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1.
Arch. argent. pediatr ; 121(5): e202202908, oct. 2023. tab
Article in English, Spanish | LILACS, BINACIS | ID: biblio-1509498

ABSTRACT

Introducción. La pandemia por COVID-19 ha puesto de manifiesto la necesidad de pruebas diagnósticas rápidas. La prueba de referencia es la reacción en cadena de la polimerasa en tiempo real (RT-PCR). Requiere un equipo y personal capacitado, y su resultado puede llevar un tiempo de espera prolongado. El sistema BD Veritor® es el método rápido cromatográfico utilizado para la detección del antígeno del coronavirus de tipo 2 del síndrome respiratorio agudo grave, en individuos sintomáticos. El objetivo primario del siguiente trabajo es evaluar sensibilidad y especificidad del test de antígeno (TA) comparadas con la RT-PCR en población pediátrica. Población y métodos. Estudio prospectivo, de prueba diagnóstica. Se incluyó a todo menor de 17 años en los primeros 5 días de inicio de síntomas, que consultó desde julio de 2021 hasta febrero de 2022. Se calculó un mínimo de 300 muestras para lograr una precisión de ± 8,76 % y de ± 3,68 % para sensibilidad y especificidad respectivamente. Se analizaron en paralelo las muestras por ambas metodologías. Resultados. De 316 muestras pareadas, 33 fueron positivas por ambos métodos; 6 fueron positivas solo por RT-PCR. La especificidad del TA fue del 100 %; la sensibilidad, del 84,6 %, con un valor predictivo positivo y negativo del 100 % y del 98 % respectivamente. Conclusiones. El TA demostró ser útil en el diagnóstico de pacientes pediátricos con COVID-19 en los primeros 5 días de inicio de síntomas, aunque aquellos con TA negativo y alta sospecha clínica deberían confirmar su resultado con la RT-PCR.


Introduction. The COVID-19 pandemic has brought to light the need for rapid diagnostic tests. The gold standard test is reverse transcription-polymerase chain reaction (RT-PCR). RT-PCR requires equipment and trained personnel, and results may take a long waiting time. The BD Veritor® System is a rapid chromatographic method used for the detection of severe acute respiratory syndrome coronavirus 2 antigen in symptomatic individuals. The primary objective of this study is to assess the sensitivity and specificity of the antigen test (AT) compared to the RT-PCR in the pediatric population. Population and methods. Prospective study with a diagnostic test. All children younger than 17 years in the first 5 days of symptom onset, who consulted between July 2021 and February 2022, were included. A minimum of 300 specimens was estimated to achieve an accuracy of ±8.76% and ±3.68% for sensitivity and specificity, respectively. Specimens were analyzed in parallel using both methodologies. Results. Of 316 paired samples, 33 were positive by both methods; 6 were positive only by RT-PCR. The specificity of the AT was 100%; sensitivity was 84.6%, with a positive and negative predictive value of 100% and 98%, respectively. Conclusions. The AT proved to be useful in the diagnosis of pediatric patients with COVID-19 in the first 5 days of symptom onset, although those with a negative AT and high clinical suspicion should confirm their result with a RT-PCR.


Subject(s)
Humans , Infant, Newborn , Infant , Child, Preschool , Child , Adolescent , COVID-19/diagnosis , Prospective Studies , Sensitivity and Specificity , Reverse Transcriptase Polymerase Chain Reaction , Reverse Transcription , Pandemics , COVID-19 Testing , SARS-CoV-2
2.
Int. j. morphol ; 41(5): 1461-1466, oct. 2023. tab, graf
Article in English | LILACS | ID: biblio-1521034

ABSTRACT

SUMMARY: Measurements of the upper strait of the pelvis can be calculated using the Anterior Pelvic Index. The objective of the study was to determine the external validity and cut-off point of the API, to classify narrow pelvises from normal ones. We selected 214 women from 15 to 55 years old, 171 had vaginal delivery and 43 by caesarean section by feto-pelvic disproportion (FPD) of maternal origin, in whom the API was calculated, of which its mean difference was established with an alpha error of <0.05. Maximum values of sensitivity and specificity, ROC curve and Youden index were determined. The student's t gave a p-value =0.000 of the mean difference between the women who had vaginal delivery and those who had cesarean section by FPD of maternal origin; the value of the area under the ROC curve was 0.758 (CI 95% 0.695 - 0.814) with a p-value=0.0001. Maximum sensitivity was 74.42 % (CI 95%: 58.8 % to 86.5 %) and maximum specificity was 73.10 % (CI 95%: 65.8 % to 79.6 %), produced a Youden index of 0.475 (CI 95% 0.283 - 0.590) which is associated with the 15.44 (CI 95% 14.19 - 15.83) of the API scale. The API is a good tool for predicting women with suspected narrow pelvis and allows its classification into three types of pelvises: an API value of more than 15.83 would indicate pelvis suitable for vaginal delivery; an API value between 14.19 and 15.83 would be suspected of pelvic narrowness; an API value less than 14.19 would confirm a narrow pelvis.


