Table 1. 18S rRNA gene qPCR performance characteristics

Analytical sensitivity

 Limit of detection (LOD)

2.045 log₁₀ parasites/mL of whole blood

 Lower limit of quantification (LLoQ)

1.50 log₁₀ parasites/mL of whole blood

 Upper limit of quantification (ULoQ)

6.50 log₁₀ parasites/mL of whole blood

Reportable range

1.50 to 6.50 log₁₀ parasites/mL of whole blood

 Precision

  Intra-assay variability

Overall standard deviation (SD) = 0.456 C_q units (0.137 log₁₀ parasites/mL)

  Inter-assay variability

Overall standard deviation (SD) = 0.604 C_q units (0.182 log₁₀ parasites/mL)

 Accuracy

  EQA program

Bias: + 0.019 log₁₀ parasites/mL against nominal parasitaemia values [38]

 Specificity

  Analytical specificity

100%

  Diagnostic specificity

100%