, Ngaire, Erin, Manjula) Do not add these terms to P29 for now until the model can accommodate more complex use cases. Craig to email full Flow Cytometry team to let them know of this decision and refute this decision over email if necessary. CT-95, CT-95 public review comments were resolved.

2. New Term requests

                                                               i.      Team discusses relative tests and what to do with CD marker string in numerator and denominator – solution 1 would be to give guidance that the forward slash needs to be used in the new NSV to demarcate the CD marker string numerator and denominator; solution 2 would be to create 2 NSVs, one for the numerator marker string and one for the denominator marker string; solution 3 would be to give guidance to report CD marker string for numerator.; solution 4 would be to not use CD marker string at all for any of these relative measures.

                                                             ii.      Sue shared that her database does contain these relative type measures but the denominator CD marker string is very short (CD4+CD8+).

3.

• Flow Cytometry Team to come up with conventions for how to represent CD marker string (team members to send in their company conventions)

                                                               i.      Positive/negative: Please use + (positive) sign for Positive and – (negative) sign for Negative.

                                                             ii.      Bright/dim: Please use

                                                            iii.      Low/High/Moderate: Is this low/high synonymous with Bright/Dim?

                                                           iv.      Negative to Low: (this is from Sue) Do not use forward slash.

1. What does +/- mean?

                                                             v.      Forward slash for denominator: Only use forward slash for denominator

1. Review open P30 new term requests
2. Flow Cytometry Team to come up with conventions for how to represent CD marker string (team members to send in their company conventions)
3. Continue with Craig database items

• Rows 8-18 – Team discussed whether to update definitions for all published LBTEST terms with ‘Total Cells’ in the denominator – change ‘…total cells…’ to ‘…total nucleated cells…’ in the definition. Ultimately decided not to and kept ‘total cells’ as is.
• Rows 19-23 – Erin to email Phil to figure out about CD8 positivity

Team re-discusses Batch 2: More complex normal cells and relative counts of normal cells. (Batch 3 will include abnormal cells and tumor cells).

Flow Cytometry Team to come up with conventions for how to represent CD marker string (team members to send in their company conventions) – Do not do today. We’ll need a full session to flesh this out.

1. Erin to present: Review last two new term requests: Rows 22, 23–Phil’s response

• Change requests on rows 22, 23 completed.
• Will need to consider an additional NSV to put information about what else is being expressed, e.g., CD8 positive Natural Killer Cells express cytokines like IFN-gamma.

1. Team to review new term requests from PGx team. 

ü  Discuss putting two lbtest values out for public review from PGx team? – Not yet; these will need to be done with P31.

ü  Update of agenda for flow cytometry topics at Wintrachange

• Craig to present: database listing and work through the next batch: More complex normal cells and relative counts of normal cells. Craig will be working in his documents to start with.
• Conventions for how to represent CD marker string; may need an additional variable that describes other things that are being expressed.