NATtrol™ Clostridium difficile Positive Control (6 x 0.5 mL) - IVD

INTENDED USE:

The 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. 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.

PRODUCT SUMMARY AND EXPLANATION:

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 NATtrolTM Clostridium difficile formulated in a Purified Protein Matrix that is fully commutable with true clinical specimens.

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