Follow-up of Immune Response in Patients with Common Variable Immunodeficiency following SARS-CoV-2 Vaccination.

The COVID-19 pandemic highlighted the importance of effective vaccination strategies in controlling the spread of infectious diseases. SARS-CoV-2 vaccine has demonstrated high efficacy in preventing COVID-19 infection in the general population. However, the efficacy of this vaccine in patients with predominantly antibody deficiencies, such as common variable immunodeficiency (CVID) and X-linked agammaglobulinemia (XLA), should be closely monitored. CVID and XLA are rare genetic disorders that impair the immune system's ability to produce antibodies, which are crucial for fighting infections. Patients with these disorders have a higher risk of severe disease and mortality from COVID-19 due to their compromised immune systems. In this study, we evaluated the humoral and cellular immune responses after four doses of mRNA-1273 and one BNT162b2 bivalent vaccine in a cohort of patients with CVID and XLA. The response in this population was lower than in the control group. However, the administration of the third dose improved the number of patients with seroconversion and the intensity of the humoral response, as well as the number of patients with a positive cellular response. Finally, the administration of the fourth and fifth doses improves the antibody titer and neutralization against wild type variant, but not against the prevalent XBB1.5 variant.

Reduced neutralizing antibody response to SARS-CoV-2 vaccine booster dose in people living with HIV with severe immunosuppression.

The aim of this study was to assess the immunogenicity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines among people living with HIV (PLWH) with severe immunosuppression, after a booster dose. The design was a case-control study nested in a prospective cohort of PLWH. All patients with CD4 cell count <200 cells/mm3 who had received additional dose of messenger RNA (mRNA) COVID-19 vaccine, after a standard immunization scheme were included. Control group: patients age- and sex-matched, with CD4 ≥ 200 cells/mm3 , in the ratio of 2:1. Antibody response to a booster dose (anti-S levels 33.8 ≥ BAU/mL) and neutralizing activity against SARS-CoV-2 B.1, B.1.617.2, and Omicron BA.1, BA.2, and BA.5 strains were assessed after the booster shot. Fifty-four PLWH were included, 18 with CD4 counts < 200 cells/mm3 . Fifty-one (94%) showed response to a booster dose. Response was less frequent in PLWH with CD4 < 200 cells/mm3 than in those with CD4 counts ≥ 200 cells/mm3 (15 [83%] vs. 36 [100%], p = 0.033). In the multivariate analysis, CD4 counts ≥ 200 cells/mm3 [incidence rate ratio (IRR) = 18.1 (95% confidence interval [CI]: 16.8-19.5), p < 0.001] was associated with a higher probability of showing antibody response. Neutralization activity against SARS-CoV-2 B.1, B.1.617, BA.1, and BA.2 strains was significantly inferior among individuals with CD4 counts < 200 cells/mm3 . In conclusion, among PLWH with CD4 counts < 200 cells/mm3 , the immune response elicited by mRNA additional vaccine dose is reduced.

In vitro neutralizing activity of BNT162b2 mRNA-induced antibodies against full B.1.351 SARS-CoV-2 variant.

