Singapore - English - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - 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.

Singapore - English - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the cepheid xpert mrsa assay performed in the genexpert® dx system (xpert mrsa) is a qualitative in vitro diagnostic test designed for rapid detection of methicillin-resistant staphylococcus aureus (mrsa) from nasal swabs in patients at risk for nasal colonization. the test utilizes automated real-time polymerase chain reaction (pcr) to detect mrsa dna. the xpert mrsa assay is intended to aid in the prevention and control of mrsa infections in healthcare settings. the xpert mrsa assay is not intended to diagnose mrsa nor to guide or monitor treatment for mrsa infections. concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing.

Singapore - English - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the cepheid xpert™ mrsa/sa assay performed in the genexpert® dx system is a qualitative in vitro diagnostic test designed for rapid and simultaneous detection of staphylococcus aureus (sa) and methicillin-resistant staphylococcus aureus (mrsa) from patients with positive blood cultures. the test utilizes automated real-time polymerase chain reaction (pcr) to detect mrsa/sa dna. the xpert™ mrsa/sa assay is intended to aid in the detection and identification of mrsa/sa from positive blood culture bottles. concomitant cultures for sa and mrsa are necessary only to recover organisms for epidemiological typing or for further susceptibility testing.

Singapore - English - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the cepheid xpert mrsa/sa skin and soft tissue infection assay (xpert mrsa/sa ssti assay) performed in the genexpert® dx system is a qualitative in vitro diagnostic test intended for the detection of staphylococcus aureus (sa) and methicillin-resistant staphylococcus aureus (mrsa) from skin and soft tissue infection swabs.

Singapore - English - HSA (Health Sciences Authority)

spd scientific pte ltd - pathology - the xpert bcr-abl ultra test is an in vitro diagnostic test for the quantitation of bcr-abl1 and abl1 mrna transcripts in peripheral blood specimens of diagnosed t(9;22) positive chronic myeloid leukemia (cml) patients expressing bcrabll fusion transcripts type e13a2 and/or e14a2. the test utilizes automated, quantitative, real-time reverse transcription polymerase chain reaction (rt-qpcr). the test is intended to measure bcr-abl1 to abl1 percent ratios on the international scale (is), and also expressed as a log molecular reduction (mr value) from a baseline of 100% (is), in t(9;22) positive cml patients during monitoring of treatment with tyrosine kinase inhibitors (tkis). the test does not differentiate between e13a2/b2a2 or e14a2/b3a2 fusion transcripts and does not monitor other rare fusion transcripts resulting from t(9;22). this test is not intended for the diagnosis of cml.the test is intended for use only on the cepheid genexpert® dx system and the genexpert infinity system.

Singapore - English - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - genexpert systems

Singapore - English - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - it is an automated, multiplex real-time rt-pcr assay intended for the in vitro qualitative detection and differentiation of influenza a, influenza b and 2009 h1n1 influenza viral rna. the xpert flu assay uses nasal aspirates/washes and nasopharyngeal swab specimens collected from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. the xpert flu assay is intended as an aid in the diagnosis of influenza.

Singapore - English - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the hcv vl assay, performed on genexpert® instrument systems, is designed for the rapid quantitation of hepatitis c virus (hcv) rna in human serum or plasma (edta) from hcv-infected individuals. the test utilizes automated reverse transcriptase polymerase chain reaction (rt-pcr) using fluorescence to detect the rna of interest for the quantitation of hcv. the hcv vl assay quantifies hcv genotypes 1–6 over the range of 10 to 100,000,000 iu/ml.the hcv vl 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 baseline and during treatment and can be utilized to predict sustained and nonsustained virological responses to hcv therapy. results from the hcv vl assay may also be used to confirm hcv infection in anti-hcv positive individuals. the assay is not intended to be used as a donor screening test for hcv.

Singapore - English - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the xpert® mrsa gen 3 assay performed on the genexpert® instrument systems is a qualitative in vitro diagnostic test designed for rapid detection of methicillin-resistant staphylococcus aureus (mrsa) from nasal swabs in patients at risk for nasal colonization. the test utilizes automated real-time polymerase chain reaction (pcr) to detect mrsa dna. the xpert® mrsa gen 3 assay is intended to aid in the prevention and control of mrsa infections in healthcare settings. the assay is not intended to diagnose mrsa nor to guide or monitor treatment for mrsa infections. concomitant cultures are necessary to recover organisms for epidemiological typing or for further antimicrobial susceptibility testing.

Singapore - English - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the xpert® mrsa nxg assay, performed on the genexpert® instrument systems, is a qualitative in vitro diagnostic test intended for the detection of methicillin-resistant staphylococcus aureus (mrsa) dna from nasal swabs in patients at risk for nasal colonization. the test utilizes automated real-time polymerase chain reaction (pcr) for the amplification of mrsa specific dna targets and fluorogenic target-specific hybridization probes for the real-time detection of the amplified dna. the xpert® mrsa nxg assay is intended to aid in the prevention and control of mrsa infections in healthcare settings. the xpert mrsa nxg assay is not intended to diagnose, guide, or monitor treatment for mrsa infections, or provide results of susceptibility to methicillin. a negative result does not preclude nasal colonization. concomitant cultures are necessary to recover organisms for epidemiological typing or for further antimicrobial susceptibility testing.