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Simplexa™ Influenza A H5N1 Direct

The discrimination of all H5N1 strains in nasal and nasopharyngeal swab specimens with a recent positive Flu A test.

The DiaSorin Molecular Simplexa™ Influenza A H5N1 Direct kit is a Research Use Only (RUO) assay intended for the discrimination of all H5N1 strains in nasal and nasopharyngeal swab specimens from human patients with a recent positive Flu A test. The assay supports the understanding of strain epidemiology for Research Use Only. Not for use in diagnostic procedures.

Disease state

Highly pathogenic avian influenza (HPAI) is a severe and highly contagious disease of poultry caused by avian influenza A viruses, most commonly subtypes H5 and H7, and is commonly referred to as avian or bird flu. HPAI viruses can be transmitted from wild birds to domestic poultry and may also infect other avian and animal species. Although avian influenza viruses do not typically infect humans, sporadic human infections have been reported. Importantly, the term "highly pathogenic" describes the severity of disease in birds and does not necessarily indicate increased pathogenicity in humans.

The value of Simplexa™ Influenza A H5N1 Direct

Fast time-to-result

Easy to use sample-to-answer system with no nucleic acid extraction and all-in-one reagents for use on nasal and nasopharyngeal swabs with results in 90 minutes

Meets the needs of the evolving respiratory landscape

A real-time RT-PCR assay that detects and differentiates Influenza A(H5N1) virus from non-H5N1 influenza A subtypes in nasopharyngeal swab specimens from human patients with a recent Flu A positive test.

How Simplexa™ Influenza A H5N1 Direct Works

The Simplexa™ Influenza A H5N1 Direct is a qualitative real-time RT-PCR assay designed for research use. It features a streamlined workflow that enables direct use of unextracted primary samples with ready-to-use PCR reagents, and runs on a reusable Direct Amplification Disc using the compact LIAISON^® MDX system, offering operational simplicity, flexibility, and high-quality performance.

Sample-to-answer

Scan 1-8 primary unextracted samples per run, ready to use single use reaction mix vials and the 8 well Direct Amplification Disc. Simply load samples and reagents directly onto the disc, place the disc on the LIAISON^® MDX Instrument and press run for results in approximately 90 minutes.

Intuitive LIAISON^® MDX Studio Software

Integrated QC checks and reporting for individual assays or use the multi-assay suite feature for compatible assays. View PCR curves and QC charts, interface with LIS and even access software during run.

Indications for Simplexa™ Influenza A H5N1 Direct use

Assay and system

A real-time RT-PCR assay run on LIAISON^® MDX to enabling detection of the discrimination of all H5N1 strains in nasal and nasopharyngeal swab specimens.

Patient types

Human patients with a recent positive flu A test.

Diagnostic lab

Hospital, commercial, reference and public health laboratories