SARS-CoV-2 variation represents a serious challenge to current COVID-19 vaccines. Recent reports suggest that B.1.351 and other variants may escape the neutralization activity of the antibodies generated by current vaccines. Ninety-nine healthcare workers undertaking BNT162b2 mRNA vaccination were sampled at baseline, on the day of the second dose, and 14 days after the latter. Neutralization activity against SARS-CoV-2 B.1, B.1.1.7 and B.1.351 was investigated using a Vero-E6 model. Eleven of the study participants had prior infection with SARS-CoV-2. Neutralization titers against the B.1 and the B.1.1.7 variants were not statistically different and were significantly higher than titers against the B.1.351 variant across pre-exposed and non-pre-exposed vaccinated individuals (p < .01). While all vaccinated individuals presented neutralizing antibodies against B.1 and B 1.1.7 after the second dose, 14% were negative against B.1.351 and 76% had low titers (1/201/80). Pre-exposed vaccinated individuals showed higher titers than non-pre-exposed after the first (median titers of 1/387 versus 1/28, respectively) and the second doses (1/995 versus 1/703, respectively). As high as 72% of the pre-exposed vaccines presented titers >1/80 after a single dose, while only 11% of non-exposed vaccinated individuals had titers >1/80. BNT162b2 mRNA-induced antibodies show a lower in vitro neutralizing activity against B.1.351 variant compared to neutralization against B.1.1.7 or B.1 variants. Interestingly, for individuals pre-exposed to SARS-CoV-2, one dose of BNT162b2 mRNA may be adequate to produce neutralizing antibodies against B.1.1.7 and B.1, while two doses of BNT162b2 mRNA provide optimal neutralizing antibody response against B.1.351 too.

SARS-CoV-2 neutralising antibody testing in Europe: towards harmonisation of neutralising antibody titres for better use of convalescent plasma and comparability of trial data.

We compared the performance of SARS-CoV-2 neutralising antibody testing between 12 European laboratories involved in convalescent plasma trials. Raw titres differed almost 100-fold differences between laboratories when blind-testing 15 plasma samples. Calibration of titres in relation to the reference reagent and standard curve obtained by testing a dilution series reduced the inter-laboratory variability ca 10-fold. The harmonisation of neutralising antibody quantification is a vital step towards determining the protective and therapeutic levels of neutralising antibodies.

Impacto de un modelo de capacitación de la prueba Evaluación del Desarrollo Infantil en la atención primaria / Impact of a training model for the Child Development Evaluation Test in primary care

ResumenIntroducción: La prueba Evaluación del Desarrollo Infantil (EDI) es una herramienta de tamiz para la detección oportuna de problemas del desarrollo, diseñada y validada en México. Para que sus resultados sean confiables, se requiere que el personal que la aplique haya adquirido los conocimientos necesarios previamente, a través de un curso de capacitación en la unidad de salud que labore. El objetivo de este trabajo fue evaluar el impacto de un modelo de capacitación impartido al personal que trabaja en atención primaria en seis entidades federativas en México. Lo anterior mediante la comparación de los conocimientos adquiridos en la capacitación.Método: Se realizó un estudio de evaluación de antes y después, considerando como intervención el haber acudido a un curso de capacitación sobre la prueba EDI de octubre a diciembre de 2013.Resultados: Se incluyeron 394 participantes. Las profesiones fueron las siguientes: medicina general (73.4%), enfermería (7.7%), psicología (7.1%), nutrición (6.1%), otras profesiones (5.6%). En la evaluación inicial, el 64.9% obtuvo una calificación menor a 20. En la evaluación final, disminuyó al 1.8%. En la evaluación inicial aprobó el 1.8% comparado con el 75.1% en la evaluación final. Las preguntas con menor porcentaje de respuestas correctas fueron las relacionadas con la calificación de la prueba.Conclusiones: El modelo de capacitación resultó adecuado para adquisición de conocimientos generales sobre la prueba. Para mejorar el resultado global se requiere reforzar los temas de calificación e interpretación de los resultados en futuras capacitaciones, y que los participantes realicen una lectura previa del material de apoyo.

AbstractBackground: The Child Development Evaluation (CDE) Test is a screening tool designed and validated in Mexico for the early detection of child developmental problems. For professionals who will be administering the test in primary care facilities, previous acquisition of knowledge about the test is required in order to generate reliable results. The aim of this work was to evaluate the impact of a training model for primary care workers from different professions through the comparison of knowledge acquired during the training course.Methods: The study design was a before/after type considering the participation in a training course for the CDE test as the intervention. The course took place in six different Mexican states from October to December 2013. The same questions were used before and after.Results: There were 394 participants included. Distribution according to professional profile was as follows: general physicians 73.4%, nursing 7.7%, psychology 7.1%, nutrition 6.1% and other professions 5.6%. The questions with the lowest correct answer rates were associated with the scoring of the CDE test. In the initial evaluation, 64.9% obtained a grade lower than 20 compared with 1.8% in the final evaluation. In the initial evaluation only 1.8% passed compared with 75.15% in the final evaluation.Conclusions:The proposed model allows the participants to acquire general knowledge about the CDE Test. To improve the general results in future training courses, it is required to reinforce during training the scoring and interpretation of the test together with the previous lecture of the material by the participants.

