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CovidNow / SalivaNow Assays

 

Instructions for Use

 

This test has not been FDA cleared or approved; this test is for use by laboratories certified under CLIA, 42 U.S.C. § 263a, to perform high complexity tests. Review under the EUA program is pending. Distributed in accordance with the guidance on Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency, Section IV.C.2.

CovidNow / SalivaNow SARS-CoV-2 Assay Kits

The CovidNow & SalivaNow SARS-CoV-2 Assay Kits are a real-time RT-PCR test intended for the qualitative detection of nucleic acid from severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) in human upper respiratory specimens (i.e. nasopharyngeal swab, anterior nasal swab, and mid-turbinate nasal swab specimens) from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories designated by Lighthouse Lab Services and certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a that meet requirements to perform high complexity tests.

Test Highlights:

  • Real-time RT-PCR test
  • Molecular in vitro diagnostic kit
  • Submission currently pending for FDA EUA approval

  • Follows the CDC’s current diagnostics panel
  • A high-throughput diagnostic test
  • Full-service support from Lighthouse Lab Services

Summary and Explanation – Product Description 

The CovidNow & SalivaNow SARS-CoV-2 Assay Kits are molecular in vitro diagnostic kits intended for the qualitative detection of SARS-CoV-2 in upper respiratory specimens (such as nasopharyngeal swabs (NPS), oropharyngeal swabs (OPS), nasal swabsor bronchoalveolar lavage (BAL). The assay is based on widely used real-time reverse transcription polymerase chain reaction (rRT-PCR) technology, which employs oligonucleotide primers and probes labeled with fluorescent reporter dyes and quenchers. The CovidNow SARS-CoV-2 Assay detects a conserved region of SARS-CoV-2 N gene as well as sequences to target the human RNase P for detection of human nucleic acids. 

The qualified laboratories in which all users, analysts, and any person reporting results from use of this device should be trained to perform and interpret the results from this procedure by a competent Lighthouse Lab Services designated instructor prior to use.

Intended Use:

Results are for the detection and identification of SARS-CoV-2 RNA. SARS-CoV-2 RNA is generally detectable in respiratory specimens during infection. 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. Laboratories within the United States and its territories are required to report all positive 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 patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

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