Rubella vaccination of unknowingly pregnant women during 2006 mass campaign in Argentina.

We report a prospective study of 56 pregnant women inadvertently vaccinated with rubella vaccine during the 2006 campaign performed in Argentina. Of these patients, 48 (87%) were immune, whereas the remaining 9 (16%) were susceptible. In the latter group, 7 presented with a primary reaction to the vaccine confirmed through immunoglobulin (Ig) G antibody avidity testing or seroconversion of IgG titers. During the clinical and laboratory follow-up, newborns did not present evidence of infection or malformations compatible with congenital rubella syndrome.

Implementación del Programa de Vigilancia Farmacéutica. Región sanitaria VI: Informe 1º Año (Período 2008-2009) / Implementation of Drug Monitoring Program Year: 1 Report (Period 2008-2009)

Informe sobre el subprograma de Farmacovigilncia, eventos adversos a medicamentos (EAMs), desvios de calidad y falla de eficacia y errores de medicaciòn; y, el subprograma de Tecnovigilacia

[Diagnosis of congenital cytomegalovirus infection in newborn dried blood spots on Guthrie cards. A promissory technique]. / Diagnóstico de la infección congénita por citomegalovirus en muestras de sangre seca de recién nacidos en la tarjeta de Guthrie. Una técnica promisoria.

Laboratories play a crucial role in the diagnosis of congenital and perinatal cytomegalovirus infection, considering that other viral infections in newborn infants have similar clinical characteristics. The objectives of this work are to compare the results of the polymerase reaction in blood spots and urine as well as point out the relevance of the result in the Guthrie cards to differentiate congenital from perinatal infection. A total of 148 patients suspicious of CMVH infections were studied in the Congenital Perinatal Infections and Sexual Transmission Laboratory, at the National Institute "Carlos G. Malbrán". The dry blood samples (Guthrie cards) and urine of all patients were studied through the polymerase chain reaction. From the 148 patients, 3 presented other infections, 95 tested negative and 50 positive for cytomegalovirus: 35 had congenital infection and 15 perinatal. In the congenital cases, the polymerase reaction in dry blood was positive (sensitivity 100%, specificity 98.9%, VPP 98% and VPN 100%). Four of them with tardive symptoms were studied retrospectively. The urine specimens from the remaining 15 patients that were taken 15 days after birth were analyzed through the same methods, showing a sensitivity of 100%, the retrospective analysis of this dry blood group yielded negative results, so the infection was considered perinatal. Thus, the dry blood polymerase reaction of the newborn infants makes it a reliable assay for diagnosing congenital cytomegalovirus infection and could be used as an alternative method to urine polymerase reaction. In addition, this test is able to reveal whether the infection is congenital or perinatal in those cases of late symptom or other cases of controversial origin.

Diagnóstico de la infección congénita por citomegalovirus en muestras de sangre seca de recién nacidos en la Tarjeta de Guthrie: una técnica promisoria / Diagnosis of congenital cytomegalovirus infection in newborn dried blood spots on Guthrie Cards: a promissory technique

En la infección congénita y perinatal por citomegalovirusel laboratorio cumple un rol decisivo, si se considera que el cuadro clínico en el recién nacido es semejante al que presentan otras infecciones. Los objetivos del trabajo son comparar los resultadosde la reacción de la polimerasa en sangre seca y en orina y señalar la importancia del resultado en la tarjeta de Guthrie, para diferenciar la infección congénita de la perinatal.En el Instituto Nacional de Enfermedades Infecciosas Dr. Carlos G. Malbrán, Servicio Virosis Congénitas Perinatales y Transmisión Sexual, se estudiaron148 pacientes derivados por sospecha deinfección por CMVH. Se analizaron las muestras de sangre seca (tarjeta de Guthrie) y de orina de todos los pacientes, mediante la reacción en cadena de la polimerasa. De 148 pacientes, 3 presentaron otra sinfecciones, 95 fueron negativos y 50 positivos paracitomegalovirus: 35 fueron infecciones congénitas y15 perinatales. En los casos congénitos, la reacción de la polimerasa en la sangre seca fue positiva (sensibilidad 100 por ciento, especificidad 98,9 por ciento, VPP 98 por ciento y VPN 100 por ciento). Cuatro de ellos, con síntomas tardíos,fueron estudiados retrospectivamente. En 15 pacientescon muestras de orina tomadas después delos 15 días y polimerasa positiva (S 100 por ciento), el análisis retrospectivo de la sangre seca fue negativo, por loque se consideró que la infección fue perinatal.La reacción de la polimerasa en sangre seca puede utilizarse alternativamente a la reacción de lapolimerasa en orina de recién nacido y permite diferenciar la infección congénita de la perinatal en los casos de infecciones congénitas con aparicióntardía de los síntomas u otros casos de origen controvertido

