Product Description

NATtrol ™ Flu / RSV / SARS-CoV-2 External Function Controls (NATFRC-6C (positive control) and NATCV9-6C (negative Control)) are formulated with intact and purified viral particles that have been chemically modified to make them non-infectious and freezer barn.

Expected Use

NATtrol ™ Flu / RSV / SARS-CoV-2 external test Controls are designed to evaluate the performance of nucleic acid tests for the determination of the presence of nucleic acids of the respiratory virus. NATFRC-6C (Positive
Control) and NATCV9-6C (negative control) enables laboratories to monitor test variation, batch-to-batch test kit
performance, operator variation and can provide assistance in identifying random or systemic errors.

Warnings & Precautions

• NATtrol ™ inactivation was carried out in virus stocks used to formulate controls. The inactivation was verified in a standard microbiological growth protocol.
• This product contains inactivated microorganisms and materials of human and animal origin. Safe practices
  suggest that controls are potentially considered infectious diseases and use universal precautions when
  driving.
• 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. Was manufactured
  of human serum albumin that has been tested and FDA found non-reactive at the donor level for HIV1 / HIV-2 Antibody, HBsAg, and HCV Antibody authorized donor screening test methods. All the materials are also tested for HIV-1 and HCV by the FDA Nucleic Acid Test Methods (NAT).
• Heat inactivated fetal bovine serum used in the manufacture of this product complies with the applicable USDA requirements for slaughter animals, traceability, and country of origin. The materials were collected in USDA Licensed or Legally Imported Establishments from countries recognized by the USDA as insignificant or controlled for risk of bovine spongiform encephalopathy (BSE) and other exotic disease agents. Donor animals were inspected before and after mortem in the slaughterhouse as required by the USDA.
• Do not use it after the expiration date on the label.
• To avoid cross-contamination, use separate pipette tips for all materials.

Recommended Storage

NATFRC-6C and NATCV9-6C must be stored at 2-8 ° C.

Instructions For Use

• Mix the tube vigorously for at least 5 seconds.
• The process according to the manufacturer’s instructions for a sample to result in tests.
• Extract nucleic acid before use in subsequent assays that do not sample to the result.

Limitation

• Quality control materials should be used in accordance with local, state, federal and
  requirements.
• This product is not designed to replace the manufacturer’s controls provided with the assay.

Expected Results

• Qualitative results are shown in Table 1 below.
• Each laboratory must evaluate the product and set its own acceptance criteria.
• The table below is for informational purposes only.