Diseño de un modelo de supervisión para la aplicación de la prueba de Evaluación del Desarrollo Infantil en las unidades de atención primaria en México / Design of a supervision model for administration of the Child Development Evaluation Test at primary care facilities in Mexico

ResumenIntroducción:La prueba Evaluación del Desarrollo Infantil (EDI), diseñada y validada en México, se ha aplicado en las unidades de atención primaria del país. Los resultados han sido heterogéneos entre los estados en que se aplicaron las pruebas, a pesar de haber utilizado un modelo de capacitación estandarizado con la misma metodología para la aplicación. El objetivo de este trabajo fue evaluar un modelo de supervisión que permita identificar la calidad de la aplicación de la prueba EDI a nivel poblacional.Métodos: Se realizó un estudio en la atención primaria tres estados del país para evaluar la aplicación de la prueba EDI por observación directa (estudio de sombra), y verificar la concordancia del resultado a través aplicar la prueba una vez más (estudio de consistencia).Resultados: Se realizaron 380 estudios de sombra a 51 psicólogos. Al comparar el resultado global, se observó una concordancia del 86.1% con el supervisor (n = 327): el 94.5% por resultado verde, el 73.2% por amarillo y el 80.0% por rojo. Se aplicó la prueba nuevamente en 302 casos, con una concordancia del 88.1% (n = 266): el 96.8% por resultado verde, el 71.7% por amarillo y el 81.8% por rojo. No se encontraron diferencias significativas por grupo.Conclusiones: Tanto el estudio de sombra como el de consistencia fueron adecuados para evaluar la calidad de la aplicación de la prueba, y pueden ser de utilidad para supervisar la aplicación de la prueba EDI en atención primaria. La decisión de uno u otro sistema depende de la disponibilidad de supervisores.

AbstractBackground:The Child Development Evaluation (CDE) test designed and validated in Mexico has been used as a screening tool for developmental problems in primary care facilities across Mexico. Heterogeneous results were found among those states where these were applied, despite using the same standardized training model for application. The objective was to evaluate a supervision model for quality of application of the CDE test at primary care facilities.Methods:A study was carried out in primary care facilities from three Mexican states to evaluate concordance of the results between supervisor and primary care personnel who administered the test using two different methods: direct observation (shadow study) or reapplication of the CDE test (consistency study).Results: There were 380 shadow studies applied to 51 psychologists. General concordance of the shadow study was 86.1% according to the supervisor: green 94.5%, yellow 73.2% and red 80.0%. There were 302 re-test evaluations with a concordance of 88.1% (n = 266): green 96.8%, yellow 71.7% and red 81.8%. There were no differences between CDE test subgroups by age.Conclusions: Both shadow and re-test study were adequate for the evaluation of the quality of the administration of the CDE Test and may be useful as a model of supervision in primary care facilities. The decision of which test to use relies on the availability of supervisors.

