Singapore - English - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the xpert mtb/rif ultra assay, performed on the genexpert instrument systems, is a semi-quantitative, nested real-time polymerase chain reaction (pcr) in vitro diagnostic test for the detection of mycobacterium tuberculosis (mtb) complex dna in unprocessed sputum samples or concentrated sediments prepared from induced or expectorated sputum. in specimens where mycobacterium tuberculosis complex is detected, the xpert mtb/rif ultra assay can also detect rifampin-resistance associated mutations of the rpob gene. the xpert mtb/rif ultra assay is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (tb) and who have received no antituberculosis therapy, or less than 3 days of therapy in the last 6 months. this test is intended as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.

Singapore - English - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the xpert hcv vl fingerstick (fs) assay is an in vitro reverse transcription polymerase chain reaction (rt-pcr) assay for the detection and quantification of hepatitis c virus (hcv) rna in human capillary fingerstick edta whole blood and venous edta whole blood from hcv-infected individuals using the automated genexpert® instrument systems. the assay is intended for use as an aid in the initial diagnosis in individuals at high risk of hcv infection or anti-hcv positive individuals. detection of hcv rna indicates that the virus is replicating and therefore is evidence of active infection. the assay is intended for use as an aid in the management of hcv infected patients undergoing antiviral therapy. the test measures hcv rna levels at any time during viremia and during treatment; and can be utilized to predict sustained and nonsustained virological responses to hcv therapy. the assay is not intended to be used as a blood donor screening test for hcv.

Singapore - English - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the xpert hiv-1 qual assay, performed on the genexpert instrument systems, is a qualitative in vitro diagnostic test designed to detect human immunodeficiency virus type 1 (hiv-1) total nucleic acids on the automated genexpert® systems using human whole blood (wb) and dried blood spot (dbs) specimens from individuals suspected of hiv-1 infection and is validated for specimens across group m (subtypes a, b, c, d, f, g, h, j, k, crf01_ae, crf02_ag, and crf03_ab), group n, and group o. the xpert hiv-1 qual assay is intended to aid in the diagnosis of hiv-1 infection in conjunction with clinical presentation and other laboratory markers. the assay is intended to be used by laboratory professionals or specifically-trained healthcare workers. the assay is not intended to be used as a blood donor screening test for hiv-1.

Singapore - English - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the xpert hiv-1 vl assay is an in vitro reverse transcriptase polymerase chain reaction (rt-pcr) assay for the detection and quantification of human immunodeficiency virus type 1 (hiv-1) rna in human plasma from hiv-1 infected individuals, using the automated genexpert instrument systems. the assay can quantify hiv-1 rna over the range of 40 to 10,000,000 copies/ml. the xpert hiv-1 vl assay is validated for quantification of rna from hiv-1 group m (subtypes a, b, c, d, f, g, h, j, k, crf01_ae, crf02_ag, and crf03_ab), group n, and group o. the xpert hiv-1 vl assay is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma hiv-1 rna levels.the xpert hiv-1 vl assay is not intended to be used as a donor screening test for hiv-1 or as a diagnostic test to confirm the presence of hiv-1 infection

Singapore - English - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the xpert carba-r assay, performed on the genexpert® instrument systems, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blakpc, blandm, blavim, blaoxa-48, and blaimp gene sequences associated with carbapenem-non susceptibility. the test utilizes automated real-time polymerase chain reaction (pcr). the xpert carba-r assay is intended as an aid to infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. a negative xpert carba-r assay result does not preclude the presence of other resistance mechanisms.

Singapore - English - HSA (Health Sciences Authority)

spd scientific pte ltd - immunology - xpert® hiv-1 qual xc (extended coverage) is an in vitro nucleic acid amplification test for the qualitative detection of human immunodeficiency virus type 1 (hiv-1) total nucleic acids, on the automated genexpert® system. the test is used to detect hiv-1 in human dried blood spots (dbs) and edta capillary or venous whole blood (wb) specimens from individuals suspected of hiv-1 infection. xpert® hiv-1 qual xc is intended to aid in the diagnosis of hiv-1 infection in conjunction with clinical presentation and other laboratory markers in infant, adolescent and adult populations. xpert® hiv-1 qual xc is intended to be used by laboratory professionals, trained health care professionals or other health care workers receiving appropriate training on the use of the device. this test may be used in laboratory or near-patient testing environments. the test is not intended to be used as a blood, organ or tissue donor screening test for hiv-1.

Singapore - English - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the xpert mtb/xdr test, performed on the genexpert instrument systems, is a qualitative, nested real-time polymerase chain reaction (pcr) in vitro diagnostic test for the detection of extensively drug resistant (xdr) mycobacterium tuberculosis (mtb) complex dna in unprocessed sputum samples, concentrated sediments prepared from sputum, or bd™ mycobacterial growth indicator tube (mgit™) culture. in specimens where mtb is detected, the xpert mtb/xdr test can also detect isoniazid (inh) resistance associated mutations in the katg and fabg1 genes, oxyr-ahpc intergenic region and inha promoter; ethionamide (eth) resistance associated with inha promoter mutations only; fluoroquinolone (flq) resistance associated mutations in the gyra and gyrb quinolone resistance determining regions (qrdr); and second line injectable drug (slid) associated mutations in the rrs gene and the eis promoter region.

Singapore - English - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the xpert xpress sars-cov-2 test is a real-time rt-pcr test intended for the qualitative detection of nucleic acid from the sars-cov-2 in nasopharyngeal swab and nasal swab collected from individuals who are suspected of covid-19 infection.

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

cepheid, u.s.a - vaginal endocervical specimen collection kit -

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

cepheid, u.s.a - hbv viral load -