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

For In Vitro Diagnostic Use

For Use Under Emergency Use Authorization Only

Rx Only

This test has not been FDA cleared or approved;

This test has been authorized by FDA under an EUA for use by authorized laboratories;

This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

This kit contains sufficient IFCs, Control Line Fluid syringes, and reagents for 1,920 samples and quality controls.

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

Intended Use

The Advanta Dx SARS-CoV-2 RT-PCR Assay is a real-time Reverse Transcription (RT) PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider.

Testing is limited to laboratories which are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet requirements to perform high complexity tests.

This test is also for use with saliva specimens that are self-collected at home with or without the supervision of a healthcare provider (HCP) with the AZOVA COVID-19 Test Collection Kit from individuals suspected of COVID-19 by their HCP.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in saliva during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Clinical correlation with individual history and other diagnostic information is necessary to determine individual 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. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for individual management decisions. Negative results must be combined with clinical observations, individual history, and epidemiological information. Negative results for SARS-CoV-2 RNA from saliva should be confirmed by testing of an alternative specimen type if clinically indicated.

The Advanta Dx SARS-CoV-2 RT-PCR Assay is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Advanta Dx SARS-CoV-2 RT-PCR Assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

The complete Instruction for Use can be downloaded here.

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