A systematic review of maternal TORCH serology as a screen for suspected fetal infection.

BACKGROUND: The acronym 'TORCH' refers to well-recognised causes of perinatal infections: toxoplasmosis, rubella, cytomegalovirus (CMV) and herpes simplex virus (HSV). A TORCH serology panel is often used to test for maternal primary infection following detection of ultrasound abnormalities in pregnancy. AIM: This review aims to estimate the diagnostic yield of maternal TORCH serology in pregnancy following fetal ultrasound abnormalities. MATERIALS AND METHODS: Primary studies published since 2000 that assessed maternal TORCH serology for suspected fetal infection and included information on indications for testing, definition of positive TORCH serology results, and perinatal outcomes were included. RESULTS: Eight studies with a total of 2538 pregnancies were included. The main indications for testing were polyhydramnios, fetal growth restriction and hyperechogenic bowel. There were 26 confirmed cases of congenital CMV, of which 15 had multiple ultrasound abnormalities. There were no cases of congenital toxoplasmosis, rubella or HSV confirmed in any of the eight studies. CONCLUSIONS: The clinical utility of TORCH serology for non-specific ultrasound abnormalities such as isolated fetal growth restriction or isolated polyhydramnios is low. It is time to retire the TORCH acronym and the reflex ordering of 'TORCH' panels, as their continued use obscures, rather than illuminates, appropriate investigation for fetal ultrasound abnormalities.

Epidemiology of breast cancer in women based on diagnosis data from oncologists and senologists in Algeria.

BACKGROUND: Breast cancer (BC) is a major health issue threatening women's life. No reliable epidemiological data on BC diagnosed by oncologists/senologists are available in Algeria. METHODS: The BreCaReAl study, a non-interventional prospective cohort study, included adult women with confirmed BC in Algeria. Disease incidence, patients and disease characteristics, treatment patterns, and mortality rate were recorded up to 12 months of follow-up. RESULTS: Overall, 1,437 patients were analysed: median age was 48 [41;57] years and 337 (23.5%) women had a family history of BC. BC incidence was 22.3 (95% CI: 21.5; 23.2) cases per 100,000 inhabitants over 8 months. Delayed diagnosis was reported in 400 (29.2%) patients. First line of treatments were mainly chemotherapy and surgery. Twenty-eight serious adverse events were reported including 10 (37.0%) events which led to death. Mortality rate reached 3.2% at 12 months CONCLUSION: A delayed diagnosis highlights the importance of implementing more effective screening strategies.

Análisis de resultados del Programa de Control de Calidad Externo SEIMC. Año 2016 / Analysis of the results of the SEIMC External Quality Control Program. Year 2016

Se presenta el análisis anual de los resultados remitidos durante el año 2016 por los participantes inscritos en el Programa de Control de Calidad de la Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC), que incluye las áreas de bacteriología, serología, micología, parasitología, micobacterias, virología, microbiología molecular y genotipos de resistencia bacteriana. Los resultados obtenidos por los centros participantes destacan, de nuevo, la adecuada capacitación de la inmensa mayoría de los laboratorios españoles de microbiología clínica, como ya iba sucediendo en los últimos años. Sin embargo, el programa muestra que es posible obtener un resultado erróneo, incluso en determinaciones de la mayor trascendencia y en cualquier laboratorio. Una vez más, se resalta la importancia de complementar el control interno que lleva a cabo cada laboratorio con estudios de intercomparación externos, como los que ofrece el Programa de Control de Calidad SEIMC. Información sobre el suplemento: este artículo forma parte del suplemento titulado "Programa de Control de Calidad Externo SEIMC. Año 2016", que ha sido patrocinado por Roche, Vircell Microbiologists, Abbott Molecular y Francisco Soria Melguizo, S.A

