ABSTRACT
Introduction: Genomic analysis of hepatitis B virus (HBV) identifies phylogenetic variants, which may lead to distinct biological and clinical behaviors. The satellite hepatitis D virus (HDV) may also influence clinical outcomes in patients with hepatitis B. The aim of this study was to investigate HBV genetic variants, including clinically relevant mutations, and HDV infection in acute and chronic hepatitis B patients in central Argentina. Methods: A total of 217 adult HBV infected patients [acute (AHB): n = 79; chronic (CHB): n = 138] were studied; 67 were HBV/human immunodeficiency virus (HIV) coinfected. Clinical and demographic data were obtained from medical records. Serological markers were determined. Molecular detection of HBV and HDV was carried out by RT-Nested PCR, followed by sequencing and phylogenetic analysis. Results: Overall, genotype (gt) F [sub-genotype (sgt) F1b] was the most frequently found. In AHB patients, the gts/sgts found were: F1b (74.7%) > A2 (13.9%) > F4 (7.6%) > C (2.5%) > A1 (1.3%). Among CHB patients: F1b (39.1%) > A2 (23.9%) > F4 (18.2%) > D (9.4%) > C and F6 (3.6% each) > A1, A3 and B2 (0.7% each). The distribution of sgt A2 and gt D was significantly different between HBV mono and HBV/HIV coinfected patients [A2: 15.9% vs. 35.7% (p < 0.05), respectively and D: 14.6% vs. 1.8% (p < 0.05), respectively]. Mutation frequency in basal core promoter/pre-Core (BCP/pC) region was 35.5% (77/217) [AHB: 20.3% (16/79), CHB: 44.2% (61/138)]. In the open reading frame (ORF) S, mutations associated with vaccine escape and diagnostic failure were detected in 7.8% of the sequences (17/217) [AHB: 3.8% (3/79), CHB: 10.1% (14/138)]. ORF-P amino acid substitutions associated with antiviral resistance were detected in 3.2% of the samples (7/217) [AHB: 1.3% (1/79), CHB 4.3%, (6/138)]. The anti-HDV seropositivity was 5.2% (4/77); one sample could be sequenced, belonging to gt HDV-1 associated with sgt HBV-D3. Discussion: We detected an increase in the circulation of genotype F in Central Argentina, particularly among AHB patients, suggesting transmission advantages over the other genotypes. A low rate of mutations was detected, especially those with antiviral resistance implications, which is an encouraging result. The evidence of HDV circulation in our region, reported for the first time, alerts the health system for its search and diagnosis.
ABSTRACT
OBJECTIVES: To assess the prevalence and patterns of pre-treatment HIV drug resistance (PDR) and HIV-1 subtype in infants from Argentina with exposure to different antiretroviral drugs (ARVs) for the prevention of mother-to-child transmission (PMTCT). PATIENTS AND METHODS: HIV-1 genotyping was performed in 115 infants (median age = 2.3 months) born between 2007 and 2014 to screen for drug resistance mutations (DRMs) before starting first-line ART. HIV-1 subtype was characterized by phylogenetic and recombination analysis. RESULTS: Overall, DRMs were found in 34 of 115 infants (PDR level 30% to any ARV, 3.5% to PIs, 12% to NRTIs and 22% to NNRTIs). Of the 115 infants, 22 (19.1%) were ARV-unexposed. Another 93 were ARV-exposed: 28 (24.3%) to short-course zidovudine monotherapy ARV prophylaxis; 25 (21.7%) to nevirapine-based ARV prophylaxis; 12 (10.4%) to perinatal infant zidovudine prophylaxis + maternal combination ART with NNRTIs; and 28 (24.3%) to perinatal infant zidovudine prophylaxis+maternal combination ART with PIs. Transmitted drug resistance among ARV-unexposed infants was 32% (5% to PIs, 9% to NRTIs and 18% to NNRTIs). ART-exposed infants showed multi-class ARV resistance. Importantly, vertical transmission of a triple-class-resistant virus was confirmed in one case. Patterns of DRMs predicted high-level resistance to NNRTIs in a similar and high proportion (>50%) of infants with at least one DRM independently of ARV exposure. BF recombinants were found in 74%, subtype B in 20%, subtype C in 3% and novel AG and AB recombinants in 3%. CONCLUSIONS: PDR in HIV-1-infected children from Argentina is among the highest reported, jeopardizing successful lifelong suppressive ART as well as the efficacy of current PMTCT regimens.
