Singapore - English - HSA (Health Sciences Authority)

biomerieux singapore pte. ltd. - microbiology - biofire joint infection panel is a multiplexed nucleic-acid-based intended for simultaneous qualitative detection, identification of multiple bacterial, yeast nucleic acids and select antimicrobial resistance genes from synovial fluid obtained from individuals suspected to have a joint infection. the biofire ji panel is indicated as an aid in the diagnosis of specific agents of joint infection and results should be used in conjunction with other clinical and laboratory findings. the biofire ji panel is not intended to monitor treatment for joint infections.

Singapore - English - HSA (Health Sciences Authority)

biomerieux singapore pte. ltd. - microbiology - the biofire® blood culture identification 2 (bcid2) panel is a multiplexed nucleic acid test intended for use with biofire® filmarray® 2.0 or biofire® filmarray® torch systems for the simultaneous qualitative detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants associated with antimicrobial resistance. the biofire bcid2 panel test is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. results are intended to be interpreted in conjunction with gram stain results. the biofire bcid2 panel is indicated as an aid in the diagnosis of specific agents of bloodstream infection and results should be used in conjunction with other clinical and laboratory findings. positive results do not rule out co-infection with organisms not included in the biofire bcid2 panel. it is not intended to monitor treatment for bloodstream infection

Singapore - English - HSA (Health Sciences Authority)

biomerieux singapore pte. ltd. - microbiology - the biofire respiratory panel 2.1 (rp2.1) is a pcr- based multiplexed nucleic acid test intended for use with the biofire filmarray® 2.0 or biofire filmarray® torch systems for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections, including covid-19. the following organism types and subtypes are identified using the biofire rp2.1:adenovirus, coronavirus 229e, coronavirus hku1,coronavirus nl63, coronavirus oc43, severe acute respiratory syndrome coronavirus 2 (sars- cov-2), human metapneumovirus, human rhinovirus/enterovirus, influenza a, including subtypes h1, h1-2009, and h3, influenza b, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, respiratory syncytial virus, bordetella parapertussis, bordetella pertussis, chlamydia pneumoniae, mycoplasma pneumonia.

Singapore - English - HSA (Health Sciences Authority)

biomerieux singapore pte. ltd. - microbiology - the biofire respiratory panel 2.1 plus (rp2.1plus) is a pcr- based multiplexed nucleic acid test intended for use with the biofire filmarray® 2.0 or biofire filmarray® torch systems for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections, including covid-19. the following organism types and subtypes are identified using the biofire rp2.1plus: adenovirus, coronavirus 229e, coronavirus hku1,coronavirus nl63, coronavirus oc43, mers-cov, sars-cov-2, human metapneumovirus, human rhinovirus/enterovirus, influenza a virus including subtypes h1, h1-2009, and h3, influenza b, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, respiratory syncytial virus, bordetella parapertussis, bordetella pertussis, chlamydia pneumoniae, mycoplasma pneumonia.

Singapore - English - HSA (Health Sciences Authority)

biomerieux singapore pte. ltd. - microbiology - the biofire® joint infection (ji) panel is a multiplexed nucleic-acid-based, in vitro diagnostic test intended for use with biofire® filmarray® 2.0 and biofire® filmarray® torch systems for the simultaneous qualitative detection and identification of multiple bacterial and yeast nucleic acids and select antimicrobial resistance genes from synovial fluid obtained from individuals suspected to have a joint infection. the following organisms are identified using the biofire ji panel:gram positive bacteria, gram negative bactieria and yeast.

Singapore - English - HSA (Health Sciences Authority)

biomerieux singapore pte. ltd. - microbiology - the biofire® filmarray® pneumonia panel (biofire pneumonia panel) & pneumonia panel plus (biofire pneumonia panel plus) are multiplexed nucleic acid test intended for use with biofire® filmarray® 2.0 (biofire 2.0) or biofire® filmarray® torch (biofire torch) systems for the simultaneous detection and identification of multiple respiratory viral and bacterial nucleic acids, as well as select antimicrobial resistance genes, in sputum-like specimens (induced or expectorated sputum, or endotracheal aspirates) or bronchoalveolar lavage (bal)-like specimens (bal or mini-bal) obtained from individuals suspected of lower respiratory tract infection. the detection and identification of mers-cov is only available on the biofire® filmarray® pneumonia panel plus. the results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Singapore - English - HSA (Health Sciences Authority)

biomerieux singapore pte. ltd. - microbiology - the filmarray blood culture identification (bcid) panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with the filmarray instrument. the filmarray bcid panel is capable of simultaneous detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants of antimicrobial resistance. the filmarray bcid panel assay is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. results are intended to be interpreted in conjunction with gram stain results.the filmarray bcid panel is indicated as an aid in the diagnosis of specific agents of bacteremia and fungemia and results should be used in conjunction with other clinical and laboratory findings. positive filmarray results do not rule out co-infection with organisms not included in the filmarray bcid panel. the filmarray bcid panel is not intended to monitor treatment for bacteremia or fungemia.

Singapore - English - HSA (Health Sciences Authority)

biomerieux singapore pte. ltd. - microbiology - the filmarray gastrointestinal (gi) panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with filmarray systems. the filmarray gi panel is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in cary blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection. the filmarray gi panel is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness and results are meant to be used in conjunction with other clinical, laboratory, and epidemiological data.

Singapore - English - HSA (Health Sciences Authority)

biomerieux singapore pte. ltd. - microbiology - the filmarray instrument is an automated in vitro diagnostic device intended for use in combination with assay specific reagent pouches to detect multiple nucleic acid targets contained in clinical samples. the instrument interacts with the reagent pouch to both purify nucleic acids and amplify targeted nucleic acid sequences using nested multiplex pcr in a closed system. the resulting pcr products are evaluated using dna melting analysis. the filmarray software automatically determines the results and provides a test report.

Singapore - English - HSA (Health Sciences Authority)

biomerieux singapore pte. ltd. - microbiology - the filmarray meningitis/encephalitis (me) panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with filmarray systems. the filmarray me panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids directly from cerebrospinal fluid (csf) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis. the filmarray me panel is indicated as an aid in the diagnosis of specific agents of meningitis and/or encephalitis and results are meant to be used in conjunction with other clinical, epidemiological, and laboratory data. results from the filmarray me panel are not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions. filmarray me panel is intended to be used in conjunction with standard of care culture for organism recovery, serotyping, and antimicrobial susceptibility testing.