The COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit is a real-time RT-PCR test intended for the qualitative detection of SARS-CoV-2 nucleic acid in respiratory samples such as nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, middle turbinate nasal swabs, bronchoalveolar lavage (BAL), and nasopharyngeal washes/aspirates or nasal aspirates from people suspected of COVID-19 by your 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 highly complex tests.
The results are for the identification of SARS-CoV-2 RNA. SARS-CoV-2 RNA is generally detected in respiratory samples during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA.
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. The agent detected may not be the definitive cause of the disease. Laboratories in the United States and its territories must report all positive results to the appropriate public health authorities.
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.
The COVID-19 RT-PCR PNA Kit is designed for use by qualified clinical laboratory personnel specifically instructed and trained in real-time PCR techniques and in vitro diagnostic procedures. The COVID-19 RT-PCR PNA Kit is for use only under the Food and Drug Administration Emergency Use Authorization.
Special conditions for declarations of use
-Only for emergency use authorization (USA)
-For prescription use only
-Only for in vitro diagnostic use
Special instrument requirements
– The COVID-19 RT-PCR PNA Kit must be used with the CFX 96 Real-time PCR Detection System (Bio-rad) or the Applied Biosystems 7500/7500 Rapid Thermal Cycler Instruments. Assay results are analyzed with Bio-Rad CFX software, such as Bio-Rad CFX Maestro or Bio-Rad CFX Manager 3.0 or 3.1, or 7500 v2.3 software.
The COVID-19 RT-PCR PNA Kit uses 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 (N- (2-aminoethyl) -glycine repeating units) that form peptide bonds. PNAs exhibit stronger binding to their complementary sequences than a DNA oligomer and cannot be degraded by the exonuclease activity of enzymes such as DNA polymerase.
The kit targets two specific SARS-CoV-2 genomic regions in a multiplex reaction: the RNA-dependent RNA polymerase (RdRP) gene and the nucleocapsid (N) gene. PNA probes for the detection of SARS-CoV-2 are labeled with fluorescent dyes FAM (N gene) and HEX (RdRP). The results of the amplification of the individual target are identified by different colors and can therefore be analyzed independently.
This kit also includes an internal control that amplifies the human acidic ribosomal protein (HuPO) gene. Successful amplification of HuPO confirms correct transcription of RNA to cDNA and subsequent PCR amplification. The PNA probe for the HuPO gene is labeled with a Cy5 fluorophore.