Implementation and monitoring of a quality management system based on the standard UNE-EN-ISO 15189 in a urine culture unit.

OBJECTIVES: To evaluate the implementation of a quality management system based on ISO-15189 in a urine culture unit. DESIGN AND METHODS: The effectiveness of improvement actions was measured by quality indicators. RESULTS: The errors in the pre-analytical phase and the rate of contaminated urine decreased significantly. The traceability, response time and external quality control were fulfilled. CONCLUSIONS: The implementation of ISO-15189 was effective in improving the management of a urine culture unit.

Development and preliminary evaluation of a rapid oligochromatographic assay for specific detection of new human influenza A H1N1 virus.

A new oligochromatographic assay, Speed-Oligo Novel Influenza A H1N1, was designed and optimized for the specific detection of the 2009 influenza A H1N1 virus. The assay is based on a PCR method coupled to detection of PCR products by means of a dipstick device. The target sequence is a 103-bp fragment within the hemagglutinin gene. The analytical sensitivity of the new assay was measured with serial dilutions of a plasmid that contained the target sequence, and we determined that down to one copy per reaction of the plasmid was reliably detected. Diagnostic performance was assessed with 103 RNAs from suspected cases (40 positive and 63 negative results) previously analyzed with a reference real-time PCR technique. All positive cases were confirmed, and no false-positive results were detected with the new assay. No cross-reactions were observed when other viral strains or clinical samples with other respiratory viruses were tested. According to these results, this new assay has 100% sensitivity and specificity. The turnaround time for the whole procedure was 140 min. The assay may be especially useful for the specific detection of 2009 H1N1 virus in laboratories not equipped with real-time PCR instruments.