Subject(s)
Drug Resistance, Viral , HIV Infections/prevention & control , HIV Infections/virology , HIV-1/genetics , Infectious Disease Transmission, Vertical/prevention & control , Anti-HIV Agents/pharmacology , Anti-HIV Agents/therapeutic use , Argentina/epidemiology , Female , Genotype , HIV Infections/epidemiology , HIV Infections/transmission , HIV-1/drug effects , Humans , Infant , Male , Mutation , Prevalence , Public Health Surveillance , Risk Factors , pol Gene Products, Human Immunodeficiency VirusABSTRACT
INTRODUCTION: Whooping cough is a re-emerging infection in the world and Latin America. OBJECTIVE: It was considered relevant to investigate the clinical and epidemiological profile of Bordetella spp. and Bordetella pertussis infection in Córdoba province, Argentina; evaluating, at the same time, the co-infection with virus producing respiratory infections that may be confused with whooping cough. MATERIAL AND METHODS: All whooping cough suspected cases were studied by Polimerase Chain Reaction, amplifying the repeated insertion sequence (IS) 481 and the promoter gene encoding pertussis toxin, between 2011 and 2013. The data were obtained from the clinical and epidemiological records. RESULTS: From 2,588 whooping cough suspected cases, 11.59% was infected by Bordetella spp. and 9.16% was confirmed as Bordetella pertussis infection. The rate of infection was 7.22 and 1.84 per 100,000 for 2011 and 2012, respectively. The infection presented a seasonal tendency and it was mainly found on the group of children between 13 and 24 months old. The co-infection with virus producing respiratory infections, were uncommon. Paroxysmal cough, cyanosis and/or vomiting were predictors of the infection for Bordetella pertussis. DISCUSSION AND CONCLUSIONS: To deal with the re-emergence of whooping cough is important the knowledge of the regional epidemiological situation. This paper shows the situation of these infections in the regional clinical and epidemiological context, and makes the information available for health decision-making.
Subject(s)
Bordetella/genetics , Communicable Diseases, Emerging/epidemiology , Whooping Cough/diagnosis , Argentina/epidemiology , Bordetella/classification , Bordetella pertussis/genetics , Child , Child, Preschool , Communicable Diseases, Emerging/diagnosis , Communicable Diseases, Emerging/virology , Diagnosis, Differential , Female , Humans , Infant , Male , Polymerase Chain Reaction , Whooping Cough/epidemiology , Whooping Cough/virologyABSTRACT
Introduction: Whooping cough is a re-emerging infection in the world and Latin America. Objective: It was considered relevant to investigate the clinical and epidemiological profile of Bordetella spp. and Bordetella pertussis infection in Córdoba province, Argentina; evaluating, at the same time, the co-infection with virus producing respiratory infections that may be confused with whooping cough. Material and Methods: All whooping cough suspected cases were studied by Polimerase Chain Reaction, amplifying the repeated insertion sequence (IS) 481 and the promoter gene encoding pertussis toxin, between 2011 and 2013. The data were obtained from the clinical and epidemiological records. Results: From 2,588 whooping cough suspected cases, 11.59% was infected by Bordetella spp. and 9.16% was confirmed as Bordetella pertussis infection. The rate of infection was 7.22 and 1.84 per 100,000 for 2011 and 2012, respectively. The infection presented a seasonal tendency and it was mainly found on the group of children between 13 and 24 months old. The co-infection with virus producing respiratory infections, were uncommon. Paroxysmal cough, cyanosis and/or vomiting were predictors of the infection for Bordetella pertussis. Discussion and Conclusions: To deal with the re-emergence of whooping cough is important the knowledge of the regional epidemiological situation. This paper shows the situation of these infections in the regional clinical and epidemiological context, and makes the information available for health decision-making.
Introducción: Coqueluche es una enfermedad reemergente en el mundo y en Latinoamérica. Objetivo: Resultó de interés caracterizar el perfil clínico-epidemiológico de la infección por Bordetella spp. y Bordetella pertussis en Córdoba, Argentina; evaluando además, la frecuencia de infecciones de etiología viral que, por cursar con un síndrome coqueluchoide (SC), pueden ser confundidas con cuadros de coqueluche. Material y Métodos: Los casos sospechosos de coqueluche, se estudiaron por reacción de polimerasa en cadena; amplificando la secuencia repetida de inserción (IS) 481 y la región promotora del gen de la toxina pertussis; entre 2011 y 2013. Los datos de los pacientes se obtuvieron de las fichas clínicoepidemiológicas. Resultados: De 2.588 pacientes, 11,59% presentó una infección por Bordetella spp. y en 9,16% se confirmó una infección por Bordetella pertussis. La tasa de infección fue 7,22 y 1,84 por 100.000 habitantes en 2011 y 2012, respectivamente. La infección presentó una tendencia estacional y se concentró principalmente en niños entre 13 y 24 meses. La tos paroxística, cianosis y/o vómitos fueron predictores de la infección por B. pertussis. La coinfección con virus productores de infecciones respiratorias fue poco frecuente. Discusión y Conclusiones: Es fundamental el conocimiento de la situación epidemiológica regional. Este trabajo presenta la situación de Córdoba y pone a disposición de la comunidad sanitaria la información para la toma de decisiones en el contexto clínico-epidemiológico regional.
