QUIDEL

Develops, manufactures and markets rapid diagnostic tests at the point-ofcare (POC) that focus on infectious diseases and reproductive health
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Covid-19 QUIDEL

Clinical Laboratory

Respiratory Viral Panel
Savanna RVP4 Assay

The Savanna RVP4 Assay (Respiratory Viral Panel-4) is a rapid, multiplexed real-time PCR test intended for use with the Savanna instrument for the simultaneous qualitative detection and differentiation of influenza A (Flu A), influenza B (Flu B), respiratory syncytial virus (RSV), and SARS-CoV-2 RNA isolated from human nasal or nasopharyngeal swabs in media obtained from patients with signs and symptoms of respiratory tract infection. Consisting of a self-contained, single-use assay cartridge, the Savanna RVP4 Assay requires no sample or reagent preparation prior to inserting the cartridge into the Savanna instrument. All sample and reagent preparation, nucleic acid extraction and amplification, and real-time detection of viral RNA is fully automated and completed by the Savanna instrument in approximately 22 minutes.
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COVID-19 Rapid Antibody Test
CoronaCHEK Rapid Antibody Convenience Kit

The CoronaCHEK COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum, or plasma. The FDA EUA authorized and CLIA waived kit comes with one procedure card, one package insert, two fact sheets, and 20 individually packaged devices. Each package includes one test cassette, one dropper, one lancet, one single-use buffer, and one alcohol wipe.
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COVID-19 IgG/IgM Rapid Test
Ecotest COVID-19 IgG/IgM Rapid Test Devices

The Ecotest COVID-19 IgG/IgM Rapid Test Device is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. The Ecotest COVID-19 IgG/IgM Rapid Test Device is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.
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COVID-19 Rapid Test Cassette
RightSignCOVID-19 Rapid Test Cassette

The RightSignCOVID-19 Rapid Test Cassette is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium heparin, potassium EDTA, and sodium citrate), serum or plasma (sodium heparin, potassium EDTA and sodium citrate), and fingerstick whole blood. The test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
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SARS-CoV-2 Antigen Test
QuickVue SARS Antigen Test

The QuickVue SARS Antigen Test detects SARS-CoV-2 antigens directly from anterior nares swab specimens. The test provides accurate and reliable results in 10 minutes, allowing for testing of patients suspected of COVID-19/2019-nCoV in near-patient testing environments.
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SARS-CoV-2 Assay
Solana SARS-CoV-2 Assay

The Solana SARS-CoV-2 Assay is an isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens from individuals suspected of COVID-19 by their healthcare provider. The assay consists of two major steps: (1) specimen preparation, and (2) amplification and detection of target sequences specific to SARS-CoV-2 using isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) in the presence of target-specific fluorescence probes which is performed in the Solana instrument. Results are displayed on the touchscreen, can be saved to the instrument, printed, and are capable of being sent to the LIS and exported through one of Solana’s five USB ports.
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Flu + SARS Antigen Test
Sofia 2 Flu + SARS Antigen FIA

The Sofia 2 Flu + SARS Antigen Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from influenza A and influenza B, and SARS-CoV-2. The Sofia 2 Flu + SARS Antigen FIA with the Sofia 2 analyzer provides automated and objective results in 15 minutes, allowing for testing of patients suspected of influenza A, influenza B, and COVID-19/2019-nCoV at the Point of Care.
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SARS-CoV-2 Assay
Lyra SARS-CoV-2 Assay

The Lyra SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the in vitro qualitative detection of human coronavirus SARS-CoV-2 from viral RNA extracted from nasal, nasopharyngeal or oropharyngeal swab specimens from patients with signs and symptoms of COVID-19. The authorized testing consists of nucleic acid extraction on the bioMerieux NucliSENS easyMAG system or EMAG system, followed by RT-PCR on six thermocyclers.
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SARS Antigen Fluorescent Immunoassay
Sofia SARS Antigen Fluorescent Immunoassay (FIA)

The Sofia SARS Antigen Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from SARS-CoV-2. The Sofia SARS Antigen FIA, with the Sofia 2 and Sofia analyzers, provides automated and objective results in 15 minutes, allowing for testing of patients suspected of COVID-19/2019-nCoV in near-patient testing environments.
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SARS-CoV-2 Assay
Lyra Direct SARS-CoV-2 Assay

The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the in vitro qualitative detection of human coronavirus SARS-CoV-2 from viral RNA extracted from nasal, nasopharyngeal or oropharyngeal swab specimens from patients with signs and symptoms of COVID-19. The assay targets the non-structural Polyprotein (pp1ab) of the SARS-CoV-2 virus and has a one-step reagent set-up and three-step sample prep with test results available in less than 70 minutes.
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Respiratory Viral Panel

Model: Savanna RVP4 Assay
Respiratory Viral Panel

Description:

The Savanna RVP4 Assay (Respiratory Viral Panel-4) is a rapid, multiplexed real-time PCR test intended for use with the Savanna instrument for the simultaneous qualitative detection and differentiation of influenza A (Flu A), influenza B (Flu B), respiratory syncytial virus (RSV), and SARS-CoV-2 RNA isolated from human nasal or nasopharyngeal swabs in media obtained from patients with signs and symptoms of respiratory tract infection.
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Full Description Features Specifications

Description

The Savanna RVP4 Assay (Respiratory Viral Panel-4) is a rapid, multiplexed real-time PCR test intended for use with the Savanna instrument for the simultaneous qualitative detection and differentiation of influenza A (Flu A), influenza B (Flu B), respiratory syncytial virus (RSV), and SARS-CoV-2 RNA isolated from human nasal or nasopharyngeal swabs in media obtained from patients with signs and symptoms of respiratory tract infection. Consisting of a self-contained, single-use assay cartridge, the Savanna RVP4 Assay requires no sample or reagent preparation prior to inserting the cartridge into the Savanna instrument. All sample and reagent preparation, nucleic acid extraction and amplification, and real-time detection of viral RNA is fully automated and completed by the Savanna instrument in approximately 22 minutes.

Features

• RT-PCR Technology: Rapid molecular results using real-time PCR.
• Simple workflow: Sample-to-result technology. Decreased hands-on time with no upfront sample or reagent preparation required prior to inserting the cartridge into the Savanna instrument.
• Room temperature storage: Cartridge is stored at 2°C to 30°C. No need for freezers.
• Fast turnaround time: Simultaneously detect four respiratory pathogens from a single sample in approximately 22 minutes.
• Test Select: Select clinically relevant analytes and unlock deselected analytes within 48 hours without the need to collect the sample and run the test again.

Specifications

• Sample type: Nasal swabs and nasopharyngeal swabs in transport media* obtained from patients symptomatic of respiratory infection
• Time to results: Approximately 22 minutes
• Cartridge storage conditions: 2°C to 30°C Request Information

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