NATtrol™ B. pertussis/parapertussis Positive Control, 6 x 0.25 mL
NATtrol™ Bordetella pertussis/parapertussis Positive Control (NATBRD-6L)* is formulated with purified, intact bacterial cells that have been chemically modified to render them non-infectious and refrigerator stable. Each control pack contains 6 x 0.25 mL vials of NATtrolTM B.pertussis/parapertussis. These controls are supplied in a purified protein matrix that mimics the composition of a true clinical specimen.
• NATtrol™ Bordetella pertussis/parapertussis Positive Control is a full process control designed to evaluate the performance of nucleic acid tests for determination of the presence of Bordetella pertussis and Bordetella parapertussis DNA. NATBRD-6L can also be used for quality control of clinical assays and training of laboratory personnel. • NATBRD-6L 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 bacterial stock used to formulate each control pack. The inactivation was verified by the absence of bacterial growth in a validated growth protocol. • Purified protein matrix used in the manufacture of this product is treated with 0.09% sodium azide. It was manufactured from materials that have been tested and found non-reactive at the donor level for HIV-1/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 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.
• Although NATtrol™ Bordetella pertussis/parapertussis Positive Control contains inactivated bacterial cells, it should be handled as if potentially infectious. • Use Universal Precautions when handling these products. • To avoid cross-contamination, use separate pipette tips for all reagents.
• NATtrol™ Bordetella pertussis/parapertussis Positive Control should be stored at 2-8°C.
INSTRUCTIONS FOR USE WITH ARIES BORDETELLA ASSAY:
• Vortex NATtrolTM sample for 5-10 seconds. • Pipet 200 µL of sample into cassette. • Run cassette per manufacturer’s instructions.
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.