QUIDEL

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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Recently updated

Auto Multiparameter POC Analyzer
Triage MeterPro

Triage MeterPro is designed to provide diagnostic results quickly and easily. With a variety of immunoassays and the ability to use whole blood, plasma, or urine, the platform gives labs a flexible solution at the point-of-care.
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Cardiac Panel
Triage Cardiac Panel

The Triage Cardiac Panel is a rapid, point of care fluorescence immunoassay used with the Triage MeterPro. This test is designed to determine the level of creatine kinase MB (CK-MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens. This can be used as an aid in the diagnosis of myocardial infarction (injury).
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NT-proBNP Test
Triage NT-proBNP Test

The Triage NT-proBNP Test is a rapid, quantitative test for the measurement of NT-proBNP that helps empower heart failure treatment decisions or risk stratify patients with ACS at the point of care or in the laboratory.
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Clinical Laboratory

Auto Multiparameter POC Analyzer
Triage MeterPro

Triage MeterPro is designed to provide diagnostic results quickly and easily. With a variety of immunoassays and the ability to use whole blood, plasma, or urine, the platform gives labs a flexible solution at the point-of-care.
More details

Cardiac Panel
Triage Cardiac Panel

The Triage Cardiac Panel is a rapid, point of care fluorescence immunoassay used with the Triage MeterPro. This test is designed to determine the level of creatine kinase MB (CK-MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens. This can be used as an aid in the diagnosis of myocardial infarction (injury).
More details

NT-proBNP Test
Triage NT-proBNP Test

The Triage NT-proBNP Test is a rapid, quantitative test for the measurement of NT-proBNP that helps empower heart failure treatment decisions or risk stratify patients with ACS at the point of care or in the laboratory.
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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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HSV 1+2/VZV Assay
Lyra Direct HSV 1+2/VZV Assay

The Lyra Direct HSV 1+2/VZV Assay is a multiplex in vitro test that detects and differentiates Herpes simplex virus type 1, Herpes simplex virus type 2, and Varicella-zoster virus nucleic acids isolated and purified from cutaneous or mucocutaneous swab specimens obtained from symptomatic patients. The assay has one-step reagent set-up and a three-step sample prep. Test results are available in less than 70 minutes. The Lyra Direct HSV 1+2/VZV Assay is available for use on Applied Biosystems 7500 Fast Dx, QuantStudio Dx Real-Time PCR Instrument, and Cepheid SmartCycler II.
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HSV 1+2/VZV Assay
Solana HSV 1+2/VZV Assay

The Solana HSV 1+2/VZV Assay is a multiplex in vitro diagnostic test for the detection and differentiation of Herpes simplex virus type 1 (HSV-1), Herpes simplex virus type 2 (HSV-2), and Varicella-zoster virus (VZV) nucleic acids isolated and purified from cutaneous or mucocutaneous swab specimens obtained from symptomatic patients. The assay consists of two major steps: (1) specimen preparation, and (2) amplification and detection of target sequence specific to HSV-1, HSV-2 and/or VZV using isothermal Helicase-Dependent Amplification (HDA) in the presence of target-specific fluorescence probe.
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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.
More details

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.
More details

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.
More details

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.
More details

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.
More details

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.
More details

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.
More details

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.
More details

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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iFOB Test
QuickVue iFOB

The QuickVue iFOB (immunochemical Fecal Occult Blood) Test detects the presence of blood in stool specimens and provides results in five minutes. It requires only one specimen, and because it is specific to human hemoglobin, patients are not required to adhere to strict dietary or medication restrictions.
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Immunoassay Test
Sofia Strep A+ FIA

The Sofia Strep A+ FIA uses advanced immunofluorescence-based lateral-flow technology to detect Group A Streptococcal antigens from throat swabs of symptomatic patients. It offers fast time to results of five minutes for truly rapid strep testing and uses self-contained test cassette that is clean, easy to use and dispose.
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Immunoassay Test
Solana GAS Assay

The Solana GAS Assay is a rapid in vitro diagnostic test for the qualitative detection of Group A β-hemolytic Streptococcus (Streptococcus pyogenes) nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat. The Solana GAS Assay, when performed on the Solana instrument, allows for the rapid, accurate detection of Group A Strep without the need for culture confirmation.
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Immunoassay Test
Sofia Lyme FIA

The Sofia Lyme Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral-flow technology to provide rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens from patients suspected of B. burgdorferi infection. The test is intended for use with either the Sofia or Sofia 2 analyzer and provides automated and objective results in 10 minutes, allowing Lyme testing to be performed in near-patient testing environments.
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Immunoassay Analyzer
Sofia 2

The Sofia 2 is a small bench top immunoassay analyzer that uses advanced fluorescence detection with an ultraviolet LED energy source to collect hundreds of data points on the test strip contained inside of a Sofia FIA Test Cassette. It uses proprietary algorithms to analyze the data, interpret the signals and determine the results automatically to deliver objective and reliable results.
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Immunoassay Test
Sofia Influenza A+B FIA

The Sofia Influenza A+B Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral-flow technology to detect influenza A and influenza B viral nucleoprotein antigens. Using Advance Result Technology (ART), it delivers accurate, objective and automated results in as few as three minutes.
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Real-Time PCR
QuantStudio Dx

The QuantStudio Dx real-time PCR instrument enables the creation of new assays in 96-well plates in IVD mode, while qPCR Microfluidic card formats provide easily interchangeable thermal cycling blocks to accommodate throughput assay development. A simplified instrument and assay workflow as well as intuitive software makes the entire test—from processing to reporting—efficient and cost-effective.
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Real-Time PCR
Applied Biosystems 7500 Fast Dx

The Applied Biosystems 7500 Fast Dx is a 96-well, five-color real-time PCR instrument for in vitro diagnostic use based on a proven platform in a plate-based format to allow for multi-well multiplexing. It features intuitive software that offers the flexibility to develop assays and also run pre-optimized protocols for users operating in a secure environment.
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Immunoassay System
Solana

The Solana combines Quidel’s Helicase-dependent amplification (HDA) with fluorescence detection to deliver molecular results. It can test a single specimen or batch up to 12 tests at a time, and offers an intuitive, touch screen interface with guided operation and customizable settings.
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Immunoassay Analyzer
Sofia

The Sofia benchtop analyzer offers flexible workflow options, security features, and digital/LIS capabilities. Key benefits include enhanced data management, guided user interface, easy-to-use barcode scanner, walk-away automation, and greater stability and sensitivity.
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