Results of Continuous Monitoring of the Performance of Rubella Virus IgG and Hepatitis B Virus Surface Antibody Assays Using Trueness Controls in a Multicenter Trial
| Autor: | Allan Lau, Sam Ratnam, Paul Van Caeseele, Brian Timmons, Jutta Preiksaitis, Graham Tipples, Tamara Kruk, Greg B. Horsman, Todd F. Hatchette |
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| Jazyk: | angličtina |
| Rok vydání: | 2012 |
| Předmět: |
Microbiology (medical)
Quality Control medicine.medical_specialty Canada Hepatitis B virus Clinical Biochemistry Immunology medicine.disease_cause Antibodies Viral Rubella Serology Rubella virus IgG Multicenter trial Internal medicine Diagnostic Laboratory Immunology medicine Immunology and Allergy Humans Serologic Tests Hepatitis B Antibodies Hepatitis B Virus Surface Antibody Hepatitis B Surface Antigens business.industry Rubella virus Hepatitis B medicine.disease Virology Immunoglobulin G business |
| Popis: | We conducted a multicenter trial in Canada to assess the value of using trueness controls (TC) for rubella virus IgG and hepatitis B virus surface antibody (anti-HBs) serology to determine test performance across laboratories over time. TC were obtained from a single source with known international units. Seven laboratories using different test systems and kit lots included the TC in routine assay runs of the analytes. TC measurements of 1,095 rubella virus IgG and 1,195 anti-HBs runs were plotted on Levey-Jennings control charts for individual laboratories and analyzed using a multirule quality control (MQC) scheme as well as a single three-standard-deviation (3-SD) rule. All rubella virus IgG TC results were “in control” in only one of the seven laboratories. Among the rest, “out-of-control” results ranged from 5.6% to 10% with an outlier at 20.3% by MQC and from 1.1% to 5.6% with an outlier at 13.4% by the 3-SD rule. All anti-HBs TC results were “in control” in only two laboratories. Among the rest, “out-of-control” results ranged from 3.3% to 7.9% with an outlier at 19.8% by MQC and from 0% to 3.3% with an outlier at 10.5% by the 3-SD rule. In conclusion, through the continuous monitoring of assay performance using TC and quality control rules, our trial detected significant intra- and interlaboratory, test system, and kit lot variations for both analytes. In most cases the assay rejections could be attributable to the laboratories rather than to kit lots. This has implications for routine diagnostic screening and clinical practice guidelines and underscores the value of using an approach as described above for continuous quality improvement in result reporting and harmonization for these analytes. |
| Databáze: | OpenAIRE |
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