Search Results

The Quidel Molecular RSV + hMPV Assay is a multiplex Real-Time PCR (RT-PCR) assay for the qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA) extracted from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV. Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. The Quidel Molecular RSV + hMPV Assay can be performed using either the Life Technologies QuantStudio™ Dx RT-PCR Instrument, the Applied Biosystems® 7500 Fast Dx RT-PCR Instrument, or the Cepheid SmartCycler® II System.

The Quidel Molecular RSV + hMPV Assay detects viral nucleic acids that have been extracted from a patient sample using the bioMérieux NucliSENS easyMAG automated extraction platform. A multiplex RT-PCR reaction is carried out under optimized conditions in a single tube generating amplicons for each of the target viruses present in the sample. This reaction is performed utilizing the Cepheid SmartCycler II, the Applied Biosystems 7500 Fast Dx. or the Life Technologies QuantStudio Dx. Identification of RSV, hMPV, and the process control (PRC) occurs by the use of target-specific primers and fluorescent-labeled probes that hybridize to conserved regions in the genomes of RSV and hMPV and the PRC.

The Quidel Molecular Influenza A+B Assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection and differentiation of influenza A and influenza B viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of influenza A and influenza B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay does not detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2011 and 2013 influenza seasons when influenza A/H3 and 2009 H1N1 influenza were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. The assay can be performed using either the Life Technologies QuantStudio™ Dx, the Applied Biosystems® 7500 Fast Dx, or the Cepheid SmartCycler® II.

The Quidel Molecular Influenza A+B Assay detects viral nucleic acids that have been extracted from a patient sample using the NucliSENS® easyMAG® automated extraction platform. A multiplex real-time RT-PCR reaction is carried out under optimized conditions in a single tube generating amplicons for each of the target viruses present in the sample. This reaction is performed utilizing the Life Technologies QuantStudio™ Dx, the Applied Biosystems® 7500 Fast Dx, or the Cepheid SmartCycler® II platform. Identification of influenza A occurs by the use of target specific primers and a fluorescentlabeled probe that hybridizes to a conserved influenza A sequence within the matrix protein gene. Identification of influenza B occurs by the use of target specific primers and fluorescent-fabeled probes that will hybridize to a conserved influenza B sequence within the neuraminidase gene.

The Sofia RSV FIA employs immunofluorescence for detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients. This qualitative test is intended for use as an aid in the rapid diagnosis of acute RSV infections in pediatric patients less than 19 years of age. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative result is presumptive, and it is recommended these results be confirmed by virus culture or an FDA-cleared RSV molecular assay.

The Sofia RSV FIA test employs immunofluorescence technology that is used with the Sofia Analyzer for the rapid detection of RSV antigens. The Sofia RSV FIA test involves the disruption of RSV viral antigens. The patient specimen is placed in the Reagent Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. After disruption, the specimen is dispensed into the Cassette sample well. From the sample well. the specimen migrates through a test strip containing various unique chemical environments. If RSV viral antigens are present, they will be trapped in a specific location. Note: Depending upon the user's choice, the cassette is either placed inside of the Sofia Analyzer for automatically timed development (Walk Away Mode) or placed on the counter or bench top for a manually timed development and then placed into the Sofia Analyzer to be scanned (Read Now Mode). The Sofia Analyzer will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. The Sofia Analyzer will display the test results (Positive, Negative, or Invalid) on the screen. The results can also be automatically printed on an integrated printer if this option is selected.

The Sofia hCG FIA is an immunofluorescence-based lateral flow assay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine specimens and is designed to aid early detection of pregnancy. The test is intended for prescription use only, including use at point-of-care sites.

The test kit consists of individually packaged test Cassettes-each containing monoclonal murine antibodies for the capture and detection of hCG; disposable specimen transfer pipettes; and a package insert. The test is a qualitative immunofluorescence-based assay used to detect concentrations of 20 mIU/mL hCG or more in urine.

The Sofia Influenza A+B FIA employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients. This qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections. The test is not intended to detect influenza C antigens. A negative test is presumptive and it is recommended these results be confirmed by virus culture or FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use. Performance characteristics for influenza A and B were established during February through March 2011 when influenza viruses A/California/7/2009 (2009 H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008 (Victoria-Like) were the predominant influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC entitled "Update: Influenza Activity--United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine". Performance characteristics may vary against other emerging influenza viruses. If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The Sofia Influenza A+B FIA employs immunofluorescence technology that is used with the Sofia Analyzer to detect influenza virus nucleoproteins. The Sofia Influenza A+B FIA is a lateral-flow immunoassay that uses monoclonal antibodies that are specific for influenza antigens and have no known cross-reactivity to normal flora or other known respiratory pathogens. Nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens are used for this test. The patient specimen is placed in the Reagent Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. After disruption, the specimen is dispensed into the cassette sample well. From the sample well, the specimen migrates through a test strip containing various unique chemical environments. If influenza viral antigen is present, they will be trapped in a specific location. - Note: Depending upon the user's choice, the cassette is either placed inside of the Sofia Analyzer for automatically timed development (Walk Away Mode) or placed on the counter or bench top for a manually timed development and then placed into the Sofia Analyzer to be scanned (Read Now Mode). The Sofia Analyzer will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. The Sofia Analyzer will display the test results (Positive, Negative, or Invalid) on the screen. The results can also be automatically printed on an integrated printer if this option is selected.