The External Quality Control Programme of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) includes controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology, molecular microbiology, and genotypic bacterial resistance. As in previous years, the results obtained in 2016 confirm the excellent skill and good technical standards in the vast majority of clinical microbiology laboratories in Spain. However, erroneous results can be obtained in any laboratory and in clinically relevant determinations. Once again, the results of this programme highlight the need to implement both internal and external controls. Supplement information: This article is part of a supplement entitled "SEIMC External Quality Control Programme. Year 2016", which is sponsored by Roche, Vircell Microbiologists, Abbott Molecular and Francisco Soria Melguizo, S.A

Hepatitis E: aparición de casos esporádicos en el Área de Salud de Mérida / Hepatitis E: appearance of sporadic cases in Merida health area

El virus de la infección por hepatitis E (HEV) es un importante problema de salud pública en muchos países en desarrollo, causando principalmente hepatitis aguda autolimitada por el consumo de agua contaminada. En países industrializados, la hepatitis E aguda presenta una incidencia puntual aunque de mayor gravedad, detectándose en viajeros procedentes de zonas endémicas, así como casos fortuitos debidos al consumo o contacto con carne de cerdo cruda o poco cocinada. En el Área de Salud de Mérida, se realizó un estudio de los casos de hepatitis E durante el periodo comprendido entre enero del 2013 y junio del 2015. Como resultado se detectaron 9 casos, localizados entre septiembre del 2014 y junio del 2015. Dichos casos se caracterizaban por hipertransaminasemia y, además, 5 de ellos presentaban factores de riesgo para la predisposición de la enfermedad. Los resultados en nuestro medio corresponden a casos esporádicos, en donde no se ha podido identificar la vía de trasmisión. Sin embargo, se sugiere la zoonosis como la causa más probable, al ser uno de los reservorios el cerdo doméstico y el jabalí salvaje, los cuales presentan una gran importancia en la agroalimentaria en el Área de Extremadura (AU)

Virus infection hepatitis E (HEV) is a serious public health problem in many developing countries, mainly self-limited acute hepatitis caused by drinking contaminated water. In industrialized countries, acute hepatitis E has a punctual incidence detected although more serious incident. It is detected in travelers from endemic areas and incidental circumstances due to raw or undercooked pork consumption or contact. A study of cases of hepatitis E was taken in Merida Health Area during the period of January 2013 to June 2015. As a result, nine cases were detected between September 2014 to June 2015. These cases were characterized by transaminases elevation. In addition, five of them presented HEV-disease predisposition risk factors. Sporadic cases were the result in our area. The route of HEV transmission has not been identified. However, zoonosis is suggested as the most probably transmission via. Domestic pigs and wild boar are the principal HEV reservoirs, which present an enormous importance over nutrition and agriculture in the Extremadura Area (AU)

Diagnosis of Helicobacter pylori: what should be the gold standard?

Since the discovery of Helicobacter pylori (H. pylori) in 1983, numerous detection methods for the presence of the bacterium have been developed. Each one of them has been associated with advantages and disadvantages. Noninvasive tests such as serology, (13)C urea breath test (UBT) and stool antigen tests are usually preferred by the clinicians. Serology has its own limitation especially in endemic areas while (13)C UBT is technically very demanding. The stool antigen detection method, although specific, is usually associated with poor sensitivity. The (13)C UBT is believed to be specific, but with present revelation of the fact that stomach is colonized by many other urease producing bacteria makes it questionable. Histology, culture, rapid urease test and polymerase chain reaction (PCR) are the tests which are carried out on antral biopsies collected by invasive means. Histology has been proposed to be very sensitive and specific but the question is how by simply looking the morphology of the bacteria in the microscope, one can claim that the curved bacterium is exclusively H. pylori. Rapid urease test (RUT), the doctor's test, is also challenged because the presence of other urease producing bacteria in the stomach cannot be denied. Moreover, RUT has been reported with poor sensitivity specially, when density of the bacterium is low. Isolation of H. pylori is essential to investigate its growth requirements, antibiotic susceptibility testing, studying virulence factor to develop vaccine and many more explorations. It has also got several disadvantages i.e., special condition for transporting, media, incubation and few days waiting for the colonies to appear, apart from the speed essentially needed to process the specimens. Till date, majority of the microbiological laboratories in the world are not equipped and trained to isolate such fastidious bacterium. The option left is PCR methods to detect H. pylori's DNA in gastric mucosa, gastric juice, saliva, dental plaques and environmental specimens. There are speculations for false positivity due to detection of non-pylori Helicobacters due to genetic sharing; and false negativity due to low bacterial counts and presence of PCR inhibitors. However, specimen collection, transportation and processing do not require speed and special conditions. PCR based diagnosis may be considered as gold standard by designing primers extremely specific to H. pylori and targeting at least more than one conserved genes. Similarly specificity of PCR may be improved by use of internal Primers. Further, nested PCR will take care of false negatives by countering the effect of PCR inhibitors and low bacterial counts. Therefore, nested PCR based methods if performed properly, may be proposed as gold standard test.

