Bio-Speedy® Respiratory Tract 4T RT-qPCR Kit is a one-step reverse transcription and real-time PCR (RT-qPCR) test intended for the qualitative detection of the RNA from SARS-CoV-2, Influenza A, Influenza B and Respiratory Syncytial Virus A/B. The Bio-Speedy® Respiratory Tract 4T RT-qPCR Kit is applied to nucleic acids obtained from nasopharyngeal swab, oropharyngeal swab, oral/saliva swab, bronchoalveolar lavage, nasopharyngeal aspirate, saliva, gargle, and sputum samples. Detection with the kit is achieved via rapid nucleic acid extraction from nasopharyngeal swab, oropharyngeal swab, oral/saliva swab, bronchoalveolar lavage, nasopharyngeal aspirate, saliva, gargle, and sputum samples followed by multiplex RT-q PCR targeting the SARS-CoV-2-specific Open Reading Frame 1ab (ORF1ab), Nucleocapsid (N), Influenza A-specific Membrane Protein (M), Influenza B-specific Nuclear Export Protein (NEP), Respiratory Syncytial Virus A/B-specific Nucleocapsid (N) genes in real-time PCR instruments that are equipped with FAM, HEX, ROX, CY5 and CY5.5 detection channels. The kit allows to achieve RT-qPCR results in less than 30 minutes (Run time may vary depending on the instrument and the thermal cycling protocol). The oligonucleotide set targeting the human RNase P mRNA functions as a control of the sampling, nucleic acid extraction, reverse transcription, and qPCR since the oligonucleotide set targets the exon-exon junction. The kit also contains negative and positive control templates for testing the contamination and the RT-qPCR reagent stability, respectively. Bio-Speedy® Respiratory Tract 4T RT-qPCR Kit is intended for use by laboratory personnel trained in the techniques of RT-qPCR. RUO  

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Bio-Speedy® Respiratory Tract 4T RT-qPCR Kit is a one-step reverse transcription and real-time PCR (RT-qPCR) test intended for the qualitative detection of the RNA from SARS-CoV-2, Influenza A, Influenza B and Respiratory Syncytial Virus A/B. The Bio-Speedy® Respiratory Tract 4T RT-qPCR Kit is applied to nucleic acids obtained from nasopharyngeal swab, oropharyngeal swab, oral/saliva swab, bronchoalveolar lavage, nasopharyngeal aspirate, saliva, gargle, and sputum samples.Detection with the kit is achieved via rapid nucleic acid extraction from nasopharyngeal swab, oropharyngeal swab, oral/saliva swab, bronchoalveolar lavage, nasopharyngeal aspirate, saliva, gargle, and sputum samples followed by multiplex RT-q PCR targeting the SARS-CoV-2-specific Open Reading Frame 1ab (ORF1ab), Nucleocapsid (N), Influenza A-specific Membrane Protein (M), Influenza B-specific Nuclear Export Protein (NEP), Respiratory Syncytial Virus A/B-specific Nucleocapsid (N) genes in real-time PCR instruments that are equipped with FAM, HEX, ROX, CY5 and CY5.5 detection channels. The kit allows to achieve RT-qPCR results in less than 30 minutes (Run time may vary depending on the instrument and the thermal cycling protocol).The oligonucleotide set targeting the human RNase P mRNA functions as a control of the sampling, nucleic acid extraction, reverse transcription, and qPCR since the oligonucleotide set targets the exon-exon junction. The kit also contains negative and positive control templates for testing the contamination and the RT-qPCR reagent stability, respectively.Bio-Speedy® Respiratory Tract 4T RT-qPCR Kit is intended for use by laboratory personnel trained in the techniques of RT-qPCR. RUO

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Direct RT-qPCR SARS-CoV-2 Intended use: Bio-Speedy® Direct RT-qPCR SARS-CoV-2 kit is a real-time and one-step reverse transcription PCR test used to detect the SARS-CoV-2-specific ORF1ab gene qualitatively. The vNAT® Buffer included in the kit obtains and preserves nucleic acid extract from the samples in VTM tubes. Targets: The Bio-Speedy® Direct RT-qPCR SARS-CoV-2 kit targets the ORF1ab gene in the SARS-CoV-2 genome and is read in the FAM channel of the Real-Time PCR instrument. The RNase P gene targeted as an internal control is also read in the HEX channel. Operation and Duration: Bio-Speedy® Direct RT-qPCR SARS-CoV-2 kit makes samples taken in VTM ready for Real-Time PCR within 5 minutes after combining them with vNAT® Buffer and provides Real-Time PCR results in 55 minutes.  Validated and Compatible Devices: The kit is validated for 10 and 20 µL qPCR volumes using Roche LightCycler® 96, Bio-Rad CFX96 Touch™, and Qiagen Rotor-Gene® 5 Plex Real-Time PCR Systems. Sensitivity: 97.8%Specificity: 100% The Bio-Speedy® Direct RT-qPCR SARS-CoV-2 kit is an Emergency Use Authorization (EUA) kit authorized by the U.S. FDA for use by licensed laboratories. IFU  

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Direct RT-qPCR SARS-CoV-2 Intended use: Bio-Speedy® Direct RT-qPCR SARS-CoV-2 kit is a real-time and one-step reverse transcription PCR test used to detect the SARS-CoV-2-specific ORF1ab gene qualitatively. The vNAT® Buffer included in the kit obtains and preserves nucleic acid extract from the samples in VTM tubes. Targets: The Bio-Speedy® Direct RT-qPCR SARS-CoV-2 kit targets the ORF1ab gene in the SARS-CoV-2 genome and is read in the FAM channel of the Real-Time PCR instrument. The RNase P gene targeted as an internal control is also read in the HEX channel. Operation and Duration: Bio-Speedy® Direct RT-qPCR SARS-CoV-2 kit makes samples taken in VTM ready for Real-Time PCR within 5 minutes after combining them with vNAT® Buffer and provides Real-Time PCR results in 55 minutes.  Validated and Compatible Devices: The kit is validated for 10 and 20 µL qPCR volumes using Roche LightCycler®96, Bio-Rad CFX96 Touch™, Qiagen Rotor-Gene® 5 Plex Real-Time PCR Systems. Sensitivity: 97.8%Specificity: 100% The Bio-Speedy® Direct RT-qPCR SARS-CoV-2 kit is an Emergency Use Authorization (EUA) kit authorized by the U.S. FDA for use by licensed laboratories. IFU  

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