Comprehensive quality control programme for serology and nucleic acid testing using an Internet-based application

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

“…initial and repeat reactor rates) [1]. The performance of assays found suitable for blood screening in evaluations can vary over time due to changes in reagent batches [12], instruments [1,11,19] or operators [19,23] and due to inadequate transport or storage conditions. Generally, laboratories do not use the same batch of kit (Internal) controls over a long period of time and therefore long‐term monitoring of assay performance using the results of kit controls is not possible.…”

“…Data were submitted into a single database using a real‐time, Internet‐based application, EDCNet (http://www.nrlqa.net). This application was developed by the NRL and implemented in 2001 [12,20,23].…”

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

“…In infectious disease serology, such as the detection of anti-HIV antibodies, the paradigm above does not apply [21,23]. There are generally no CRM to facilitate quantification; the exception being analytes such as antihepatitis B surface antigen and anti-rubella IgG [12].…”

“…Serological assays used to test for infectious diseases often experience considerable variation associated with the introduction of new assay lot numbers [12,23,24,41]. Therefore, after setting control limits using the traditional method of determining the mean ± 2 or 3 times the SD from a previous approximately 20 QC sample results, subsequent results frequently fall outside these control limits when a new assay lot number is introduced.…”

“…Laboratories testing the QC sample enter results and associated information into an internetbased program (EDCNet; NRL, Melbourne, Australia). Results are monitored through a range of tabular and graphical reports and QC test results for laboratories testing the same assay and QC combination (peer group) can be compared [23]. In this way, NRL has collected thousands of QC sample results from different lots of QC for each peer group.…”