Rapid and accurate determination of the potency of varicella vaccine by quantitative polymerase chain reaction

• Published in: Vaccine Vol. 29; no. 47; pp. 8490 - 8495
• Main Authors: Russell, Marsha S, Li, Changgui, Larocque, Louise, Wang, Junzhi, Farnsworth, Aaron, He, Runtao, Li, Xuguang
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 03.11.2011; Elsevier; Elsevier Limited
• Subjects: Allergy and Immunology; Applied microbiology; Biological and medical sciences; Chicken pox; Chickenpox Vaccine - genetics; Chickenpox Vaccine - immunology; Chickenpox Vaccine - standards; Flow cytometry; Fundamental and applied biological sciences. Psychology; Herpes viruses; Human viral diseases; Humans; Immunization; Infections; Infectious diseases; Medical sciences; Microbiology; pathogenicity; Polymerase chain reaction; Polymerase Chain Reaction - methods; Potency determination; Process controls; Quality Control; Quantitative polymerase chain reaction; Regulatory agencies; Technology, Pharmaceutical - methods; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Varicella vaccine; Varicella-zoster virus; Viral diseases; Viral diseases with cutaneous or mucosal lesions and viral diseases of the eye; Viral infections; viruses; Varicella vaccine; Quantitative polymerase chain reaction; Potency determination; Infection; Polymerase chain reaction; Skin disease; Viral disease; Varicella; Vaccine; Quantitative analysis
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2011.09.017

Highlights ► The potency of varicella vaccines is currently determined by a plaque assay, which is laborious and has considerable inter- and intra-assay variability. ► The increasing demand for varicella vaccine requires a rapid, reliable assay to facilitate the availability of the vaccine. ► A new potency assay for varicella vaccine based on quantitative polymerase chain reaction in conjunction with a much more efficient virus infection step is described. ► The new assay is much faster and possesses high-throughput capacity in addition to acceptable accuracy and reproducibility when compared with the plaque assay. ► Using 23 vaccine lots from 7 manufacturers, we found no significant difference in infectivity between the new assay and plaque assay, suggesting that the assay could potentially be a viable alternative for vaccine analyses.