Development and performance evaluation of a qPCR-based assay for the fully automated detection of group B Streptococcus (GBS) on the Panther Fusion Open Access system.

Streptococcus agalactiae [group B Streptococcus (GBS)] poses a major threat as the primary cause of early-onset neonatal invasive disease, particularly when mothers are colonized rectovaginally. Although culture remains the gold standard for antepartum GBS screening, quantitative polymerase chain reaction (qPCR) offers advantages in terms of sensitivity and turnaround time. The aim of this study was to validate the clinical utility of an automated qPCR laboratory-developed test (LDT) for antepartum GBS screening using the Panther Fusion Open Access system (Hologic, California, USA). The LDT targeted a conserved region of the GBS surface immunogenic protein gene, demonstrating no cross-reactivity and high coverage (99.82%-99.99%). The limit of detection (LoD) was 118 CFU/mL. Comparison with commercial qPCR assays (Panther Fusion GBS and VIASURE Streptococcus B Real-Time) revealed an overall agreement of 99.7%, with a robust Cohen's kappa coefficient of 0.992. Testing of 285 rectovaginal swabs from pregnant women and 15 external quality assessment samples demonstrated exceptional diagnostic performance of the LDT, achieving a diagnostic sensitivity and specificity of 100%, underscoring its accuracy. Prevalence and predictive values were also determined to reinforce test reliability. Our research highlights the limitations of culture-based screening and supports the suitability of our qPCR-based LDT for GBS detection in a clinical setting.IMPORTANCERectovaginal colonization by GBS is a major risk factor for early-onset invasive neonatal disease. The most effective approach to reducing the incidence of early-onset disease (EOD) has been described as universal screening, involving assessment of GBS colonization status in late pregnancy and intrapartum antibiotic prophylaxis. Despite its turnaround time and sensitivity limitations, culture remains the gold standard method for GBS screening. However, nucleic acid amplification-based tests, such as qPCR, have been utilized due to their speed and high sensitivity and specificity. This study validated the clinical usefulness of an automated qPCR-LDT for antepartum GBS screening through the Panther Fusion Open Access system (Hologic). Our study addresses the critical need for more robust, sensitive, and rapid strategies for GBS screening in pregnant women that could favorably impact the incidence of EOD.

Eficacia del implante de células mononucleares autólogas en el tratamiento de la periodontitis crónica / Effectiveness of autologous mononuclear cells implant in patients with chronic periodontitis

Introducción: los buenos resultados en la regeneración de tejidos mediante la implantación de células mononucleares en distintas especialidades médicas en el mundo y en Cuba, ha motivado a considerar el periodonto como candidato para esta terapia.Objetivo: determinar la eficacia del implante de células mononucleares autólogas en el tratamiento de la periodontitis crónica a 48 meses de evolución. Material y Métodos: se realizó un ensayo clínico fase III, aleatorizado y controlado en pacientes con periodontitis crónica durante los años 2008 a 2014. De ese grupo de pacientes se evaluaron 30 que tenían 48 ó más meses de recibir tratamiento en la consulta de Periodoncia del Hospital Enrique Cabrera en el período comprendido de febrero a mayo de 2015; 15 habían recibido tratamiento con células mononucleares (grupo estudio) y 15 terapia convencional (grupo control). La movilización a la sangre periférica de las células mononucleares se realizó mediante la aplicación del factor estimulador de colonias de granulocitos (FEC-G). Resultados: se aprecia una disminución del promedio de todas las variables clínicas, que es marcada en cada uno de los períodos evolutivos con respecto al estado inicial de los pacientes a los 6, 12, 36 y 48 meses posteriores al tratamiento en el grupo de estudio, mientras que en el control las manifestaciones de la enfermedad fueron reapareciendo paulatinamente a medida que avanzaba el tiempo post-tratamiento. Estos resultados fueron significativos. Conclusiones: la terapia celular regenerativa con células mononucleares autólogas es eficaz para el tratamiento de pacientes con periodontitis y su efecto es prolongado(AU)

Introduction: over the last years, in Cuba and other countries, encouraging results have been obtained in different medical specialties in the field of tissue regeneration by implanting stem cells; it has motivated us to consider periodontal tissue as a target for this therapy. Objective: To determine the efficacy of the implant of mononuclear autologous cells for the treatment of 48 months evolution chronic periodontitis. Material and Methods: 30 patients attending the Periodontology Clinic of the "Enrique Cabrera" hospital for over48 months during years 2008 to 2014 where included in the study, divided into two groups 15 patients each: group A were treated with autologous mononuclear cells and group B, who underwent classic therapy. The peripheral blood autologous mononuclear cells (MNC-SP) were mobilized with granulocyte colony- stimulating factor (G-CSF). Results: group A patients showed a significant average decrease in all clinical variables, more remarkable in every of the evolution periods as compared to the initial stage of every patient at 6, 12, 24 and 48 months after starting the treatment. In Group B patients, signs of the disease gradually reappeared as the post-treatment period proceeded.Conclusions: regenerative cell therapy with MNC-SP is effective and long lasting in patients with periodontitis(AU)

Terapia celular regenerativa con células mononucleares autólogas aplicada a pacientes con periodontitis / Use of stem cell therapy in patients suffering periodontitis