Subject(s)
Humans , Male , Female , Infant , Child, Preschool , Child , Bordetella/genetics , Whooping Cough/diagnosis , Communicable Diseases, Emerging/epidemiology , Argentina/epidemiology , Bordetella/classification , Bordetella pertussis/genetics , Whooping Cough/epidemiology , Whooping Cough/virology , Polymerase Chain Reaction , Communicable Diseases, Emerging/diagnosis , Communicable Diseases, Emerging/virology , Diagnosis, DifferentialABSTRACT
BACKGROUND: Rilpivirine-based regimens are now preferred or alternative first-line regimens according to many HIV treatment guidelines. Recently, a surveillance study conducted in Argentina determined that prevalence of pretreatment resistance to first-generation non-nucleoside reverse transcriptase inhibitors (NNRTIs) was 10%. The aim of this study was to analyse the prevalence of resistance mutations to newer generation NNRTIs in the population starting ART in Argentina. METHODS: We analysed the prevalence of resistance mutations to rilpivirine and etravirine (according to the IAS list), obtained through a nationally representative pretreatment HIV-drug resistance (PDR) surveillance study performed in Argentina in 2014-2015. Briefly, 25 ART-dispensing sites throughout the country were randomly chosen to enrol 330 adults starting ART. Samples were processed with Trugene (Siemens)® and analysed using the Stanford algorithm. RESULTS: All 270 samples corresponding to participants with no prior exposure to antiretroviral drugs were included in this analysis. Median (IQR) age was 35 years (28-43); 66.7% were male; median (IQR) CD4+ T-cell count was 284 cells/mm3 (112-489). The prevalence of resistance to any antiretroviral was 16% (±5%) and prevalence of NNRTI RAMs was 13% (±4%). The prevalence of resistance to rilpivirine was 8% (±3%). Prevalence of resistance to etravirine was 4% (±3%). The most frequent mutations conferring resistance to rilpivirine were: E138A (n=6) and G190A (n=4). CONCLUSIONS: This PDR surveillance study showed concerning levels of HIV drug resistance (HIVDR) in Argentina, not only for first-generation NNRTIs but also to rilpivirine. In our setting, performing resistance testing would be necessary before prescription of ART even if a second-generation NNRTI-based regimen was used as first-line therapy.
Subject(s)
Anti-HIV Agents/pharmacology , Drug Resistance, Viral , HIV Infections/epidemiology , HIV Infections/virology , HIV-1/drug effects , Adult , Anti-HIV Agents/therapeutic use , Antiretroviral Therapy, Highly Active , Argentina/epidemiology , CD4 Lymphocyte Count , Female , HIV Infections/drug therapy , HIV Infections/immunology , HIV-1/genetics , Humans , Male , Middle Aged , Prevalence , Public Health Surveillance , Viral LoadABSTRACT
La transmisión vertical es la principal vía de contagio del HIV en la edad pediátrica. El diagnóstico de la infección congénita antes de los 18meses se realiza mediante ensayos virológicos: detección de genoma viral como ARN plasmático y ADN proviral. La sensibilidad de estos ensayos varía según la edad del niño, con valores de especificidad mayores al 95%. El objetivo de este trabajo fue evaluar el desempeño del ensayo de carga viral (CV) COBAS Taqman HIV-1 Test, v1.0 (Roche), y su concordancia con una PCR múltiple anidada in-house para la detección del ADN proviral. De 341 muestras procesadas, 15 resultaron positivas y 326 negativas por ambas metodologías. Para la metodología de CV, la sensibilidad general fue del 88,2% y la especificidad del 100%. Nuestros resultados indican que la metodología de CV evaluada puede utilizarse como técnica alternativa para el diagnóstico de infección congénita por HIV
Vertical transmission is the main route of HIV infection in childhood. Because of the persistence of maternal HIV antibodies, virologic assays that directly detect HIV are required to diagnose HIV infection in infants younger than 18months of age. The sensitivity of HIV RNA/DNA assays increases as the child becomes older. These tests have specificity values greater than 95%. The aim of this study was to evaluate the performance of the COBAS Taqman HIV-1 Test, v1.0 assay (Roche) and its concordance with a Multiplex Nested-PCR. Of 341 samples processed, 15 were positive and 326 negative by both methods. Sensitivity and specificity overall values for the viral load assay were 88.2% and 100%, respectively. Our results indicate that the COBAS Taqman assay evaluated could be used as an alternative method to diagnose HIV congenital infection
Subject(s)
Humans , Male , Female , Infant, Newborn , Infant , Acquired Immunodeficiency Syndrome/congenital , Viral Load/genetics , Reagent Kits, Diagnostic/statistics & numerical data , Acquired Immunodeficiency Syndrome/diagnosis , Viral Load/methodsABSTRACT
Vertical transmission is the main route of HIV infection in childhood. Because of the persistence of maternal HIV antibodies, virologic assays that directly detect HIV are required to diagnose HIV infection in infants younger than 18 months of age. The sensitivity of HIV RNA/DNA assays increases as the child becomes older. These tests have specificity values greater than 95%. The aim of this study was to evaluate the performance of the COBAS Taqman HIV-1 Test, v1.0 assay (Roche) and its concordance with a Multiplex Nested-PCR. Of 341 samples processed, 15 were positive and 326 negative by both methods. Sensitivity and specificity overall values for the viral load assay were 88.2% and 100%, respectively. Our results indicate that the COBAS Taqman assay evaluated could be used as an alternative method to diagnose HIV congenital infection.
