An international quality control programme for PRISM chemiluminescent immunoassays in blood service and blood product laboratories

Abstract

Analysis of test results of an external QC sample can be used as a statistical process control through ongoing measurement of imprecision. When laboratories test the same QC sample in the same assay and submit test results to a single database, the results can be compared and a measure of bias can be calculated. The resulting QC programme can offer detection of unexpected variation in the testing processes and the source of variation investigated.

Determination of quality control limits for serological infectious disease testing using historical data

“…Our institution, NRL (Melbourne Australia) has conducted an international QC program (www.nrl.gov.au/ qconnect) for laboratories performing infectious disease serology for over a decade [22]. QConnect QC samples (previously known as PeliSpy) are selected to give lowlevel reactivity on specific assays [21,22].…”

“…QConnect QC samples (previously known as PeliSpy) are selected to give lowlevel reactivity on specific assays [21,22]. Each lot of QC is manufactured using the same stock material at the same concentration, thereby minimising the lot-tolot variation.…”

The new screening program to prevent cervical cancer using HPV DNA: getting the balance right in maintaining quality

“…The results from a participating laboratory can be compared with those from other laboratories using the same assay and QC sample. This process provides real‐time monitoring of assay sensitivity by the QC provider, and results that exceed expected limits can be immediately investigated . Daily use of an externally sourced nonmanufacturer supplied control is also mandated in the draft standard .…”

Visual and Statistical Assessment of Quality Control Results for the Detection of Hepatitis-B Surface Antigen among Australian Blood Donors

“…Like all biological assays, the PRISM IAs are subject to variation due to changes in reagent batches, instrument variability, inconsistencies in operator processes and environmental factors. Over the past decade, NRL (Australia; www.nrl.gov.au) has conducted a QC program for monitoring the performance of serological screening of blood donors for TTI [12,15,16]. This QC program assesses the day-to-day variability of the testing procedure and is based on established methodologies and statistical rules [17][18][19].…”