NATtrol™ Respiratory/Sore Throat (R/ST) Control Ki
Catalog number
NATRSTK-BIO-IVD-CE
Device description
The NATtrol™ Respiratory/Sore Throat (R/ST) Control Kit is an unassayed in vitro diagnostic control intended to be used with qualitative molecular assays for the detection of nucleic acids from Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Streptococcus dysgalactiae, Streptococcus pyogenes, Adenovirus, Coronavirus (seasonal), Human metapneumovirus, Human rhinovirus/enterovirus, Influenza A virus, Influenza A H1N1pdm virus, Influenza A H3 virus, Influenza B virus, Parainfluenza virus, Respiratory Syncytial virus, and SARS-CoV-2. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Respiratory/Sore Throat (R/ST) Control Kit contains intact and recombinant organisms and should be run in a manner identical to that used for clinical specimens. This qualitative control is not automated and does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms (e.g., viruses and bacteria) associated with respiratory disease and/or multiple genes conferring antimicrobial resistance in microorganisms present in a clinical specimen.
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