TABLE 1.
Cell titers and mycoplasma DNA concentrations in mycoplasma culture preparationsa
| Preparation and Mycoplasma species or medium | Panel member no. | Total cell titer (no. of CFU/ml) |
Mycoplasma DNA |
|||||
|---|---|---|---|---|---|---|---|---|
| No. of copies/ml |
Mean estimated no. of NAT-detectable units/ml (95% confidence interval) after lyo | |||||||
| Target | Harvest | Before lyo | After lyo | Before lyo | After lyo | |||
| Feasibility study panel | ||||||||
| Acholeplasma laidlawii | 1 | 1.0E+05 | 0.86E+05 | 0.69E+05 | 6.90E+02 | 4.77E+05 | 4.08E+05 | |
| 9 | 1.0E+07 | 0.98E+07 | 0.33E+07 | 5.45E+04 | 7.02E+07 | 4.03E+07 | 1.04E+07 (3.55E+06–3.16E+07) | |
| Mycoplasma fermentans | 2 | 1.0E+03 | 1.75E+03 | 0.57E+03 | 9.25E+01 | 1.44E+04 | 1.71E+04 | |
| 8 | 1.0E+05 | 1.67E+05 | 0.69E+05 | 0.10E+05 | 2.62E+06 | 2.23E+06 | 5.75E+05 (2.57E+05–1.31E+06) | |
| Mycoplasma orale | 3 | 1.0E+03 | 0.87E+03 | 0.45E+03 | 0.31E+03 | 1.02E+03 | 1.56E+03 | |
| 7 | 1.0E+05 | 0.84+05 | 0.46E+05 | 0.24E+05 | 1.44E+05 | 2.37E+05 | 1.35E+05 (6.45E+04–2.81E+05) | |
| Mycoplasma pneumoniae | 4 | 1.0E+03 | 1.47E+03 | 1.10E+03 | 0.19E+03 | 2.53E+03 | 5.90E+03 | |
| 6 | 1.0E+05 | 1.47E+05 | 1.15E+05 | 0.24E+05 | 1.99E+06 | 1.07E+06 | 3.01E+5 (1.44E+05–6.45E+05) | |
| Friis culture medium | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| WHO IS preparation, Mycoplasma fermentans | 1.0E+05 | 0.79E+05 | 0.75E+05 | 2.63E+03 | 1.24E+06 | 0.73E+06 | 1.82E+05 (0.81E+05–4.31E+05) | |
Mycoplasma preparations were tested at different stages by the culture method (which provided results as the number of CFU per milliliter) and by NAT (which provided results as the number of copies per milliliter or the number of NAT-detectable units per milliliter). Stages included source materials (harvest), materials obtained just before lyophilization (lyo), and materials obtained after reconstitution of the lyophilized preparations. The amount of mycoplasma DNA in materials before and after lyophilization was determined with a quantitative NAT assay reporting the number of copies per milliliter (Intego Mycoplasma). The mean number of NAT-detectable units and the corresponding 95% confidence intervals were calculated for the neat lyophilized preparations on the basis of the results of 19 different NAT assays.