Analytical validation of a real-time hydrolysis probe PCR assay for quantifying Plasmodium falciparum parasites in experimentally infected human adults

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%

ISSN: 1475-2875