Las medidas del estrecho superior de la pelvis pueden calcularse mediante el Índice Pelviano Anterior. El objetivo del estudio fue determinar la validez externa y el punto de corte del API, para clasificar pelvis estrechas de las normales. Seleccionamos 214 mujeres de 15 a 55 años, 171 tuvieron parto vaginal y 43 mediante cesárea por DFP de origen materno, en quienes se calculó el API, del cual se estableció su diferencia de medias con un error alfa de <0,05. Se determinaron valores máximos de sensibilidad y especificidad, curva ROC e índice de Youden. La t de Student dio un p-valor=0,000 de la diferencia de medias entre las mujeres de tuvieron parto vaginal y las que fueron sometidas a cesárea por DFP de origen materno; el valor del área bajo la curva ROC fue 0,758 (IC 95% 0,695 - 0,814) con un p- valor=0,0001. La máxima sensibilidad (74,42 %. IC 95%: 58,8 % a 86,5 %) y máxima especificidad (73,10 %. IC 95%: 65,8 % a 79,6 %), produjeron un índice de Youden de 0,475 (IC 95% 0,283 - 0,590) el cual está asociado al valor 15,44 (IC 95% 14,19 - 15,83) de la escala del API. El API es una buena herramienta de predicción de mujeres con sospecha de pelvis estrecha y permite su clasificación en tres tipos de pelvis: un valor de API de mas de 15,83 indicaría pelvis aptas para un parto vaginal; un valor de API entre 14,19 y 15,83 se sospecharía de estrechez pélvica; un valor de API menor a 14,19 confirmaría una pelvis estrecha.


Subject(s)
Humans , Female , Pregnancy , Adolescent , Adult , Middle Aged , Young Adult , Pelvimetry/methods , Cephalopelvic Disproportion/diagnosis , Cross-Sectional Studies , Predictive Value of Tests , ROC Curve , Sensitivity and Specificity
3.
Int. j. morphol ; 41(4): 1036-1042, ago. 2023. ilus, tab
Article in Spanish | LILACS | ID: biblio-1514342

ABSTRACT

La anemia afecta a miles de niños. Para el diagnóstico se cuantifica la hemoglobina (Hb); técnica que no se encuentra al alcance de toda la población. Contar con un instrumento validado de fácil aplicación, puede ayudar al diagnóstico. El objetivo de este estudio fue validar una aplicación móvil (APP) para diagnosticar anemia en niños de 2 a 5 años, aplicable por padres o tutores. Estudio de validación de escalas. Mediante búsqueda bibliografía se recopilaron ítems y dominios relacionados con anemia en niños. Una vez reducidos, se construyó un cuestionario para pilotaje, con tres hematólogos pediatras. El resultado de este fue posteriormente validado por 22 expertos mediante aplicación de escalas tipo Likert. Los ítems validados, se contrastaron con la Hb de niños de 267 niños de 2 a 5 años de los andes ecuatorianos (2.560 msnm). Se determinó asociación de los ítems con Hb y con los resultados obtenidos y se construyó la APP. 14 ítems fueron analizados. Todos ellos puntuaron sobre la mediana de la distribución (35,5 puntos) y fueron valorados por, al menos el 50 % de los expertos. Se seleccionaron palidez palmar, astenia y sueño en horas no habituales. Todos mostraron asociación significativa con anemia (p<0,05), y fueron aplicados como preguntas a padres o tutores y contrastados con el valor de Hb. Sensibilidad y especificidad para palidez fue: 85,1 % y 85,0 %; astenia: 72,3 % y 87,7 %; sueño en horas no habituales: 68,1 % y 87,7 %; palidez más astenia o sueño: 95,7 % y 74,6 %; y debilidad más sueño: 92,5 % y 76,8 %. Se desarrolló y validó una APP para diagnóstico de anemia en niños de 2 a 5 años aplicable por padres o tutores.


