Download Supporting Table 1: Cell safety control testing result chart

Supporting Table 1: Cell safety control testing result chart, used for donor testing from donor
umbilical vein blood/plasma. A panel of quality control test procedures was performed on the
resulting cell suspension in order to ensure acceptable quality of cells for clinical use. If at least one
of the tests with an asterisc was positive (P), the fetal tissue was not accepted for processing (see
ref.36 for more details on risk analysis and reduction).
Infectivology
CMV Ab IgM
P
*
CMV Ab IgG
Rubella IgM
Molecular Biology
P
HCV RNA qual.
*
HIV RNA qual.
*
*
Rubella IgG
Toxoplasma IgM
*
Toxoplasma IgG
HSV Ab IgM
*
HSV 1 IgG
HSV 2 IgG
*
Parvovirus B19 IgM
*
Parvovirus B19 IgG
VZV Ab IgM
*
VZV Ab IgG
VDRL
TPHA
FTA IgM (VDRL e/o TPHA
+)
HHV6 IgM
*
*
HHV6 IgG
HHV8 IgM
*
HHV8 latent IgG
*
HBsAg
*
HBsAb
HBcAb
HCV Ab
*
HIV 1/2 Ab
*
Microbiology using the BactAlert 3D test and the
mycoplama MycoAlert test
*
Supporting Table 2: Cell safety control test result criteria for the isolated cells prior to clinical use.
If at least one of the tests was not acceptable, the fetal tissue was not accepted for processing (see
ref.36 for more details on risk analysis and reduction).
QUALITY CONTROL TESTING FOR HUMAN FETAL LIVER CELLS
ASSAY
METHOD
ACCEPTANCE CRITERIA
Human fetal liver
Trypan blue exclusion method
≥ 70%
Viability
(microscopy)
Sterility test 1
GRAM Stain (microscopy)
No detection of bacteria
using light microscopy
Sterility test 2
Culture for aerobes, anaerobes
No grow by fluid culture
and fungi with BacT/Alert 3D
automated microbial detection
system (bioMerieux)
Mycoplasma test
MycoAlert Mycoplasma
Ratio < 1
Detection Kit (Lonza)
LAL assay / endotoxin
test
Gel Clot Assay (Microtest)
Absence of gel in the cell
suspension