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The Cole Palmer NATtrolSARS-CoV-2 (recombinant) Stock SKU 0831042 was manufactured in a BL1 facility which has a Quality Management
System that is ISO 13485 certified.
Cole Palemer NATtrol™ SARS-CoV-2 (recombinant) Stock* is
formulated with purified, intact bacterial cells containing
synthetic SARS-CoV-2 sequence.
The cells have been
chemically modified to render them non-infectious and
refrigerator stable. Each vial contains 1.0 mL of NATtrol™
SARS-CoV-2 (recombinant) Stock in a purified protein
matrix.
*Pat.:http://www.zeptometrix.com/patent-information/
INTENDED USE:
• NATtrol™ SARS-CoV-2 (recombinant) Stock is
designed to evaluate the performance of nucleic
acid tests for determination of the presence of
SARS-CoV-2 N gene. NATtrol™ SARS-CoV-2
(recombinant) Stock can also be used for
validation of clinical assays, development of
diagnostic tests and training of laboratory
personnel.
ETIOLOGIC STATUS/BIOHAZARD TESTING:
• NATtrol™ inactivation was carried out on the stock
used to formulate this product. The inactivation
was verified in a standard microbiological growth
protocol.
• Purified protein matrix used in the manufacture of
this product is treated with 0.09% sodium azide. It
was manufactured from Human Serum Albumin
(HSA) that has 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 Fetal Bovine Serum (FBS) 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 NATtrol™ SARS-CoV-2 (recombinant)
Stock contains inactivated bacteria, 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™ SARS-CoV-2 (recombinant) Stock*
should be stored at 2-8°C.
INSTRUCTIONS FOR USE:
• Extract nucleic acid prior to use in downstream
assays.