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Invalid test runs when using external controls for NAT testing to screen donors for HIV and HCV

A hospital blood bank in Pennsylvania has set up NAT testing (HIV and HCV RNA) for screening blood donors. They are using external controls and are invalidating many test runs based on the external controls, even when the internal controls are functioning properly. The inquiring colleague wants to know if other centers are using external controls in HIV and HCV NAT testing and, if so, has invalidation of many test runs also been a problem. If so, what has been the corrective action to resolve this issue?

The following comments have been received.

ADDENDA Apr. 21, 2005

1. A colleague in Florida reports that her lab, like the hospital blood bank in Pennsylvania, is performing multiplex NAT testing for HIV-1 and HCV and experiencing what seems to be a similar problem with "perfect runs" that are invalidated due to "external controls". She states this is very frustrating, time-consuming and expensive, and asks if others can suggest a solution for this problem.

Please submit comments to the e-Network Forum.

Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator
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Posted: July 30, 2004

Addenda: April 21, 2005

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