The Importance of Third Party Controls - LT324USA MAR 2014 | Page 5

The Importance of Third Party Quality Controls

Detecting...

Detecting...

shifts after changing reagent batch

procedural errors

A real life laboratory situation
1)  laboratory using Randox Acusera Immunoassay
A

A real life laboratory situation
1)  laboratory using Randox Immunoassay Premium Plus
A

Premium Plus Control reported their QC results for

Control reported their QC results for SHBG were much

Thyroglobulin were four times higher on their main

higher than the target value provided

analyzer compared to other systems
2)  hey ran the instrument manufacturer’s control alongside
T
the Acusera control but it did not show the same
problem
3)  fter reviewing PT data, the Randox Technical Support
A
team confirmed there was a significant difference in
results compared t o other instruments
4)  he customer contacted their instrument manufacturer, who
T
advised of a positive bias with several batches of reagent

2)  hey also ran the reagent manufacturer’s control and
T
confirmed results were as expected
3)  fter reviewing the reagent kit insert, the Randox
A
Technical Support team noted that their instrument
automatically dilutes patient samples but not controls
4)  he customer was unaware of this and had not been
T
diluting the controls. Good laboratory practice is to
run quality control materials the same way as a patient
sample

Conclusion

Conclusion

The Randox Immunoassay Control detected a shift in results

The Randox Immunoassay Control detected a procedural

that the instrument manufacturer’s control did not.

error that the reagent manufacturer’s control did not.