The QuickVue Influenza A+B test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, nasal aspirate, and nasal wash specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and type B viral infections. The test is not intended to detect influenza C antigens. Negative results should be confirmed by cell culture; they do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

The QuickVue Influenza A+B test involves the extraction of influenza A and B viral antigens. The patient specimen is placed in the Extraction Reagent Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. After extraction, the Test Strip is placed in the Extraction Reagent Tube where nucleoproteins in the specimen will react with the reagents in the Test Strip. If the extracted specimen contains influenza A or B antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip indicating a positive result. The Test Line for influenza A or B will develop at separate specified locations on the same Test Strip. If influenza A or B antigens are not present, or are present at very low levels, only the blue procedural Control Line will appear.

The Quidel Molecular RSV + hMPV assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection and identification of respiratory syncytial virus and human metapneumovirus viral RNA extracted from nasal and nasopharyngeal swabs specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of respiratory syncytial virus and human metapneumovirus infections. This test is not intended to differentiate the four genetic sub-lineages of hMPV. Negative results do not preclude RSV or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

The Quidel Molecular RSV + hMPV Assay detects viral nucleic acids that have been extracted from a patient sample using the NucliSENS® easyMAG® automated extraction platform. A multiplex RT-PCR reaction is carried out under optimized conditions in a single tube generating amplicons for each of the target viruses present in the sample. This reaction is performed utilizing either the Cepheid SmartCycler® II or the Applied Biosystems 7500 Fast DX. Identification of RSV and hMPV and the PRC occurs by the use of target-specific primers and fluorescent-labeled probes that hybridize to conserved regions in the genomes of RSV and hMPV and the PRC.

The Quidel Molecular Direct C. difficile Assay is a qualitative, multiplexed in vitro diagnostic test for the direct detection of toxin A gene (tcdA) or toxin B gene (tcdB) sequences of toxigenic strains of Clostridium difficile from unformed (liquid or soft) stool specimens collected from patients suspected of having Clostridium difficile-Associated Disease (CDAD). The Quidel Molecular Direct C. difficile Assay is a real-time PCR test and utilizes proprietary sample preparation with fluorescently labeled primers and probes. The assay can be performed using either the Life Technologies QuantStudio® Dx; the Applied Biosystems 7500 Fast Dx, or the Cepheid SmartCycler II, to detect the toxin gene sequences associated with toxin-producing C. difficile strains. The assay is intended to be performed directly on CDAD-suspected stool specimens, and is indicated for use as an aid in the diagnosis of CDAD.

The Quidel Molecular Direct C. difficile Assay detects nucleic acids that have been prepared from a patient sample using proprietary sample preparation. A multiplex real-time PCR reaction is performed under optimized conditions in a single well generating amplicons for each of the targets present in the sample. Identification occurs by the use of oligonucleotide primers and probes that are complementary to conserved regions in the tcdA and tcdB genes of the pathogenicity locus (PaLoc). The Quidel Molecular Direct C. difficile Assay contains sufficient reagents to process 96 specimens or quality control samples.

