Have you stress tested your assay?

Zheng Cao, Ping Wang

Research output: Contribution to journalArticlepeer-review

Abstract

Objectives: When a clinical assay is stressed with extraordinarily high volume of specimens over a short period of time, extra caution may be needed to avoid systematic errors and biases. Here we report our experience with a HgbA1c assay used for high volume wellness screening purpose, to illustrate the importance of stress testing during assay validation. Design and Methods: Over 15,000 whole blood specimens were tested for HgbA1c in a period of 2 months. HgbA1c was tested by an immunoturbidimetric method on a high through-put automation line. The HgbA1c population distribution in our study was compared to that from the NHANES database. Daily distributions of HgbA1c values ≥6%, means and medians were plotted. Correlation studies were performed between the high through-put immunoturbidimetric assay and a medium through-put HPLC method. Results: We observed a shift of HgbA1c distribution to the higher values compared to the NHANES. A bias of 15-20% was noted from further stress testing where large number of samples were batched and tested using the immunoturbidimetric assay. A 5-7% higher bias remained after implementing a cuvette washing program after each HgbA1c sample. We hypothesized this bias was caused by build-up of blood cell fragments in the cuvettes when continuous whole blood samples are run through the system. Our experience suggests stress testing needs to be incorporated early in the test validation process for high volume batched screening applications. This seemingly extra validation step may save significant troubleshooting and retesting efforts down the road.

Original languageEnglish (US)
Pages (from-to)21-23
Number of pages3
JournalPractical Laboratory Medicine
Volume5
DOIs
StatePublished - Aug 1 2016

Keywords

  • Automation
  • HPLC
  • Hemoglobin A1c
  • High volume
  • Immunoturbidimetric assay
  • Quality assurance
  • Systematic bias

ASJC Scopus subject areas

  • Radiological and Ultrasound Technology
  • Clinical Biochemistry

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