TABLE 5.

Quality control schedule for infectious disease molecular assays

Test typeProcedure
QualitativeControlsa
    Amplification controls (positive for each anylate, negative, sensitivity, every run, establish target/range values and monitor)
    Internal control (or demonstrate no inhibition)
    Extraction control
Calibration verification (verify cutoff)b
QuantitativeControlsa
    Amplification controls (at least 2 levels of positive control at relevant decision points to verify that calibration status is maintained, negative, every run, establish target/range values and monitor)
    Internal control (or demonstrate no inhibition)
    Extraction control
Calibration verification (verify cutoff)b
Analytical measurement range validationb
  • a A positive control that is taken through the extraction process may dually serve as both an extraction control and an amplification control. For multiplex assays, a pooled control that contains all analytes can be used or individual controls can be rotated after lot/shipment validation of all targets.

  • b Every 6 months, after changes of major system components, after lot changes of all reagents, and after failure of quality control, major maintenance, etc., as appropriate.