The Quidel® Molecular Influenza A+B assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection and differentiation of influenza A and influenza B viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of influenza A and influenza B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay does not detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2010 to 2011 influenza season when influenza A/H3 and 2009 H1N1 influenza were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The Quidel Molecular Influenza A+B Assay detects viral RNA that have been extracted from a patient sample using the NucliSENS® easyMAG® automated extraction platform. A multiplex RT-PCR reaction is carried out under optimized conditions in a single tube generating amplicons for each of the target viruses present in the sample. This reaction is performed utilizing the Cepheid SmartCycler® II platform. Identification of influenza A occurs by the use of target specific primers and a fluorescent- labeled probe that hybridizes to a conserved influenza A sequence within the matrix protein gene. Identification of influenza B occurs by the use of target specific primers and fluorescentlabeled probes that will hybridize to a conserved influenza B sequence within the neuraminidase gene. The following is a summary of the procedure: 1. Sample Collection: Obtain nasal swabs and nasopharyngeal swabs specimens using standard techniques from symptomatic patients. These specimens are transported, stored, and processed according to established laboratory procedures. 2. Nucleic Acid Extraction: Extract Nucleic Acids from the specimens with the NucliSENS easyMAG System following the manufacturer's instructions using the appropriate reagents. Prior to the extraction procedure add 20 µL of the Process Control (PRC) to each 180 uL aliquot of specimen. The PRC serves to monitor inhibitors in the extracted specimen, assures that adequate amplification has taken place and that nucleic acid extraction was sufficient. 3. Rehydration of Master Mix: Rehydrate the lyophilized Master Mix using 135uL of Rehydration Solution. The Master Mix contains oligonucleotide primers. fluorophore and quencher-labeled probes targeting highly conserved regions of the influenza A and influenza B viruses as well as the process control sequence. The primers are complementary to highly specific and conserved regions in the genome of these viruses. The probes are dual labeled with a reporter dye attached to the 5'end and a quencher attached to the 3' end. The rehydrated Master Mix is sufficient for eight reactions. 4. Nucleic Acid Amplification and Detection: Add 15 µL of the rehydrated Master Mix to each reaction tube. SuL of extracted nucleic acids (specimen with PRC) is then added to the tube. Then place the tube into the Cepheid SmartCycler® II. Once the reaction tubes are added to the instrument, the assay protocol is initiated. This protocol initiates reverse transcription of the RNA targets generating complementary DNA, and the subsequent amplification of the target amplicons occurs. The Quidel Molecular Influenza A+B assay is based on TaqMan® chemistry, and uses an enzyme with reverse transcriptase, DNA polymerase, and 5'-3' exonuclease activities. During DNA amplification, this enzyme cleaves the probe bound to the complementary DNA sequence, separating the quencher dye from the reporter dye. This step generates an increase in fluorescent signal upon excitation by a light source of the appropriate wavelength. With each cycle, additional dye molecules are separated from their quenchers resulting in additional signal. If sufficient fluorescence is achieved by 45 cycles, the sample is reported as positive for the detected nucleic acid.

The Quidel Molecular Influenza A+B assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection and differentiation of influenza A and influenza B viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of influenza A and influenza B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay does not detect the presence of influenza C virus. Negative results do not preclude Influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2010-2011 influenza season when influenza A/H3 and 2009 H1N1 influenza were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The Quidel Molecular Influenza A+B Assay detects viral nucleic acids that have been extracted from a patient sample using the NucliSENS® easyMAG® automated extraction platform. A multiplex real-time RT-PCR reaction is carried out under optimized conditions in a single tube generating amplicons for each of the target viruses present in the sample. This reaction is performed utilizing the Applied Biosystems® 7500 Fast Dx platform. Identification of influenza A occurs by the use of target specific primers and a fluorescentlabeled probe that hybridizes to a conserved influenza A sequence within the matrix protein gene. Identification of influenza B occurs by the use of target specific primers and fluorescent-labeled probes that will hybridize to a conserved influenza B sequence within the neuraminidase gene. The following is a summary of the procedure: 1. Sample Collection: Obtain nasal swab and nasopharyngeal swab specimens using standard techniques from symptomatic patients. These specimens are transported, stored, and processed according to established laboratory procedures. 2. Nucleic Acid Extraction: Extract Nucleic Acids from the specimens with the NucliSENS easyMAG System following the manufacturer's instructions using the appropriate reagents. Use of other extraction systems with the Quidel Molecular Influenza A+B kit has not been validated. Validation of these systems is the responsibility of the end-user. Prior to the extraction procedure add 20 uL of the Process Control (PRC) to each 180 uL aliquot of specimen. The PRC serves to monitor inhibitors in the extracted specimen, assures that adequate amplification has taken place and that nucleic acid extraction was sufficient. 3. Rehydration of Master Mix: Rehydrate the lyophilized Master Mix using 135uL of Rehydration Solution. The Master Mix contains oligonucleotide primers, fluorophore and quencher-labeled probes targeting highly conserved regions of the influenza A and influenza B viruses as well as the process control sequence. The primers are complementary to highly specific and conserved regions in the genome of these viruses. The probes are dual labeled with a reporter dye attached to the 5-end and a quencher attached to the 3'-end. The rehydrated Master Mix is sufficient for eight reactions. 4. Nucleic Acid Amplification and Detection: Add 15 uL of the rehydrated Master Mix to each reaction plate well. 5uL of extracted nucleic acids (specimen with PRC) is then added to the plate well. Then place the plate into the ABI 7500 FastDx. Once the plate is added to the instrument, the assay protocol is initiated. This protocol initiates reverse transcription of the RNA targets generating complementary DNA, and the subsequent amplification of the target amplicons occur. The Quidel Molecular Influenza A+B assay is based on TaqMan® chemistry, and uses an enzyme with reverse transcriptase, DNA polymerase, and 5'-3' exonuclease activities. During DNA amplification, this enzyme cleaves the probe bound to the complementary DNA sequence, separating the quencher dye from the reporter dye. This step generates an increase in fluorescent signal upon excitation by a light source of the appropriate wavelength. With each cycle, additional dye molecules are separated from their quenchers resulting in additional signal. If sufficient fluorescence is achieved by 35 cycles during the data collection stage of amplification, the sample is reported as positive for the detected nucleic acid.