QC Investigations

Investigation of QConnect Blue (DM180201) change in reactivity in the Abbott ARCHITECT HBsAg Qualitative II CMIA  2/7/2019

 

Summary:

A proactive investigation of peer group data for QConnect Blue: DM18021 tested in the Abbott ARCHITECT HBsAg Qualitative II demonstrated a shift in reactivity outside of QConnect limits from the 1 March-27 May 2019. Twelve participants reported results below QConnect limits and on review, for nine participants, this shift in reactivity was attributed to reagent lot variation, involving the following  five reagent lots: 93249FN00, 94049FN00, 94053FN00, 95021FN00 and 96091LI00. NRL recommends continued monitoring of the Abbott ARCHITECT HBsAg Qualitative II assay to establish if future reagent lots continue to result in decreased QC S/Co values to determine if further investigation is warranted.

 

Investigation of QConnect HEPR (DM17216) in the Abbott ARCHITECT Anti-HBs CMIA  5/4/2019

Summary:

An investigation was requested by participant 299 in regards to the variability in reactivity of QConnect HEPR (DM17216) when tested in the Abbott Architect Anti- HBs CMIA commencing from October 2018 with kit lot: 88304FN00. On review,  NRL identified variability  in both QConnect HEPR (DM17216) and kit controls across this peer group. This variability was likely due to a combination of laboratory instrument and environmental factors including calibration, maintenance and/or sample handling and potentially changes in reagent lot manufacturing.assay test process at the time

 

Investigation of QConnect Blue:DM16233 change in reactivity in the Abbott ARCHITECT rHTLV-I/II Assay  08/08/2018

Summary:

A proactive investigation of Participant 418’s results showed QConnect Blue:DM16233 results tested in the Abbott ARCHITECT rHTLV-I/II assay were found to be outside of the NRL’s QConnect limits. Results reported by Participant 418 and other laboratories were reviewed. The shift in reactivity appeared to be due to instrument calibration. It was recommended that participants who experienced similar shifts in their data identify whether instrument calibration coincided with these shifts in reactivity or whether there was a change in a reagent used in the assay test process at the time

 

Investigation of QConnect HIVp24 DM 17089 change in reactivity in the Abbott ARCHITECT HIV Ag/Ab Combo CMIA 11/01/2018

Summary:

An investigation was requested by Participant 43 into the reactivity of QConnect HIVp24 DM 17089 when tested in the Abbott ARCHITECT HIV Ag/Ab Combo CMIA based on elevated %CV. When the data was investigated, NRL looked at all participants reporting results for QConnect HIVp24 with this assay and overall there was an elevated trend in %CV. It was considered most likely that the reagent lot 78018LI00 has been a potential cause for greater variation but this was not conclusive.

 


Investigation of QConnect HBVDNA+ (174374) change in reactivity in the Grifols Procleix Ultrio Elite HIV/HCV/HBV TMA 09/08/2017

 

Summary:

Participant 335 contacted NRL to investigate the reactivity of QConnect HBVDNA+ (174374) where results were observed to be slightly higher than the NRL Upper QConnect Limit using the Grifols Procleix Ultrio Elite HIV/HCV/HBV TMA reagent lot: 154471 between March to May 2017. Participant 335 tested two reagent lots (154471 and 159260) between January 2014 and June 2017 and most results observed to be above the NRL QConnect Upper Limit were for reagent lot:154471. This same reagent lot was used when testing another QConnect HBVDNA+ (160532) and this also yielded results above the Upper NRL QConnect Limit. This investigation shows that QConnect HBVDNA+ (174374) data demonstrated slightly higher reactivity using lot: 154471 however these results were consistent within the reagent lot. This slight shift in reactivity may be due to variation in components used in making this reagent lot.

 


Investigation of QConnect AntiHBs (442701) change in reactivity in the Abbott ARCHITECT Anti-HBs CMIA 1/09/2016

 

Summary:

A proactive investigation of Participant 30’s QConnect AntiHBs (422701) tested in the Abbott ARCHITECT Anti-HBs CMIA showed that some data between September 2015-January 2016 were above the NRL Upper QConnect limit in comparison to other participant data. Analysis showed that data from the ARCHITECT i1000SR were within QConnect limits whereas data from the ARCHITECT i2000SR were not. Given that results from the ARCHITECT i2000SR were within QConnect Limits from the 29.1.16 -11.4.16, it is suggested that an instrument recalibration at this time contributed to this change.

 


Investigation of QConnect Red (154453) change in reactivity in the Roche Elecsys HBsAg II ECLIA  5/04/2016

 

Summary:

Participant 174 experienced an increase in reactivity of QConnect Red (154453) when tested in the Roche Elecsys HBsAg II ECLIA (lot: 187706) when compared to other participants’ data. As no obvious causes could be determined for this occurrence, NRL suggested that participant 174 check their instrument calibration data to see if this correlates with the shift in data seen.

 

 

Investigation of QConnect RubellaG (330101) change in reactivity in the Abbott ARCHITECT Rubella IgG Assay   5/04/2016

 

Summary:

An investigation of January 2016 QConnect EDCNet data revealed two participants’ QConnect RubellaG (330101) results shifted within an Abbott ARCHITECT Rubella IgG CMIA reagent lot and two participants’ data showed QC results reacting from high to low repeatedly over time. It would appear the shifts in QConnect RubellaG (330101) within a reagent lot may be due to data entry error whereas the drop in reactivity from high to low observed with the other two participants’ results may be attributed to the recalibration of instrument.
 

