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. Emergency use of this test is limited to authorized laboratories.
There are many companies which provide molecular diagnostic system using PCR(Polymerase Chain Reaction) system. TNS Co., Ltd (BioTNS) is also one of these company, fountained since 2011 with goal to achieve more comfortable and more accurately detectable diagnostic system development. Many manufactures tend to dive into Human disease diagnostic field intensively at the first time, Bio TNS expands our horizon range from disease diagnostic not only human disease for example food poisoning but also aquatic animal disease
for instance Red Sea bream Iridoviral disease to species detection of bacteria, virus and animal. All of these contents developed following to take our own line on technical training and improving method for various Real-time PCR and reverse transcription(RT) PCR techniques, based on SYBR intercalator, TaqMan probe,
and PNA (peptide nucleic acid).
Since that, although we are very small and may be non-famous, absence of brand name now, We catch the many chances to gain many experiences of researching and development various contents broad ranges and co-working achievements with Public institutions including Korea National Fishery Products Quality Management Service (NFGS) and Korea National Institute of Fisheries Science, also involved many National research projects reporting meaningful business performances. In other words, It means that BioTNS has not only very
strong potential in this area but also high reliability about our own performance results.
Also, BioTNS currently has EIGHTEEN patents registration, TWENTY-SEVEN patents application and SIX technology transfers. With confidence and proud of our own growing step for achieving our aims that
more comfortable and more accurately detectable diagnostic system development, BioTNS looks forward to being known about our ability for developing suitable diagnostic system to large range of and satisfying various
needs with our products.
Following our brand names meaning, BioTNS will always do our best with ‘Technology and Science’ in diagnostic system field.
The COVID-19 RT-PCR Peptide Nucleic Acid (PNA) KIT is a real-time reverse transcription (RT)-Polymerase chain reaction (PCR) assay 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 collected from individuals 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, to perform high complexity tests.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper 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
The COVID-19 RT-PCR PNA KIT is intended for use by qualified and trained 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 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. Overall, these features should contribute to greater RT-PCR specificity for the detection of SARS-CoV-2 virus.
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.