Jump to content

Validation of Biorad IH500

Recommended Posts

Hi All

Just wondering if anyone has gone through validation of the IH500 analyser and if they could share any issues that may have occurred ?

I am currently writing the Validation policy/plan and would be good if we could prempt some of the IQ before it gets to the PQ. I am following the BSH guidelines. 




Share this post

Link to post
Share on other sites

We have validate our IH1000 recently . I guess it's same protocol when you have to perform IQ. 

UR1 : analyser reading right barcode label and transiting right result to right patient. 

UR2 : Run 10 samples for each group and compare reaction with manual as well as existing analyser.  

UR3: Run known antibody positive sample and compare reaction. Also need to run NIBSC . 

UR4 validate all the reagents on board give expected reaction and no difference in reaction up to expiry

UR5; validate all the test such as baby group, DAT and panel and same as above. 

UR5: check all the abnormal sample such as lipamic, Haemolysed, and insufficient picked up by analyser. 

UR6: Run same barcode sample on analyser to identify duplicates barcodes. 

UR7 : check LIMS on both direction.

Share this post

Link to post
Share on other sites

Sorry few more.

Reaction specifity and strength correctly interprets as compare to previous result.

Analyser recognise that QC has failed


Share this post

Link to post
Share on other sites

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!

Register a new account

Sign in

Already have an account? Sign in here.

Sign In Now

  • Advertisement


Important Information

We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.