BioQControl offers an external quality assessment scheme for HBsAg, anti-HCV, anti-HIV-1/2 and anti-HTLV-1 screening assays. The program focuses on consistent detection of viral standard dilution series. It will enable laboratories using the same assay to compare their signal/cut-off ratios. As such it monitors the consistent analytical sensitivity of the assays. The scheme is organised in collaboration with Dr. C. Weykamp at the Queen Beatrix Hospital in Winsterswijk, the Netherlands. The program is operational since 1996 and also supplies SKML (dutch foundation of quality control in hospital laboratories). Every quarter 6-member panel is supplied to the laboratories. All samples are lyophilised, so we send the samples by regular post at ambient temperatures. You can submit the results on an internet accessible database (www.viralqc.com). After the closure of the study you can access the reports. The reports compile all available data on a dilution tested in the same assay. Applying descriptive statistics the 95 % and 99 % confidence intervals are calculated. When you are repeatative outside the confidence intervals this may indicate lack of performance. Participants will receive every year a certificate of participation and a performance report.
Monitoring clinical sensitivity may be a better objective; however we cannot access sufficient plasma's from early seroconversions, escape mutants, rare geno, subtypes or late stages of the disease which are needed for a comprehensive program. Secondly IVD manufacturers need to validate the assay on seroconversion series and rare geno, subtypes as part of CE marking and/or 510 k Approval thereby proving the assays reacts against all infected specimens. As only seroconversion series of common geno, subtypes are available comparison of diagnostic sensitivity on the rare variants is not possible.