Subject(s)
HIV Infections/diagnosis , HIV Infections/transmission , Infectious Disease Transmission, Vertical , AIDS Serodiagnosis , HIV Infections/virology , Humans , Infant , Infant, Newborn , Polymerase Chain Reaction , Viral LoadABSTRACT
Vertical transmission is the main route of HIV infection in childhood. Because of the persistence of maternal HIV antibodies, virologic assays that directly detect HIV are required to diagnose HIV infection in infants younger than 18months of age. The sensitivity of HIV RNA/DNA assays increases as the child becomes older. These tests have specificity values greater than 95
. The aim of this study was to evaluate the performance of the COBAS Taqman HIV-1 Test, v1.0 assay (Roche) and its concordance with a Multiplex Nested-PCR. Of 341 samples processed, 15 were positive and 326 negative by both methods. Sensitivity and specificity overall values for the viral load assay were 88.2
and 100
, respectively. Our results indicate that the COBAS Taqman assay evaluated could be used as an alternative method to diagnose HIV congenital infection.
ABSTRACT
The introduction of nucleic acid amplification techniques (NAT) in blood banks was intended to reduce the residual risk of transfusion-transmitted infections. Co-circulation of a great diversity of HIV-1 variants in Argentina portrays the need to assess the sensitivity of serological and molecular assays available for their detection. In this study, we evaluated the sensitivity of the COBAS AmpliScreen™ HIV-1 Test, version 1.5 (Roche) for the detection of HIV-1 RNA in plasma samples of infected individuals from Argentina. The results of this study reveal that this technique has high sensitivity for the detection of HIV-1 RNA under assay conditions: using mini-pool testing, pools ≥ 50 RNA copies per ml achieved ≥ 92 % sensitivity, whereas in the standard procedure, samples ≥ 207 RNA copies/ml achieved 100 % sensitivity. Moreover, the COBAS AmpliScreen™ HIV-1 Test, version 1.5 (Roche) is suitable for detecting prevailing HIV-1 variants.
Subject(s)
Colorimetry/methods , HIV Infections/virology , HIV-1/isolation & purification , RNA, Viral/blood , Reverse Transcriptase Polymerase Chain Reaction/methods , Viremia/virology , Argentina/epidemiology , Blood Safety , Genotyping Techniques , HIV Infections/blood , HIV Infections/epidemiology , HIV-1/classification , HIV-1/genetics , Humans , Mass Screening/methods , Reagent Kits, Diagnostic , Sensitivity and Specificity , Ultracentrifugation , Viral LoadABSTRACT
Las técnicas de amplificación de ácidos nucleicos (NAT) se incorporaron en los bancos de sangre para reducir el riesgo residual de transmisión de infecciones por vía transfusional. La cocirculación de distintas variantes del HIV-1 en Argentina indica la necesidad de evaluar la sensibilidad de los ensayos serológicos y moleculares disponibles para su detección. En este trabajo se evaluó la sensibilidad del equipo COBAS AmpliScreenTM HIV-1 Test, versión 1.5 (Roche), para detectar ARN viral en plasmas de individuos infectados con HIV-1 de Argentina. Los resultados demuestran que esta técnica tiene una alta sensibilidad para detectar ARN de HIV-1 en las condiciones ensayadas: para ensayo de mini-pooles (pooles ≥ 50 copias de ARN/ml), la sensibilidad fue ≥ 92 %, y para procedimiento estándar (plasmas ≥ 207 copias de ARN/ml), la sensibilidad fue 100 %. Además, la técnica COBAS AmpliScreenTM HIV-1 Test, versión 1.5 (Roche), es adecuada para la detección de las variantes de HIV-1 prevalentes
The introduction of nucleic acid amplification techniques (NAT) in blood banks was intended to reduce the residual risk of transfusion-transmitted infections. Co-circulation of a great diversity of HIV-1 variants in Argentina portrays the need to assess the sensitivity of serological and molecular assays available for their detection. In this study, we evaluated the sensitivity of the COBAS AmpliScreenTM HIV-1 Test, version 1.5 (Roche) for the detection of HIV-1 RNA in plasma samples of infected individuals from Argentina. The results of this study reveal that this technique has high sensitivity for the detection of HIV-1 RNA under assay conditions: using mini-pool testing, pools ≥ 50 RNA copies per ml achieved ≥ 92 % sensitivity, whereas in the standard procedure, samples ≥ 207 RNA copies/ ml achieved 100 % sensitivity. Moreover, the COBAS AmpliScreenTM HIV-1 Test, version 1.5 (Roche) is suitable for detecting prevailing HIV-1 variants
