Value assignment for quality control materials

[AQARA]

Hello everyone,

I would appreciate your help and guidance on this, please.

we are manufacturing quality control panel for creatinine testing from a stock solution of commercially available material. we would need to assign value to each level. i would need to know how many vial/level, how many replicate/vial and how many days i need to run these samples for? are there a specific guidelines to establish QC release criteria for IVD testing?

thanks a lot.

 

[Randy]

Hello everyone,

I would appreciate your help and guidance on this, please.

we are manufacturing quality control panel for creatinine testing from a stock solution of commercially available material. we would need to assign value to each level. i would need to know how many vial/level, how many replicate/vial and how many days i need to run these samples for? are there a specific guidelines to establish QC release criteria for IVD testing?

thanks a lot.

Sorry to say this but your question does not fit into a Human Factors subject

 

[AQARA]

Sorry to say this but your question does not fit into a Human Factors subject

no need to be sorry. you are right.

i dont know how to post this as a new question. if you could tell me how to do so that would be great.

 

[Miner]

no need to be sorry. you are right.

i dont know how to post this as a new question. if you could tell me how to do so that would be great.

No need. I moved the thread to another sub-forum that should be more appropriate.