TABLE 3.

Comparability study results: potency of proposed WHO IS relative to that of panel member 8 (the reference)^a

Assay	Assay type	Potency of WHO IS candidate relative to that of panel member 8	95% confidence interval	No. of copies/ml reported for WHO IS candidate
In-house RT-PCR A	Quantitative	0.288	0.163–0.477	7.4 × 105
In-house RT-PCR B	Quantitative	0.272	0.110–0.535	5.2 × 105
Microsart AMP Mycoplasma	Quantitative	0.282	0.204–0.382	2.7 × 105
Intego Mycoplasma	Quantitative	0.309	0.223–0.421	3.1 × 105
MycoTool Mycoplasma real-time PCR	Semiquantitative	0.270	0.202–0.358
MycoSEQ Mycoplasma real-time PCR	Semiquantitative	0.392	0.274–0.549
In-house RT-PCR F	Qualitative	0.150	0.000–4.251
In-house RT-PCR G	Qualitative	0.750	0.356–1.582
CytoInspect PCR/microarray	Qualitative	0.603	0.062–5.707
Venor GeM Advance	Qualitative	0.747	0.204–2.658
MycoTool Mycoplasma amplification and detection kits	Qualitative	0.383	0.140–1.049
Combinedb		0.316	0.277–0.360

^aRelative potencies were estimated by means of a parallel line model (quantitative data) and probit analysis (qualitative data; the Spearman-Kaerber method was used instead of the probit method in cases where the slope of the curves could not be estimated). The overall potency estimator is based on a weighted combination of results. No outliers were removed from the combination due to relatively homogeneous results.

^bWeighted combination estimator.