Subject(s)
Humans , HIV-1/isolation & purification , Nucleic Acid Amplification Techniques/methods , HIV Infections/bloodABSTRACT
The introduction of nucleic acid amplification techniques (NAT) in blood banks was intended to reduce the residual risk of transfusion-transmitted infections. Co-circulation of a great diversity of HIV-1 variants in Argentina portrays the need to assess the sensitivity of serological and molecular assays available for their detection. In this study, we evaluated the sensitivity of the COBAS AmpliScreen HIV-1 Test, version 1.5 (Roche) for the detection of HIV-1 RNA in plasma samples of infected individuals from Argentina. The results of this study reveal that this technique has high sensitivity for the detection of HIV-1 RNA under assay conditions: using mini-pool testing, pools  50 RNA copies per ml achieved  92
sensitivity, whereas in the standard procedure, samples  207 RNA copies/ml achieved 100
sensitivity. Moreover, the COBAS AmpliScreenÔäó HIV-1 Test, version 1.5 (Roche) is suitable for detecting prevailing HIV-1 variants.
Subject(s)
Colorimetry/methods , HIV Infections/virology , HIV-1/isolation & purification , RNA, Viral/blood , Reverse Transcriptase Polymerase Chain Reaction/methods , Viremia/virology , Argentina/epidemiology , Blood Safety , Genotyping Techniques , HIV Infections/blood , HIV Infections/epidemiology , HIV-1/classification , HIV-1/genetics , Humans , Mass Screening/methods , Reagent Kits, Diagnostic , Sensitivity and Specificity , Ultracentrifugation , Viral LoadABSTRACT
Alternative algorithms were evaluated in order to reduce the number of false reactive results for antibodies against HTLV-1/2. From 20,210 samples tested, 0.37% (74/20,210) was reactive by ELISA Murex. Of these, 23 were confirmed as positive by the indirect immunofluorescence assay whereas 51 were negative, being the positive predictive value (PPV) 31.08%. From a combination of the ELISA Murex assay with the particle agglutination assay (PA) and ELISA MP, the following results were obtained: 26/74 were reactive by ELISA Murex and PA, PPV 88.5% and 32/74 were reactive by ELISA Murex and ELISA MP, PPV 71.8 %. The ROC curve analysis determined that for an RP 4.74, the values for sensitivity, specificity, PPV and NPV by ELISA Murex were 100%, 98.04%, 95.8% and 100%, respectively. We propose that reactive samples by ELISA Murex with an RP d 4.74 should be retested in duplicate by PA, and the resulting concordantly nonreactive samples should be defined as negative for HTLV-1/2.
Subject(s)
Antibodies, Viral/blood , Blood Donors , Donor Selection/methods , HTLV-I Infections/blood , HTLV-I Infections/diagnosis , HTLV-II Infections/blood , HTLV-II Infections/diagnosis , Human T-lymphotropic virus 1/immunology , Human T-lymphotropic virus 2/immunology , Enzyme-Linked Immunosorbent Assay , Humans , Serologic TestsABSTRACT
Alternative algorithms were evaluated in order to reduce the number of false reactive results for antibodies against HTLV-1/2. From 20,210 samples tested, 0.37
(74/20,210) was reactive by ELISA Murex. Of these, 23 were confirmed as positive by the indirect immunofluorescence assay whereas 51 were negative, being the positive predictive value (PPV) 31.08
. From a combination of the ELISA Murex assay with the particle agglutination assay (PA) and ELISA MP, the following results were obtained: 26/74 were reactive by ELISA Murex and PA, PPV 88.5
and 32/74 were reactive by ELISA Murex and ELISA MP, PPV 71.8
. The ROC curve analysis determined that for an RP 4.74, the values for sensitivity, specificity, PPV and NPV by ELISA Murex were 100
, respectively. We propose that reactive samples by ELISA Murex with an RP d 4.74 should be retested in duplicate by PA, and the resulting concordantly nonreactive samples should be defined as negative for HTLV-1/2.
