NATtrol BCID2 Panel

NATtrol™ Blood Culture Identification 2 (BCID2) Panel

BCID2 Panel (35 x 0.2mL)

BioFire™ FilmArray® BCID2 Panel

Catalog Number: NATBCP2-BIO

PRODUCT DESCRIPTION:

NATtrol™ Blood Culture Identification 2 (BCID2) Panel* is formulated with purified, intact bacterial and fungal cells. The cells have been chemically modified to render them non-infectious and refrigerator stable. NATBCP2-BIO contains 34 x 0.2 mL vials of bacterial and fungal NATtrol™ and 1 x 0.2mL of negative (matrix only) as listed in Table 1. The panel members are supplied in a proprietary matrix.

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

INTENDED USE:

• NATtrol™ BCID2 Panel is designed to evaluate the performance of nucleic acid tests for determination of the presence of bacterial and fungal nucleic acids (from organisms listed in Table 1). NATtrol™ Blood Culture Identification 2 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 matrix used in the manufacture of this product is treated with 0.09% sodium azide. It was manufactured from Human Serum Albumin that has been tested and found to be non-reactive at the donor level for HIV1/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 Fetal Bovine Serum used in the manufacture of this product meets 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™ BCID2 Panel should be stored at 2-8°C.

INSTRUCTIONS FOR USE:

• Mix vial vigorously for at least 5 seconds.
• 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:

**This strain is sourced and used under license from the National Collection of Type Cultures (NCTC® ), Public Health England.