Value of repeat testing using Cepheid GeneXpert CT/NG for indeterminate PCR results when diagnosing Chlamydia trachomatis and Neisseria gonorrhoeae.

Nucleic acid amplification tests (NAATs) are the most sensitive method for diagnosing chlamydia and gonorrhoea. We use the COBAS 4800 CT/NG combined assay (Roche Molecular Diagnostics, CA, USA), and whilst the majority of samples yield definitive results, a small proportion are reported as indeterminate. In these instances, it is usual practice to request repeat samples which delays diagnosis. This audit was twofold: first to establish the proportion of indeterminate results with current NAAT testing requiring re-sampling. Second, to determine whether a second NAAT such as Cepheid GeneXpert CT/NG assay (Cepheid, CA, USA) could be used on initial indeterminate samples to resolve indeterminate results, therefore reducing need for repeat sampling. During 2012, 144/21,931 (0.66%) samples were indeterminate for Neisseria gonorrhoeae, Chlamydia trachomatis or both, and a repeat sample was received in only 51.77% of patients with final results being delayed for more than 24 h. Over the next six months, there were 77/9472 (0.81%) indeterminate results. After an evaluation and introduction of the Cepheid assay, the number of indeterminate results fell to 9 (0.10%). Thus, use of the Cepheid assay significantly reduced indeterminate results, reduced reliance on a repeat sampling and significantly improved turnaround time, laboratory workflow and patient experience.

Republished: developing capable quality improvement leaders.

BACKGROUND/OBJECTIVE: Cincinnati Children's Hospital Medical Center created the Intermediate Improvement Science Series (I(2)S(2)) training course to develop organisational leaders to do improvement, lead improvement and get results on specific projects. DESIGN METHODS: Each multidisciplinary class consists of 25-30 participants and 12 in-class training days over 6 months. Instructional methods include lectures, case studies, interactive application exercises and dialogue, participant reports and assigned readings. Participants demonstrate competence in improvement science by completing a project with improvement in outcome and/or process measures. They present on their projects and receive feedback during each session and one-on-one coaching between sessions. RESULTS: Since 2006, 279 participants in 11 classes have completed the I(2)S(2) course. Participant evaluations have consistently rated satisfaction, learning, application, impact and value very high. Large and statistically significant changes were observed in pre-course to post-course self-assessment of knowledge of five quality improvement topics. Approximately 85% of the projects demonstrated measurable improvement. At follow-up, 72% of improvement projects were completed and made a part of everyday operations in the participant's unit or were the focus of continuing improvement work. Many changes were spread to other units or programmes. Most (88%) responding graduates continued to participate in formal quality improvement efforts and many led other improvement projects. Nearly half of the respondents presented their results at one or more professional conference. CONCLUSIONS: Through the I(2)S(2) course, the authors are developing improvement leaders, accelerating the shift in the culture from a traditional academic medical centre to an improvement-focused culture, and building cross-silo relationships by developing leaders who understand the organisation as a large system of interdependent subsystems focused on improving health.

Developing capable quality improvement leaders.

BACKGROUND/OBJECTIVE: Cincinnati Children's Hospital Medical Center created the Intermediate Improvement Science Series (I(2)S(2)) training course to develop organisational leaders to do improvement, lead improvement and get results on specific projects. DESIGN METHODS: Each multidisciplinary class consists of 25-30 participants and 12 in-class training days over 6 months. Instructional methods include lectures, case studies, interactive application exercises and dialogue, participant reports and assigned readings. Participants demonstrate competence in improvement science by completing a project with improvement in outcome and/or process measures. They present on their projects and receive feedback during each session and one-on-one coaching between sessions. RESULTS: Since 2006, 279 participants in 11 classes have completed the I(2)S(2) course. Participant evaluations have consistently rated satisfaction, learning, application, impact and value very high. Large and statistically significant changes were observed in pre-course to post-course self-assessment of knowledge of five quality improvement topics. Approximately 85% of the projects demonstrated measurable improvement. At follow-up, 72% of improvement projects were completed and made a part of everyday operations in the participant's unit or were the focus of continuing improvement work. Many changes were spread to other units or programmes. Most (88%) responding graduates continued to participate in formal quality improvement efforts and many led other improvement projects. Nearly half of the respondents presented their results at one or more professional conference. CONCLUSIONS: Through the I(2)S(2) course, the authors are developing improvement leaders, accelerating the shift in the culture from a traditional academic medical centre to an improvement-focused culture, and building cross-silo relationships by developing leaders who understand the organisation as a large system of interdependent subsystems focused on improving health.

Evidence of occult hepatitis B virus infection among Omani blood donors: a preliminary study.