Coinfección por VIH/VHB: estrategias terapéuticas y control serológico / HIV/HBV coinfection: Serological control and therapeutic strategies

Objetivos. La evolución y pronóstico de los pacientes coinfectados por el virus de la inmunodeficiencia humana (VIH) y el de la hepatitis B (VHB) no es bien conocida. Este estudio describe el tratamiento y el control serológico, virológico, bioquímico y elastográfico de los pacientes coinfectados por VIH/VHB. Pacientes y métodos. Estudio descriptivo, retrospectivo, de la totalidad de pacientes coinfectados por VIH/VHB seguidos en una consulta monográfica de VIH entre el 1 de enero de 2007 y el 30 de noviembre de 2008. A los pacientes se les realizaron determinaciones virológicas y serológicas para el VHB y el VIH, así como linfocitos CD4 y transaminasas, antes de comenzar el tratamiento antirretroviral y en el momento del análisis. Resultados. Se identificaron 54 (5,4%) pacientes coinfectados por VIH/VHB. Las medianas de CD4 nadir y actual fueron de 179 y 437 células/μl, respectivamente. El 70% tenían RNA-VIH indetectable. Cincuenta y dos pacientes (96,3%) seguían terapia con fármacos activos frente al VHB. Un 68,8% presentaron negativización del antígeno «e» del VHB, con un 81,6% de respuesta virológica. El antígeno de superficie del VHB se negativizó en el 10,4%. La alanina aminotransferasa era normal en el75,5%. Se realizó FibroScan® a 30 (55,6%) pacientes, obteniéndose una mediana de 7.0 KPa. Conclusiones. Los resultados obtenidos sugieren un buen control serológico, virológico, bioquímico y elastográfico de los pacientes coinfectados por VIH/VHB con los tratamientos recomendados por las guías clínicas(AU)

Objectives. The evolution and prognosis of patients co-infected by human immunodeficiency virus (HIV) and hepatitis B (HBV) is not well know. This study describes the treatment and serological, virological and biochemical and elastographic responses of HIV and HBV-coinfected patients. Patients and methods. A descriptive, retrospective study of all the HIV/HBV-coinfected patients seen in a specialized HIV department between 1 January 2007 and 30 November 2008 was performed. Virological and serological determinations of HIV and HBV infections as well as CD4 lymphocytes and transaminases prior to antiretroviral treatment and at the time of analysis were obtained. Results. A total of 54 (5.4%) cases of HIV/HBV coinfection were identified. The median nadir and current CD4 were 179 and 437 cells/L, respectively. There was undetectable RNA-HIV in 70%. There were 52 patients (96.3%) who followed active drugs treatment against HBV. After treatment, 68.8% had HBeAg negative result, with 81.6% virologic response. The HBsAg became negative in 10.4%. ALT was normal in 75.5%. FibroScan® was performed in 30 (55.6%) patients, yielding a median of 7.0kPa. Conclusions. The results obtained suggest a good serological, virological and biochemical control of HIV/HBV-coinfected patients with treatments recommended by clinical guidelines(AU)

Análisis comparativo de las serologías realizadas a los inmigrantes en la región sanitaria de Lleida / Comparative analysis of serological tests performed in immigrants in the lleida health area