Evaluación diagnóstica del nivel de desarrollo en niños identificados con riesgo de retraso mediante la prueba de Evaluación del Desarrollo Infantil / Diagnostic evaluation of the developmental level in children identified at risk of delay through the Child Development Evaluation Test

ResumenIntroducción: La prueba Evaluación del Desarrollo Infantil (EDI), diseñada en México, clasifica a los niños de acuerdo con su desarrollo en desarrollo normal, rezago en el desarrollo y riesgo de retraso. La versión modificada se desarrolló y validó, pero no se conocen sus propiedades en base poblacional. El objetivo de este trabajo fue establecer la confirmación diagnóstica en niños de 16 a 59 meses identificados con riesgo de retraso por la prueba EDI.Métodos: Se realizó un estudio transversal de base poblacional en una entidad federativa de México. Se aplicó la prueba EDI a 11,455 niños de 16 a 59 meses, de diciembre de 2013 a marzo de 2014. Se consideró como población elegible al 6.2% (n = 714) que obtuvo como resultado riesgo de retraso. Para la inclusión en el estudio se realizó una aleatorización estratificada por bloques para sexo y grupo de edad. A cada participante se le realizó la evaluación diagnóstica utilizando el Inventario de Desarrollo de Battelle 2ª. edición.Resultados: De los 355 participantes incluidos, el 65.9% fue de sexo masculino y el 80.2% de medio rural. El 6.5% fueron falsos positivos (cociente total de desarrollo ¿ 90) y el 6.8% no tuvo ningún dominio con retraso (cociente de desarrollo de dominio < 80). Se calculó la proporción de retraso en las siguientes áreas: comunicación (82.5%), cognitivo (80.8%), personal-social (33.8%), motor (55.5%) y adaptativo (41.7%). Se observaron diferencias en los porcentajes de retraso por edad y dominio/subdominio evaluado.Conclusiones: Se corroboró la presencia de retraso en al menos un dominio evaluado por la prueba diagnóstica en el 93.2% de la población estudiada.

AbstractBackground: The Child Development Evaluation (or CDE Test) was developed in Mexico as a screening tool for child developmental problems. It yields three possible results: normal, slow development or risk of delay. The modified version was elaborated using the information obtained during the validation study but its properties according to the base population are not known. The objective of this work was to establish diagnostic confirmation of developmental delay in children 16- to 59-months of age previously identified as having risk of delay through the CDE Test in primary care facilities.Methods:A population-based cross-sectional study was conducted in one Mexican state. CDE test was administered to 11,455 children 16- to 59-months of age from December/2013 to March/2014. The eligible population represented the 6.2% of the children (n = 714) who were identified at risk of delay through the CDE Test. For inclusion in the study, a block randomization stratified by sex and age group was performed. Each participant included in the study had a diagnostic evaluation using the Battelle Development Inventory, 2nd edition.Results: From the 355 participants included with risk of delay, 65.9% were male and 80.2% were from rural areas; 6.5% were false positives (Total Development Quotient ¿90) and 6.8% did not have any domain with delay (Domain Developmental Quotient <80). The proportion of delay for each domain was as follows: communication 82.5%; cognitive 80.8%; social-personal 33.8%; motor 55.5%; and adaptive 41.7%. There were significant differences in the percentages of delay both by age and by domain/subdomain evaluated.Conclusions: In 93.2% of the participants, developmental delay was corroborated in at least one domain evaluated.

Escrutinio poblacional del nivel de desarrollo infantil en menores de 5 años beneficiarios de PROSPERA en México / Population-based study of child developmental screening in Mexican PROSPERA beneficiaries younger than 5 years old

