Historically, testing for antibodies to infectious diseases was performed using biological assays such as haemagglutination inhibition or complement fixation. In recent times, this testing has moved to binding assays, firstly microtitre plate enzyme immunoassays and then to high throughput instruments. These instruments perform a range of testing for clinical chemistry, immunoassay as well as infectious diseases, and are commonly managed by the clinical chemistry laboratorians. It is not surprising therefore that approaches used to monitor the performance of clinical chemistry assays have been applied to infectious disease testing. However, infectious disease testing, in particular the detection of disease specific antibodies is quite different to the quantification of inert chemicals such as glucose and potassium.
This session will comprise of three main presentations. The initial presentation will review the differences between testing for infectious diseases and inert chemicals. It will highlight the heterogeneity of antibodies compared with chemistry analytes, discussing the changes in antibodies throughout the maturation process, the differences in responses to different strains of organisms and review the concepts of antibody avidity and affinity. The presentation will also review the regulatory environment applied to the manufacture and registration of in-vitro diagnostics devices (IVDs) used for infectious disease testing.
The second presentation will discuss the complications experienced when applying traditional quality control (QC) rules to infectious disease serology and explain the deficiencies of traditional rules in this setting. The presentation will introduce the concept of QConnect, a QC monitoring approach designed for infectious disease testing that uses historical data to estimate QC acceptance limits. A comparison of QConnect and other traditional QC approaches will be provided.
The final presentation will be interactive QC case studies. Using true QC data, several real-world cases will be presented and discussed. This will emphasise the information presented in the first two presentations and give the participant a deeper understanding of the principles of QC especially where qualitative data that use numbers are concerned. It is expected the participant will better understand the nature of QC for infectious diseases and make informed decisions when implementing QC programs in their laboratory.
Audience take away:
- Better understanding of the differences between infectious disease serology and clinical chemistry testing
- Identify the reasons why using traditional QC methods are inappropriate for infectious disease serology, even when tested on automated platforms.
- Offer a different approach to QC monitoring
- Provide options for introducing a more fit-for-purpose and efficient, cost-effective approach to QC of infectious disease testing.