Objetivo: Evaluar el proceso de cribado y detección de virus de la inmunodeficiencia humana (VIH), virus de la hepatitis B (VHB) y de la hepatitis C (VHC) y sífilis en los inmigrantes de nuestra región sanitaria, determinando las proporciones de resultados positivos entre colectivos durante un año. Diseño: Estudio descriptivo multicéntrico donde se analizaron todas las serologías realizadas a inmigrantes y autóctonos atendidos durante todo el año 2007. Emplazamiento: Provincia de Lleida (España). Participantes: Se incluyeron 255.410 usuarios. Mediciones principales: Edad, sexo, país de origen y tiempo de permanencia en nuestro país y los resultados para VIH, hepatitis B, hepatitis C y sífilis. Se evaluó si había asociación entre las tasas de marcadores positivos y la zona geográfica de procedencia. Se calcularon las tasas ajustadas por grupos de edad estandarizadas según el método directo. Resultados: El colectivo de origen inmigrante presenta 4,6 veces más probabilidades de tener VHB que el colectivo autóctono (razón de porcentajes [RP]=4,6), siendo el colectivo sudafricano y de Europa del Este el que presenta una mayor probabilidad de VHB (RP=11,7 y 4,5). En la sífilis el porcentaje de positivos es 3 veces mayor en el colectivo inmigrante con las diferencias mayores detectadas en el colectivo latinoamericano (RP=5,5). En el VIH la RP en inmigrantes fue de 2,3 (específicamente en subsaharianos una RP=7,4). En la hepatitis C los inmigrantes obtienen un menor riesgo de ser positivos que los autóctonos (RP=0,4). Conclusiones: Se constatan diferencias importantes en la probabilidad de detectar un resultado positivo de hepatitis B, sífilis o VIH en el cribado cuando el usuario es de origen inmigrante(AU)

Objective: Evaluate the process of screening and detection of HIV, HBV, HCV and syphilis in the province of Lleida by determining the proportions of positive results in the different groups during one year. Design: Descriptive, multicentre study of all the serological tests performed in immigrants and natives attended in 2007.SettingProvince of Lleida (Spain). Participants: 255,410 users. Main measurements: Age, sex, country of origin and period of residence in Spain, and the results for HIV, hepatitis B, hepatitis C and syphilis. We calculated the proportions in which a serological test had been requested, and examined the association between the rates of positive tests and the geographical area of origin, and calculated age-adjusted rates taking the age distribution of the native population as the reference. Results: Risk of HBV was 4.6 times higher in immigrants than in natives (11.7 times in sub-Saharan Africans). The rate of positive syphilis tests was three times higher in the immigrant group. For HIV the PR was 2.3 (sub-Saharan Africans 7.4). For hepatitis C the risk was lower in immigrants than in natives (PR=0.4). Conclusions: Immigrants have a higher probability of testing positive in screening in hepatitis B, syphilis and HIV. The rates differ significantly according to the origin of the immigrant(AU)

Experiencia en el diagnóstico de hepatitis E en una unidad de enfermedades infecciosas tropicales / Experience in the diagnosis of hepatitis e in a tropical infectious diseases unit

El virus de la hepatitis E (VHE) es endémico en algunos países en vías de desarrollo. Produce cuadros de hepatitis aguda con casos esporádicos o epidemias. La principal vía de transmisión es fecal-oral sobre todo por aguas contaminadas. En países desarrollados cada vez se describen más casos debido fundamentalmente a los movimientos poblacionales (viajeros, inmigrantes, adopciones internacionales) aunque también han aumentado los casos autóctonos. Actualmente disponemos de técnicas serológicas y moleculares para el diagnóstico de la infección. Describimos la experiencia diagnóstica de la infección por VHE en una Unidad de Patología Infecciosa y Tropical Pediátrica de Madrid(AU)

The hepatitis E virus (HEV) is endemic in some developing countries. It produces acute hepatitis in sporadic cases or epidemics. The main transmission route is faecal-oral by contaminated waters. In developed countries the cases described are more and more frequent, mainly due to population movement (travellers, immigrants, international adoptions), although there have also been increases in the local population. We currently have serological and molecular techniques for the diagnosis of this infection. We describe the experience in the diagnosis of the infection by HEV in a Paediatric Tropical Infectious Diseases Unit in Madrid(AU)

Human papillomavirus antibody reference reagents for use in postvaccination surveillance serology.

