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comment_72427

Is Fetal screen lot to lot testing a requirement? Can someone give me an insight what you do in your institution?

thank you,

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  • David Saikin
    David Saikin

    I just run the old controls with the new lot kit.  Never had a problem with inspections.  My anticipated results are positive with the old and new pos cts and negative with the old and new neg cts.

  • Same as above. Here is the form I made in case you need it. l to l to send.docx

  • The requirement is from the CAP all common checklist. If a test kit comes with positive and negative controls, lot to lot comparison is required.

comment_72430

Yes it is. I use cells from old lot with antisera from new lot and cells from new lot with antisera from old lot. On a different thread I noticed that someone else was using controls from old lot with antisera and indicator cells from new lot, then controls from new lot with antisera and indicator cells from old lot. That is a better method than mine I think. You will need to indicate what acceptable results are - like number of rosettes in the positive controls must match within whatever % or give a range for the number of rosettes expected from the positive control. The negative control should be negative, of course.

comment_72440

I just run the old controls with the new lot kit.  Never had a problem with inspections.  My anticipated results are positive with the old and new pos cts and negative with the old and new neg cts.

comment_72442

We run the old controls (before they expire) and the new controls with the new lot kit. 

comment_72448

Same as above. Here is the form I made in case you need it.

l to l to send.docx

comment_72471

How do I know when a lot to lot correlation is needed?  Is there a standard that says a lot to lot is required? If yes what is it? I could not find anything in the AABB standards, CFR, or The Joint Commission. I could have missed it or misinterpreted it. 

comment_72483
On 2/9/2018 at 1:43 PM, tkakin said:

How do I know when a lot to lot correlation is needed?  Is there a standard that says a lot to lot is required? If yes what is it? I could not find anything in the AABB standards, CFR, or The Joint Commission. I could have missed it or misinterpreted it. 

The requirement is from the CAP all common checklist. If a test kit comes with positive and negative controls, lot to lot comparison is required.

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comment_72495

Excellent answers from all and thank you for sharing your worksheet lpregeno.

Edited by simret
Error

comment_72503

Here is my worksheet as well if anyone wants it.  It may look a little funny because I had to convert it from a PDF file.

We take the controls from the new lot and test on the old and controls from the old and test on the new lot.  We do this at receipt of the kit.

 

Fetal Screen Lot to Lot.docx

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