FAS tips and tricks assay validation

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In light of the urgent need of novel diagnostic assays to come to market for COVID-19 testing, it is important not to forget about assay quality and accuracy, and this applies to ALL diagnostic assays. Assays need to be properly validated in order to ensure that accurate and appropriate results are produced and reported for each patient.

Things to remember when validating an assay:

01

Determine the purpose or end-result needed in the assay.

04

Consider what you will validate the assay against. Is there a gold standard assay, or will you validate using clinical data, or enrol in an external quality assessment (EQA) programme?

02

Do some reading on what the most appropriate test is. Search published articles and company websites. Ask a Field Application Scientist (FAS) for advice.

05

Controls, controls, controls! Always run controls. Are there commercial controls available?

How will you select appropriate laboratory controls?

03

Determine what the acceptable accuracy, limits of detection, sensitivity and specificity of the assay are.

06

Review the data before approving the assay for diagnostic use. Is the test accurate, robust and reproducible?

When in doubt, ask a Diagnostech Field Application Scientist (FAS) to assist!

Category: TrainingBy Catherine Worsley April 14, 2020

Tags: Assay Controls Diagnostics Sensitivity Validation

Author: Catherine Worsley

Catherine was part of the Diagnostech team between 2018 and 2020. She is registered with the Health Professions Council of South Africa and examines intern medical scientist portfolios and audits accredited training laboratories. She is also a committee member of the South African Immunological Society (SAIS) which promotes basic and advanced immunology in South Africa.