Suitably controlled serosurveillance surveys are essential for evaluating human papillomavirus (HPV) immunization programs. A panel of plasma samples from 18-year-old females was assembled, the majority of the samples being from recipients of the bivalent HPV vaccine. Antibody specificities were evaluated by three independent laboratories, and 3 pools that displayed no antibodies to any HPV type tested or intermediate or high levels of antibody to HPV16, HPV18, HPV31, and HPV45 were created. These pools will be useful as control reagents for HPV serology.

[Analysis of the results of the SEIMC External Quality Control Program. Year 2009]. / Análisis de resultados del Programa Externo de Control de Calidad SEIMC. Año 2009.

The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) includes controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology and molecular microbiology. In this article, the most important conclusions and lessons from the 2009 controls are presented. As a whole, the results obtained in 2009 confirm the excellent skill and good technical standards found in previous editions. However, erroneous results can be obtained in any laboratory and in clinically relevant determinations. The results of this program highlight the need to implement both internal and external controls in order to ensure maximal quality of microbiological tests.

El virus de la hepatitis B en niños recién inmigrados / Hepatitis B serology in immigrant children

Fundamento. La inmigración es importante en nuestro medio. Algunos protocolos de atención al niño inmigrante incluyen la determinación del estado serológico respecto al virus de la hepatitis B (VHB). Objetivo. Valorar la conveniencia de la determinación sistemática del antígeno de superficie (HBsAg), anticuerpo contra el core (HBSerologia del virus de l’hepatitis B en infants recentment immigrats Ana Estabanell 1, Rosa M. Masvidal 2, Elisa de Frutos 2, Dolors Riera 3, Cecilia Cruz 1, Beatriz Miguel 2 1 CAP Gòtic (annex Rull). ABS Gòtic. Institut Català de la Salut. Barcelona. 2 CAP Dr. Lluís Sayé. ABS Raval Nord. Institut Català de la Salut. Barcelona. 3 CAP Drassanes. ABS Raval Sud. Institut Municipal d’Assistència Sanitària de Barcelona. cAc), anticuerpo contra el Ag de superficie (HBsAc), en niños inmigrantes. Determinar la prevalencia del HBsAc positivo en los vacunados contra el VHB. Método. Se determinaron HbsAg, HBsAc, HBcAc en niños de 6 meses a 15 años procedentes de países de baja renta que habían llegado hacía menos de 12 meses. Se registró su estado vacunal. Se estimó la prevalencia y el intervalo de confianza del resultado. Resultados. De los 1.226 niños/as, se determinó el HbsAg en 1.098 (89,5%), siendo 8 positivos: 0,79% (intervalo de confianza (IC) 95%: 0,37-1,43), dos de éstos constaban como vacunados para el VHB. En 1.024 se determinó el HBcAc, siendo el único marcador positivo en 7 casos: 0,98% (IC 0,47-1,80); el HBsAc se determinó en 987 y fue positivo en el 33,23%. De los 333 niños vacunados con tres dosis, en 267 se determinó el HBsAc, siendo positivo en el 59,9% (IC 95%: 55,15-64,45). Conclusiones. Consideramos indicada la determinación del HbsAg a los niños inmigrantes, incluyendo los que aportan datos de vacunación del VHB completa. No creemos justificado solicitar el HBcAc de manera sistemática. En niños inmigrantes vacunados puede estar indicado determinar los HBsAc(AU)

