PRODUCT DESCRIPTION:
NATtrol™ CT/NG/TV Positive Control* is formulated with purified, intact microorganisms. The microorganisms have been chemically modified to render them non-infectious and refrigerator stable. NATtrol™ CT/NG/TV Negative Control* is formulated in the absence of any microorganisms. Each control pack contains 6 x 1.0 mL of NATtrol™ CT/NG/TV Positive Control or NATtrol™ CT/NG/TV Negative Control. These controls are provided in a proprietary matrix
*Pat.:http://www.zeptometrix.com/patent-information/
INTENDED USE:
• NATtrol™ CT/NG/TV Positive Control and NATtrol™ CT/NG/TV Negative Control are designed to evaluate the performance of nucleic acid tests for determination of the presence of C. trachomatis, N. gonorrhoeae, and T. vaginalis DNA. NATtrol™ CT/NG/TV Positive Control and NATtrol™ CT/NG/TV Negative Control enable laboratories to monitor test variation, lot-to-lot test kit performance, operator variation, and can provide assistance in identifying random or systemic error.
WARNINGS AND PRECAUTIONS:
• NATtrol™ inactivation was carried out on C. trachomatis, N. gonorrhoeae, and T. vaginalis stocks used to formulate the product. 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 be considered potentially infectious and to use Universal Precautions when handling. • Refer to CDC guidelines and local regulations for handling and disposal. • The proprietary diluent used in the manufacture of this product contains buffers and preservative. • Do not use past the expiration date on the label. • To avoid cross-contamination, use separate pipette tips for all materials.
RECOMMENDED STORAGE:
• NATtrol™ CT/NG/TV Positive Control and NATtrol™ CT/NG/TV Negative Control should be stored at 2-8°C.
INSTRUCTIONS FOR USE:
• Mix tubes vigorously for at least 5 secs. • Process according to manufacturer’s instructions for sample to result assays. • Extract nucleic acids prior to use in downstream assays that are not sample to result.
LIMITATION:
• FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES • Quality control materials should be used in accordance with local, state, federal, and accreditation requirements. • This product is not intended to replace the manufacturer’s controls provided with the assay
EXPECTED RESULTS:
• Each laboratory must evaluate the product and establish their own acceptance criteria. • Organism information and expected results listed in table below.
