Does a change in quality control results influence the sensitivity of an anti-HCV test?

Clinical Chemistry and Laboratory Medicine : CCLM
Wayne DimechMegan Wieringa

Abstract

Background Laboratories use quality control (QC) testing to monitor the extent of normal variation. Assay lot number changes contribute the greatest amount of variation in infectious disease serology testing. An unexpected change in six lots of an anti-HCV assay allowed the determination of the effect these lot changes made to the assay's clinical sensitivity. Methods Two sets of seroconversion samples comprising of 44 individual samples and 9 external quality assessment scheme (EQAS) samples, all positive to anti-HCV, were tested in affected and unaffected assay lots, and the difference in the quantitative and qualitative results of the samples was analyzed. Results Of 44 low-positive seroconversion samples tested in affected and unaffected assay lots, only three samples had results reported below the assay cutoff when tested on two of the six affected assay lot. A further sample had results below the cutoff for only one affected lot. None of the EQAS samples reported false-negative results. Samples having a signal to cutoff value of less than 6.0 generally had lower results in the affected lots compared with the unaffected lots. Conclusions Unexpected changes in QC reactivity related to variation, in particular assay lot chan...Continue Reading

References

May 23, 2001·Clinica Chimica Acta; International Journal of Clinical Chemistry·A Kallner
May 16, 2007·Journal of Viral Hepatitis·J M MicallefG J Dore
Sep 28, 2013·Journal of Clinical Pathology·Helen KinnsDanielle B Freedman
Aug 26, 2014·Clinical Chemistry and Laboratory Medicine : CCLM·Wayne DimechMarina Karakaltsas
May 26, 2018·Clinical Chemistry and Laboratory Medicine : CCLM·Wayne DimechGiuseppe A Vincini
Oct 3, 2019·Sensors·Shrikant Dashrath WarkadSatish Balasaheb Nimse

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Citations

Apr 15, 2020·Clinical Chemistry and Laboratory Medicine : CCLM·Claudio Galli, Mario Plebani

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