To anyone analysing serum hCG on the Roche e411,

 

We have a persistent positive bias on the hCG assay on the e411 using  HCG+B lot 259199 and HCG+B CalSet lot 221092.

We use third party controls and the low level IQC (target 10IU/L) runs fine, but our high level IQC (target 500IU/L) shows a persistent positive bias of ~10%.

The 10% positive bias at concentrations >100 IU/L is also demonstrated in patient samples.

We have seen the same issue on 3 different e411’s.

The IQC/EQA results are fine on the Cobas 6000 line using the same lot of reagent and calibrator.

 

Would be interested to hear if anyone has observed the same issue with the e411.

 

Many thanks,

Sally

 

 

Sally Willett

Consultant Biochemist

Blood Sciences

North Cumbria University Hospitals NHS Trust,

Cumberland Infirmary,

CARLISLE, CA2 7HY.

Tel:     01228 814521                  Fax:    01228 814831

The NCUHT Pathology Handbook can be found here

For general information on tests see Lab Tests Online

 

 

 

 

 

 



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