NATtrol GI Verification Panel

NATtrol™ GI Verification Panel

GI Verification Panel (EA) #NATGIP-QIA

PRODUCT DESCRIPTION:

NATtrol™ GI Verification Panel* is formulated with purified, intact bacterial cells, fungal cells, and viral particles. The cells and viral particles have been chemically modified to render them noninfectious and refrigerator stable. NATGIP-QIA contains 23 x 0.25 mL vials of bacterial, fungal, and viral NATtrol™ and 4 x 1.0 mL of negative control as listed in Table 1. The panel members are supplied in a proprietary matrix.

*Pat.:http://www.zeptometrix.com/patent-information/

INTENDED USE:

• NATtrol™ GI Verification Panel is designed to evaluate the performance of nucleic acid tests for determination of the presence of bacterial, fungal, and viral nucleic acids (from organisms listed in Table 1). NATtrol™ GI Verification Panel can also be used for validation of clinical assays, development of diagnostic tests, and training of laboratory personnel.

WARNINGS AND PRECAUTIONS:

• NATtrol™ inactivation was carried out on microorganism stocks used to formulate the panel members. The inactivation was verified in a standard microbiological growth protocol.
• This panel 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 stool diluent used in the manufacture of this product contains 0.05% gentamicin sulfate and 0.125% 2- chloroacetamide.
• Heat inactivated Bovine Serum Albumin 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.
• Do not use past the expiration date on the label.
• To avoid cross-contamination, use separate pipette tips for all materials.

RECOMMENDED STORAGE:

• NATtrol™ GI Verification Panel should be stored at 2-8 °C.

INSTRUCTIONS FOR USE:

• Mix tube vigorously for at least 5 secs.
• Process according to manufacturer’s instructions for sample to result assays. • Extract nucleic acid prior to use in downstream assays that are not sample to result.

LIMITATION:

• FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES

TABLE 1: PANEL MEMBERS

 **These strains, 92.0147 and 7.1493, were supplied by Dr. Chobi DebRoy of the E. coli Reference Center, through a license with the Penn State Research Foundation.