Zeptometrix NATtrols & MMQCI Blood Culture Identification Panels Verified on BioFire FilmArray

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/

EXPECTED USE:

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.

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:

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
K. aerogenes	Z052	Negative	N/A
K. oxytoca	Z115