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FDA Approval for First Nucleic Acid HBV Blood Screening Test

The FDA have approved the COBAS AmpliScreen HBV Test for use in a mini-pool format as a screening test for the detection of Hepatitis B (HBV) in donated whole blood, blood components, source plasma and other living donors.

The test is the first nucleic acid test designed for screening whole blood for HBV to be approved by the FDA.

In the clinical study presented to the FDA, the COBAS AmpliScreen HBV identified two HBV "window cases" (cases within the time between infection and detection of infection by antigen tests) which may have gone undetected by currently licensed HBsAg tests. In these tests, conducted at five blood centers in the US, Roche Diagnostics evaluated 581,790 individual donations in pools of 24. In addition, Roche Diagnostics presented non-clinical study data illustrating that the COBAS AmpliScreen HBV Test reduced the window period by an average of 17 days in 40 seroconversion panels when compared to the currently implemented Hepatitis B surface antigen test.

Following the conclusion of the clinical study period, three of the five centers voluntarily chose to continue using Roche Diagnostics' test under a cost-recovery IND (Investigational New Drug) protocol. Since conclusion of the clinical trial period in 2004, three additional "window cases" out of an additional one million donated blood units were identified using the COBAS AmpliScreen HBV Test.

NOTE: This item is from our 'historic' database and may contain information which is not up to date.

Source: Roche Diagnostics View latest company information

Posted: May 9, 2005
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