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. 2021 Jul 10;3(4):100317. doi: 10.1016/j.jhepr.2021.100317

Table 1.

Technical validation.

Test Conditions tested Number of
  • 1)

    Lots

  • 2)

    Operators

  • 3)

    Samples

 Minimal acceptance criteria Reference
Analyte stability – storage Samples were stored at -80, 8, and 25°C for up to 14 months.
Samples measured at 24 , 48 , 72 h, 8 days, 1, 3, 6, 12, and 24 months
  • 1)

    1

  • 2)

    1

  • 3)

    10

 RE% ≤10% from nominal concentration and a weighted deeming slope of 1.0±0 Guideline on bioanalytical method validation24
Analyte stability – freeze-thaw Samples tested for 3 freeze-thaw cycles
  • 1)

    1

  • 2)

    1

  • 3)

    10

 RE% ≤10% from nominal concentration and a weighted deeming slope of 1.0±0 Guideline on bioanalytical method validation24
Reagent stability Samples tested at 0, 3, 6, 9, 12, and 14 months. Samples stored at -80°C. Timepoint 0
  • 1)

    1

  • 2)

    1

  • 3)

    3 internal controls (kit calibrator and 2 controls), and 10 samples

 RE% ≤10% from nominal concentration and a weighted deeming slope of 1.0±0 CLSI EP2525 and BS EN ISO 23640:201526
Interference Endogenous and exogenous substances were tested at low and high concentrations according to recommendations
  • 1)

    1

  • 2)

    1

  • 3)

    1 low (10–12 ng/ml) and 1 high (20–25 ng/ml)

 RE% ≤10% from nominal concentration CLSI EP7-A227
Precision Patients samples were used to generate 6 pools of PRO-C3 concentrations covering the measurement range. The study was performed on 2 reagent lots by 2 different operators (operators were swapped between reagent lots every day) along 20 non-consecutive days.
  • 1)

    2

  • 2)

    2

  • 3)

    6

 For each sample: CV% ≤10% within 1 run
Between-operator reproducibility: for each sample CV% ≤15%.
Lot-to-lot variability: for each sample CV% ≤15% between reagent lots.
Total precision: For each sample CV% ≤15%.		 CLSI EP05-A328

All validations were performed in serum samples from non-alcoholic fatty liver disease patients. CLSI, Clinical and Laboratory Standards Institute; CV%, coefficient of variation; RE%, percent recovery.