OBJECTIVES: The aim of this study was to determine the prevalence of hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (anti-HBc) and hepatitis B virus (HBV) DNA among a selected group of Omani blood donors. MATERIALS AND METHODS: Two hundred HBsAg-negative donors were screened for anti-HBc. Those found to be positive were investigated for HBV DNA by polymerase chain reaction. HBsAg was retested on these sera following an immune complex dissociation technique. RESULTS: HBsAg was present in 2.8% of the donors. Forty-one out of 200 (20.5%) HBsAg-negative donors were positive for anti-HBc. Eleven were positive for HBsAg after dissociation, whereas 8 gave readings just over the cutoff. HBV DNA was not detected in this group. CONCLUSION: Findings indicate that testing donors for HBsAg alone is not sufficient to eliminate HBV from the blood supply in Oman.

Detection of serum antibodies to hepatitis C virus in 'false-seronegative' blood donors in Oman.

OBJECTIVE: To detect hepatitis C virus (HCV) antibodies in seronegative donors by disruption of the immune complexes (ICs). SUBJECTS AND METHODS: HCV antibody detection was carried out on 600 seronegative donors following an IC dissociation assay. Reverse transcription polymerase chain reaction (RT-PCR) was then performed on the positive results. RESULTS: Nine of the 600 samples (1.5%) were positive for IC-dissociated HCV antibodies. Of the 9 only 3 antibody-positive samples had detectable HCV RNA. CONCLUSION: Screening for antibodies to HCV in combination with PCR appears to be the safest way to reduce the residual risk of HCV in blood transfusion.

Laboratory diagnosis of viral hepatitis C: The Sultan Qaboos University Hospital experience.

OBJECTIVES: A retrospective study was carried out to assess the performance of hepatitis C diagnostic assays in our laboratory, and to determine the prevalence of hepatitis C among blood donors at the Sultan Qaboos University Hospital. METHODS: From 1991 to 2001, approximately 55,000 serum samples collected from blood donors and patients were submitted to our laboratory for testing. All sera were screened for antibodies to hepatitis C virus (HCV) by three successive generations of the enzyme-linked immunosorbent assay (ELISA). Anti-HCV positive sera were further tested by recombinant immunoblot assay (RIBA). Reverse-transcriptase polymerase chain reaction (RT-PCR) for HCV RNA was carried out on a limited number (241) of ELISA positive samples. RESULTS: Out of 30012 samples from blood donors that were screened for anti-HCV, 272 (0.91%) were positive. Of these, 46.5% were confirmed positive by RIBA. The proportion of patient sera that were confirmed positive varied from 95% among intravenous drug users to 81% in patients with hepatitis to 70% in those with haemoglobinopathies. HCV RNA was detected in 67%, 6%, and 0% of the RIBA positive, indeterminate and negative samples respectively. CONCLUSIONS: Based on RIBA, the prevalence of anti-HCV among blood donors in Oman is close to 0.5%. In our experience, RIBA-positivity is predictive of HCV infection in two thirds of subjects, and HCV infection is highly unlikely in those who are RIBA-negative. The experience at SQUH with three types of HCV assays has enabled the laboratory to develop a test algorithm, starting with screening anti-HCV ELISA.

Fluctuating antibody response in a cohort of hepatitis C patients.

OBJECTIVE: This project was designed to longitudinally study persons who had antibodies to hepatitis C virus (HCV) to characterise the serologic course of infection. METHODS: The subjects were 149 multitransfused patients (141 with thalassaemia major, 3 with thalassaemia intermedia, and 5 with sickle cell anaemia) who had been regularly followed up for 3 to 7 years. Sequential serum samples obtained semi-annually between January 1994 and January 2001 were tested, prospectively, by second or third generation HCV enzyme-linked immunosorbent assay (ELISA), followed by confirmatory recombinant immunoblot assay (RIBA-2 or RIBA-3). RESULTS: Of the 149 patients, 90 did not seroconvert to HCV, whereas 59 had detectable antibodies. On the basis of RIBA results in these 59 patients, 24 (41%) had persistent high antibody levels to structural and non structural HCV antigens, 11 (19%) had persistent low antibody levels, 17 (29%) showed fluctuating antibody levels, and in 5 patients (8%) there was a total or a partial disappearance of specific antibodies (seroreversion), mainly anti-core antibodies. Two patients (3%) had antibody responses that did not fit into any of these four categories. In patients with fluctuating antibody levels, there were periods ranging from 6 months to 2 years when anti-HCV antibodies could not be detected. CONCLUSION: This study shows that the antibody response to HCV in patients who receive frequent blood transfusions is very variable. Individuals who exhibit intermittent seropositivity are a challenge to diagnosis.