Table 3.
Virus tests recommended in the characterization of cell lines (modified from Dellepiane et al., 2000 and EMEA, 1997)
| Test | Master bank | Work bank | Cell at the limit |
|---|---|---|---|
| Electron microscopy | + | − | + |
| Reverse transcriptasea | + | − | + |
| In vitro cell inoculation | + | − | + |
| In vivo animal inoculation | + | − | + |
| Antibody production testsb | + | − | − |
| Infectivityc | + | − | + |
| Other virus specific testsd | + | − | + |
a
Not necessary if positive by retrovirus infectivity test.
b
e.g., MAP, RAP, HAP—Usually applicable for rodent cell lines.
c
For retroviruses and other endogenous viruses.
d
Tests for cell lines derived from human, non-human primate or other cell lines as appropriate.