NATtrol GI Controls

NATtrol™ GI Controls

GI Controls (12 x 0.2 mL) #NATGIC-BIO

BioFire™ FilmArray® GI Controls

PRODUCT DESCRIPTION:

NATtrol™ GI Controls (NATGIC-BIO)* are formulated with purified, intact virus partricles and bacterial cells that have been chemically modified to render them non-infectious and refrigerator stable. NATGIC-BIO contains 6 x 0.2 mL vials of GI Control 1 and 6 x 0.2 mL vials of GI Control 2. NATtrolTM GI Controls are supplied in a Stool Diluent that mimics the composition of a true clinical specimen. Table 1 lists the GI targets and expected results when tested on FilmArray® GI assay. *Pat.:http://www.zeptometrix.com/patent-information/

INTENDED USE:

• NATtrol™ GI Panel is designed to evaluate the performance of nucleic acid tests for determination of the presence of viral and bacterial nucleic acids. NATGICBIO can also be used for verification of clinical assays, development of diagnostic tests and training of laboratory personnel.
• NATGIC-BIO contains intact organisms and should be run in a manner identical to that used for clinical specimens.

ETIOLOGIC STATUS/BIOHAZARD TESTING:

• NATtrol™ inactivation was carried out on the viral and bacterial stocks used to formulate each control. The inactivation was verified by the absence of viral growth in validated tissue culture based infectivity assay and bacterial growth in a validated growth protocol.
• Stool Diluent used in the manufacture of this product contains stabilizers and antimicrobial agents. 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.

PRECAUTIONS:

• Although NATGIC-BIO contains inactivated organisms, it should be handled as if potentially infectious.
• Use Universal Precautions when handling this product.
• To avoid cross-contamination, use separate pipette tips for all reagents.

RECOMMENDED STORAGE:

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

INSTRUCTIONS FOR USE:

• These controls have been tested with the BioFire Diagnostics FilmArray® Gastrointestinal (GI) Panel assay and provide all expected results for the targets listed in Table 1.
• Follow manufacturer instructions for loading pouches.
• Extract Nucleic Acids prior to use in assays that are not sample to result. TABLE 1: CONTROL MEMBERS

TABLE 1: CONTROL MEMBERS

DO NOT USE IN HUMANS. FOR RESEARCH USE ONLY. NOT

FOR USE IN DIAGNOSTIC PROCEDURES.

These products are intended for research, product development, quality assurance or manufacturing use. These products are NOT intended for use in the manufacture or processing of injectable products subject to licensure under section 351 of the Public Health Service Act or for any other product intended for administration to humans.

**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.