SUMMARY: Anemia affects thousands of children, and to reach a diagnosis, hemoglobin (Hb) is quantified. This technique however, is not always accessible to the general population. Therefore, the availability of a validated instrument can be useful in the diagnosis. The aim of this study was to validate a mobile application (APP), to diagnose anemia in children from 2 to 5 years old, applicable by parents or guardians. Scale validation study. Through a bibliographic search, items and domains related to anemia in children were collected. Once reduced, a pilot questionnaire was constructed with three pediatric hematologists. The result was later validated by 22 experts through the application of the Likert-type scales. The validated items were contrasted with the Hb of children of 267 children from 2 to 5 years of age from the Ecuadorian Andes (2,560 meters above sea level). The association of the items with Hb and with the results obtained was determined, and the APP was constructed. 14 items were analyzed. All of them scored above the median of the distribution (35.5 points) and were valued by at least 50 % of the experts. Palmar pallor, asthenia, and sleep at unusual hours were selected. All showed a significant association with anemia (p<0.05) and were applied as questions to parents or guardians and contrasted with the Hb value. Sensitivity and specificity for pallor was: 85.1 % and 85.0 %; asthenia: 72.3 % and 87.7 %; sleep at unusual hours: 68.1 % and 87.7 %; paleness plus fatigue or sleepiness: 95.7 % and 74.6 %; and weakness plus sleep: 92.5 % and 76.8 %. An APP for the diagnosis of anemia in children from 2 to 5 years old applicable by parents or guardians was developed and validated.


Subject(s)
Humans , Male , Female , Child, Preschool , Adult , Mobile Applications , Anemia/diagnosis , Surveys and Questionnaires , Sensitivity and Specificity
4.
Rev. chil. obstet. ginecol. (En línea) ; 88(3): 138-142, jun. 2023. tab
Article in Spanish | LILACS | ID: biblio-1515202

ABSTRACT

Objetivo: Determinar el grupo RhD fetal a través del estudio del gen RHD en ADN fetal que se encuentra libre en plasma de embarazadas RhD negativo. Método: Se analizó la presencia de los genes RHD, SRY y BGLO en ADNfl obtenido de plasma de 51 embarazadas RhD negativo no sensibilizadas, utilizando una qPCR. Los resultados del estudio genético del gen RHD se compararon con el estudio del grupo sanguíneo RhD realizado por método serológico en muestras de sangre de cordón, y los resultados del estudio del gen SRY fueron cotejados con el sexo fetal determinado por ecografía. Se calcularon la sensibilidad, la especificidad, los valores predictivos y la capacidad discriminativa del método estandarizado. Resultados: El gen RHD estaba presente en el 72,5% de las muestras y el gen SRY en el 55,5%, coincidiendo en un 100% con los resultados del grupo RhD detectado en sangre de cordón y con el sexo fetal confirmado por ecografía, respectivamente. Conclusiones: Fue posible deducir el grupo sanguíneo RhD del feto mediante el estudio del ADN fetal que se encuentra libre en el plasma de embarazadas con un método molecular no invasivo desarrollado y validado para este fin. Este test no invasivo puede ser utilizado para tomar la decisión de administrar inmunoglobulina anti-D solo a embarazadas RhD negativo que portan un feto RhD positivo.


Objective: To determine the fetal RhD group through the study of the RHD gene in fetal DNA found free in plasma of RhD negative pregnant women. Method: The presence of the RHD, SRY and BGLO genes in fetal DNA obtained from plasma of 51 non-sensitized RhD negative pregnant women was analyzed using qPCR. The results of the genetic study of the RHD gene were compared with the RhD blood group study performed by serological method in cord blood samples, and the results of the SRY gene study were compared with the fetal sex determined by ultrasound. Sensitivity, specificity, predictive values and discriminative capacity of the standardized method were calculated. Results: The RHD gene was present in 72.5% of the samples and the SRY gene in 55.5%, coinciding 100% with the results of the RhD group detected in cord blood, and with the fetal sex confirmed by ultrasound, respectively. Conclusions: It was possible to deduce the RhD blood group of the fetus through the study of fetal DNA found free in the plasma of pregnant women with a non-invasive molecular method developed and validated for this purpose. This non-invasive test can be used to make the decision to administer anti-D immunoglobulin only to RhD-negative pregnant women carrying an RhD-positive fetus.


Subject(s)
Humans , Female , Pregnancy , Rh-Hr Blood-Group System/genetics , DNA , Erythroblastosis, Fetal/diagnosis , Erythroblastosis, Fetal/genetics , Phenotype , Prenatal Diagnosis , Rh-Hr Blood-Group System/blood , Predictive Value of Tests , Sensitivity and Specificity , Rho(D) Immune Globulin , Genes, sry/genetics , Erythroblastosis, Fetal/blood , Fetal Diseases/diagnosis , Fetal Diseases/genetics , Fetal Diseases/blood , Genotype
5.
Int. j. morphol ; 41(1): 25-29, feb. 2023. tab, graf
Article in English | LILACS | ID: biblio-1430513

