NATtrol Blood Culture Identification Panel 2 (BCID2) * is formulated with purified and intact bacterial and fungal cells. The cells have been chemically modified to make them non-infectious and stable in the refrigerator. NATBCP2-BIO contains 34 vials of 0.2 ml of bacterial and fungal NATtrol ™ and 1 x 0.2 ml of negative (matrix only) as indicated in Table 1. Panel members are supplied in a proprietary matrix.
*Pat .: http://www.zeptometrix.com/patent-information/
The NATtrol BCID2 panel is designed to evaluate the performance of nucleic acid tests for the presence of bacterial and fungal nucleic acids (from the organisms listed in Table 1). The NATtrol ™ Blood Culture Identification Panel 2 can also be used for clinical trial validation, diagnostic test development, and laboratory personnel training.
WARNINGS AND PRECAUTIONS:
NATtrol ™ inactivation was carried out in microorganism pools used to formulate panel members. 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 controls are considered potentially infectious and that universal precautions are used when handling them.
Consult 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. 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 donor screening methods with FDA license. All materials are also tested for HIV-1 and HCV using FDA approved Nucleic Acid Test (NAT) methods.
The heat-inactivated fetal bovine serum used in the manufacture of this product meets the applicable USDA requirements for slaughterhouse animals, traceability, and country of origin. The materials were collected from USDA licensed facilities or legally imported from countries recognized by the USDA as insignificant or controlled for the risk of bovine spongiform encephalopathy (BSE) and other exotic diseases. Donor animals were inspected ante and post mortem at the slaughterhouse as required by the USDA. Do not use it after the expiration date on the label. To avoid cross-contamination, use different pipette tips for all materials.
- 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.
FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES
TABLE 1: PANEL MEMBERS:
|Panel Member||Strain||Panel Member||Strain|
|A. baumannii||307-0294||K. pneumoniae||Z460** (CTX-M/NDM)|
|B. fragilis||Z029||K. pneumoniae||KPC-2|
|C. albicans||Z006||K. pneumoniae||Z138, OXA-48|
|C. auris||Z485||L. monocytogenes||serotype 1/2b|
|C. gattii||Z156||N. meningitidis||serogroup A|
|C. glabrata||Z007||P. aeruginosa||Z139, VIM-1|
|C. krusei||Z009||P. mirabilis||Z050|
|C. neoformans||serotype A||S. agalactiae||Z019|
|C. parapsilosis||Z011||S. aureus||MRSA; COL|
|C. tropicalis||Z012||S. enterica typhimurium||Z005|
|E. cloacae||Z101||S. epidermidis||MSSE; HER 1292|
|E. coli||Z297; IMP**||S. lugdunensis||Z097|
|E. coli||Z521; mcr-1**||S. maltophilia||Z074|
|E. faecalis||VRE, Z345, vanB||S. marcescens||Z053|
|E. faecium||VRE, Z347, vanA||S. pneumoniae||Z022|
|H. influenzae||MinnA||S. pyogenes||Z018|