ABSTRACT
The Advisory Committee on Immunization Practices (ACIP) recommended that dengue pre-vaccination screening tests for Dengvaxia administration have at least 98% specificity and 75% sensitivity. This study evaluates the performance of commercial anti-DENV IgG tests to identify tests that could be used for pre-vaccination screening. First, for seven tests, we evaluated sensitivity and specificity in early convalescent dengue virus (DENV) infection, using 44 samples collected 7-30 days after symptom onset and confirmed by RT-PCR. Next, for the five best-performing tests and two additional tests (with and without an external test reader) that became available later, we evaluated performance to detect past dengue infection among a panel of 44 specimens collected in 2018-2019 from healthy 9- to 16-year-old children from Puerto Rico. Finally, a full-scale evaluation was done with the four best-performing tests using 400 specimens from the same population. We used virus focus reduction neutralization test and an in-house DENV IgG ELISA as reference standards. Of seven tests, five showed ≥75% sensitivity in detecting anti-DENV IgG in early convalescent specimens with low cross-reactivity to the Zika virus. For the detection of previous DENV infections, the tests with the highest performance were the Euroimmun NS1 IgG ELISA (sensitivity 84.5%, specificity 97.1%) and CTK Dengue IgG rapid test R0065C with the test reader (sensitivity 76.2% specificity 98.1%). There are IgG tests available that can be used to accurately classify individuals with previous DENV infection as eligible for dengue vaccination to support safe vaccine implementation. IMPORTANCE: The Advisory Committee on Immunization Practices (ACIP) has set forth recommendations that dengue pre-vaccination screening tests must exhibit at least 98% specificity and 75% sensitivity. Our research rigorously assesses the performance of various commercial tests against these benchmarks using well-characterized specimens from Puerto Rico. The findings from our study are particularly relevant given FDA approval and ACIP recommendation of Sanofi Pasteur's Dengvaxia vaccine, highlighting the need for accurate pre-vaccination screening tools.
Subject(s)
Antibodies, Viral , Dengue Vaccines , Dengue Virus , Dengue , Immunoglobulin G , Sensitivity and Specificity , Humans , Dengue/diagnosis , Dengue/prevention & control , Dengue/immunology , Immunoglobulin G/blood , Dengue Virus/immunology , Child , Antibodies, Viral/blood , Adolescent , Dengue Vaccines/immunology , Puerto Rico , Enzyme-Linked Immunosorbent Assay/methods , Male , Female , Vaccination , Neutralization Tests/methodsABSTRACT
The diagnosis of dengue disease, caused by the dengue virus (DENV) (a flavivirus), often requires serologic testing during acute and early convalescent phases of the disease. Some symptoms of DENV infection, such as nonspecific fever, are similar to those caused by infection with SARS-CoV-2, the virus that causes COVID-19. In studies with few COVID-19 cases, positive DENV immunoglobulin M (IgM) results were reported with various serologic tests, indicating possible cross-reactivity in these tests for DENV and SARS-CoV-2 infections (1,2). DENV antibodies can cross-react with other flaviviruses, including Zika virus. To assess the potential cross-reactivity of SARS-CoV-2, DENV, and Zika virus IgM antibodies, serum specimens from 97 patients from Puerto Rico and 12 U.S.-based patients with confirmed COVID-19 were tested using the DENV Detect IgM Capture enzyme-linked immunosorbent assay (ELISA) (InBios International).* In addition, 122 serum specimens from patients with confirmed dengue and 121 from patients with confirmed Zika virus disease (all from Puerto Rico) were tested using the SARS-CoV-2 pan-Ig Spike Protein ELISA (CDC). Results obtained for DENV, Zika virus IgM, and SARS-CoV-2 antibodies indicated 98% test specificity and minimal levels of cross-reactivity between the two flaviviruses and SARS-CoV-2. These findings indicate that diagnoses of dengue or Zika virus diseases with the serological assays described in this report are not affected by COVID-19, nor do dengue or Zika virus diseases interfere with the diagnosis of COVID-19.
Subject(s)
Antibodies, Viral/blood , Dengue Virus/immunology , Immunoglobulin M/immunology , SARS-CoV-2/immunology , Serologic Tests , Zika Virus/immunology , COVID-19/diagnosis , Cross Reactions/immunology , Dengue/diagnosis , Enzyme-Linked Immunosorbent Assay , Humans , Puerto Rico , Sensitivity and Specificity , United States , Zika Virus Infection/diagnosisABSTRACT
Objetivo: revisar las bases histológicas y los criterios diagnósticos diferenciales de la aplicación de la inmunohistoquímica en la patología mamaria. Caso clínico : se presenta el caso de una paciente con lesión mamaria esclerosante compleja, tipo adenosis microglandular (MGA), que requirió el uso de inmunohistoquímica como técnica auxiliar para diferenciar la lesión de un adenocarcinoma de mama in situ, y definir así el tratamiento. Materiales y métodos: se realizó una búsqueda de la información en las bases de datos Medline vía PubMed, SciELO y en libros de la especialidad. Se reportaron 25 títulos, 12 correspondían con el tema: 4 reportes de caso, 1 con revisión de la literatura, una carta al editor y 7 artículos relacionados de forma más general con el tema. Conclusión: la inmunohistoquímica permite hacer el diagnóstico diferencial de las lesiones mamarias complejas, como la adenosis esclerosante y el cáncer de mama in situ o microinvasor.
Objective: reviewing the histological basis and differential diagnostic criteria for applying immunohistochemistry in breast pathology. Clinical case: the case of a patient suffering from complex sclerosing lesion (CSL) of the breast, microglandular adenosis (MGA) pattern is presented; she required immunohistochemistry as an auxiliary technique for differentiating an adenocarcinoma-related breast lesion in situ and thus defining its treatment. Materials and methods: a search was made of the pertinent information in Medline databases via PubMed, SciELO and in books on the specialty; 25 titles were reported, 12 of them corresponding to the immediate topic: 4 were case reports with a literature review and one was a letter to the editor. 7 articles dealt with the topic in a more general way. Conclusion: immunohistochemistry led to the differential diagnosis of complex breast lesions such as sclerosing adenosis, and in situ or microinvase breast cancer.
Subject(s)
Adult , Female , Breast , PathologyABSTRACT
Objetivo: revisar la epidemiología y el cuadro histopatológico de los sarcomas uterinos. Presentación del caso: mujer de 35 años de edad atendida en el Hospital General de Medellín (Hospital de 3er nivel de atención, público, centro de referencia Obstétrica), por sangrado genital. Presentaba anemia y masa pélvica, que en el estudio histopatológico mostró como leiomiosarcoma uterino de alto grado. Discusión: se describe como una lesión tumoral benigna atípica con celularidad variable, degenera en una lesión leiomiosarcoma de comportamiento agresivo, con intervalo de ataques de síntomas en fase temprana.