Subject(s)
Antibodies, Viral/blood , Blood Donors , HTLV-I Infections/diagnosis , HTLV-I Infections/blood , HTLV-II Infections/diagnosis , HTLV-II Infections/blood , Donor Selection/methods , Human T-lymphotropic virus 1/immunology , /immunology , Enzyme-Linked Immunosorbent Assay , Humans , Serologic TestsABSTRACT
Alternative algorithms were evaluated in order to reduce the number of false reactive results for antibodies against HTLV-1/2. From 20,210 samples tested, 0.37
(74/20,210) was reactive by ELISA Murex. Of these, 23 were confirmed as positive by the indirect immunofluorescence assay whereas 51 were negative, being the positive predictive value (PPV) 31.08
. From a combination of the ELISA Murex assay with the particle agglutination assay (PA) and ELISA MP, the following results were obtained: 26/74 were reactive by ELISA Murex and PA, PPV 88.5
and 32/74 were reactive by ELISA Murex and ELISA MP, PPV 71.8
. The ROC curve analysis determined that for an RP 4.74, the values for sensitivity, specificity, PPV and NPV by ELISA Murex were 100
, 98.04
, 95.8
and 100
, respectively. We propose that reactive samples by ELISA Murex with an RP d 4.74 should be retested in duplicate by PA, and the resulting concordantly nonreactive samples should be defined as negative for HTLV-1/2.
Subject(s)
Antibodies, Viral/blood , Blood Donors , Donor Selection/methods , HTLV-I Infections/blood , HTLV-I Infections/diagnosis , HTLV-II Infections/blood , HTLV-II Infections/diagnosis , Human T-lymphotropic virus 1/immunology , Human T-lymphotropic virus 2/immunology , Enzyme-Linked Immunosorbent Assay , Humans , Serologic TestsABSTRACT
At the time of influenza A (H1N1) emergency, the WHO responded with remarkable speed by releasing guidelines and a protocol for a real-time RT-PCR assay (rRT-PCR). The aim of the present study was to evalúate the performance of the "Real Time Ready Influenza A/H1N1 Detection Set" (June 2009)-Roche kit in comparison to the CDC reference rRT-PCR protocol. The overall sensitivity of the Roche assay for detection of the Inf A gene in the presence or absence of the H1 gene was 74.5 %. The sensitivity for detecting samples that were only positive for the Inf A gene (absence of the H1 gene) was 53.3 % whereas the sensitivity for H1N1-positive samples (presence of the Inf A gene and any other swine gene) was 76.4 %. The specificity of the assay was 97.1 %. A new version of the kit (November 2009) is now available, and a recent evaluation of its performance showed good sensitivity to detect pandemic H1N1 compared to other molecular assays.
Subject(s)
Influenza A Virus, H1N1 Subtype , Influenza, Human/diagnosis , Reagent Kits, Diagnostic , Argentina/epidemiology , Centers for Disease Control and Prevention, U.S. , Disease Outbreaks , Hemagglutinin Glycoproteins, Influenza Virus/genetics , Humans , Influenza A Virus, H1N1 Subtype/genetics , Influenza A Virus, H1N1 Subtype/isolation & purification , Influenza, Human/epidemiology , Influenza, Human/virology , Nasal Cavity/virology , Nucleocapsid Proteins , Pharynx/virology , RNA, Viral/genetics , RNA-Binding Proteins/genetics , Real-Time Polymerase Chain Reaction/methods , Reproducibility of Results , Sensitivity and Specificity , United States , Viral Core Proteins/geneticsABSTRACT
At the time of influenza A (H1N1) emergency, the WHO responded with remarkable speed by releasing guidelines and a protocol for a real-time RT-PCR assay (rRT-PCR). The aim of the present study was to evalúate the performance of the "Real Time Ready Influenza A/H1N1 Detection Set" (June 2009)-Roche kit in comparison to the CDC reference rRT-PCR protocol. The overall sensitivity of the Roche assay for detection of the Inf A gene in the presence or absence of the H1 gene was 74.5 %. The sensitivity for detecting samples that were only positive for the Inf A gene (absence of the H1 gene) was 53.3 % whereas the sensitivity for H1N1-positive samples (presence of the Inf A gene and any other swine gene) was 76.4 %. The specificity of the assay was 97.1 %. A new version of the kit (November 2009) is now available, and a recent evaluation of its performance showed good sensitivity to detect pandemic H1N1 compared to other molecular assays.
