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The sensitivity, specificity, �� index, positive predictive value (PPV) and negative predictive value of the BinaxNOW Influenza A&B test results as compared with those of the rRT-PCR assay were calculated using standard formulas. The calculations were performed with VassarStats tools (http://faculty.vassar.edu/lowry/VassarStats.htm), and 95%?CIs were calculated for each value. Fisher��s exact test was performed with the STATA?9.0 program (Stata Corp., College Station, Texas, USA), and a p-value of find more both techniques. The median age was 20?years (range, 4?days to 87?years). There were 258 (52%) males. Only four cases of seasonal influenza?A were detected, and they were not considered in the calculation. The period of greatest percentage of H1N1-positive tests (33.8%) was from 16 October to 15 November. Influenza?B was not detected with the rapid test in any patient. Among the 512 valid samples, 227 were rRT-PCR (CDC)-positive. Of these, 137 were detected using the BinaxNOW assay, corresponding to a sensitivity of 60.3%. The test parameters are presented in Table?1. The PPV in patients less than 18?years E-64 old was greater than in adult patients and similar if it was considered only during the acute stage of the epidemic. The high PPV of the BinaxNOW assay observed in this study indicates that positive results do not need to be confirmed by rRT-PCR. However, negative BinaxNOW results, as well as negative results obtained with other rapid antigen assays, should be confirmed by rRT-PCR. Various R428 previous reports have described low sensitivity of the BinaxNOW assay in comparison with rRT-PCR [5�C7] for detection of the novel influenza?A (H1N1) virus. These authors found the sensitivity of BinaxNOW to be in the range of 11�C40%. Unlike previous reports, our data show high sensitivity and specificity for detection of the novel influenza?A (H1N1) virus using the BinaxNOW Influenza A&B test. The high sensitivity of the test might be explained by the study population, the majority of whom were children (62%), who had more viral shedding, and also by the high quality of specimen collection. Only nasopharyngeal aspirates, and not swabs, were collected, and patients were selected on the basis of high suspicion by expert clinicians. Furthermore, previous studies [5�C7] considered small numbers of patients. Balish et?al. [5] reported that the sensitivity of a rapid diagnostic influenza test declines as the viral titre in the specimen decreases. In agreement with these results, our findings show that the sensitivity of the BinaxNOW assay declined substantially with lower viral titres (determined by Ct values). Over cycle?27, the sensitivity dropped to 28% (Fisher��s exact test, p?0.049).