. 2004 Oct 12;8:31–44. doi: 10.1016/j.ijid.2004.09.002

Table 4.

Tests performed to control ACAM2000 for adventitious agents (blank spaces in the table indicate that the test was not performed).

Description of Test	Method	Master Virus Seed (ACAM1000/2000) P7	Production Virus Seed (ACAM2000) P8	Vaccine lot (ACAM2000) P10
Sterility	Culture for bacteria and fungi	X	X	X

Mycobacteria	42-day guinea pig test	X

Mycoplasma	Cultivation Method	X	X	X
	Polymerase chain reaction (PCR), agar cultivatable and non-cultivatable	X	X	X

Adventitious Virus (general)	In vitro virus assay (Vero, MRC-5, and either HeLa and RK cells or A9 cells)	X	X	X

Adventitious Virus (general)	In vivo virus assay (suckling and adult mice, guinea pigs, embryonated eggs)	X	X	X

Adventitious virus (animal)	Bovine viral diarrhea (PCR)	X	X	X^a
	Bovine viral diarrhea (in vitro infectivity)		X
	Bovine parainfluenza type 3 (PCR)	X	X	X^a
	Bovine respiratory syncytial virus (PCR)	X	X	X^a
	Bovine adenovirus (PCR)	X	X	X^a
	Bovine parvovirus (PCR)	X	X	X^a
	Porcine parvovirus (PCR)	X		X^a
	Bovine herpes virus-I (bovine rhinotracheitis) and bovine herpes-IV (PCR)		X	X^a
	Bovine reovirus (PCR)		X	X^a
	Rabies virus (PCR)		X	X^a
	Bluetongue virus (PCR)		X	X^a
	Bovine polyoma virus (PCR)	X	X	X^a

Adventitious Viruses (human)	HIV 1 and 2 (PCR)	X	X	X^a
	Hepatitis B (PCR)	X	X	X^a
	Cytomegalovirus (PCR)	X	X	X^a
	Epstein Barr Virus (PCR)	X	X	X^a
	Human herpesvirus type 6 (PCR)	X	X	X^a
	Human herpesvirus type 7 (PCR)	X	X	X^a
	Human herpesvirus type 8 (PCR)		X	X^a
	Hepatitis C (PCR)	X	X	X^a
	HTLV I and II (PCR)	X	X	X^a
	Parvovirus B19 (PCR)	X	X	X^a
	Reovirus (PCR)		X	X^a
	JC/BK virus (PCR)		X	X^a
	SV40 virus (PCR)		X	X^a
	Coronavirus (PCR)		X	X^a
	Human Papilloma Virus (PCR)		X	X^a
	Hepatitis A virus (PCR)		X	X^a
	Enterovirus (PCR)		X	X^a
	Influenza C (PCR)		X	X^a
	Human parainfluenza types 1, 2, 3 (PCR)		X	X^a
	Human respiratory syncytial virus Types A and B (PCR)		X	X^a
	Retrovirus (f-PERT)	X	X

Performed on three successive lots to demonstrate consistent freedom from adventitious agents.