Docket Management
Docket: 02D-0081 - A Modified Lot-Release Spec for Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Ms. Anita Ducca Date/Time 2002-07-10 16:43:43
Organization American Red Cross Biomedical Services
Category Company

Comments for FDA General
1. General Comments July 10, 2002 Docket Management Branch (HFA-305) Docket No. 02D-0081 Food and Drug Administration 5630 Fishers Lane Rockville, MD 20852 RE: Draft Guidance for Industry: A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood, Blood Components and Source Plasma Donations. (67 FR 17704; April 11, 2002; Docket No. 02D-0081) Dear Docket Officer: This letter is to provide public comments on behalf of the American Red Cross (Red Cross) concerning the Food and Drug Administration’s (FDA’s) draft guidance “A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood, Blood Components and Source Plasma Donations” (hereafter referred to as The Draft Guidance). The Red Cross is committed to the safety of our volunteer donors, the patients, and the public we serve. The Red Cross, through our 36 Blood Service regions and eight testing laboratories , supplies approximately half of the nation’s blood for transfusion needs. The Red Cross further processes and fractionates volunteer donated blood into plasma derivatives. The Red Cross fully supports the intent of this guidance, which is to increase the sensitivity of HBsAg assays for blood donation screening. The following comments address specific sections in The Draft Guidance. Section II: Background The Red Cross is concerned that The Draft Guidance does not establish a transition plan to aid in the implementation of the new lot release criteria. Specifically, The Draft Guidance states: FDA believes that this [approach] will result in minimal or no disruption in the availability of HBsAg assays for blood establishments during the implementation of changes in lot release specifications. However, the Red Cross is highly concerned about our ability to make the computer system modifications necessary to implement Ortho Clinical Diagnostics’ HBsAg System 3 before October 31, 2002. Because the Red Cross was planning to implement PRISM technology months ago, our National Testing Laboratories are not operating on the Ortho Assay System (OAS) version needed to support the Ortho Clinical Diagnostic HBsAg System 3 assay. The Red Cross not only will need to implement this new assay but will also need to implement the assay server system, OAS 2.0, to support the execution of this assay. In addition, the Red Cross will need to modify the laboratory information system (i.e., Data Management System) to accommodate the HBsAg System 3 assay as it will now be required to transmit to the DMS as “HB3” instead of “HBS”. The unplanned implementation of Ortho Clinical Diagnostics’ HBsAg System 3 will also require the implementation of the Ortho Clinical Diagnostics’ HBsAg System 3 neutralization assay within the Red Cross. This will involve modifications to the Confirmatory Laboratory information system. That said, the Red Cross recommends that The Draft Guidance provide a well-defined transition plan so that an uninterrupted supply of HBsAg kits meeting the FDA lot release specifications for both the 0.5 ng/mL and 0.2-0.3 ng/mL panels be readily available. Due to circumstances leading to the decision to implement Ortho Clinical Diagnostics’ HBsAg System 3 assay when FDA licensed, the Red Cross is concerned about the magnitude of change required by our organization to implement this assay. While the Red Cross will make every effort to convert to HBsAg System 3, on or before December 1, 2002, we are gravely concerned about an October 31, 2002 implementation date for this guidance. As we explain below, there is also some ambiguity regarding the application of The Draft Guidance’s deadline. Section III. Recommendations and Section IV Implementation The Red Cross believes that The Draft Guidance requires clarification as to the meaning of the implementation date. Specifically, The Draft Guidance provides FDA’s expectations for the performance of the test kits in Section III and an implementation date in Section IV as follows: FDA recommends that HBsAg detection assays that are used to test blood, blood components, and Source Plasma donations have a lower limit of detection capability of 0.50 ng HBsAg/mL or less. The expected performance of test kits that are used to test blood and Source Plasma donations when testing the CBER HBsAg Lot-Release Panel #12 is shown in the following Table. This guidance is intended for implementation by October 31, 2002. The Red Cross interprets these statements to mean that the lot release criteria for manufacturers’ submitted HBsAg kits will change effective October 31, 2002 such that all manufactured product lots submitted to CBER on or after October 31, 2002 must meet the new requirement. Further, blood establishments can continue to use HBsAg kits manufactured before October 31, 2002 that meet the old specification until supplies are exhausted. Therefore, the Red Cross believes FDA does not mean that Blood establishments will have implemented and are using HBsAg test kits meeting new specifications by October 31, 2002. If this interpretation is correct, the Red Cross recommends that FDA revise Section IV to state “This guidance is intended for implementation by test kit manufacturers by October 31, 2002.” Alternative Approach The Red Cross believes that allowing implementation of the PRISM technology, including HBsAg assays, is an appropriate, and optimal, alternative to implement increased HBsAg panel sensitivity and specificity. The Red Cross encourages FDA to consider allowing this alternative by coordinating the new lot release criteria with the FDA approval of the PRISM HBsAg assay. This would ensure the availability of the most sensitive testing platform, meet the intent of this guidance and allow implementation of state of the art process control features offered by PRISM. The added benefits of this alternative include minimizing chances of human error on any infectious diseases screening assay, not only HBsAg. In addition, Red Cross would only have to perform one implementation (i.e., PRISM) in lieu of two implementations (i.e., Ortho upgrade and PRISM) thereby increasing efficiency. Conclusion The Red Cross appreciates this opportunity to comment on The Draft Guidance. If you have any questions, please contact Anita Ducca, Director of Regulatory Affairs, at 703-312-5601 or Susan Stramer, Ph.D., Executive Scientific Officer, at 301-212-2801. Sincerely, Gary Dolch, Ph.D. Senior Vice President Quality and Regulatory Affairs Biomedical Services

EC -1