IVD Makers Get Draft Guidance on Influenza Tests

In vitro diagnostic (IVD) makers will have more direction on proving analytical and clinical performance of influenza tests because of a recent draft FDA guidance.

The draft outlines recommendations for clinical studies of tests that detect, or detect and differentiate, influenza viruses. These include tests that detect one specific type or subtype of influenza as well as those that detect more than one and differentiate among them.

Public health officials have stressed the need for reliable influenza diagnostic devices since failure of these tests may lead to inappropriate public health responses, the guidance says.

Manufacturers must assess the ability of their tests to detect influenza viruses in fresh specimens from patients suspected of having an influenza infection, the guidance says. Frozen archived specimens may be useful for preclinical data but are not recommended for studies to calculate clinical sensitivity or specificity.

When conducting performance studies, the agency recommends using appropriate external controls — such as vaccine or prototypic vaccine strains, low pathogenic viruses and inactivated viruses — during every day of testing.

The draft guidance, “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses,” can be seen at www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0095-GDL.pdf.