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FDA EUA Covid-19 PCR

Posted on August 9, 2021August 9, 2021 by Dominic

The BioTNS product is a qualitative test for the qualitative detection of SARS-CoV-2 nucleic acid in respiratory specimens such as nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, bronchoalveolar lavage (BAL), and nasopharyngeal lavage/aspirates or nasal aspirates of people suspected of COVID-19 by your healthcare provider.

SARS-CoV-2 nucleic acid is generally detected in respiratory samples during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid.

A clinical correlation with the patient’s history and other diagnostic information is necessary to determine the patient’s infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results should be combined with clinical observations, patient history, and epidemiological information.

To use your product, the SARS-CoV-2 nucleic acid is first extracted, isolated, and purified from nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, BAL, and nasopharyngeal washes/aspirates or nasal aspirates. The purified nucleic acid is then reverse transcribed into cDNA followed by PCR amplification and detection of hybridized fluorescent peptide (PNA) nucleic acid probes using a licensed real-time PCR (RT) instrument. The COVID-19 RT-PCR PNA Kit includes the following or other licensed materials: 2X RT qPCR PreMix, COVID-10 mix, Positive Control, and Negative Control.

The BioTNS product requires the following control materials, or other authorized control materials, which must be included with each batch of samples tested with your product. All controls listed below must produce the expected results for a test to be considered valid, as described in the Instructions for Use:

Positive Control (PC): RNA artificially synthesized from the SARS-CoV-2 genomic regions targeted by the kit (RdRP and N genes), as well as the internal control. The PC is used to assess the reliability of the assay performance. All targets must be detected to be valid.

Negative control (NC): distilled water without nucleases. The NC is used to assess the cross-contamination of the PCR kit, supplements, reagents, and instrument. Not all targets must be detected to be valid.

Internal control (IC): human acid ribosomal protein (HuPO) detected in clinical samples and positive control. The IC is used to evaluate the process of extracting RNA from clinical samples and assessing the reliability of the assay performance. The IC must be detected for a negative SARS-CoV-2 result to be reported; however, a positive SARS-CoV-2 result will be reported if IC is not detected.

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