1887

Abstract

Since 1996 the Meningococcal Reference Unit (MRU) in Manchester has provided a national service for PCR confirmation of meningococcal and pneumococcal disease. serogroup B is predominant in the UK, accounting for >60 % of cases. In response to this, the MRU has developed a quadruplex quantitative PCR that detects capsule transporter (), serogroup B sialyltransferase ( ), pneumolysin () and an internal control. The assay was prepared in a ready-to-use lyophilized format by Applied Biosystems. Laboratory validation showed excellent performance in a specificity panel of 52 isolates and improved detection in comparison with the routine assay. Testing of 244 patient samples showed sensitivity of 93 % [95 % confidence interval (CI): 88–98 %] for the assay, 95 % (95 % CI: 91–100 %) for the assay and 100 % (95 % CI: 95–100 %) for the assay. Specificity was 100 % (95 % CI: 98–100 %) for both meningococcal targets and 95 % (95 % CI: 92–98 %) for . The quadruplex also retained high performance in mixed samples and had acceptable reproducibility. After introduction of the quadruplex into routine use the turnaround time for group B PCR confirmation reduced from 37 to 29 h and the internal control has proved useful for detecting inhibitory samples. The quadruplex assay provides rapid group B confirmation of meningococcal positive samples, enabling timely public health interventions for the most common disease-causing meningococcal serogroup in the UK.

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2015-11-01
2019-08-18
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