NATtrol GI Panel

NATtrol™ GI Panel

GI Panel (22 x 0.25mL; 4 x 0.85 mL) - #NATGIP-BIO

GI Panel (17 x 0.25mL; 2 x 0.85 mL) - #NATGIP-ABC

BioFire™ FilmArray® GI Panel. Only #NATGIP-BIO

Applied BioCode MDx 3000. Only #NATGIP-BIO

1. NATtrol™ GI Panel #NATGIP-BIO

PRODUCT DESCRIPTION:

NATtrol™ GI (GastroIntestinal) Panel (NATGIP-BIO)* is formulated with purified, intact virus particles and bacterial cells that have been chemically modified to render them non-infectious and refrigerator stable. NATGIP-BIO contains 22 x 0.25 mL vials of viral and bacterial NATtrol™ and 4 x 0.85 mL vials of Negative Control as listed in Table 1. These panels are supplied in a Stool Diluent that mimics the composition of a true clinical specimen.

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. NATGIP-BIO can also be used for verification of clinical assays, development of diagnostic tests and training of laboratory personnel.
• NATGIP-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 stock used to formulate panel members. The inactivation was verified by the absence of viral and bacterial growth in validated tissue culture based infectivity assays.
• 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 NATGIP-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 Panel should be stored at 2-8°C.

INSTRUCTIONS FOR USE:

• This panel has been tested with the BioFire Diagnostics FilmArray® Gastrointestinal (GI) Panel assay and provides all expected results for the panel members listed in Table 1. Follow Assay manufacturer recommendations for use of this verification panel.
• Extract Nucleic Acids prior to use in assays that are not sample to result.

Table 1: PANEL 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.

2. NATtrol™ GI Panel #NATGIP-BIO

PRODUCT DESCRIPTION:

NATtrol™ GI (Gastrointestinal) Panel (NATGIP-ABC)* is formulated with purified, intact virus particles and bacterial cells that have been chemically modified to render them noninfectious and refrigerator stable. NATGIP-ABC contains 17 x 0.25 mL vials of viral and bacterial NATtrol™ and 2 x 0.85 mL of Negative Control as listed in Table 1. This panel is supplied in a Stool Diluent that mimics the composition of a true clinical specimen. *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. NATGIP-ABC can also be used for verification of clinical assays, development of diagnostic tests and training of laboratory personnel.
• NATGIP-ABC contains intact organisms and should be run in a manner similar to that used for clinical specimens.

ETIOLOGIC STATUS/BIOHAZARD TESTING:

• NATtrol™ inactivation was carried out on the viral and bacterial stocks used to formulate panel members. The inactivation was verified by the absence of viral and bacterial growth in validated tissue culture based infectivity assays and growth protocols.
• 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 NATGIP-ABC 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 Panel should be stored at 2-8°C.

INSTRUCTIONS FOR USE:

• Extract Nucleic Acids prior to use in downstream assays

Table 1: PANEL 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.