Laboratories play a crucial role in the diagnosis of congenital and perinatal cytomegalovirus infection, considering that other viral infections in newborn infants have similar clinical characteristics. The objectives of this work are to compare the results of the polymerase reaction in blood spots and urine as well as point out the relevance of the result in the Guthrie cards to differentiate congenital from perinatal infection. A total of 148 patients suspicious of CMVH infections were studied in the Congenital Perinatal Infections and Sexual Transmission Laboratory, at the National Institute “Carlos G. Malbrán”. The dry blood samples (Guthrie cards) and urine of all patients were studied through the polymerase chain reaction. From the 148 patients, 3 presented other infections, 95 tested negative and 50 positive for cytomegalovirus: 35 had congenital infection and 15 perinatal. In the congenital cases, the polymerase reaction in dry blood was positive (sensitivity 100%, specificity 98.9%, VPP 98% and VPN 100%). Four of them with tardive symptoms were studied retrospectively. The urine specimens from the remaining 15 patients that were taken 15 days after birth were analyzed through the same methods, showing a sensitivity of 100%, the retrospective analysis of this dry blood group yielded negative results, so the infection was considered perinatal. Thus, the dry blood polymerase reaction of the newborn infants makes it a reliable assay for diagnosing congenital cytomegalovirus infection and could be used as an alternative method to urine polymerase reaction. In addition, this test is able to reveal whether the infection is congenital or perinatal in those cases of late symptom or other cases of controversial origin.

Diagnóstico de la infección congénita por citomegalovirus en muestras de sangre seca de recién nacidos en la Tarjeta de Guthrie: una técnica promisoria / Diagnosis of congenital cytomegalovirus infection in newborn dried blood spots on Guthrie Cards: a promissory technique

En la infección congénita y perinatal por citomegalovirusel laboratorio cumple un rol decisivo, si se considera que el cuadro clínico en el recién nacido es semejante al que presentan otras infecciones. Los objetivos del trabajo son comparar los resultadosde la reacción de la polimerasa en sangre seca y en orina y señalar la importancia del resultado en la tarjeta de Guthrie, para diferenciar la infección congénita de la perinatal.En el Instituto Nacional de Enfermedades Infecciosas Dr. Carlos G. Malbrán, Servicio Virosis Congénitas Perinatales y Transmisión Sexual, se estudiaron148 pacientes derivados por sospecha deinfección por CMVH. Se analizaron las muestras de sangre seca (tarjeta de Guthrie) y de orina de todos los pacientes, mediante la reacción en cadena de la polimerasa. De 148 pacientes, 3 presentaron otra sinfecciones, 95 fueron negativos y 50 positivos paracitomegalovirus: 35 fueron infecciones congénitas y15 perinatales. En los casos congénitos, la reacción de la polimerasa en la sangre seca fue positiva (sensibilidad 100 por ciento, especificidad 98,9 por ciento, VPP 98 por ciento y VPN 100 por ciento). Cuatro de ellos, con síntomas tardíos,fueron estudiados retrospectivamente. En 15 pacientescon muestras de orina tomadas después delos 15 días y polimerasa positiva (S 100 por ciento), el análisis retrospectivo de la sangre seca fue negativo, por loque se consideró que la infección fue perinatal.La reacción de la polimerasa en sangre seca puede utilizarse alternativamente a la reacción de lapolimerasa en orina de recién nacido y permite diferenciar la infección congénita de la perinatal en los casos de infecciones congénitas con aparicióntardía de los síntomas u otros casos de origen controvertido (AU)

