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  • Stock Update - November 2024

    To all of our QC customers, please note the stock update for the next 3 – 6 months. To purchase any of the below, please get in touch via [email protected]

     

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NRL Quality Control Services Everything connected to QC is streamlined into a single portal: ordering customised QC samples, results management and reporting, control limits, Uncertainty of Measurement (MU) reports, troubleshooting and the ability to liaise with other users.

 

Becoming a QConnect member is free and included with the purchase of QConnect products.

Simply click on the “Join Now” button below.

 

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Why use QConnect Concept for Monitoring Infectious Disease Testing?

Traditionally, laboratories set QC acceptance limits using as few as 15 data points and then calculate mean +/- 2 standard deviations to establish control limits.  Westgard rules are used to identify results that are “out of control”.  However, this method has been proven to be not fit for purpose and causes unnecessary work troubleshooting “false rejections”, resulting in extra cost and delays in patient testing.

As specialists in infectious disease quality control, NRL has developed and validated a more appropriate approach to monitoring infectious disease QC.  QConnect uses historical data submitted into our real-time QC software EDCNet, to calculate acceptance limits for each QC/Assay combination, using thousands of QC results.  In this way, participants can be confident that any QC results falling outside this range, truly represents an unexpected variation, which requires investigation.

NRL QConnect approach is the only scientifically validated way to monitor infectious disease testing QC results.

What is the QConnect Concept?

  1. Highest quality control samples, using true human disease-state plasma, optimised for each test system
  2. Data collection into the cloud-based EDCNet software
  3. EQC test results, analysed against peer (EQC/Test Kit) test results, displayed in graphical and tabular forms
  4. QConnect Limits, established using thousands of peer results, set upper and lower acceptance limits of EQC results, flagging when unacceptable results are detected.

QConnect Instructions For Use

QConnect IFU's

QConnect Safety Data Sheets (SDS) and Certificates of Analysis (CofA)

SDS and CofA

Latest Quality Control Services Investigations

  • PMM-QC-2025

    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. 

    Click here to download!

    PMM-QC-1878

    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.

    Click here to download!

    PMM-QC-1784

    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.

    Click here to download!

    PMM-QC-1661

    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.

    Click here to download

    PMM-QC-1593

    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.

    Click here to download

    PMM-QC-1583
    NRL was contacted by EDCNet participants regarding negative S/Co values observed for Optitrol HIVp24 lot DM22200 when testing with the DiaSorin LIAISON XL MUREX HIV Ab/Ag Assay, on reagent lot 139054.  NRL investigated all data reported by the peer group. All Optitrol HIVp24 and reagent lots in use were reviewed for the DiaSorin LIAISON XL MUREX HIV assay along with data for all other assays where Optitrol HIVp24 is recommended for use, to establish if the negative S/Co values were observed for any other participant, Optitrol HIVp24 or reagent lot.
    Click here to download!
    PMM-QC-1480

    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.

    Click here to download

    PMM-QC-982

    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.

    Click here to download

    PMM-QC-981

    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.

    Click here to download

    PMM-QC-885

    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.

    Click here to download

    PMM-QC-860

    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.

    Click here to download

    PMM-QC-794

    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.

    Click here to download

    PMM-QC-713

    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.

    Click here to download

    PMM-QC-706

    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.

    Click here to download

    PMM-QC-689

    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.

    Click here to download

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