Product Description
The COVID-19 RT-PCR Peptide Nucleic Acid (PNA) Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens such as nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, bronchoalveolar lavage (BAL), and nasopharyngeal wash/aspirates or nasal aspirates from individuals who are suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high complexity tests.
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BioTNS FDA EUA Covid-19 RT-PCR PNA Kit DataSheet
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of 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 COVID-19 RT-PCR PNA Kit 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 COVID-19 RT-PCR PNA Kit is only for use under the Food and Drug Administration’s Emergency Use Authorization.
Special Conditions for Use Statements
-For Emergency Use Authorization (EUA) only
-For prescription use only
-For in vitro diagnostic use only
Special Instrument Requirements
- The COVID-19 RT-PCR PNA Kit is to be used with the CFX 96 Real-time PCR detection system (Bio-rad) or Applied Biosystems 7500/7500 Fast thermocycler instruments. Assay results are analyzed with the Bio-Rad CFX software, such as Bio-Rad CFX Maestro or Bio-Rad CFX Manager 3.0 or 3.1, or the 7500 software v2.3.
The COVID-19 RT-PCR PNA kit utilizes a Peptide Nucleic Acid (PNA) as a reusable fluorescence hybridization probe for real-time PCR. Peptide nucleic acids are artificially synthesized oligomers in which nucleic acid bases are attached to a neutrally charged backbone consisting of (repeating N-(2- aminoethyl)-glycine units) that form peptide bonds. PNAs exhibit stronger binding to their complementary sequences than a DNA oligomer would and cannot be degraded by exonuclease activity of enzymes such as DNA polymerase.
The kit targets two specific genomic regions of SARS-CoV-2 in a multiplex reaction: the RNA-dependent RNA Polymerase (RdRP) gene and the Nucleocapsid (N) gene. The PNA probes for the detection of SARS-CoV-2 are labeled with FAM (N gene) and HEX (RdRP) fluorescent dyes. Individual target amplification results are identified with different colors and thus able to be independently analyzed.
This kit also includes an internal control which amplifies the Human acidic ribosomal protein (HuPO) gene. Successful amplification of HuPO confirms correct RNA transcription to cDNA and subsequent PCR amplification. The PNA probe for the HuPO gene is labeled with a Cy5 fluorophore.
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