Laboratories play a crucial role in the diagnosis of congenital and perinatal cytomegalovirus infection, considering that other viral infections in newborn infants have similar clinical characteristics. The objectives of this work are to compare the results of the polymerase reaction in blood spots and urine as well as point out the relevance of the result in the Guthrie cards to differentiate congenital from perinatal infection. A total of 148 patients suspicious of CMVH infections were studied in the Congenital Perinatal Infections and Sexual Transmission Laboratory, at the National Institute ¶Carlos G. Malbrán÷. The dry blood samples (Guthrie cards) and urine of all patients were studied through the polymerase chain reaction. From the 148 patients, 3 presented other infections, 95 tested negative and 50 positive for cytomegalovirus: 35 had congenital infection and 15 perinatal. In the congenital cases, the polymerase reaction in dry blood was positive (sensitivity 100%, specificity 98.9%, VPP 98% and VPN 100%). Four of them with tardive symptoms were studied retrospectively. The urine specimens from the remaining 15 patients that were taken 15 days after birth were analyzed through the same methods, showing a sensitivity of 100%, the retrospective analysis of this dry blood group yielded negative results, so the infection was considered perinatal. Thus, the dry blood polymerase reaction of the newborn infants makes it a reliable assay for diagnosing congenital cytomegalovirus infection and could be used as an alternative method to urine polymerase reaction. In addition, this test is able to reveal whether the infection is congenital or perinatal in those cases of late symptom or other cases of controversial origin.(AU)

Human cytomegalovirus: detection of congenital and perinatal infection in Argentina.

BACKGROUND: Human cytomegalovirus (CMV) is one of the most commonly found agents of congenital infections. Primary maternal infection is associated with risk of symptomatic congenital diseases, and high morbidity is frequently associated with very low birth weight. Neonates with asymptomatic infection develop various sequelae during infancy. This is the first Argentine study performed in neonates with congenital and postnatal HCMV infection. The purpose of this study was to evaluate the performance of the polymerase chain reaction (PCR) technique with different pairs of primers, to detect cytomegalovirus isolated in tissue cultures and directly in urine and dried blood spot (DBS) specimens. Results were compared with IgM detection. METHODS: The study was performed between 1999 and 2001 on routine samples in the Laboratory. A total of 61 urine and 56 serum samples were selected from 61 newborns/infants, 33 patients whose samples were analyzed during the first two to three weeks of life were considered congenital infections; the remaining 28 patients whose samples were taken later than the third week were grouped as perinatal infections, although only in 4 the perinatal transmission of infection was determined unequivocally. Cytomegalovirus diagnosis was made by isolating the virus from urine samples in human foreskin fibroblast cells. Three different primer pairs directed to IE, LA and gB genes were used for the HCMV PCR assay in viral isolates. Subsequently, PCR and nested PCR (nPCR) assays with gB primers were performed directly in urine and in 11 samples of dried blood spot (DBS) on Guthrie Card, these results were then compared with serology. RESULTS: The main clinical manifestations of the 33 patients with congenital infection were purpura, jaundice, hepatomegaly and anaemia. Three patients presented low birth weight as single symptom, 10, intracranial calcifications, and 2, kidney failure. In the 28 patients grouped as with perinatal infection, anaemia, hepatosplenomegaly and enzymatic alteration were predominant, and 4 patients were HIV positive. The primers used to amplify the gB region had a PCR positivity rate of 100%, whereas those that amplified IE and LA regions had a PCR positivity rate of 54% and 61% respectively, in CMV isolates. Amplification by PCR of urine samples (with no previous DNA extraction), using primers for the gB region, detected 34/61 positive samples. Out of the 33 samples from patients with congenital infection, 24 (73%) were positive. When nPCR was used in these samples, all were positive, whereas in the remaining 28 patients, two negative cases were found. Cytomegalovirus DNA detection in 11 samples was also carried out in DBS: 7 DBS samples were positive and 4 were negative. CONCLUSIONS: Primers directed to the gB fragment region were the best choice for the detection of CMV DNA in positive isolates. In congenital infections, direct PCR in urine was positive in a high percentage (73%) of samples; however, in patients grouped as with perinatal infection only 36% of the cases were positive. With n-PCR, total sample positivity reached 97%. PCR technique performed in DBS allowed identifying congenital infection in four patients and to be confirmed in 3. These results show the value of nPCR for the detection of all cases of CMV infection. The assay offers the advantage that it may be performed within the normal working day and provides reliable results in a much shorter time frame than that required for either traditional tissue culture or the shell-viral assay.