Advanta Dx SARS-CoV-2 RT-PCR Assay Reagent and IFC Bundle, CE-IVD

This bundle contains sufficient IFCs, Control Line Fluid syringes, assays and reagents for 1,920 samples and quality controls. For use with the Advanta Dx SARS-CoV-2 RT-PCR Assay.
For In Vitro Diagnostic Use.

Kit contains:

  • 10 Advanta™ Dx 192.24 IFCs
  • Advanta Dx Control Line Fluid—10 pack
  • 2 tubes of Advanta Dx SLR, 250 µL
  • 3 tubes of Advanta Dx ALR, 120 µL
  • 1 tube of Advanta Dx PF1, 1.5 mL
  • 4 tubes of Advanta Dx PCR MM, 1.1 mL
  • 3 tubes of Advanta Dx PCR Water, 1.8 mL
  • 2 bottles of Advanta Dx PF2, 2.04 mL
  • 2 bottles of Advanta Dx RT PA MM, 3.3 mL
  • 5 bottles of Advanta Dx Dilution Reagent, 25 mL
  • 1 tube of 2019-nCoV_N1 Oligo Mix, 370 µL
  • 1 tube of 2019-nCoV_N2 Oligo Mix, 370 µL
  • 1 tube of RP Oligo Mix, 170 µL

Intended Use

The Advanta Dx SARS-CoV-2 RT-PCR Assay is a reverse transcription (RT) and real-time polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in Saliva from patients who are suspected of COVID-19.

Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

The Advanta Dx SARS-CoV-2 RT-PCR Assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

The complete Instruction for Use can be downloaded here.


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