Singapur - anglès - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - 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. 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.

Singapur - anglès - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the cepheid xpert flu/rsv xc assay is an automated, multiplex real-time, reverse transcriptase polymerase chain reaction (rt-pcr) assay intended for the in vitro qualitative detection and differentiation of influenza a, influenza b, and respiratory syncytial virus (rsv) viral rna. the xpert flu/rsv xc assay uses nasopharyngeal swab and nasal aspirate/wash specimens collected from patients with signs and symptoms of respiratory infection. the xpert flu/rsv xc assay is intended as an aid in the diagnosis of influenza and respiratory syncytial virus infections in conjunction with clinical and epidemiological risk factors. negative results do not preclude influenza virus or respiratory syncytial virus infection and should not be used as the sole basis for treatment or other patient management decisions.

Singapur - anglès - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the xpert mtb/rif test for use with the cepheid genexpert® system is a semi-quantitative nested real-time pcr in-vitro diagnostic test for: 1) 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; and 2) the detection of rifampin resistance associated mutations of the rpob gene in samples from patients at risk for rifampin resistance. the mtb/rif test is intended for use with specimens from untreated patients for whom there is clinical suspicion of tuberculosis (tb).

Singapur - anglès - HSA (Health Sciences Authority)

spd scientific pte ltd - gastroenterology & urology - the cepheid xpert norovirus assay, performed on the genexpert instrument systems, is a qualitative in vitro diagnostic test for the identification and differentiation of norovirus genogroup i and genogroup ii rna 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 (rt-pcr) to detect norovirus rna. the xpert norovirus assay is intended to aid in the diagnosis of norovirus infections when used in conjunction with clinical evaluation, laboratory findings, and epidemiological information. the assay also aids in the detection and identification of norovirus infections in the context of outbreaks.

Singapur - anglès - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the cepheid® xpert sa nasal complete assay performed in the genexpert® system is a qualitative in vitro diagnostic test designed for rapid detection of staphylococcus aureus (sa) and 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/sa dna. the xpert sa nasal complete assay is intended to aid in the prevention and control of mrsa/sa infections in healthcare settings. the xpert sa nasal complete assay is not intended to diagnose, guide or monitor treatment for mrsa/sa infections, or provide results of susceptibility to methicillin. a negative result does not preclude mrsa/sa nasal colonization. concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

Singapur - anglès - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the cepheid xpert vana/vanb assay, performed on genexpert instrument systems, 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). the xpert vana/vanb assay is intended to aid in the recognition, prevention and control of vancomycin-resistant organism colonization in healthcare settings. the xpert vana/vanb assay is not intended to diagnose vre nor to guide or monitor treatment for vre infections. concomitant cultures are necessary only to recover organisms for epidemiological typing, susceptibility testing and for further confirmatory identification of vre.

Singapur - anglès - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the cepheid xpert xpress flu/rsv assay, performed on the genexpert instrument systems, is an automated, multiplex real-time, reverse transcriptase polymerase chain reaction (rt-pcr) assay intended for the in vitro qualitative detection and differentiation of influenza a, influenza b, and respiratory syncytial virus (rsv) viral rna. the xpert xpress flu/rsv assay uses nasopharyngeal (np) swab and nasal swab (ns) specimens collected from patients with signs and symptoms of respiratory infection. the xpert xpress flu/rsv assay is intended as an aid in the diagnosis of influenza and respiratory syncytial virus infections in conjunction with clinical and epidemiological risk factors. negative results do not preclude influenza virus or rsv infection and should not be used as the sole basis for treatment or other patient management decisions

Singapur - anglès - HSA (Health Sciences Authority)

spd scientific pte ltd - pathology - the xpert bcr-abl ultra, performed on the cepheid genexpert® instrument systems, is an in vitro diagnostic test for the quantitative detection of the bcr-abl1 chromosomal translocation mrna transcripts (types e13a2/b2a2 or e14a2/b3a2) and the abl1 endogenous control mrna transcript in peripheral blood specimens from patients previously diagnosed with chronic myelogenous leukemia (cml). the test utilizes automated, quantitative, real-time reverse transcription polymerase chain reaction (qpcr). xpert bcr-abl ultra will not report the specific type of bcr-abl1 mrna transcript present. the xpert bcr-abl ultra is indicated as aid in the monitoring of bcr-abl1 mrna transcript levels in patients diagnosed with cml. serial testing for bcr-abl1 mrna transcript levels should be used in conjunction with other clinical measures of disease status, risk factors, and professional guidelines to guide patient management.

Singapur - anglès - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the cepheid xpert® c. difficile/epi assay is a qualitative in vitro diagnostic test for rapid detection of toxin b gene sequences and for presumptive identification of 027/nap1/bi strains of toxigenic clostridium difficile from unformed (liquid or soft) stool specimens collected from patients suspected of having c. difficile infection (cdi).

Singapur - anglès - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the cepheid xpert carba-r assay, performed on the genexpert® instrument systems, is a qualitative in vitro diagnostic test designed for rapid detection and differentiation of the blakpc, blandm, blavim, blaoxa-48, and blaimp-1 gene sequences associated with carbapenem-non-susceptibility in gram-negative bacteria obtained from rectal swab specimens from patients at risk for intestinal colonization with carbapenem-non-susceptible bacteria. the test utilizes automated real-time polymerase chain reaction (pcr). the xpert carba-r assay is intended to aid in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. the xpert carba-r assay is not intended to guide or monitor treatment for carbapenemnon- susceptible bacterial infections. concomitant cultures are necessary to recover organisms for epidemiological typing, antimicrobial susceptibility testing, and for further confirmatory identification of carbapenem-non-susceptible bacteria.