Background. Immigration is an important phenomenon in our environment. Some guidelines for the care of the immigrant child include the evaluation of hepatitis B virus (HBV) serology. Objective. To evaluate the need for the systematic measurement of surface antigen (HBsAg), core antigen antibody (HBcAb), and surface antigen antibody (HBsAb) in young immigrants, and to determine the prevalence of HBsAb in those who receive HBV vaccination. Method. HBsAg, HBsAb, and HBcAb values were determined in children from 6 months to 15 years of age who emigrated from low-income countries within the prior 12 months. The prevalence and confidence intervals were calculated. Results. Of the 1,226 children evaluated, HBsAg was measured in 1,098 (89.5%) and was positive in 8 (0.79%, CI 0.37-1.43), including two cases in whom vaccination had been documented; HBcAb was measured in 1,024 and was the only positive HBV marker in 7 cases (0.98%, CI 0.47-1.80); and HBsAb was measured in 987 and was positive in 33.26%. In 30.8% of the children, the only positive marker was HBsAb. Of the 333 children Background. Immigration is an important phenomenon in our environment. Some guidelines for the care of the immigrant child include the evaluation of hepatitis B virus (HBV) serology. Objective. To evaluate the need for the systematic measurement of surface antigen (HBsAg), core antigen antibody (HBcAb), and surface antigen antibody (HBsAb) in young immigrants, and to determine the prevalence of HBsAb in those who receive HBV vaccination. Method. HBsAg, HBsAb, and HBcAb values were determined in children from 6 months to 15 years of age who emigrated from low-income countries within the prior 12 months. The prevalence and confidence intervals were calculated. Results. Of the 1,226 children evaluated, HBsAg was measured in 1,098 (89.5%) and was positive in 8 (0.79%, CI 0.37-1.43), including two cases in whom vaccination had been documented; HBcAb was measured in 1,024 and was the only positive HBV marker in 7 cases (0.98%, CI 0.47-1.80); and HBsAb was measured in 987 and was positive in 33.26%. In 30.8% of the children, the only positive marker was HBsAb. Of the 333 children(AU)

[Analysis of the results of the SEIMC External Quality Control Program, 2007]. / Análisis de resultados del Programa Externo de Control de Calidad SEIMC. Año 2007.

The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) includes controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology and molecular microbiology. This article presents the most important conclusions and lessons drawn from the 2007 controls. As a whole, the results obtained in 2007 confirm the excellent skill and good technical standards found in previous years. However, erroneous results can be obtained in any laboratory and in clinically relevant determinations. A few deviations were observed in some controls, calling for critical reflection. Once again, the results of this program highlighted the need to complement internal with external controls, such as those offered by the SEIMC program.

Efficacy of serologic marker screening in identifying hepatitis B virus infection in organ, tissue, and cell donors.

BACKGROUND & AIMS: Screens for serologic markers of hepatitis B virus (HBV) are used to prevent its transmission through transplantation. However, exclusion of noninfectious seropositive donors exacerbates graft shortages, and a residual risk of transmission by seronegative donors also exists. This study assessed the risk of HBV associated with different HBV serologic profiles in organ, tissue, and cell transplants, as well as the risk of HBV transmission from seronegative donors. METHODS: A total of 11,155 consecutive organ, tissue, and cell donors were screened for HBV serologic markers. HBV DNA was screened for in 626 donors with at least one HBV serologic marker and 1433 multiple organ donors who were HBV seronegative or had anti-hepatitis B surface antigens (HBs) antibodies alone. RESULTS: HBV DNA was detected in most HBs-antigen-positive donors, but HBV-DNA levels were considerably lower than in patients with chronic hepatitis B. HBV DNA also was found in organ and cornea donors without HBs antigen. The prevalence of HBV DNA in organ donors with no HBV serologic markers or isolated anti-HBs antibodies was 0.07% (95% confidence interval, 0.01%-0.40%). One HBV-DNA-positive organ donor with isolated anti-HBs antibodies had amino acid substitutions in the hepatitis B surface antigen sequence. CONCLUSIONS: The analytic sensitivity of commercial hepatitis B surface antigen assays and their ability to detect HBsAg mutants should be improved. The utility and cost-efficacy ratio of systematic HBV-DNA testing should be assessed with the goal of excluding HBV-DNA-positive donations not identified through serologic testing while retaining donations that carry no risk of HBV transmission.