Durante la pandemia de influenza A (H1N1), la OMS recomendó algoritmos y protocolos de detección del virus mediante RT-PCR en tiempo real. El objetivo del presente estudio fue evaluar el desempeño del equipo que comercializa la empresa Roche, Real Time Ready Influenza A/H1N1 Detection Set (junio de 2009), en comparación con el protocolo de RT-PCR en tiempo real de los CDC. La sensibilidad global del ensayo de Roche para la detección del gen Inf A en presencia o ausencia del gen H1 fue 74,5 %. La sensibilidad para la detección de muestras positivas solo para el gen Inf A (ausencia del gen H1) fue 53,3 % y la sensibilidad para la detección de muestras positivas para H1N1 (presencia del gen Inf A y cualquier otro gen porcino) fue 76,4 %. La especificidad fue 97,1 %. Existe una nueva versión del equipo (noviembre 2009) que, según se ha descrito, presenta buena sensibilidad en comparación con otros ensayos moleculares para detectar H1N1 pandémica.
Subject(s)
Humans , Influenza A Virus, H1N1 Subtype , Influenza, Human/diagnosis , Reagent Kits, Diagnostic , Argentina/epidemiology , Centers for Disease Control and Prevention, U.S. , Disease Outbreaks , Hemagglutinin Glycoproteins, Influenza Virus/genetics , Influenza A Virus, H1N1 Subtype/genetics , Influenza A Virus, H1N1 Subtype/isolation & purification , Influenza, Human/epidemiology , Influenza, Human/virology , Nasal Cavity/virology , Pharynx/virology , Reproducibility of Results , RNA, Viral/genetics , RNA-Binding Proteins/genetics , Real-Time Polymerase Chain Reaction/methods , Sensitivity and Specificity , United States , Viral Core Proteins/geneticsABSTRACT
At the time of influenza A (H1N1) emergency, the WHO responded with remarkable speed by releasing guidelines and a protocol for a real-time RT-PCR assay (rRT-PCR). The aim of the present study was to evalúate the performance of the "Real Time Ready Influenza A/H1N1 Detection Set" (June 2009)-Roche kit in comparison to the CDC reference rRT-PCR protocol. The overall sensitivity of the Roche assay for detection of the Inf A gene in the presence or absence of the H1 gene was 74.5 %. The sensitivity for detecting samples that were only positive for the Inf A gene (absence of the H1 gene) was 53.3 % whereas the sensitivity for H1N1-positive samples (presence of the Inf A gene and any other swine gene) was 76.4 %. The specificity of the assay was 97.1 %. A new version of the kit (November 2009) is now available, and a recent evaluation of its performance showed good sensitivity to detect pandemic H1N1 compared to other molecular assays.(AU)
Durante la pandemia de influenza A (H1N1), la OMS recomendó algoritmos y protocolos de detección del virus mediante RT-PCR en tiempo real. El objetivo del presente estudio fue evaluar el desempeño del equipo que comercializa la empresa Roche, Real Time Ready Influenza A/H1N1 Detection Set (junio de 2009), en comparación con el protocolo de RT-PCR en tiempo real de los CDC. La sensibilidad global del ensayo de Roche para la detección del gen Inf A en presencia o ausencia del gen H1 fue 74,5 %. La sensibilidad para la detección de muestras positivas solo para el gen Inf A (ausencia del gen H1) fue 53,3 % y la sensibilidad para la detección de muestras positivas para H1N1 (presencia del gen Inf A y cualquier otro gen porcino) fue 76,4 %. La especificidad fue 97,1 %. Existe una nueva versión del equipo (noviembre 2009) que, según se ha descrito, presenta buena sensibilidad en comparación con otros ensayos moleculares para detectar H1N1 pandémica.(AU)
Subject(s)
Humans , Influenza A Virus, H1N1 Subtype , Influenza, Human/diagnosis , Reagent Kits, Diagnostic , Argentina/epidemiology , Centers for Disease Control and Prevention, U.S. , Disease Outbreaks , Hemagglutinin Glycoproteins, Influenza Virus/genetics , Influenza A Virus, H1N1 Subtype/genetics , Influenza A Virus, H1N1 Subtype/isolation & purification , Influenza, Human/epidemiology , Influenza, Human/virology , Nasal Cavity/virology , Pharynx/virology , RNA, Viral/genetics , RNA-Binding Proteins/genetics , Real-Time Polymerase Chain Reaction/methods , Reproducibility of Results , Sensitivity and Specificity , United States , Viral Core Proteins/geneticsABSTRACT
At the time of influenza A (H1N1) emergency, the WHO responded with remarkable speed by releasing guidelines and a protocol for a real-time RT-PCR assay (rRT-PCR). The aim of the present study was to evalúate the performance of the "Real Time Ready Influenza A/H1N1 Detection Set" (June 2009)-Roche kit in comparison to the CDC reference rRT-PCR protocol. The overall sensitivity of the Roche assay for detection of the Inf A gene in the presence or absence of the H1 gene was 74.5 %. The sensitivity for detecting samples that were only positive for the Inf A gene (absence of the H1 gene) was 53.3 % whereas the sensitivity for H1N1-positive samples (presence of the Inf A gene and any other swine gene) was 76.4 %. The specificity of the assay was 97.1 %. A new version of the kit (November 2009) is now available, and a recent evaluation of its performance showed good sensitivity to detect pandemic H1N1 compared to other molecular assays.(AU)
