STAT-Dx DiagCORE Respiratory Panel 2, Instructions For Use Manual, Page: 44 / 67

44 DiagCORE Respiratory Panel 2 Instructions for Use
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Limitations of the procedure

Results from the DiagCORE ® Respiratory Panel 2 are not intended to be used as the sole basis
for the diagnosis, treatment, or other patient management decisions.

Positive results do not rule out co-infection with organisms not included in the DiagCORE ®
Respiratory Panel 2. The agent detected may not be the definitive cause of the disease.

Negative results do not preclude infection of the upper respiratory tract. Not all agents of acute
respiratory infection are detected by this assay, and sensitivity in some clinical settings may
differ from that described in the package insert.

A negative result with the DiagCORE
®
Respiratory Panel 2 does not exclude the infectious nature
of the syndrome. Negative assay results may originate from several factors and their
combinations, including sample handling mistakes, variation in the nucleic acid sequences
targeted by the assay, infection by organisms not included in the assay, organism levels of
included organisms that are below the limit of detection for the assay, and use of certain
medications, therapies, or agents.

The DiagCORE
®
Respiratory Panel 2 is not intended for testing of samples other than those
described in these instructions for use. Test performance characteristics have been established
only with nasopharyngeal swab samples collected in transport medium, from individuals with
acute respiratory symptoms.

The DiagCORE
®
Respiratory Panel 2 is intended to be used in conjunction with standard of care
culture for organism recovery, serotyping, and/or antimicrobial susceptibility testing where
applicable.

The results from the DiagCORE
®
Respiratory Panel 2 must be interpreted by a trained healthcare
professional within the context of all relevant clinical, laboratory, and epidemiological findings.

The DiagCORE ® Respiratory Panel 2 can be used only with the DiagCORE ® Analyzer.

The DiagCORE
®
Respiratory Panel 2 is a qualitative assay and does not provide a quantitative
value for detected organisms.

Viral and bacterial nucleic acids may persist in vivo, even if the organism is not viable or
infectious. Detection of a target marker does not imply that the corresponding organism is the
causative agent of the infection or the clinical symptoms.

Detection of viral and material nucleic acids depends on proper sample collection, handling,
transportation, storage, and loading into the DiagCORE
®
Respiratory Panel 2 Cartridge.
Improper operations for any of the aforementioned can cause incorrect results, including false-
positive or false-negative results.