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QConnect Limits

 

QConnect Limits take advantage of peer data sharing and provide users robust, pre-determined control limits. QC limits are based on up to 10 years of QC data and are available for commonly used QC sample/assay combinations. These statistically validated QC limits give you the confidence to know immediately when your system is not running to specification.


What are QConnect Limits?

Traditional QC approaches used to determine QC limits have been derived or modified from clinical chemistry and may not be applicable to serology or NAT. QConnect Limits, developed by NRL, utilise historical data by determining expected upper and lower values of results for each QC sample/assay combination.

Dimech W, Vincini G, Karakaltsas M. Determination of quality control limits for serological infectious disease testing using historical data. Clin Chem Lab Med. 2014 Aug 12.

All QConnect participants using the same assay and the same QC sample submit results to EDCNet. Over time, multiple lots of QC samples have been tested by many laboratories, operators and instruments across numerous lots of reagents. These results reflect the expected extent of variation for that QC sample/assay combination. These results have been extracted and analysed in collaboration with a biostatistician. The variation of QC results, both within each QC lot and between each QC lot was used to determine an upper and lower limit for each QC sample/ assay combination. These limits allows for the identification of any unexpected QC result, potentially identifying unacceptable variation from a range of sources including reagent lot numbers; instruments or equipment calibration and maintenance; operator errors; assay and QC sample storage and transport or environmental conditions.

Download: QConnect Limits Overview


How to use QConnect Limits

When entering data into EDCNet, results outside the QConnect Limits for that QC sample/assay combination are flagged in red indicating further investigation is required. All results outside the QConnect Limits are held in quarantine until they are validated by an NRL staff member. Participants can overlay the QConnect Limits on Levey-Jennings and other EDCNet charts in conjunction with laboratory-specific and peer group limits. NRL also provides a suggested approach, including a check list, for the investigation and troubleshooting of unexpected results.

Note: QConnect QC samples are used in addition to the manufacturers’ controls and as such, the manufacturers’ instructions for validating an assay should be adhered to.


Download: Investigation of Unexpected Quality Control Results

Download: First Line Check