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FDA EUA Covid-19 PCR

BioTNS product is a qualitative test 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 suspected of COVID-19 by their healthcare provider. The SARS-CoV-2 nucleic acid is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 nucleic acid; 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. 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.
To use your product, 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 wash/aspirates or nasal aspirates. The purified nucleic acid is then reverse transcribed into cDNA followed by PCR amplification and detection of hybridized fluorescent peptide nucleic acid (PNA) probes using an authorized real-time (RT) PCR instrument. The COVID-19 RT-PCR PNA kit includes the following materials or other authorized materials: 2X RT qPCR PreMix, COVID-10 mix, Positive Control, and Negative Control.

BioTNS product requires the following control materials, or other authorized control materials, that are required to be included with each batch of specimens tested with your product. All controls listed below must generate expected results in order for a test to be considered valid, as outlined in the Instructions for Use:
• Positive Control (PC) – Artificially synthesized RNA of SARS-CoV-2 genomic regions targeted by the kit (RdRP and N genes) as well as the Internal Control. The PC is used to evaluate performance reliability of the assay. All targets must be detected to be valid.
• Negative Control (NC) - Nuclease-free, distilled water. The NC is used to evaluate cross-contamination of the kit, supplements, reagents and PCR instrument. All targets must not be detected to be valid.
• Internal Control (IC) – Human acidic ribosomal protein (HuPO) detected in clinical specimens and positive control. The IC is used to evaluate the RNA extraction process of clinical samples and evaluate performance reliability of the assay. The IC must be detected for a SARS-CoV-2 negative result to be reported; however, a SARS-CoV-2 positive result will be reported if the IC is not detected.