ABSTRACT

SUMMARY: Digit ratio established in utero is positivelly correlated with intrauterine level of estrogen. Since the breast cancer is related to excessive and prolonged exposure to estrogen, digit ratio might be considered as useful marker in breast cancer risk assessment. The aim of the present study was to compare digit ratios in breast cancer patients and healthy controls. The study group consisted of 98 breast cancer patients aged between 29 to 84 years while the control group included 141 healthy women aged between 21 and 67 years. After collecting anamnestic data concerning menopausal status, the length of second and fourth fingers were measured and the digit ratios were calculated for both hands, as well as the difference between right and left digit ratio. Digit ratio was significantly higher on right hand in breast cancer patients compaired to healthy controls (1.003±0.05 vs. 0.990±0.03). Right digit ratio showed better predictive capacity for the breast cancer development then the left (AUC:0.609 vs. 0.541). Negative statistically significant correlation between right digit ratio and the age of breast cancer diagnosis was observed (r=-0.271). Higher values of right digit ratio in women with breast cancer when compared to healthy women suggest their higher prenatal estrogen exposure that confirms the importance of digit ratio determination in breast cancer risk assessment.


La proporción de dígitos establecida en el útero, se correlaciona positivamente con el nivel intrauterino de estrógeno. Dado que el cáncer de mama está relacionado con una exposición excesiva y prolongada a los estrógenos, la proporción de dígitos podría considerarse un marcador útil en la evaluación del riesgo de cáncer de mama. El objetivo del presente estudio fue comparar proporciones de dígitos en pacientes con cáncer de mama y controles sanos. El grupo de estudio consistió en 98 pacientes con cáncer de mama con edades comprendidas entre los 29 y los 84 años, mientras que el grupo de control incluyó a 141 mujeres sanas con edades comprendidas entre los 21 y los 67 años. Después de recopilar datos anamnésticos sobre el estado menopáusico, se midió la longitud de los dedos segundo y anular y se calcularon las proporciones de los dedos para ambas manos, así como la diferencia entre la proporción de los dedos derecho e izquierdo. La proporción de dígitos fue significativamente mayor en la mano derecha en pacientes con cáncer de mama en comparación con controles sanos (1,003 ± 0,05 frente a 0,990 ± 0,03). La proporción del dígito derecho mostró una mejor capacidad predictiva para el desarrollo de cáncer de mama que el izquierdo (AUC: 0.609 vs. 0.541). Se observó una correlación estadísticamente significativa negativa entre la proporción de dígitos derechos y la edad del diagnóstico de cáncer de mama (r=-0,271). Los valores más altos de la proporción de dígitos derechos en mujeres con cáncer de mama en comparación con mujeres sanas sugieren una mayor exposición prenatal a estrógenos que confirma la importancia de la determinación de la proporción de dígitos en la evaluación del riesgo de cáncer de mama.


Subject(s)
Humans , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Young Adult , Breast Neoplasms/diagnosis , Breast Neoplasms/pathology , Fingers/anatomy & histology , ROC Curve , Sensitivity and Specificity , Age Factors , Digit Ratios
6.
ABCS health sci ; 48: e023225, 14 fev. 2023. tab
Article in English | LILACS | ID: biblio-1518574

ABSTRACT

INTRODUCTION: Studies have suggested using thermography as a resource to diagnose fibromyalgia, although there has been no evidence confirming this hypothesis so far. OBJECTIVE: To evaluate the sensitivity and specificity of computerized infrared thermography as an auxiliary method for diagnosing fibromyalgia. METHODS: It is a diagnostic accuracy studywith cross-sectional design. One hundred and three individuals were evaluated for global pain using the Visual Analogue Scale. The measurement of pain at tender points was assessed by algometry, and skin temperature was assessed by thermography. To evaluate sensitivity and specificity, the analysis was performed using the Receiver Operating Characteristic Curve, measured by the area under the curve with their respective confidence intervals. RESULTS: Thermography has not been very sensitive or specific for pain (tender points) and diagnosis of fibromyalgia, according to the evaluation of the Receiver Operating Characteristic Curve, with an area under the curve equal to or lower than 0.75. CONCLUSION: In this study the thermography was not sensitive and specific as a tool for diagnosing the fibromyalgia syndrome. This study highlights important clinical implications concerning the current methods for diagnosing it, which, despite all efforts, are still subjective and poorly reproducible.