ResumenIntroducción:La prueba de Evaluación del Desarrollo Infantil (EDI), diseñada y validada en México, clasifica a los niños de acuerdo con su desarrollo en desarrollo normal (verde) y desarrollo anormal (amarillo o rojo). No se conocen los resultados de su aplicación en base poblacional. El objetivo de este trabajo fue evaluar el nivel de desarrollo de niños menores de 5 años en situación de pobreza (beneficiarios del Programa PROSPERA) utilizando la prueba EDI.Método:La prueba EDI fue aplicada por personal capacitado y con los estándares para la aplicación de la prueba en menores de 5 años que acudieron al control del niño sano en unidades de atención primaria de noviembre de 2013 a mayo de 2014 en un estado del norte de México.Resultados: Se aplicó la prueba EDI a 5,527 niños de 1-59 meses de edad. El 83.8% (n = 4,632) se encontró con desarrollo normal y el 16.2%, con desarrollo anormal: amarillo con el 11.9% (n = 655) y rojo con el 4.3% (n = 240). La proporción con resultado anormal fue del 9.9% en < 1 año y del 20.8% a los 4 años. Por edad, las áreas más afectadas fueron el lenguaje a los 2 años (9.35%) y el conocimiento a los 4 años (11.1%). Las áreas motor grueso y social tuvieron mayor afección en el área rural. En el sexo masculino, las áreas de motor fino, lenguaje y conocimiento.Conclusiones: La proporción de niños con resultado anormal es similar a lo reportado en otros estudios de base poblacional. La mayor proporción de afección a mayores edades refuerza la importancia de la intervención temprana. La diferencia en las áreas afectadas entre el medio urbano y rural sugiere la necesidad de una intervención diferenciada.

AbstractBackground:Evaluación del Desarrollo Infantil or Child Development Evaluation (CDE) test, a screening tool designed and validated in Mexico, classifies child development as normal (green) or abnormal (developmental lag or yellow and risk of delay or red). Population-based results of child development level with this tool are not known. The objective of this work was to evaluate the developmental level of children aged 1-59 months living in poverty (PROSPERA program beneficiaries) through application of the CDE test.Methods: CDE tests were applied by specifically trained and standardized personnel to children <5 years old who attended primary care facilities for a scheduled appointment for nutrition, growth and development evaluation from November 2013 to May 2014.Results: There were 5,527 children aged 1-59 months who were evaluated; 83.8% (n = 4,632) were classified with normal development (green) and 16.2% (n = 895) as abnormal: 11.9% (n = 655) as yellow and 4.3% (n = 240) as red. The proportion of abnormal results was 9.9% in children <1 year of age compared with 20.8% at 4 years old. The most affected areas according to age were language at 2 years (9.35%) and knowledge at 4 years old (11.1%). Gross motor and social areas were more affected in children from rural areas; fine motor skills, language and knowledge were more affected in males.Conclusions: The proportion of children with abnormal results is similar to other population-based studies. The highest rate in older children reinforces the need for an early-based intervention. The different pattern of areas affected between urban and rural areas suggests the need for a differentiated intervention.

[Impact of a training model for the Child Development Evaluation Test in primary care]. / Impacto de un modelo de capacitación de la prueba Evaluación del Desarrollo Infantil en la atención primaria.

BACKGROUND: The Child Development Evaluation (CDE) Test is a screening tool designed and validated in Mexico for the early detection of child developmental problems. For professionals who will be administering the test in primary care facilities, previous acquisition of knowledge about the test is required in order to generate reliable results. The aim of this work was to evaluate the impact of a training model for primary care workers from different professions through the comparison of knowledge acquired during the training course. METHODS: The study design was a before/after type considering the participation in a training course for the CDE test as the intervention. The course took place in six different Mexican states from October to December 2013. The same questions were used before and after. RESULTS: There were 394 participants included. Distribution according to professional profile was as follows: general physicians 73.4%, nursing 7.7%, psychology 7.1%, nutrition 6.1% and other professions 5.6%. The questions with the lowest correct answer rates were associated with the scoring of the CDE test. In the initial evaluation, 64.9% obtained a grade lower than 20 compared with 1.8% in the final evaluation. In the initial evaluation only 1.8% passed compared with 75.15% in the final evaluation. CONCLUSIONS: The proposed model allows the participants to acquire general knowledge about the CDE Test. To improve the general results in future training courses, it is required to reinforce during training the scoring and interpretation of the test together with the previous lecture of the material by the participants.

