Clostridium difficile Positive Control (6 x 0.5 mL Vials)
- Volume: 0.5mL
- Units/Pack: 6
- Storage Condition: 2-8°C
- Hazardous Information: Non-Infectious
- Matrix: Purified protein matrix treated with 0.09% sodium azide
- Product Type: Control
European Mark of Conformity.
NATtrol Clostridium difficile Positive Control is formulated with purified, intact Clostridium difficile bacterium that have been chemically modified to render them non-infectious and refrigerator stable. Each NATtrol Clostridium difficile Positive Control contains 6 x 0.5 mL vials of NATtrol Clostridium difficile formulated in a Purified Protein Matrix that is fully commutable with true clinical specimens.
NATtrol Clostridium difficile 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 Clostridium difficile Positive Control contains intact 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.
NATtrol Clostridium difficile Positive Controls are USA FDA Class 1 exempt, unassayed, external run controls intended for in vitro diagnostic use and are for professional use only. NATtrol Clostridium difficile Positive Controls are not intended for use as a substitute for the internal controls provided by in vitro diagnostic kit manufacturers. NATtrol Clostridium difficile Positive Controls are not intended for use as a primary reference standard or material for any assay or testing procedure. Quality control materials should be used in accordance with local, state, federal and accreditation requirements.