 

Investigation of QConnect Yellow (154429 and 433507) change in reactivity in the Abbott PRISM HIV O Plus ChLIA    18/02/2016

 

Summary:

Participant 275 observed changes in reactivity of QConnect Yellow (154429 and 433507) when tested by different Abbott PRISM HIV O Plus ChLIA reagent lots. The QConnect Yellow (154429 and 433507) reactivity was consistent within each reagent lot run though testing by reagent lot 55333Q500 appeared to yield higher readings. Most of the changes observed in the Yellow QConnect results were still within the NRL QConnect limits. It is surmised that change in reagent lot due to production differences is contributing to the shift in QConnect Yellow reactivity. The production of the reagent lot meets with specifications and thus not expected to impact on patient test results.


 

Investigation of QConnect Purple (154432) reactivity in the Abbott PRISM HTLV-I/HTLV-II ChLIA   17/02/2016

 

Summary:

Participant Five experienced an increase in reactivity of QConnect Purple (154432) when tested by the Abbott PRISM HTLV-I/HTLV-II ChLIA.  After investigation by NRL, it appears the elevated results were specific to testing in the PRISM channel 1 (01097), sub channel A in reagent lot: 58182LI00.

 

Investigation of QConnect Blue (424521) reactivity in the Abbott ARCHITECT HCV Assay   23/11/2015

 

Summary:

The mean results of QConnect Blue (424521) between reagent lots 48294L100 and 53126L100 appeared to be lower than expected. Reactivity observed for reagent lots before 48294L100 and after 53126L100 are consistent with one another. The decrease in QConnect Blue (424521) reactivity appeared to be due to lot to lot variation of the Abbott ARCHITECT HCV Assay.

 

Investigation of QConnect Blue (424521) low reactivity in the Abbott ARCHITECT HCV assay   16/11/2015

 

Summary:

Participant 50 tested QConnect Blue (424521) in two Abbott ARCHITECT HCV reagent lots between 3/6/2015-11/11/2015. During that time many of their QConnect Blue results were lower than 1.9 S/Co but within the revised NRL QConnect Control Limits of 1.7-2.9 S/Co. From October 2015, 8 out of 62 of their results for QConnect Blue (424521) tested by the Abbott ARCHITECT HCV reagent lot 52159LI00 were below 1.9 S/Co. The drop in this reactivity appears to be random.

 

Investigation of the suitability of the HCV reactivity of QConnect Blue (413301) tested in the DiaSorin Murex HCV Ag/Ab Comination EIA   13/05/2015

Summary:

The drop in reactivity for QConnect Blue (413301) may be due to a combination of lot variation and a QConnect lot performing lower than previous QConnect lots. From the currect EDCNet data the mean reactivity of QConnect Blue (413301) tested in the DiaSorin Murex HCV Ag/Ab Combination EIA was S/Co 1.37 (1,789 specimens) which suggests this sample is reacting close to the cut-off of the assay. Occasionally data were non-reactive yet as the results were consistent between reagent lots it does not appear that the QConnect Blue sample is degrading. Participant 809’s data showed that with the change in reagent lot the reactivity of QConnect Blue dropped to being non-reactive when compared with the reactivity of the previous reagent lots tested. However, the results were consistent within the reagent lot.

 

Investigation of lower QConnect Blue (413301) reactivity tested in reagent lot 49159LI00 when compared with previous reagent lots of the Abbott ARCHITECT Anti-HCV CMIA   13/04/2015

Summary:

The drop in reactivity levels of QConnect Blue (413301) in reagent lot 46159LI00 appeared to be due to lot variation.

Investigation of the rise and fall in reactivity of QConnect Blue (413301) data submitted by Participant 877 for the Siemens ADVIA Centaur HIV Ag/Ab Combo (CHIV) ChLIA   25/03/2015

 

Summary:

Participant 877 informed the NRL that the highest result for QConnect Blue (413301) tested in the Siemens ADVIA Centaur HIV Ag/Ab Combo (CHIV) ChLIA occurs when they calibrate the assay and then over a week or two the values drop until they recalibrate and the cycle begins again. Participant 877 is working with the manufacturer to resolve this issue.

 

Investigation of low reactivity of QConnect Rubella G (330101) tested in reagent lot 63978UN14 of the Abbott ARCHITECT Rubella IgG CMIA   10/03/2015

Summary:

Participant 9 suspected that the low Rubella G (330101) reactivity was due to the calibrator lot tested and was in the process of obtaining another calibrator lot to test at the time of this investigation.

 

Investigation of the reactivity of QConnect Red (411103) tested in the bioMerieux VIDAS HBsAg Ultra ELFA (Long Protocol)   11/02/2015

 

Summary:

The reactivity of QConnect Red (411103) tested in the bioMerieux VIDAS HBsAg Ultra ELFA (Long Protocol) was investigated. Participant 13 was concerned that the results may have been trending down. The investigation showed that changes in QC reactivity were due to lot to lot variation.

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