Table I: Characterisation and comparison of various pyrogen tests

Limit of detection (IU/ml) Quantification Accuracy Precision Robustness Sensitivity/ specificity Costs Acceptance Spectrum Practicability Standardisation
Rabbit pyrogen tests ± 0.5-3 - n.a. n.a. + + - -a + - -
Bacterial endotoxin tests + 0.03 + +b +b ± ± + +a - ± +
In vitro pyrogen tests + 0.03-0.1 + + + u.e. +c + +a + ± u.e.

Overall judgement: + = positive, - = disadvantage, ± = intermediate.
n.a. = not applicable, apublic versus scientific opinion, bLPS only, cpredominantly artificial contamination, u.e. = under evaluation, 1IU = 100 pg.