NATtrol SARS-Related Coronavirus 2 Positive Control (6 x 1.0mL)

ZeptoMetrix external controls have demonstrated performance on a variety of molecular assays. The product has been tested with the Visby Medical, BD Max™, Cepheid® GeneXpert®, BioFire®, Luminex® Aries®, GenMark®ePlex®, Abbott ID NOW™, or QIAGEN® QIAstat-Dx® system or a real-time PCR thermal cycler and provides the expected results, however performance characteristics must be established by the end user.

• Formulated with purified, intact organisms
• Organisms are chemically modified to render them noninfectious
• Refrigerator stable—store between 2 and 8°C
• Purified protein matrix treated with 0.09% sodium azide
• 6 x 1.0 mL vials
• Target concentration of 50,000 copies/mL

The NATtrol™ SARS-Related Coronavirus 2 Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ SARS-Related Coronavirus 2 Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.

• ENGLISH (SDS)
• ENGLISH (PI)
• DE (PI)
• ES (PI)
• FI (PI)
• FR (PI)
• IT (PI)
• NL (PI)
• NO (PI)
• SV (PI)

NATtrol SARS-Related Coronavirus 2 Positive Control is a US FDA Class 1 device, 501(K) exempt, in vitro diagnostic external run control (unassayed) intended for professional use only. This product is not intended for use as a substitute for internal controls provided by in vitro diagnostic kit manufacturers. Quality control materials should be used in accordance with local, state, federal, and accreditation requirements. 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.