NATtrol Neisseria gonorrhoeae Positive Control Pack
The NATtrol Neisseria gonorrhoeae (NG) Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. 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 Neisseria gonorrhoeae Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control 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.
NATtrol NG Positive Controls are formulated with purified, intact organisms that have been chemically modified to render them noninfectious and refrigerator stable. Each NATtrol NG Positive Control Pack contains 6x 1.25 mL vials of NATtrolTM Neisseria gonorrhoeae formulated in a Purified Protein Matrix that is fully commutable with true clinical specimens.
The NG Positive Controls contain Neisseria gonorrhoeae cells inactivated by ZeptoMetrix?s patented NATtrol process formulated in a proprietary Purified Protein Matrix that mimics the composition of a true clinical specimen. These are full process controls designed to monitor the effectiveness of extraction, amplification, and detection in nucleic acid testing procedures. These controls are suitable for use in in-house molecular assays and commercially available platforms.
Platform : BD Probetec,Cepheid GeneXpert ; Test : CT/NG ; IVD-CE MARKED ; IVD alternative : NATNG-6MC / +2? to +8? C.
Material Safety Data Sheet.pdf
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