Table 4.
Porcine islet macrobead screening
| Porcine viral screening by qPCR/qRT‐PCR | ||||||||
|---|---|---|---|---|---|---|---|---|
| Lot (isolation dates): | 062812‐092012‐101012 | 101612‐112912‐121312 | 010913‐012413‐041113 | 121213‐011614‐021314 | ||||
| Target agent | Sensitivitya | Result | Sensitivitya | Result | Sensitivitya | Result | Sensitivitya | Result |
| BDV | 1000 | (‐) | 100 | (‐) | 100 | (‐) | 100 | (‐) |
| BVDV‐1 | 1000 | (‐) | 100 | (‐) | 100 | (‐) | 1000 | (‐) |
| BVDV‐2 | 1000 | (‐) | 1000 | (‐) | 1000 | (‐) | 1000 | (‐) |
| PEV | 1000 | (‐) | 100 | (‐) | 100 | (‐) | 100 | (‐) |
| PAdV | 10 000 | (‐) | 10 000 | (‐) | 10 000 | (‐) | 10 000 | (‐) |
| PCV | 50 | (‐) | 50 | (‐) | 50 | (‐) | 50 | (‐) |
| PCMV | 10 | (‐) | 10 | (‐) | 10 | (‐) | 10 | (‐) |
| PHEV | 25 | (‐) | 25 | (‐) | 25 | (‐) | 25 | (‐) |
| PLHV‐1, ‐2, ‐3 | 100 | (‐) | 100 | (‐) | 100 | (‐) | 100 | (‐) |
| PPV | 10 | (‐) | 10 | (‐) | 10 | (‐) | 10 | (‐) |
| PRotA | 100 | (‐) | 100 | (‐) | 100 | (‐) | 100 | (‐) |
| PRotC | 10 000 | (‐) | 10 000 | (‐) | 10 000 | (‐) | 10 000 | (‐) |
| PRV | 100 | (‐) | 100 | (‐) | 100 | (‐) | 100 | (‐) |
| PTV | 1000 | (‐) | 1000 | (‐) | 1000 | (‐) | 1000 | (‐) |
| Rabies | 100 | (‐) | 100 | (‐) | 100 | (‐) | 100 | (‐) |
| REO‐1, ‐2, ‐3 | 1000 | (‐) | 1000 | (‐) | 1000 | (‐) | 1000 | (‐) |
| SEOV | 10 | (‐) | 10 | (‐) | 10 | (‐) | 10 | (‐) |
| SNV | 1000 | (‐) | 1000 | (‐) | 1000 | (‐) | 1000 | (‐) |
| EMCV | 1000 | (‐) | 1000 | (‐) | 1000 | (‐) | 1000 | (‐) |
| HEV | 1000 | (‐) | 1000 | (‐) | 100 | (‐) | 100 | (‐) |
| SVDV | 100 | (‐) | 100 | (‐) | 100 | (‐) | 100 | (‐) |
| SWPOX | 10 | (‐) | 10 | (‐) | 10 | (‐) | 10 | (‐) |
| TTV | 100 | (‐) | 100 | (‐) | 100 | (‐) | 100 | (‐) |
| TGEV | 10 | (‐) | 10 | (‐) | 10 | (‐) | 10 | (‐) |
| EEEV | 100 | (‐) | 100 | (‐) | 100 | (‐) | 100 | (‐) |
| VEEV | 100 | (‐) | 100 | (‐) | 100 | (‐) | 100 | (‐) |
| WEEV | 100 | (‐) | 100 | (‐) | 100 | (‐) | 100 | (‐) |
| WNV | 100 | (‐) | 100 | (‐) | 100 | (‐) | 100 | (‐) |
| 28‐day in vitro co‐culture assay for detection of viral contaminants | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Isolation Date: | 062812 | 092012 | 101012 | 101612 | 112912 | 121312 | 010913 | 012413 | 041113 | 121213 | 011614 | 021314 | ||||||||||||
| Cell Line | cpe | HA | cpe | HA | cpe | HA | cpe | HA | cpe | HA | cpe | HA | cpe | HA | cpe | HA | cpe | HA | cpe | HA | cpe | HA | cpe | HA |
| MRC‐5 | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) |
| BHK‐21 | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) |
| ST | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) |
| MA104 | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) |
| Microbiological screening of porcine islet macrobeads | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Isolation Date: | 062812 | 092012 | 101012 | 101612 | 112912 | 121312 | 010913 | 012413 | 041113 | 121213 | 011614 | 021314 |
| Test | ||||||||||||
| Sterility | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) |
| Endotoxinb | 0.006 | <0.005 | <0.005 | <0.005 | <0.005 | <0.005 | <0.005 | <0.005 | <0.005 | <0.005 | <0.005 | <0.005 |
| Mycoplasm | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) |
| TEM | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | (‐) | (‐) | (‐) | (‐) | (‐) | (‐) |
Cpe, cytopathic effect; HA, hemadsorption.
a
sensitivity = limit of detection (gene copies per PCR).
b
EU/macrobead, transmission electron microscopy (TEM), not done (n.d.).
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