Subject(s)
Humans , Female , Adult , Middle Aged , Thermography , Fibromyalgia/diagnosis , Sensitivity and Specificity , Cross-Sectional Studies
7.
Article in English | LILACS | ID: biblio-1429004

ABSTRACT

Cervical cancer is still one of the leading causes of cancer and mortality in women, especially in low- and middle-income countries. Normally, the prevention of its occurrence is done through efficient screening and treatment programs for high-grade epithelial lesions, which are pre-malignant lesions. Cheaper diagnostic techniques ensure greater access to women, which can prevent a large number of cancer cases worldwide. Objective: The aim of the study was to evaluate the accuracy of visual inspection either with acetic acid or with Lugol's iodine, cervical cytology and colposcopy in the diagnosis of cervical intraepithelial neoplasia 2 and 3. Methods: This is a study of diagnostic accuracy. We evaluated 115 women with high-grade squamous intraepithelial lesion confirmed by biopsy, 54 with cervical intraepithelial neoplasia 2 and 61 with cervical intraepithelial neoplasia 3, from January 2016 to December 2018 at the Lower Genital Tract Pathology and Colposcopy Service of the Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil. A comparative analysis of the visual inspection, Pap smear and colposcopy diagnostic methods was performed. Results: The average age was 33.1 years (standard deviation=9.83) for cervical intraepithelial neoplasia 2 cases and 35.2 years (standard deviation=7.97) for cervical intraepithelial neoplasia 3. In the cervical intraepithelial neoplasia 2 group, visual inspection tests were positive for high-grade squamous intraepithelial lesion in 98.1% of the cases with acetic acid and 94.4% with Lugol's iodine. Colposcopy identified a probable high-grade squamous intraepithelial lesion in 94.4% of the cases, while cytology only in 42.6%. In the cervical intraepithelial neoplasia 3 group, the visual inspection tests were positive for high-grade squamous intraepithelial lesion in 91.8% of the cases with acetic acid and 95.1% with Lugol's iodine. Colposcopy identified a probable high-grade squamous intraepithelial lesion in 93.5% of the cases, while cytology in 65.6%. Conclusion: Visual inspection with acetic acid and Lugol's iodine, and colposcopy test were more accurate for the diagnosis of cervical intraepithelial neoplasia 2 and 3 than through cytopathology. (AU)


Introdução: O câncer do colo de útero ainda é uma das principais causas de câncer e mortalidade em mulheres, especialmente em países de baixa e média renda. Normalmente, a prevenção de sua ocorrência é feita por meio de programas eficientes de triagem e tratamento de lesões epiteliais de alto grau, que são as lesões pré-malignas. Técnicas diagnósticas mais baratas garantem maior acesso às mulheres, podendo evitar um grande número de casos de câncer no mundo inteiro. Objetivo: O objetivo deste estudo foi avaliar a acurácia da inspeção visual (com ácido acético e com solução de lugol), da citologia cervical e da colposcopia no diagnóstico de neoplasias intraepiteliais cervicais 2/3. Métodos: Trata-se de um estudo de acurácia diagnóstica. Foram avaliadas 115 mulheres com lesão intraepitelial escamosa de alto grau confirmada por biópsia, 54 com neoplasias intraepiteliais cervicais 2 e 61 com neoplasias intraepiteliais cervicais 3, no período de janeiro de 2016 a dezembro de 2018 no Serviço de Patologia e Colposcopia do Trato Genital Inferior do Hospital de Clínicas de Porto Alegre, em Porto Alegre, Brasil. Foi realizada análise comparativa dos métodos de diagnóstico Inspeção visual com ácido acético, Inspeção visual com Solução de Lugol, colpocitologia oncótica e colposcopia. Resultados: A média de idade foi de 33,11 anos (DP 9,83) para os casos de neoplasias intraepiteliais cervicais 2 e de 35,28 anos (DP 7,97) para neoplasias intraepiteliais cervicais 3. No grupo de neoplasias intraepiteliais cervicais 2, os testes de inspeção visual foram positivos para tratamento de lesões epiteliais de alto grau em 98,1% dos casos com Inspeção visual com ácido acético e em 94,4% daqueles com Inspeção visual com Solução de Lugol. A colposcopia identificou provável tratamento de lesões epiteliais de alto grau em 94,4% dos casos, enquanto a citologia apenas 42,6%. No grupo neoplasias intraepiteliais cervicais 3, os testes de inspeção visual foram positivos para tratamento de lesões epiteliais de alto grau em 91,8% dos casos com Inspeção visual com ácido acético e em 95,1% daqueles com Inspeção visual com Solução de Lugol. A colposcopia identificou provável tratamento de lesões epiteliais de alto grau em 93,5% dos casos, enquanto a citologia em 65,6%. Conclusão: A inspeção visual (com ácido acético e com Solução de Lugol) e a colposcopia foram mais precisas para o diagnóstico de neoplasias intraepiteliais cervicais 2/3 do que a citopatologia. (AU)