Introducción: la periodontitis constituye un proceso crónico en el que la pérdida ósea es el signo más significativo y de no recibir adecuada atención lleva a la pérdida dentaria. El uso de células madre hematopoyéticas ha dado lugar a un nuevo tipo de tratamiento, su empleo con fines regenerativos es de gran interés para la comunidad científica y el periodonto se considera un potencial para ello. Objetivo: evaluar la eficacia de la terapia celular regenerativa con células mononucleares autólogas en pacientes con periodontitis. Material y Métodos: se estudiaron 84 pacientes, atendidos en la consulta de Periodoncia del Servicio de Cirugía Maxilofacial del Hospital «William Soler¼, durante los años 2008-2012; de estos, 42 recibieron tratamiento con células mononucleares autólogas (grupo de estudio) y 42 con terapia convencional (grupo control). Resultados: se encontró una evidente disminución de dientes afectados y presencia de bolsas periodontales a los 6 meses posteriores al tratamiento en ambos grupos, tendencia que se mantuvo presente durante los 12, 18, 24 y 30 meses posteriores en el grupo de estudio, mientras que en el control, las manifestaciones de la enfermedad fueron apareciendo paulatinamente a medida que avanzaba el tiempo. Se demostró un aumento mantenido en la mejoría de los signos de la periodontitis, así como ganancia de la inserción periodontal por formación de nuevo hueso, lo que no ocurrió en los que recibieron tratamiento convencional. Conclusiones: la terapia celular regenerativa con células mononucleares autólogas es eficaz para el tratamiento de pacientes con periodontitis.

Introduction: periodontitis is a chronic process in which the bone loss is the most significant sign and in the event that the patient does not receive the appropriate dental care it may cause the teeth loss. Using the hematopoietic stem cells has brought about a new type of treatment; its use for regenerative purposes is of great interest to the scientific community and the periodontium is considered a potential in this process. Objective: To report on the progress of patients suffering from periodontitis treated with autologous mononuclear cells . Material and Method: a study was done on 84 patients assisted at the Periodontics practice of the Maxillofacial Service of William Soler Hospital from 2008 to 2012. 42 out of the 84 patients received treatment with autologous mononuclear stem cells (study group) and 42 with conventional therapy (control group). Results: a significant lower rate of disturbed teeth and periodontal pockets were found in both groups of patients 6 months after the treatment, which was present in the following 12, 18, 24 and 30 month-period in the study group while the signs of the disease were appearing eventually in the control group. Statistically, these results were highly significant (p < 0, 05). Conclusions: the patients receiving treatment with autologous mononuclear stem cells as well as in the periodontal insertion due to the growth of new bone, as compared to the control group.

Terapia celular regenerativa con células mononucleares autólogas aplicada a pacientes con periodontitis / Use of stem cell therapy in patients suffering periodontitis

Introducción: la periodontitis constituye un proceso crónico en el que la pérdida ósea es el signo más significativo y de no recibir adecuada atención lleva a la pérdida dentaria. El uso de células madre hematopoyéticas ha dado lugar a un nuevo tipo de tratamiento, su empleo con fines regenerativos es de gran interés para la comunidad científica y el periodonto se considera un potencial para ello. Objetivo: evaluar la eficacia de la terapia celular regenerativa con células mononucleares autólogas en pacientes con periodontitis. Material y Métodos: se estudiaron 84 pacientes, atendidos en la consulta de Periodoncia del Servicio de Cirugía Maxilofacial del Hospital William Soler, durante los años 2008-2012; de estos, 42 recibieron tratamiento con células mononucleares autólogas (grupo de estudio) y 42 con terapia convencional (grupo control).Resultados: se encontró una evidente disminución de dientes afectados y presencia de bolsas periodontales a los 6 meses posteriores al tratamiento en ambos grupos, tendencia que se mantuvo presente durante los 12, 18, 24 y 30 meses posteriores en el grupo de estudio, mientras que en el control, las manifestaciones de la enfermedad fueron apareciendo paulatinamente a medida que avanzaba el tiempo. Se demostró un aumento mantenido en la mejoría de los signos de la periodontitis, así como ganancia de la inserción periodontal por formación de nuevo hueso, lo que no ocurrió en los que recibieron tratamiento convencional.Conclusiones: la terapia celular regenerativa con células mononucleares autólogas es eficaz para el tratamiento de pacientes con periodontitis(AU)

Introduction: periodontitis is a chronic process in which the bone loss is the most significant sign and in the event that the patient does not receive the appropriate dental care it may cause the teeth loss. Using the hematopoietic stem cells has brought about a new type of treatment; its use for regenerative purposes is of great interest to the scientific community and the periodontium is considered a potential in this process. Objective: To report on the progress of patients suffering from periodontitis treated with autologous mononuclear cells . Material and Method: a study was done on 84 patients assisted at the Periodontics practice of the Maxillofacial Service of William Soler Hospital from 2008 to 2012. 42 out of the 84 patients received treatment with autologous mononuclear stem cells (study group) and 42 with conventional therapy (control group). Results: a significant lower rate of disturbed teeth and periodontal pockets were found in both groups of patients 6 months after the treatment, which was present in the following 12, 18, 24 and 30 month-period in the study group while the signs of the disease were appearing eventually in the control group. Statistically, these results were highly significant (p < 0, 05). Conclusions: the patients receiving treatment with autologous mononuclear stem cells as well as in the periodontal insertion due to the growth of new bone, as compared to the control group(AU)