Сингапур - английский - HSA (Health Sciences Authority)

vela operations singapore pte. ltd. - microbiology - the sentosa sa bkv quantitative pcr test is a real-time pcr-based in vitro diagnostic test intended for use in the detection and quantitation of bk virus (bkv) dna using sentosa sx101 instrument in conjunction with the rotor-gene® q mdx 5plex hrm instrument. for human edta plasma, serum and urine samples, sentosa sx virus total nucleic acid kit v2.0 is used for dna extraction; and for human edta whole blood samples, sentosa® sx whole blood kit is used for dna extraction. the sentosa sa bkv quantitative pcr test is intended for use in the detection and quantitation of bkv dna from symptomatic patients as an aid in bkv diagnosis and the management of transplant or immunocompromised patients who have been diagnosed with bkv infection. the results from the sentosa sa bkv quantitative pcr test must be interpreted within the context of all relevant clinical and laboratory findings.

Сингапур - английский - HSA (Health Sciences Authority)

vela operations singapore pte. ltd. - microbiology - the sentosa® sa cmv quantitative pcr test is a real-time pcr-based in vitro diagnostic test intended for use in the detection and quantitation of cytomegalovirus (cmv) dna using sentosa® sx101 instrument in conjunction with the rotor-gene® q mdx 5plex hrm instrument. for human edta plasma, serum, urine and cerebrospinal fluid (csf) samples, sentosa® sx virus total nucleic acid kit v2.0 is used for dna extraction; and for human edta whole blood samples, sentosa® sx whole blood kit is used for dna extraction. the sentosa® sa cmv quantitative pcr test is intended for use in the detection and quantitation of cmv dna from symptomatic patients as an aid in cmv diagnosis and the management of transplant or immunocompromised patients who have been diagnosed with cmv infection. the results from the sentosa® sa cmv quantitative pcr test must be interpreted within the context of all relevant clinical and laboratory findings.

Сингапур - английский - HSA (Health Sciences Authority)

vela operations singapore pte. ltd. - microbiology - the sentosa sa influenza a/b & 2009 h1n1 rt-pcr test is a real-time pcr-based in vitro diagnostic test for the qualitative detection and differentiation of influenza a, influenza b and 2009 h1n1 (pandemic influenza a h1n1nv) in nasal swab and nasopharyngeal swab samples from human patients with signs and symptoms of respiratory tract infections. this diagnostic test kit is configured for use with the sentosa sx101 nucleic acid extraction platform, with the sentosa sx virus total nucleic acid kit, in conjunction with the rotor-gene q mdx 5plex hrm system. test results can be used as supplementary data for diagnosis, or large scale screening of influenza infection in cases of a flu outbreak. negative results do not preclude influenza infection and should not be used as a sole basis for treatment and other patient management decisions.

Сингапур - английский - HSA (Health Sciences Authority)

vela operations singapore pte. ltd. - microbiology - the sentosa sa zikv rt-pcr test is a real-time rt-pcr test intended for the qualitative detection of rna from the zika virus (zikv) in serum, edta plasma or urine (collected alongside a patient-matched serum or plasma specimen) from individual patients. test results are for the identification of zikv rna.

Сингапур - английский - HSA (Health Sciences Authority)

vela operations singapore pte. ltd. - pathology - the sentosa sa braf v600 pcr test is a real-time polymerase chain reaction (pcr) based in vitro diagnostic test for the qualitative detection of mutations in the braf gene. it detects both v600e and v600k mutations in formalin-fixed, paraffin-embedded (ffpe) samples from patients with signs and symptoms of melanoma. this in vitro diagnostic test is configured for use with the sentosa sx101 instrument, with the sentosa sx ffpe gdna kit, in conjunction with the rotor-gene q mdx 5plex hrm instrument. the test results can be used as supplementary data for diagnosis. negative results should not be used as a sole basis for treatment and other patient management decisions.

Сингапур - английский - HSA (Health Sciences Authority)

vela operations singapore pte. ltd. - microbiology - the sentosa™ sa c.diff pcr test is a real-time polymerase chain reaction pcr) based in vitro diagnostic test, for the qualitative detection of clostridium difficile nucleic acids isolated and purified from liquid or soft stool specimens obtained from symptomatic patients. this test targets the c. difficile toxin b gene (tcdb) and is intended for use to aid the diagnosis of toxigenic c. difficile infections. this in vitro diagnostic test is configured for use on the sentosa™ sx101 instrument, with the sentosa™ sx bacteria gdna kit v2.0, in conjunction with the rotor-gene® q mdx 5plex hrm instrument. the test results can be used as supplementary data for diagnosis. negative results do not preclude c. difficile infection and should not be used as a sole basis for treatment and other patient management decisions

Сингапур - английский - HSA (Health Sciences Authority)

vela operations singapore pte. ltd. - microbiology - the sentosa™ sa chikv rt-pcr test is a duplex, real-time pcr based in vitro diagnostic test. this test is intended for rapid in vitro qualitative detection of the e1 gene sequences in chikungunya viruses present in clinical samples (serum/plasma) obtained from patients. this in vitro diagnostic test is configured for use on the sentosa™ sx101 instrument, with sentosa™ sx virus total nucleic acid kit v2.0, in conjunction with the rotor-gene q mdx 5 plex hrm instrument.

Сингапур - английский - HSA (Health Sciences Authority)

vela operations singapore pte. ltd. - microbiology - the sentosa® sa direct mrsa/sa pcr test is a real-time polymerase chain reaction (pcr)-based in vitro diagnostic test for the qualitative detection of staphylococcus aureus (sa) and methicillin-resistant staphylococcus aureus (mrsa) from nasal swabs in patients at risk for nasal colonization. the test is validated for use with the sentosa® sx lysis beads, followed by automated pcr set-up on sentosa® sx101 instrument or manual pcr set-up, in conjunction with pcr on the rotor-gene® q mdx 5plex hrm instrument and automated result calling and report generation with sentosa® sa reporter. the sentosa® sa direct mrsa/sa pcr test is intended to aid in the prevention and control of mrsa/sa infections in healthcare settings. it 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.

Сингапур - английский - HSA (Health Sciences Authority)

vela operations singapore pte. ltd. - microbiology - the sentosa™ sa ebv quantitative pcr test is an in vitro real-time pcr-based test intended for use in the detection and quantitation of epstein-barr virus (ebv) dna using sentosa™ sx101 instrument in conjunction with the rotor-gene® q mdx 5plex hrm instrument. for human edta plasma, serum and cerebrospinal fluid (csf) samples, sentosa™ sx virus total nucleic acid kit v2.0 is used for dna extraction; and for whole blood samples, sentosa™ sx whole blood kit is used for dna extraction. the sentosa™ sa ebv quantitative pcr test is intended for use in the detection of ebv dna from transplant or immunosuppressed patients who have been diagnosed with ebv infection. the results from the sentosa™ sa ebv quantitative pcr test must be interpreted within the context of all relevant clinical and laboratory findings.

Сингапур - английский - HSA (Health Sciences Authority)

vela operations singapore pte. ltd. - microbiology - the sentosa™ sa hsv1/2 pcr test is a multiplex, real-time pcr-based in vitro diagnostic test intended for use in the detection and differentiation of herpes simplex virus 1&2 (hsv1/2) dna in genital or oral swabs in utm, edta plasma, serum and cerebrospinal fluid (csf) from patients with signs and symptoms of hsv infections. this in vitro diagnostic test is validated to be performed on the automated sentosa™ sx101 instrument, using the sentosa™ sx virus total nucleic acid kit v2.0, in conjunction with the rotor-gene® q mdx 5plex hrm instrument.