Product Description
The Respiratory Panel is an in-vitro multiplex real-time reverse transcription polymerase chain reaction (rRT-PCR)
assay for the qualitative identification of nucleic acids from organisms frequently found in the respiratory tract. This
method a highly accurate, analytically sensitive, and is used to identify organisms by amplifying and detecting genetic
material of pathogens in samples. The panel will aid in the research of causative agents of respiratory tract infections
and their prevalence.
The target organisms included in the panel are as follows: Adenovirus, Bocavirus, Coronavirus (229E, HKU1, NL63,
OC43), Epstein–Barr virus, Enterovirus, Human Metapneumovirus (HMPV A&B), Influenza A&B, Parainfluenza (types
1-4), Rhinovirus, Respiratory syncytial virus, SARS-CoV-2, Bordetella pertussis, Chlamydophila pneumoniae,
Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, Streptococcus
pneumoniae and Streptococcus pyogenes (Group A Strep).
Usage Information
Reagent Storage and Use Guidelines | |
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The Following is Included in the Kit | |
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The Following is Supplied by the User: Materials |
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Equipment | |
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Instrumentation | |
CFX96 Touch Real-Time PCR Detection System (or equivalent) |
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Limitations of Use
This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories; This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §
360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.