Revised minimal standards for description of new species of the class Mollicutes (division Tenericutes).

Minimal standards for novel species of the class Mollicutes (trivial term, mollicutes), last published in 1995, require revision. The International Committee on Systematics of Prokaryotes Subcommittee on the Taxonomy of Mollicutes proposes herein revised standards that reflect recent advances in molecular systematics and the species concept for prokaryotes. The mandatory requirements are: (i) deposition of the type strain into two recognized culture collections, preferably located in different countries; (ii) deposition of the 16S rRNA gene sequence into a public database, and a phylogenetic analysis of the relationships among the 16S rRNA gene sequences of the novel species and its neighbours; (iii) deposition of antiserum against the type strain into a recognized collection; (iv) demonstration, by using the combination of 16S rRNA gene sequence analyses, serological analyses and supplementary phenotypic data, that the type strain differs significantly from all previously named species; and (v) assignment to an order, a family and a genus in the class, with an appropriate specific epithet. The 16S rRNA gene sequence provides the primary basis for assignment to hierarchical rank, and may also constitute evidence of species novelty, but serological and supplementary phenotypic data must be presented to substantiate this. Serological methods have been documented to be congruent with DNA-DNA hybridization data and with 16S rRNA gene placements. The novel species must be tested serologically to the greatest extent that the investigators deem feasible against all neighbouring species whose 16S rRNA gene sequences show >0.94 similarity. The investigator is responsible for justifying which characters are most meaningful for assignment to the part of the mollicute phylogenetic tree in which a novel species is located, and for providing the means by which novel species can be identified by other investigators. The publication of the description should appear in a journal having wide circulation. If the journal is not the International Journal of Systematic and Evolutionary Microbiology, copies of the publication must be submitted to that journal so that the name may be considered for inclusion in a Validation List as required by the International Code of Bacteriological Nomenclature (the Bacteriological Code). Updated informal descriptions of the class Mollicutes and some of its constituent higher taxa are available as supplementary material in IJSEM Online.

Bayesian sample-size determination for inference on two binomial populations with no gold standard classifier.

We consider the impact of test properties on the required sample size for the Bayesian design problem for comparing two proportions with error-prone data. Specifically, we examine four cases: a single diagnostic test and two independent diagnostic tests, both when the test properties are identical across populations and when they differ. Interval-based and moment-based sample-size determination criteria are contrasted using Monte Carlo simulation methods. We consider an application in which Strongyloides infections are compared in two populations.

Model selection methodology for inter-laboratory standardisation of antibody titres.

The aim of the European Sero-Epidemiology Network 2 (ESEN2) is to compare standardised serological results of vaccine preventable diseases across Europe. In order to adjust for laboratory and assay differences, the participant laboratories tested a standardisation panel for each disease and the results were plotted against those of a reference centre in order to obtain standardisation equations. We describe an algorithm for obtaining these equations which took into account outliers, censored data and model selection, and needed to be robust due to the variety of assays and diseases under investigation. If the standardisation equations explained sufficient variability, these were used to convert each country's main serum bank results to a common unitage, thereby allowing international comparisons to be made.

Serological studies of monoclonal RH antibodies with RH1 (D), RH2 (C), RH3 (E) and RH5 (e) variant RBCs.

One hundred and forty five Mabs against RH antigens were tested. In this paper, we chose to detail reactivity of MoAbs directed against variant RBCs of the CNRGS collection for which we studied the molecular background. Because we developed procedures to identify variants of the RhD, RhC, RhE and Rhe antigens, we were especially interested in finding new monoclonal antibodies that could help us to characterize more accurately these variants. Therefore, we drew parallels between our procedures and results obtained with the 2001 workshop antibodies.