Melanomas frequently harbor BRAFV600 mutations. Vemurafenib (RG7204/PLX4032), a small-molecule inhibitor of mutant BRAF, has shown striking clinical efficacy in BRAFV600 mutant melanoma, creating the need for a well-validated companion diagnostic to select patients for treatment. We describe analytic performance characteristics of the cobas 4800 BRAF V600 Mutation Test, the test used to select patients for the pivotal vemurafenib trials. This real-time polymerase chain reaction assay was designed to detect the V600E (1799T>A) mutation DNA from formalin-fixed paraffin-embedded tissue samples. Sensitivity was assessed using blends of cell lines or tumor DNA, and tumor specimens with low levels of mutant alleles, as determined by 454 sequencing (a quantitative next-generation pyrosequencing method). A >96% hit rate was obtained across all specimen types with 5% mutant alleles at a DNA input of 125 ng, an amount readily obtained from one 5-μm section. The cobas test showed a higher sensitivity and specificity than direct bidirectional sequencing in a panel of 219 melanoma specimens. Cross reactivity with V600K and V600D was observed. Repeated testing of 5 specimens by 2 operators, using different instruments and reagent lots, yielded correct calls in 158/160 tests (98.8%). A set of 26 highly pigmented samples were identified that gave invalid test results. A simple 1:2 dilution resulted in a valid test result of 76% in such cases. The cobas test is a reproducible assay that detects some non-V600E mutations and is more accurate than direct sequencing in detecting BRAFV600E.
Despite a lower device use ratio in our ICUs, our device-associated healthcare-associated infection rates are higher than National Healthcare Safety Network, but lower than International Nosocomial Infection Control Consortium Report.
Implementing the six components of the INICC approach simultaneously was associated with a significant reduction in the CLABSI rate in India, which remained stable during 36 months of follow-up.
C. auris is an emerging fungal pathogen with high prevalence of resistance to current antifungal agents. Central nervous system infection with C. auris has been infrequently described. We describe here an adult with nosocomial CSF shunt infection due to multi drug resistant C. auris. Systemic therapy with echinocandin and flucytosine failed. Fortunately, administration of daily intraventricular caspofungin 10 mg for 10 days in conjunction with systemic voriconazole resulted in both clinical and microbiological cure.
Healthcare worker (HCW) infections due to COVID-19 are of serious consequence. Testing for antibodies against COVID-19 in HCWs has been previously recommended. We conducted a serosurvey in HCWs at a private hospital in Mumbai which is treating COVID patients. A total of 244 HCWs were tested. The prevalence of infection in asymptomatic HCWs was 4.3% and in previously symptomatic untested HCWs was 70%. We recommend that HCWs with a previous history of COVID symptoms who were not tested/tested negative by reverse transcription–polymerase chain reaction should be tested for antibodies at least 2 weeks after onset of symptoms.
In most types of surgical procedures, surgical site infections rates were higher than those reported by the CDC-NHSN, but similar to INICC. This study is an important advancement towards the knowledge of surgical site infections epidemiology in the participating Indian hospitals that will allow us to introduce targeted interventions.
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