
2/15/2008 Email - Rotarix


 

 
From: Henchal, Laraine 

Sent: Friday, February 15, 2008 1:31 PM 

To: 'Donna.2.Boyce@gsk.com' 

Subject: Neisseria assay info request 

Sorry, Donna,

I overlooked one of our reviewer's questions-this should have gone out with the 1/23 info request:

The method validation report (MC1DPCV02) for the measurement of total IgG antibody to Neisseria meningitidis type C (by ELISA, --- -------- format) lists an LOQ of ---- µg/mL and a corresponding cut-off value of ---- µg/mL. As with the pneumococcal assays, this LOQ is only supported when assay variability is accounted for. In addition, it appears that the cut-off value and subsequent ----------------µg/mL) are somewhat arbitrary. Please submit data to support these values as well as your rationale for setting these limits ----- the ------ LOQ. Finally, when a ------------- test confirms that a sample is negative (------ µg/mL), the result is reported as ------ µg/mL. What is the rationale for reporting these values as ------ µg/mL when validation data indicate that some of these values may be above the actual LOQ?

Thanks

Laraine S. Henchal, MAS
 Microbiologist Reviewer, Team Leader
 Viral Vaccines Branch
 Division of Vaccines and
 Related Products Applications
 Office of Vaccines Research and Review
 Center for Biologics Evaluation and Research
 Food and Drug Administration
 Phone: 301-827-3070
 Fax: 301-827-3532
