A laboratory running a competitors 3^rd party Microalbumin QC noticed shifts in their QC values whenever they changed reagent batch.

They tested two levels of quality control over three different batches of reagent the results can be seen in the table below.

Competitor Control – Microalbumin
Reagent Batch	QC Level One	QC Level Two
1	19.9	81.0
2	29.7	90.5
3	50.4	122.4

 

As can be seen from the findings above, Microalbumin results shifted significantly each time they changed reagent batch. This was the case for both the level one and level two control however when the lab tested the same set of patient samples across the three reagent batches results were consistent and did not show the same shifts.

The laboratory decided to contact Randox and ask about our Microalbumin controls. They were concerned about the shifts seen with their current supplier and highlighted the fact they were no longer confident in the results they were releasing. This led to them trialling the Randox liquid ready-to-use Microalbumin control with the same three reagent batches they tested previously.

Having tested two levels of the Randox quality control over the same three reagent batches the laboratory reported to us that their results were back on track and they were delighted with the outcome! The results of the Randox control can be seen in the table below.

Randox Control – Microalbumin
Reagent Batch	QC Level One	QC Level Two
1	33.5	158.8
2	34.9	164.9
3	34.8	168.0

 

The difference seen with the Randox control across the three reagent batches was much smaller than that of their previous control and was in line with the changes seen with their patient samples.

This case study highlights the commutability of the Randox QC range. By using a control with a matrix that reacts to the test system in the same manner as the patient sample the laboratory was confident in the patient test results produced and were able to meet ISO 15189:2012 requirements.