Validation of Biorad IH500

[Tabbie 6]

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. 

Thanks

 

 

[gagpinks 49]

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.

[gagpinks 49]

Sorry few more.

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

Analyser recognise that QC has failed

 

[Tabbie 6]

Great thanks for that feedback 😀

[NicolaHT 5]

 I know this is an old post, but I wonder how you got on with your validation? I have just had a IH500 installed and am thinking ahead for validation plans / routine use, if anyone was willing to share information?

Thank you,

Nic 

[Ally 8]

we have IH1000 for a year now. We followed Bio-Rad installation guide and they helped us in IQ. we did OQ and PQ.  lots of work... good luck!!

[Hajar 1]

sorry for repeating the question (validation of IH500

can you please write in steps how u validate? and how many samples? 

do we need to test for all significant antibodies ??

what population we need to test other than neonates and adult samples??

plz if anyone can write in details will be appreciating your help

[NicolaHT 5]

Alongside what gagpinks has said up above, I am primarily looking to use

• Approx 10% of our annual sample volume for ABO/D and screen (covering all ABO and D groups, positive and negative antibody screen)
• Infant groups performed on baby and cord samples which we routinely receive
• Rh/K for as many phenotypes as I can muster (I appreciate I'm highly unlikely to come acorss a r"r"  ) 
• Antibody panels (IAT and enzyme) for all clinically significant antibodies as defined in the BSH guidelines, and combinations of antibodies 
• Reagent validation for full on-board management 

 

The one thing we are very undecided about, is on-board the panel cells have a validity on 7 days (this can be cumulative over a period of the reagent validity), so what is the best method for extending the reagent validity as long as possible, when and how to QC. 

1. On put on board when required and QC each time cells are loaded 
2. QC once a day regardless of how many time cells go on and off
3. QC once a week and keep on board at all times
4. QC once a week regardless of how many time cells go on and off

I can draw many advantages and disadvantages for each, but also need to consider cost implications for reagents and QC, in conjunction with good practices and appropriate testing intervals. 

Any ideas / suggestions / thoughts are appreciated!