Dear NRL QC Services Customers,

A global announcement was communicated recently that LGC has acquired DiaMex GmbH, the manufacturer of the Optitrol molecular and serology quality control products available in ANZ via NRL, Australia.
LGC recognises Optitrol as being best-in-class given the design and manufacture of the products according to NRL’s QConnect™ concept and expects that the range will complement and improve their existing quality control portfolio.

NRL’s commitment to the highest quality products and service always remains at the forefront of our operations as we work to ensure this change will not impact the day-to-day requirements of our loyal customers.
If you have any questions, concerns or feedback please don’t hesitate to reach out to us via [email protected]

The 2024 EDCNet MU report subscriptions will expire on December 31st. If you haven’t already, now is the perfect time to ensure a stress-free MU reporting period by renewing your subscription for 2025. Haven’t tried this time-saving feature yet? Click here and get started today!

Please note, the deadline for orders to be delivered before the Christmas and New Year holidays is Friday the 13th of December. Any orders received after this date will NOT be processed until after the new year.

NRL’s Christmas closure is from Wednesday 25th of December and reopening on Thursday 2nd January. 

An investigation regarding a shift up in data observed for Optitrol Blue lot DM23117 when testing with the Abbott Alinity i rHTLV-I/II assay for reagent lot 60107BE00.  The investigation looked at all peer group data reported for this assay and related production lots of Optitrol Blue, in addition other Alinity i assay and both the Alinity s and ARCHITECT HTLV assays where Optitrol Blue were reported were also reviewed to establish whether reagent lot variation was the source of the variation observed. 

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NRL observed a shift up in S/Co values for Optitrol HEPR-2 DM24038 when tested with the Abbott Alinity i HAV Ab IgG assay. NRL investigated the performance of Optitrol HEPR-2 DM24038 and other related production lots, DM23002 and DM23080, as well as the performance of Optitrol HEPR-2 DM24038 when used with the Abbott and other assays and platforms the EQC had been designed for establish if this variation was observed across any other platforms and or Optitrol lots for root cause investigation.

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Data were reviewed for Optitrol ToRCH M DM22191 for data reported to EDCNet for all other assays and platforms Optitrol ToRCH M is validated for with no similar trend or pattern observed.

NRL contacted Roche Diagnostics Australia for information regarding any change in the manufacturer or production of the affected reagent lots which could have contributed to the observed downward trend. Figures 3 and 4 are target value sheets provided by Roche for the Roche PreciControl Toxo IgM control kit. The data for PreciControl Toxo IgM level 2 control shows a similar pattern and lower values as was observed for Optitrol ToRCHM DM22191. Approximately a 10% drop of target values from reagent lots 712936 to 740657 and approximately a 5% from lot 740657 to 783351 were noted.

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This report will review data reported to EDCNet for reagent lot numbers affected by the notice to establish if trends or variation are observed across the peer group.

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This investigation reviewed data reported to EDCNet for Optitrol Blue lots DM22009 and DM22121 reported for the Abbott Alinity s Anti-HTLV I/II assay and the Abbott Alinity i, Abbott Architect and DiaSorin Liaison platforms to establish if this variation was observed across any other platform.

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This investigation looked at all peer group data for the same assay reagent and Optitrol Blue lot and any other Optitrol Blue lot with data reported to EDCNet using the reagent lots in question (45574FN00 and 47571FN00), to establish whether these reagent lots were the source of any variation observed.

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During scheduled monitoring review of QC data submitted to EDCNet for Optitrol ToRCH M QC testing with the DiaSorin LIAISON HSV-1/2 IgM assay, it was observed that all data entered under QC lot DM20144, were entered at the upper limit of the assay, Index Value (IV) 3.50.

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During daily review of out of range (OOR) data submitted to EDCNet, a number of data were reported by multiple participants within the peer group as S/Co <1.00 for Optitrol Red QC lots DM20156 and DM21157 when testing with the Bio-Rad MONOLISA HBsAg ULTRA assay reagent lot 1K0709.

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During daily out of range (OOR) and monthly data reviews of EDCNet, a number of ‘random drops’ were noted for the Optitrol HIV Screening QC testing on the Grifols PANTHER Ultrio Elite HBV/HCV/HIV assay.

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NRL was contacted by Participant 8, to investigate a downward trend observed for QConnect HEPR lot DM20291 when testing with the Abbott Alinity i Anti-HBs and Anti-HAV IgG assays.

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NRL was contacted by participants 129 and 145 regarding the occurrence of random drops in data results, some falling below the lower QConnect range, for QConnect HIV p24, DM19142 on the Abbott ARCHITECT HIV Ab/Ag Combo assay.

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Participant 57 completed an evaluation of QConnect QC products and EDCNet. This report is a summary of the testing data submitted into EDCNet from 01 January to 30 September 2019.

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During a routine review of EDCNet, it was observed for the Abbott ARCHITECT HIV Ag/Ab Combo assay testing with QConnect Blue DM18210, Participant 39 data was above the upper limit and not in line with peer group data.

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NRL was contacted by Abbott Laboratories, Australia, regarding Participant 128 having reported that there was evidence to suggest there was greater variation observed for HEPR:DM17216 since the introduction of the ARCHITECT anti-HBs version 3.

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