[Design of a supervision model for administration of the Child Development Evaluation Test at primary care facilities in Mexico]. / Diseño de un modelo de supervisión para la aplicación de la prueba de Evaluación del Desarrollo Infantil en las unidades de atención primaria en México.

BACKGROUND: The Child Development Evaluation (CDE) test designed and validated in Mexico has been used as a screening tool for developmental problems in primary care facilities across Mexico. Heterogeneous results were found among those states where these were applied, despite using the same standardized training model for application. The objective was to evaluate a supervision model for quality of application of the CDE test at primary care facilities. METHODS: A study was carried out in primary care facilities from three Mexican states to evaluate concordance of the results between supervisor and primary care personnel who administered the test using two different methods: direct observation (shadow study) or reapplication of the CDE test (consistency study). RESULTS: There were 380 shadow studies applied to 51 psychologists. General concordance of the shadow study was 86.1% according to the supervisor: green 94.5%, yellow 73.2% and red 80.0%. There were 302 re-test evaluations with a concordance of 88.1% (n=266): green 96.8%, yellow 71.7% and red 81.8%. There were no differences between CDE test subgroups by age. CONCLUSIONS: Both shadow and re-test study were adequate for the evaluation of the quality of the administration of the CDE Test and may be useful as a model of supervision in primary care facilities. The decision of which test to use relies on the availability of supervisors.

[Diagnostic evaluation of the developmental level in children identified at risk of delay through the Child Development Evaluation Test]. / Evaluación diagnóstica del nivel de desarrollo en niños identificados con riesgo de retraso mediante la prueba de Evaluación del Desarrollo Infantil.

BACKGROUND: The Child Development Evaluation (or CDE Test) was developed in Mexico as a screening tool for child developmental problems. It yields three possible results: normal, slow development or risk of delay. The modified version was elaborated using the information obtained during the validation study but its properties according to the base population are not known. The objective of this work was to establish diagnostic confirmation of developmental delay in children 16- to 59-months of age previously identified as having risk of delay through the CDE Test in primary care facilities. METHODS: A population-based cross-sectional study was conducted in one Mexican state. CDE test was administered to 11,455 children 16- to 59-months of age from December/2013 to March/2014. The eligible population represented the 6.2% of the children (n=714) who were identified at risk of delay through the CDE Test. For inclusion in the study, a block randomization stratified by sex and age group was performed. Each participant included in the study had a diagnostic evaluation using the Battelle Development Inventory, 2nd edition. RESULTS: From the 355 participants included with risk of delay, 65.9% were male and 80.2% were from rural areas; 6.5% were false positives (Total Development Quotient ˃90) and 6.8% did not have any domain with delay (Domain Developmental Quotient <80). The proportion of delay for each domain was as follows: communication 82.5%; cognitive 80.8%; social-personal 33.8%; motor 55.5%; and adaptive 41.7%. There were significant differences in the percentages of delay both by age and by domain/subdomain evaluated. CONCLUSIONS: In 93.2% of the participants, developmental delay was corroborated in at least one domain evaluated.

[Population-based study of child developmental screening in Mexican PROSPERA beneficiaries younger than 5 years old]. / Escrutinio poblacional del nivel de desarrollo infantil en menores de 5 años beneficiarios de PROSPERA en México.

BACKGROUND: Evaluación del Desarrollo Infantil or Child Development Evaluation (CDE) test, a screening tool designed and validated in Mexico, classifies child development as normal (green) or abnormal (developmental lag or yellow and risk of delay or red). Population-based results of child development level with this tool are not known. The objective of this work was to evaluate the developmental level of children aged 1-59 months living in poverty (PROSPERA program beneficiaries) through application of the CDE test. METHODS: CDE tests were applied by specifically trained and standardized personnel to children <5 years old who attended primary care facilities for a scheduled appointment for nutrition, growth and development evaluation from November 2013 to May 2014. RESULTS: There were 5,527 children aged 1-59 months who were evaluated; 83.8% (n=4,632) were classified with normal development (green) and 16.2% (n=895) as abnormal: 11.9% (n=655) as yellow and 4.3% (n=240) as red. The proportion of abnormal results was 9.9% in children <1 year of age compared with 20.8% at 4 years old. The most affected areas according to age were language at 2 years (9.35%) and knowledge at 4 years old (11.1%). Gross motor and social areas were more affected in children from rural areas; fine motor skills, language and knowledge were more affected in males. CONCLUSIONS: The proportion of children with abnormal results is similar to other population-based studies. The highest rate in older children reinforces the need for an early-based intervention. The different pattern of areas affected between urban and rural areas suggests the need for a differentiated intervention.

