Australia - English - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct921 - enterococcus ivds - the cepheid xpert vana/vanb assay performed in the genexpert system is a qualitative in vitro diagnostic test designed for rapid detection of vancomycin-resistance (vana/vanb) genes from rectal and perianal swab specimens in patients at risk for intestinal colonization of vancomycin-resistant bacteria. the test utilizes automated real-time polymerase chain reaction (pcr) to detect the vana and vanb genes that can be associated with vancomycin-resistant enterococci (vre).

Australia - English - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct791 - mycobacteria ivds - the xpert mtb/rif assay for use with the cepheid genexpert system is a semi-quantitative, nested real-time pcr in-vitro diagnostic test for the detection of: ? mycobacterium tuberculosis complex dna in sputum samples or concentrated sediments prepared from induced or expectorated sputa that are either acid-fast bacilli (afb) smear positive or negative ? rifampin-resistance associated mutations of the rpob gene in samples from patients at risk for rifampin resistance the xpert mtb/rif assay is intended for use with specimens from untreated patients for whom there is clinical suspicion of tuberculosis (tb)

Australia - English - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct822 - trichomonas ivds - the cepheid xpert tv assay, performed on the genexpert instrument systems, is a qualitative in vitro diagnostic test for the detection of trichomonas vaginalis genomic dna. the test utilizes automated real-time polymerase chain reaction (pcr) to detect trichomonas vaginalis genomic dna. the xpert tv assay uses female and male urine specimens, endocervical swab specimens, or patient-collected vaginal swab specimens (collected in a clinical setting). the xpert tv assay is intended to aid in the diagnosis of trichomoniasis in symptomatic or asymptomatic individuals.

Australia - English - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct798 - streptococcus ivds - the cepheid xpert gbs is a qualitative in vitro diagnostic test designed to detect group b streptococcus (gbs) dna from vaginal/rectal swab specimens, using pcr) with. xpert gbs assay testing is indicated for rapid identification of antepartum and intrapartum gbs colonization.

Australia - English - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct774 - multiple-bacteria ivds - the cepheid xpert carba-r assay is a qualitative in vitro diagnostic real-time pcr test designed for the detection and differentiation of the blakpc, blandm, blavim, blaoxa-48 and bla imp gene sequences associated with carbapenem-non-susceptibility.

Australia - English - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct355 - viral infectious disease ivds - the xpert norovirus assay, performed on the cepheid genexpert? instrument systems, is a qualitative in vitro diagnostic test for the rapid identification and differentiation of norovirus genogroup i and genogroup ii from raw or unpreserved unformed stool specimens collected from individuals with symptoms of acute gastroenteritis. the test utilizes automated real-time reverse transcriptase polymerase chain reaction (rrt-pcr) to detect norovirus rna. the xpert norovirus assay is intended to aid in the diagnosis of norovirus infections.

Australia - English - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct702 - multiple-viruses ivds - the cepheid? xpert ev assay is a reverse transcription polymerase chain reaction (rt-pcr) using the genexpert dx system for the presumptive qualitative detection of enterovirus (ev) rna in cerebrospinal fluid (csf) specimens from individuals with signs and symptoms of meningitis. this test, in conjunction with other laboratory results and clinical information, may be used as an aid in the laboratory diagnosis of enterovirus infection in patients with a clinical suspicion of meningitis or meningoencephalitis. assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. caution: the results obtained with the xpert ev assay should be used only as an adjunct to clinical observations and other information available to the physician. positive xpert ev results do not rule out other causes of meningitis, including bacteria, mycobacteria, other viruses (e.g., herpes family viruses, arboviruses, mumps virus, etc.), and fungi.

Australia - English - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct704 - hepatitis b virus ivds - the cepheid xpert? hbv viral load (vl) assay is an in vitro nucleic acid amplification test designed for the quantitation of hepatitis b virus (hbv) dna in human serum or plasma (edta) from chronically hbv-infected individuals using the automated genexpert? systems. the assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiviral treatment as measured by changes in plasma or serum hbv dna levels.the test is not intended to be used as a donor screening test for hbv, or to be used as a diagnostic test to confirm the presence of hbv infection.

Australia - English - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct702 - multiple-viruses ivds - assays intended to be used in the diagnosis of respiratory viral infections due to sars-cov-2, influenza, and rsv.

Australia - English - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct353 - bacterial infectious disease ivds - rapid detection and identification of bacteria by real time polymerase chain reaction (pcr)