NATtrol Methicillin-Resistant Staphylococcus aureus/ Staphylococcus aureus (MRSA/SA) Negative Control (MDZ060) is an in vitro diagnostic external run control intended for use in evaluating and monitoring of qualitative molecular diagnostic assays for the detection of MRSA nucleic acid. 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 error.
NATtrol MRSA/SA Negative Control contains intact bacterium and should be run in a manner identical to that used for clinical specimens.
NATtrol inactivation was carried out on bacterial stocks used to formulate the controls. The inactivation was verified in a standard microbiological growth protocol.
This product contains inactivated microorganisms and materials of human and animal origin. Safe practices suggest that the controls are considered potentially infectious and to use Universal Precautions when handling.
Refer to CDC guidelines and local regulations for handling and disposal.
The matrix used in the manufacture of this product is treated with 0.09% sodium azide. It was manufactured from Human Serum Albumin has been tested and found to be nonreactive at the donor level for HIV-1/HIV-2 Antibody, HBsAg and HCV Antibody by FDA licensed donor screening test methods. All materials are also tested for HIV-1 and HCV by FDA-approved Nucleic Acid Test (NAT) methods.
Heat inactivated Fetal Bovine Serum used in the manufacture of this product meets applicable USDA requirements for abattoir sourced animals, traceability, and country of origin. The materials were collected at USDA licensed establishments or legally imported from countries recognized by the USDA as negligible or controlled for risk for Bovine Spongiform Encephalopathy (BSE) and other exotic disease agents. Donor animals were inspected ante and post mortem at the abattoir as required by the USDA.
Do not use past the expiration date on the label.
To avoid cross-contamination, use separate pipette tips for all materials.