Subject(s)
Humans , Female , Adult , Young Adult , Uterine Cervical Dysplasia/diagnosis , Colposcopy , Papanicolaou Test , Reproducibility of Results , Sensitivity and Specificity , Early Detection of Cancer
8.
Chinese Journal of Pathology ; (12): 472-479, 2023.
Article in Chinese | WPRIM | ID: wpr-985703

ABSTRACT

Objective: To explore the diagnostic values of HK2 testing and single-cell sequencing in the urothelial carcinoma (UC). Methods: The qualified urine specimens of 265 suspected UC patients or postoperative patients from the Cancer Hospital of Chinese Academy of Medical Sciences, Beijing, China were collected. Both exfoliative cytology and HK2 testing were performed on clinically suspected UC or postoperative patients. The performance of diagnostic cytology and HK2, including consistency, sensitivity, specificity, positive predictive value and negative predictive value, was evaluated based on histopathological, clinical and imaging diagnosis. Isolated HK2 metabolically abnormal cells were subject to single-cell sequencing to verify the reliability of HK2 detection performance and to explore the molecular characteristics of UC. Results: The concordance rate of HK2 testing and cytology for detecting UC was 90.3% (102/113, Kappa=0.604). Compared with cytology, the sensitivity of HK2 was significantly higher (85.2% versus 75.6%, P=0.024). The detection sensitivity of combined HK2 testing and cytology was increased to 91.1%. HK2 testing was significantly more sensitive than cytology for diagnosing UC in the upper urinary tract (81.8% versus 65.5%, P=0.022). It was also more sensitive than cytology for diagnosing early-stage UC (82.6% versus 69.5%, P=0.375) and low-grade UC (69.6% versus 47.8%, P=0.125). Single-cell sequencing of the ten patients, whose samples were positive for HK2, demonstrated highly concordant copy number variations (CNVs) in tumor cells from the same UC patient, with heterogeneity in CNV profiles among different patients. Deletion of chromosome 8p was found in 3 of the 4 urine samples of renal pelvis UC. The 2 patients with benign lesions had no CNVs in all sequenced cells. Conclusions: The test for abnormal urinary glycolytic HK2 metabolism can assist urine cytology to improve the sensitivity of UC diagnosis, and it provides a novel and reliable approach for early detection of upper urinary tract UC and lower grade UC. Meanwhile, this study has preliminarily revealed the feasibility of single-cell sequencing in urinary samples, which is expected to improve the diagnostic specificity of HK2 testing.


Subject(s)
Humans , Urinary Bladder Neoplasms/diagnosis , Carcinoma, Transitional Cell/pathology , Reproducibility of Results , DNA Copy Number Variations , Kidney Neoplasms , Ureteral Neoplasms , Sensitivity and Specificity
9.
Chinese Journal of Pathology ; (12): 466-471, 2023.
Article in Chinese | WPRIM | ID: wpr-985702

ABSTRACT

Objective: To evaluate the clinical value of the MeltPro MTB assays in the diagnosis of drug-resistant tuberculosis. Methods: A cross-sectional study design was used to retrospectively collect all 4 551 patients with confirmed tuberculosis between January 2018 and December 2019 at Beijing Chest Hospital, Capital Medical University. Phenotypic drug sensitivity test and GeneXpert MTB/RIF (hereafter referred to as "Xpert") assay were used as gold standards to analyze the accuracy of the probe melting curve method. The clinical value of this technique was also evaluated as a complementary method to conventional assays of drug resistance to increase the detective rate of drug-resistant tuberculosis. Results: By taking the phenotypic drug susceptibility test as the gold standard, the sensitivity of the MeltPro MTB assays to detect resistance to rifampicin, isoniazid, ethambutol and fluoroquinolone was 14/15, 95.7%(22/23), 2/4 and 8/9,respectively; and the specificity was 92.0%(115/125), 93.2%(109/117), 90.4%(123/136) and 93.9%(123/131),respectively; the overall concordance rate was 92.1%(95%CI:89.6%-94.1%),and the Kappa value of the consistency test was 0.63(95%CI:0.55-0.72).By taking the Xpert test results as the reference, the sensitivity of this technology to the detection of rifampicin resistance was 93.6%(44/47), the specificity was100%(310/310), the concordance rate was 99.2%(95%CI:97.6%-99.7%), and the Kappa value of the consistency test was 0.96(95%CI:0.93-0.99). The MeltPro MTB assays had been used in 4 551 confirmed patients; the proportion of patients who obtained effective drug resistance results increased from 83.3% to 87.8%(P<0.01); and detection rate of rifampicin, isoniazid, ethambutol, fluoroquinolone resistance, multidrug and pre-extensive drug resistance cases were increased by 3.2%, 14.7%, 22.2%, 13.7%, 11.2% and 12.5%, respectively. Conclusion: The MeltPro MTB assays show satisfactory accuracy in the diagnosis of drug-resistant tuberculosis. This molecular pathological test is an effective complementary method in improving test positivity of drug-resistant tuberculosis.