Durante la pandemia de influenza A (H1N1), la OMS recomendó algoritmos y protocolos de detección del virus mediante RT-PCR en tiempo real. El objetivo del presente estudio fue evaluar el desempeño del equipo que comercializa la empresa Roche, Real Time Ready Influenza A/H1N1 Detection Set (junio de 2009), en comparación con el protocolo de RT-PCR en tiempo real de los CDC. La sensibilidad global del ensayo de Roche para la detección del gen Inf A en presencia o ausencia del gen H1 fue 74,5 %. La sensibilidad para la detección de muestras positivas solo para el gen Inf A (ausencia del gen H1) fue 53,3 % y la sensibilidad para la detección de muestras positivas para H1N1 (presencia del gen Inf A y cualquier otro gen porcino) fue 76,4 %. La especificidad fue 97,1 %. Existe una nueva versión del equipo (noviembre 2009) que, según se ha descrito, presenta buena sensibilidad en comparación con otros ensayos moleculares para detectar H1N1 pandémica.(AU)
Subject(s)
Humans , Influenza A Virus, H1N1 Subtype , Influenza, Human/diagnosis , Reagent Kits, Diagnostic , Argentina/epidemiology , Centers for Disease Control and Prevention, U.S. , Disease Outbreaks , Hemagglutinin Glycoproteins, Influenza Virus/genetics , Influenza A Virus, H1N1 Subtype/genetics , Influenza A Virus, H1N1 Subtype/isolation & purification , Influenza, Human/epidemiology , Influenza, Human/virology , Nasal Cavity/virology , Pharynx/virology , RNA, Viral/genetics , RNA-Binding Proteins/genetics , /methods , Reproducibility of Results , Sensitivity and Specificity , United States , Viral Core Proteins/geneticsABSTRACT
This study shows first data on HTLV-1/2 seroprevalence among pregnant women in the non-endemic region of Argentina. In a retrospective study a representative sample (n = 3,143) of the pregnant women registered in the health public service in the province of Córdoba was evaluated. HTLV-1/2 seroprevalence was 0.191% +/- 0.0857 [IC 0.022-0.359]. This prevalence was 10 times higher in pregnant women than in blood donors [0.019 (4/21.183)]. The pregnant women would reflect the epidemiology of the general population more accurately since it constitutes a more heterogeneous group than that of blood donors. The prevalence of infection with HIV was 2.8 times higher than that of HTLV-1/2 (P < 0.05) and the presence of any of these two viruses was not a subrogating indicator of the presence of the other (Goodman and Kruskal's Tau coefficient = 0.0092). The prevalence of HBV was not significantly different from that of HTLV-1/2 (P > 0.05). We consider that it is necessary to carry out continuous studies in order to define the main risk factors for infection of these women. Thus, a decision could be made to apply the best policy in public health to prevent vertical transmission of the virus in Argentina.
Subject(s)
HIV Infections/epidemiology , HTLV-I Infections/epidemiology , HTLV-II Infections/epidemiology , Hepatitis B/epidemiology , Pregnancy Complications, Infectious/epidemiology , Argentina/epidemiology , Female , Humans , Pregnancy , Retrospective Studies , Seroepidemiologic StudiesABSTRACT
Use of detection tests for p24 HIV antigen (p24Ag) in blood banks in Argentina is recommended by the Argentinean Society of Hemotherapy and Immunohematology. In the blood bank of the National University of Cordoba (Argentina), the recent implementation of the p24Ag screening test has considerably increased the cost of the battery of screening tests and its use in all blood donations has not produced the benefits expected. A 4th generation EIA was evaluated for the screening of HIV in comparison with the currently used assays in the blood bank of National University of Cordoba (3rd generation EIA + p24Ag assay). For this comparison, 11 serum samples from subjects with early HIV infection (early seroconversion period) were tested, as well as 27 serum samples from asymptomatic HIV-infected subjects and other 39 from non-HIV infected subjects. The 3rd generation EIA and the 4th generation EIA showed the same sensitivity value (100%) but the specificity of the 3rd generation EIA was higher (97.5%) comparing with 4th generation (95.1%). Besides, the p24Ag test failed to detect 2 samples from subjects with early HIV infection. These results indicate a good performance of both 3rd and 4th generation assays for screening of HIV. However, due to the lowest cost of 4th generation EIA kit, it could replace the currently used assays for HIV screening in regional blood banks. This screening assay will lead to gain in effectiveness and reduced costs until the detection of HIV RNA can be implemented in blood banks.