Development of an enzyme-linked immunosorbent assay-based test with a cocktail of nucleocapsid and spike proteins for detection of severe acute respiratory syndrome-associated coronavirus-specific antibody.

A new enzyme-linked immunosorbent assay (ELISA)-based immunoglobulin G (IgG)-plus-IgM antibody detection test for severe acute respiratory syndrome (SARS) has been developed by using a cocktail of four recombinant polypeptides as the antigen. These recombinant fragments were designed as parts of two different structural proteins from SARS-associated coronavirus (SARS-CoV). One recombinant polypeptide, S251-683, was designed as part of the spike glycoprotein, and the other three polypeptides comprised almost the whole nucleocapsid protein, avoiding the last 25 C-terminal amino acids. Immunization with a cocktail of these four polypeptides yielded a specific polyclonal antibody that is able to recognize SARS-CoV-infected cells by an immunofluorescence assay. This polypeptide cocktail was also used to set up an ELISA-based IgG-plus-IgM antibody detection test, which showed 99% specificity and 90% sensitivity upon evaluation using sera from 100 healthy negative controls and 20 SARS patients. Separate immunoreactivity assays with each recombinant polypeptide demonstrated that a combination of N and S protein fragments was more suitable than the individual peptides for developing a serological assay for SARS-CoV.

Evaluation of a novel enzyme-linked immunosorbent assay to detect immunoglobulin G antibody to enolase for serodiagnosis of invasive candidiasis.

The performance of a new test to detect antibodies to Candida albicans recombinant enolase was investigated in 47 immunocompromised and 51 immunocompetent patients. The sensitivity, specificity, and positive and negative predictive values of the test for the diagnosis of invasive candidiasis were 81.0, 83.9, 79.1, and 85.5%, respectively.

[Relationship between the peripheral arterial occlusive disease and the infection by Chlamydophila pneumoniae]. / Relación entre la enfermedad arterial periférica oclusiva y la infección por Chlamydophila pneumoniae.

BACKGROUND AND OBJECTIVE: The relationship between peripheral arterial occlusive disease (PAOD) and Chlamydophila pneumoniae infection was studied by analyzing clinical samples from 95 patients with PAOD (cases) and 100 controls. PATIENTS AND METHOD: The following investigations were conducted: IgG and IgA against lipopolysaccharide (LPS) and against purified C. pneumoniae-specific antigens from elementary bodies (EB) with ELISA; anti-EB IgG, with MIF; C. pneumoniae DNA in arterial biopsy and peripheral blood leukocyte cells (PBLCs) with heminested PCR; LPS with ELISA; and bacteria culture in HEp-2 cells from arterial biopsy. RESULTS: The percentage of positive results in cases and controls groups for anti-LPS IgG was: 21% and 14%, respectively, with no differences; nor were there any differences with IgA (22 and 21%, respectively). However, differences were seen in the anti-EB IgG between cases (74% and 72%, for ELISA and MIF, respectively) and controls (31% and 34%). There were no differences in anti-EB IgA. Bacterial DNA was detected in 67% of atheromatous plaques (cases) vs. 12% of pudendal arteries (controls) (p = 0.0001). No C. pneumoniae DNA and LPS was detected in PBLCs and biopsic samples, respectively; and no C. pneumoniae strain could be recovered by cell culture from cases. CONCLUSIONS: On the basis of our results, PAOD is significantly associated with C. pneumoniae infection through the detection of anti-EB IgG from serum and bacterial DNA from arterial biopsy.