Subject(s)
Humans , Rifampin/therapeutic use , Antibiotics, Antitubercular/therapeutic use , Mycobacterium tuberculosis , Ethambutol/pharmacology , Isoniazid/pharmacology , Paraffin Embedding , Retrospective Studies , Cross-Sectional Studies , Drug Resistance, Bacterial , Sensitivity and Specificity , Tuberculosis, Multidrug-Resistant/drug therapy
10.
Article in Chinese | WPRIM | ID: wpr-985521

ABSTRACT

The application of metagenomic second-generation sequencing (mNGS) is shifting from research to clinical laboratories due to rapid technological advances and significant cost reductions. Although many studies and case reports have confirmed that the success of mNGS in improving the prevention, diagnosis, treatment and tracking of infectious diseases, there are still some obstacles that must be overcome. The results of mNGS show all the possible pathogens in the sample, however, in the face of thousands of microbes that can infect humans, it remains challenging to accurately identify the key pathogens. So far, there is no unified interpretation standard for mNGS in clinical practice. This article reviews the interpretation of mNGS results for pathogen infection in different systems, the clinical interpretation and application regulations of mNGS results, and the challenges of mNGS interpretation in pathogen diagnosis.


Subject(s)
Humans , Communicable Diseases , Metagenomics , Sensitivity and Specificity
11.
Article in Chinese | WPRIM | ID: wpr-985515

ABSTRACT

Objective: Compare and analyze the results of the domestic Lanyi AH600 glycated hemoglobin analyzer and other different detection systems to understand the comparability of the detection results of different detectors, and establish the best cut point of Lanyi AH600 determination of haemoglobin A1c (HbA1c) in the diagnosis of diabetes. Methods: Multi center cohort study was adopted. The clinical laboratory departments of 18 medical institutions independently collected test samples from their respective hospitals from March to April 2022, and independently completed comparative analysis of the evaluated instrument (Lanyi AH600) and the reference instrument HbA1c. The reference instruments include four different brands of glycosylated hemoglobin meters, including Arkray, Bio-Rad, DOSOH, and Huizhong. Scatter plot was used to calculate the correlation between the results of different detection systems, and the regression equation was calculated. The consistency analysis between the results of different detection systems was evaluated by Bland Altman method. Consistency judgment principles: (1) When the 95% limits of agreement (95% LoA) of the measurement difference was within 0.4% HbA1c and the measurement score was≥80 points, the comparison consistency was good; (2) When the measurement difference of 95% LoA exceeded 0.4% HbA1c, and the measurement score was≥80 points, the comparison consistency was relatively good; (3) The measurement score was less than 80 points, the comparison consistency was poor. The difference between the results of different detection systems was tested by paired sample T test or Wilcoxon paired sign rank sum test; The best cut-off point of diabetes was analyzed by receiver operating characteristic curve (ROC). Results: The correlation coefficient R2 of results between Lanyi AH600 and the reference instrument in 16 hospitals is≥0.99; The Bland Altman consistency analysis showed that the difference of 95% LoA in Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180) was -0.486%-0.325%, and the measurement score was 94.6 points (473/500); The difference of 95% LoA in the Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant II) was -0.727%-0.612%, and the measurement score was 89.8 points; The difference of 95% LoA in the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT) was -0.231%-0.461%, and the measurement score was 96.6 points; The difference of 95% LoA in the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT) was -0.469%-0.479%, and the measurement score was 91.9 points. The other 14 hospitals, Lanyi AH600, were compared with 4 reference instrument brands, the difference of 95% LoA was less than 0.4% HbA1c, and the scores were all greater than 95 points. The results of paired sample T test or Wilcoxon paired sign rank sum test showed that there was no statistically significant difference between Lanyi AH600 and the reference instrument Arkray HA8180 (Z=1.665,P=0.096), with no statistical difference. The mean difference between the measured values of the two instruments was 0.004%. The comparison data of Lanyi AH600 and the reference instrument of all other institutions had significant differences (all P<0.001), however, it was necessary to consider whether it was within the clinical acceptable range in combination with the results of the Bland-Altman consistency analysis. The ROC curve of HbA1c detected by Lanyi AH600 in 985 patients with diabetes and 3 423 patients with non-diabetes was analyzed, the area under curve (AUC) was 0.877, the standard error was 0.007, and the 95% confidence interval 95%CI was (0.864, 0.891), which was statistically significant (P<0.001). The maximum value of Youden index was 0.634, and the corresponding HbA1c cut point was 6.235%. The sensitivity and specificity of diabetes diagnosis were 76.2% and 87.2%, respectively. Conclusion: Among the hospitals and instruments currently included in this study, among these four hospitals included Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180), Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant Ⅱ), the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT), and the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT), the comparison between Lanyi AH600 and the reference instruments showed relatively good consistency, while the other 14 hospitals involved four different brands of reference instruments: Arkray, Bio-Rad, DOSOH, and Huizhong, Lanyi AH600 had good consistency with its comparison. The best cut point of the domestic Lanyi AH600 for detecting HbA1c in the diagnosis of diabetes is 6.235%.


