Table 1

Streamlined outline of laboratory developed test development and validation in an emergency setting

Step 1: assay design

  • Choose primer set(s)

  • Assess potential cross reactivity

Step 2: laboratory logistics

  • Select instrumentation, reagents and consumables

  • Source reference materials

Step 3: laboratory workflow and safety

  • Plan unidirectional workflow

  • Review safety considerations

Step 4: establish analytical sensitivity

  • Define limit of detection

  • Define reportable range

Step 5: clinical evaluation

  • Confirm performance of assay in real clinical matrix

Step 6: clinical deployment

  • Train laboratory personnel

  • Establish quality assurance procedures

  • Assess plan to scale up

  • Six critical steps in the workflow of assay development and validation are shown. The key elements of each step are briefly described.