ARCHITECT Anti-HCV Reagents

Notice type: Advisory

Date: 15/04/2010

Abbott has determined that S/CO values generated with ARCHITECT Anti-HCV (LN 6C37) may decrease when 25% or less of test volume is remaining leading to: 

• Abbott Positive Control values shift down and/or out of range low,

• Non-Abbott Positive Control values shift down and/or out of range low, and/or

• A decrease in patient result values

Abbott informed the Irish Medicines Board (IMB) that the above issue was identified through customer complaints and confirmed by internal complaint investigations. 

Abbott has advised the IMB that internal studies have shown a maximum downward shift of 40% for the positive control. Abbott has indicated that the drop in S/CO is due to an inhomogeneity within the assay diluent. 

It has been confirmed that patient samples may show a decrease in S/CO values comparable to the positive control. This may result in false negative results for low reactive patient samples. 

The investigation into the root cause of this issue is ongoing. 

Abbott has issued a Field Safety Notice (FSN) (March 2010) to all Irish customers using the ARCHITECT Anti-HCV assay recommending customers mix the ARCHITECT Anti-HCV assay diluent (LN 6C37J, green bottle label) prior to testing each day of use.