[Evaluation of a new commercial test (Candida albicans IFA IgG) for the serodiagnosis of invasive candidiasis]. / Evaluación de una nueva técnica comercializada (Candida albicans IFA IgG) para el diagnóstico de la candidiasis invasiva.

INTRODUCTION: Two tests for the detection of antibodies to Candida albicans germ tubes in patients with invasive candidiasis were compared: a new commercially available test (Candida albicans IFA IgG) and the indirect immunofluorescence test generally used for this purpose. METHODS: With the use of two indirect immunofluorescence tests, retrospective study was done on 172 sera from 51 patients classified into two groups: Group I included 123 serum samples from 32 patients with invasive candidiasis, and Group II, the control, included 49 serum samples from 19 patients with no evidence of Candida infection. RESULTS: In Group I, 84% of patients presented anti-germ tube antibody titers >or= 1:160 by the Candida albicans IFA IgG test and 78.1% of patients were positive by the generally used test. There was a high correlation between the two tests (R2 =0.9512 by patients; R2 = 0.8986 by sera). When a titer value of >or= 1:160 was used as cutoff, the Candida albicans IFA IgG test showed a sensitivity of 84.4% and a specificity of 94.7%, whereas the traditional test showed a sensitivity of 78.1% and a specificity of 100%. CONCLUSIONS: The commercially available Candida albicans IFA IgG test is similar to the test generally used for the detection of antibodies to C. albicans germ tubes and provides faster and easier diagnosis of invasive candidiasis in the clinical microbiology laboratory.

¿Puede sustituir la prueba de brucellacapt® a la prueba de coombs en el diagnóstico de la brucelosis humana? / Brucellacapt® test to replace Coombs test in the serological diagnosis of human brucellosis?

FUNDAMENTOS. En este trabajo hemos estudiado la capacidad de la prueba Brucellacapt® para sustituir a la prueba de Coombs en el diagnóstico de la brucelosis humana. MÉTODOS. Se estudiaron sueros de 66 pacientes de brucelosis. Los pacientes se dividieron en dos grupos: grupo 1 (42 pacientes primoinfectados) y grupo 2 (24 pacientes con antecedentes de la enfermedad). Como población complementaria se utilizaron 100 sueros de individuos de población general para el grupo 1, y 28 sueros de individuos sanos con antecedentes de brucelosis para el grupo 2. A todos los sueros se les practicaron las pruebas de Coombs y Brucellacapt®, y se estudió el rendimiento diagnóstico de ambas en los dos grupos mediante la elaboración de curvas ROC (receiver operating characteristic).A 397 sueros de 66 pacientes con brucelosis se les practicaron las pruebas de Coombs y Brucellacapt® y los resultados obtenidos se compararon mediante una prueba no paramétrica. RESULTADOS. En el grupo 1 ambas pruebas mostraron una sensibilidad de 1 y especificidades de 0,98 (Coombs) y 0,95 (Brucellacapt®). En el grupo 2 las sensibilidades fueron de 1 (Coombs) y 0,95 (Brucellacapt®), y las especificidades de 0,80 (Coombs) y 0,74 (Brucellacapt®). En dicho grupo las áreas bajo la curva fueron de 0,950 (Coombs) y 0,904 (Brucellacapt®) .Al comparar los resultados de ambas pruebas mediante la prueba de Wilcoxon no se observaron diferencias estadísticamente significativas (Z= -0,213; p= 0,8). CONCLUSIONES. Los resultados obtenidos en las pruebas de Brucellacapt® y Coombs, empleando sueros en diferentes fases de la enfermedad, pueden considerarse intercambiables ya que ofrecen un rendimiento diagnóstico similar (AU)