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Vaccines, Blood & Biologics

2/15/2008 Email - Rotarix

From: Henchal, Laraine

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

To: ''

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?


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

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

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Office of Communication, Outreach and Development

Food and Drug Administration

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Silver Spring, MD 20993-0002

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