[Application and examination of bioluminescent technique in the quality identification of BCG vaccines].
(1) The average viable rates of BCG Vaccines (Japan Strain/Danmark Strain) which were kept at 37c for 4 weeks were 69.4% and 57.8% respectively by BL method, while the average viable rates of the same BCG Vaccines were obtained to be 16.8% and 21.7% by CFU method. The coefficients of variation (CV) in the average viable rates of BCG vaccines were found to be 6.6% and 6.4% by BL method, while the CV were found to be 13.7% and 36.5% by CFU method. (2) The clinical immunization effects showed the positive transformation rates of skin test were 90.9% and 88.9% (P greater than 0.05) in the control group and test group by PPD check respectively. It indicated that there was no distinct difference. Because the test group was immunized with the BCG vaccine qualified only by BL method, clinical immunization effects were conformed with the detecting results of BL method.
An
Y Q
YQ
Capital Institute of Medition, Beijing.
D001500:BCG Vaccine; D001431:Bacteriological Techniques; D003114:Colony-Forming Units Assay; D008163:Luminescent Measurements; D011786:Quality Control
D001500:BCG Vaccine