NATtrol MRSA/SA Negative Control

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.

INTENDED USE:

NOT FOR USE IN HUMANS:

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.

PRODUCT SUMMARY AND EXPLANATION:

NATtrol™ MRSA/SA Negative Control is formulated with purified, intact S. epidermidis bacterium that have been chemically modified to render them non-infectious and refrigerator stable*.

Each NATtrol™ MRSA/SA Negative Control contains 6 x 0.5 mL vials of NATtrolTM S. epidermidis formulated in a Purified Protein Matrix that is fully commutable with true clinical specimens.

PRINCIPLE:

NATtrol™ MRSA/SA Negative Control contains S. epidermidis 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.

PRECAUTIONS:

These products are NOT intended for use in the manufacture or processing of injectable products subject to licensure under section

351 of the US FDA Public Health Service Act or for any other product intended for administration to humans.

RECOMMENDED STORAGE:

NATtrol™ MRSA/SA Negative Control should be stored at 2-8°C.

When stored as directed, controls are suitable for use for up to 56 days

(8 weeks) once opened.

INSTRUCTIONS FOR USE:

Vortex NATtrol™ MRSA/SA Negative Control vials for 10 seconds to mix.

Follow the manufacturer instructions for use as a clinical sample.

LIMITATIONS:

NATtrol™ MRSA/SA Negative Controls are USA FDA Class 1 exempt, unassayed, external run controls intended for in vitro diagnostic use and are for professional use only. NATtrol™ MRSA/SA Negative Controls are not intended for use as a substitute for the internal controls provided by in vitro diagnostic kit manufacturers. Quality control materials should be used in accordance with local, state,

federal and accreditation requirements.

EXPECTED RESULTS:

NATtrol™ MRSA/SA Negative Control tested negative for MRSA/SA

on the Xpert® MRSA/SA BC Assay.

Each laboratory must evaluate the controls and establish their own acceptance criteria.

Although NATtrol™ MRSA/SA Negative Control contains inactivated microorganisms, handling and disposal should be conducted as if materials are potentially infectious.

This control contains material of human and animal origin and the user should observe Universal Precautions when handling and disposing of this product. Disposal must follow local regulations, if more stringent than regulations enforced by the CDC or the FDA.

Do not pipette by mouth.

To avoid cross-contamination, use separate transfer pipettes or tips for all materials.

Do not use beyond the expiration date shown on the label.

If product is received damaged or leaking, contact ZeptoMetrix for instructions.

NATtrol™ MRSA/SA Negative Control

Part Number: MDZ060

ETIOLOGIC STATUS/BIOHAZARD TESTING:

NATtrol™ inactivation was completed on the stocks used to formulate each control and further verified by the absence of bacterial growth in a validated growth protocol.

The Purified Protein Matrix used in the manufacture of this product is treated with 0.09% sodium azide. It was manufactured from materials that have been tested and found non-reactive 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 bovine based source materials used in the manufacture of this product meet 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.

PRODUCT WARRANTY:

ZeptoMetrix LLC’s limited product warranty and other terms and conditions related to the purchase and use of ZeptoMetrix products are set forth in ZeptoMetrix’s Terms and Conditions of sale found on ZeptoMetrix’s website at  Sales Terms and Conditions.

DISCLAIMER AND LIMITATION OF LIABILITY:

ZeptoMetrix LLC disclaims all warranties with respect to this document and the information contained herein, expressed or implied, including but not limited to those of merchantability, fitness for a particular purpose, or non-infringement. To the extent allowed by law, in no event shall ZeptoMetrix LLC be liable, whether in contract, tort, warranty, or consequential damages or lost profits in connection with or arising from this document and the information contained herein, including but not limited to the use thereof even if ZeptoMetrix is advised of the possibility of such damages.