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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Roche Molecular Systems COBAS Ampliscreen HBV Test Implementation Questions and Answers

The COBAS AmpliScreen HBV Test from Roche Molecular Systems, Inc., is a qualitative in vitro test for the direct detection of Hepatitis B Virus (HBV) DNA in minipool (MP) of up to 24-samples of human plasma. This product is intended for use as a donor screening test to detect HBV DNA in plasma samples from individual human donors, including donors of Whole Blood and blood components, Source Plasma and other living donors. It is also intended for use to screen certain organ donors.

Questions and Answers

  1. What is FDA's current policy regarding routine use of the COBAS AmpliScreen HBV Test in minipool (MP) or individual donation (ID) formats for screening blood donors?

    The use of this test is currently considered optional both in minipool (MP) and individual donation (ID) formats. FDA regards use of this test for donor screening as voluntary because the estimated individual and Public Health benefits of adding this test to available screening tests are thought to be very limited.

    This decision was reached following discussions with FDA's Blood Products Advisory Committee, recommendations of the DHHS Advisory Committee on Blood Safety and Availability (ACBSA) and with the input and concurrence of the DHHS Blood Safety Committee. Public health officials will reconsider possible recommendations for routine donor screening for HBV by nucleic acid tests based on experience with and results of voluntary use of the test, further technology developments, and any other factors that might affect the health benefits expected from such testing.

  2. Can the COBAS AmpliScreen HBV Test replace currently used HBV serology tests to screen donors?

    No, data on the use of COBAS AmpliScreen HBV Test in either minipool (MP) format or individual donation (ID) format is insufficient at the present time to allow the replacement of either the HBsAg test for Whole Blood and Source Plasma donors or the anti-HBc test for Whole Blood donors. For instance, four samples in the study of approximately 600,000 donations that appeared to be HBsAg positive and HBV minipool (MP) NAT negative were later confirmed as false-positive HBsAg tests. However, this number was too small to permit a definitive conclusion to be reached that HBV minipool (MP) NAT will not miss detection of HBV in any donations with very low levels of HBsAg.

    Additionally, there were many samples positive for anti-HBc in which HBV infection was confirmed by more sensitive testing for HBV DNA, indicating that HBV MP NAT cannot replace donor screening for anti-HBc. The COBAS AmpliScreen HBV Test, when used, must be used in conjunction with HBsAg and anti-HBc tests for screening blood donors and an HBsAg test for screening Source Plasma donors.

  3. How should Blood and Source Plasma Donors and Units that tested negative for HBV DNA using the COBAS AmpliScreen HBV Test be managed?

    If a unit tests negative or is part of a minipool that tests negative for HBV DNA, donor and unit management should be consistent with FDA requirements/recommendations in regard to testing donors for HBsAg and anti-HBc (see References). FDA intends to provide guidance on further evaluation of donors to permit reentry in cases where the HBV NAT was a false positive test result.

  4. Can the units that tested negative in individual donation (ID) format or in minipool (MP) format for HBV DNA and were non-reactive for HBsAg and anti-HBc be used for transfusion?

    Yes, units that tested HBV DNA negative using the COBAS AmpliScreen HBV Test in individual donation (ID) format or in minipool (MP) format and that tested serology negative can be used for transfusion, provided that all other blood screening tests were negative and the units were otherwise suitable for release.

  5. Can the Source Plasma units of a minipool that tested negative for HBV DNA and were non-reactive for HBsAg be used for further manufacture?

    Yes, Source Plasma units that tested HBV DNA negative using the COBAS AmpliScreen HBV Test in minipool (MP) format and that tested serology negative can be used for further manufacture, provided that all other screening tests were negative and the units were otherwise suitable for release.

  6. Should blood and Source Plasma units that tested positive for HBV DNA in minipool (MP) or in individual donation (ID) formats be discarded?

    Yes, units that tested HBV DNA positive using the COBAS AmpliScreen HBV Test in minipool (MP) or in and individual donation (ID) format should be discarded and not used for blood transfusion or further manufacture.

  7. How should Blood and Source Plasma Donors that tested positive for HBV DNA using the COBAS AmpliScreen HBV Test be managed?

    Donors tested positive for HBV DNA should be indefinitely deferred until reentry algorithms could be formulated, validated, and approved. FDA intends to provide guidance on further evaluation of donors to permit reentry in cases where the HBV NAT was a false positive test result.

  8. Could the COBAS AmpliScreen HBV Test be used to screen donors who are not blood or plasma donors?

    Yes. You may use the COBAS AmpliScreen HBV Test to test individual plasma specimens from other living donors and organ donors whose specimens are obtained while the donor's heart is beating.

 

Return to COBAS AmpliScreen HBV Test Page

 

 

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