NATtrol™ SARS-CoV-2 Flu/RSV Negative Control (6 x 0.5mL)
ZeptoMetrix external quality controls, verification panels, and molecular controls have demonstrated performance on a variety of molecular platforms. Based upon the platform and assay’s product configuration, including but not limited to fill volumes and concentrations of analytes, we recommend our ZeptoMetrix SARS-CoV-2 Flu/RSV Negative Control to be used in conjunction with the Cepheid® GeneXpert® or Roche cobas® Liat® system.
NATtrol SARS-CoV-2 Flu/RSV Negative Control includes Coxsackievirus A9.
For Research Use Only. Not for use in Diagnostic Procedures.
For Research Use Only. Not for use in diagnostic procedures. Quality control materials should be used in accordance with local, state, federal, and accreditation requirements. This product is not intended to replace the manufacturer's controls provided with the assay. Propagation or commercialization are prohibited without prior written consent from Antylia Scientific.
When used as a control for nucleic acid tests, the same protocols as those used to amplify extracted clinical specimens should be employed.
The suitability and performance characteristics should be determined by your laboratory for each intended usage.
ZeptoMetrix NATtrol Flu/RSV products are ready-to-use, inactivated full process controls designed to evaluate the performance of molecular tests. They can be used for verification of assays, training of laboratory personnel, and monitoring assay-kit lot performance. NATtrol Flu/RSV products contain intact organisms and should be run in a manner similar to clinical specimens.
Warnings And Precautions SARS-CoV-2 Flu/RSV Negative Control
- NATtrol™ inactivation was carried out on virus stocks used to formulate the 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 the controls are considered potentially infectious and to use Universal Precautions when handling.
- Refer to 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. It was manufactured from Human Serum Albumin that has been tested and found to be 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 used in the manufacture of this product meets 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.
- Do not use past the expiration date on the label.
- To avoid cross-contamination, use separate pipette tips for all materials.
Recommended Storage for SARS-CoV-2 Flu/RSV Negative Control
- NATFRC-6C and NATCV9-6C should be stored at 2-8°C.
Instructions for Use of SARS-CoV-2 Flu/RSV Negative Control
- Mix tube vigorously for at least 5 secs.
- 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.
Limitations of SARS-CoV-2 Flu/RSV Negative Control
- FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES
- Quality control materials should be used in accordance with local, state, federal, and accreditation requirements.
- This product is not intended to replace the manufacturer’s controls provided with the assay.
Expected Results for SARS-CoV-2 Flu/RSV Negative Control
- Qualitative results are shown in Table 1 below.
- Each laboratory must evaluate the product and establish its own acceptance criteria.
- The table shown below is for informational purposes only.
SARS-CoV-2 Flu/RSV Negative expected results table
|Catalog Number||Organism/Strain||Expected Result|
|NATFRC-6C||Flu A (A/Brisbane/10/07) Flu B (B/Florida/02/06) RSV B (CH93(18)-18) SARS-CoV-2 (USA-WA1/2020) 1||Flu A is positive Flu B is positive RSV is positive SARS-CoV-2 is positive|
|NATCV9-6C||Coxsackievirus A9||Flu A is negative Flu B is negative RSV is negative SARS-CoV-2 is negative|
** This reagent was deposited by the Centers for Disease Control and Prevention and obtained through BEI Resources, NIAID, NIH: SARSRelated Coronavirus 2, Isolate USA-WA1/2020, NR-52281.