The COVID-19 RT-PCR Detection Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper and lower respiratory specimens (such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 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 and lower 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 infective status. The agent detected may not be the definite cause of disease. Positive results do not rule out bacterial co-infection with other viruses. 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 Detection Kit is intended for use by qualified 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 Detection Kit is only for use under the Food and Drug Administration's Emergency Use Authorization. PRINCIPLE OF DETECTION This product is a fluorescent probe-based Taqman RT-PCR assay system. Firstly, the RNA of SARS-CoV-2 will be reverse transcribed into cDNA by reverse transcriptase, and then PCR amplification will be performed with cDNA as template. During amplification of the template, the TaqMan probe will be degraded due to the 5'-3 polymerase activity and exonuclease activity of Taq DNA polymerase, then the separation of fluorescent reporter and quencher enables the fluorescent signal to be detected by instrument. The ORF1ab gene of SARS-CoV-2 will be detected qualitatively by FAM channel, the N gene of SARS-CoV-2 will be detected qualitatively by JOE channel, the E gene of SARS-CoV-2 will be detected qualitatively by ROX channel, and the internal reference will be detected by CY5 channel. dUTP and UNG enzyme are used in the kit to prevent contamination of the amplified products. Internal reference is used in the kit for quality control starting from sample collection
Medical uniforms, n95 respirators, nitrile/vinyl/latex gloves, viral transport kits (vtm/vltm), kf94/kn95/3 ply face mask, laboratory plastics & disposables, rapid test kits, syringe & needle.
Isolation Gown
Gloves
Head Cover
Surgical Kit
Innolab200600002PS-Semi-Auto Biochemistry Analyzer
SelectraPro-XL6003703ET Fully Auto Biochemistry Analyzer
SelectraPro-S-Lite6003543VS Fully Auto Biochemistry Analyzer
MSN Needle
Ultimate Blood Collection Tubes
Flashback Needle
Patient ID
Micro Pipette Fixed & Variables
Latex Tourniquet
Thermal Paper
Injection Plaster
Sample Vial
Coplin Jars
Microscope Cover Glass
