Good morning.

 

How do you interpret and/or comply with this CAP checklist items for your FMHS kits? Thanks for your help. Alana

 

COM.30450

New Reagent Lot Confirmation of Acceptability

 

New reagent lots and/or shipments are checked against old reagent lots or with suitable reference material before or concurrently with being placed in service.

NOTE: The purpose of this check is to confirm that the use of the new reagent lot or shipment does not affect patient results. Matrix interferences between different lots of reagents may impact the calibration status of instruments and consistency of patient results. Improper storage conditions during shipping of reagents may have a negative impact on their ability to perform or exhibit the same levels of reactivity as intended.

 

Qualitative

 

For qualitative nonwaived tests, minimum cross-checking includes retesting at least

one positive and negative sample with known reactivity against the new reagent lot. A weakly positive sample should also be used in systems where patient results are reported in that fashion.

Examples of suitable reference materials for qualitative tests include:

1. Positive and negative patient samples tested on a previous lot;

2. Previously tested proficiency testing materials;

3. External QC materials tested on the previous lot;

 

 

 

We do parallel testing on the kit when it comes in, along with the current kit in use. See attachment for the form that we use for documentation.

Parallel Testing Results Fetal Screen.xls

I test the controls from the old kit using the new kit.  Have done it this way for many years.

tbostock

Thank you for the form example. Alana

I test the controls from the old kit using the new kit.  Have done it this way for many years.

 

We do the same.

I do parallel testing also, here is my form

LOT TO LOT FETAL BLEED SCREEN.xlsx