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Home » Guidance on Dengue Virus Reagents Stresses Mitigation of False-Result Risk
Guidance on Dengue Virus Reagents Stresses Mitigation of False-Result Risk
Manufacturers of nucleic acid amplification test reagents for dengue virus should take a variety of steps, such as optimizing reagents and test procedures for recommended instruments, to prevent false negative or positive results, an FDA Class II special controls guidance recommends.