Application of PCR for detection of mycoplasma DNA and pestivirus RNA in human live viral vaccines.
PCR techniques were applied for the detection of mycoplasma DNA and pestivirus RNA to 43 lots of live viral vaccines (measles, mumps, rubella, and oral poliomyelitis) produced by six manufacturers in Japan. Although mycoplasma DNA was not detected in any of the vaccines tested, pestivirus RNA was detected in 12 lots (28%). The incidence of contamination among the four viral vaccines was in the range of 20 to 37%, and the incidence among the six manufacturers varied from 0 to 56%.
Sasaki
T
T
Department of Safety Research on Biologics, National Institute of Health, Tokyo, Japan.
Harasawa
R
R
Shintani
M
M
Fujiwara
H
H
Sasaki
Y
Y
Horino
A
A
Kenri
T
T
Asada
K
K
Kato
I
I
Chino
F
F
D000818:Animals; D002417:Cattle; D002478:Cells, Cultured; D003470:Culture Media; D004269:DNA, Bacterial / Q000032:analysis*; D004340:Drug Contamination; D005312:Fetal Blood / Q000382:microbiology / Q000821:virology; D006801:Humans; D007564:Japan; D008458:Measles Vaccine / Q000032:analysis / Q000592:standards; D009108:Mumps Vaccine / Q000032:analysis / Q000592:standards; D009174:Mycoplasma / Q000235:genetics / Q000302:isolation & purification*; D010576:Pestivirus / Q000235:genetics / Q000302:isolation & purification*; D011055:Poliovirus Vaccine, Oral / Q000032:analysis / Q000592:standards; D016133:Polymerase Chain Reaction; D012367:RNA, Viral / Q000032:analysis*; D012411:Rubella Vaccine / Q000032:analysis / Q000592:standards; D014765:Viral Vaccines / Q000032:analysis* / Q000592:standards
D003470:Culture Media; D004269:DNA, Bacterial; D008458:Measles Vaccine; D009108:Mumps Vaccine; D011055:Poliovirus Vaccine, Oral; D012367:RNA, Viral; D012411:Rubella Vaccine; D014765:Viral Vaccines