Subject(s)
Pregnancy , Child , Humans , Female , Glycated Hemoglobin , Cohort Studies , Diabetes Mellitus/diagnosis , Sensitivity and Specificity , ROC Curve
12.
Article in Chinese | WPRIM | ID: wpr-985446

ABSTRACT

Objective: To explore the application of up-conversing phosphor technology (UPT) to detect pathogenic organisms in the air. Methods: The performance of UPT was verified with Staphylococcus aureus, Yersinia pestis and Escherichia coli O157 as simulated strains, including stability, specificity, sensitivity and response time tests; Air particle sampler is used to collect air samples in the field microenvironment test chamber, and UPT is used for detection. At the same time, compared with the traditional culture method, the practicability of UPT is verified. Results: The coefficient of variation in laboratory was 9.62% and 8.02% when the concentration of 107 CFU/ml and 108 CFU/ml were detected by UPT. The results were less than the allowable target, and the detection system had good stability. The specificity of UPT was verified by Staphylococcus aureus. The results showed that no non-Staphylococcus aureus was detected, and the positive detection rate of different kinds of Staphylococcus aureus was 100%. The specificity of the detection system was good. The sensitivity of UPT for detecting Staphylococcus aureus was 104 CFU/ml. Detection sensitivity of Yersinia pestis ≥103 CFU/ml; The detection sensitivity of Escherichia coli O157 is ≥103 CFU/ml, and the response time of UPT to bacteria is within 15 min (all 10 min 15 s). The detection results of bacteria contentration in the air of the on-site microenvironment test cabin by UPT showed that when the concentration of Escherichia coli O157 in the air reached above 104 CFU/m3, the detection results of UPT were positive, and with the increase of air concentration, the numerical concentration measured by UPT showed an upward trend, which was positively correlated with the concentration of bacteria in the air. Conclusion: UPT may be feasible as a rapid method to evaluate the species and contentration of pathogenic organisms in the air.


Subject(s)
Humans , Sensitivity and Specificity , Technology
13.
Article in Chinese | WPRIM | ID: wpr-981535

ABSTRACT

Cardiovascular disease is the leading cause of death worldwide, accounting for 48.0% of all deaths in Europe and 34.3% in the United States. Studies have shown that arterial stiffness takes precedence over vascular structural changes and is therefore considered to be an independent predictor of many cardiovascular diseases. At the same time, the characteristics of Korotkoff signal is related to vascular compliance. The purpose of this study is to explore the feasibility of detecting vascular stiffness based on the characteristics of Korotkoff signal. First, the Korotkoff signals of normal and stiff vessels were collected and preprocessed. Then the scattering features of Korotkoff signal were extracted by wavelet scattering network. Next, the long short-term memory (LSTM) network was established as a classification model to classify the normal and stiff vessels according to the scattering features. Finally, the performance of the classification model was evaluated by some parameters, such as accuracy, sensitivity, and specificity. In this study, 97 cases of Korotkoff signal were collected, including 47 cases from normal vessels and 50 cases from stiff vessels, which were divided into training set and test set according to the ratio of 8 : 2. The accuracy, sensitivity and specificity of the final classification model was 86.4%, 92.3% and 77.8%, respectively. At present, non-invasive screening method for vascular stiffness is very limited. The results of this study show that the characteristics of Korotkoff signal are affected by vascular compliance, and it is feasible to use the characteristics of Korotkoff signal to detect vascular stiffness. This study might be providing a new idea for non-invasive detection of vascular stiffness.


Subject(s)
Humans , Vascular Stiffness , Neural Networks, Computer , Cardiovascular Diseases/diagnosis , Sensitivity and Specificity
14.
Article in Chinese | WPRIM | ID: wpr-981288

ABSTRACT

Objective To investigate the clinical value of high-frequency ultrasound in the diagnosis of pronator teres syndrome (PTS). Methods The high-frequency ultrasound was employed to examine and measure the median nerve of the pronator teres muscle in 30 patients with PTS and 30 healthy volunteers (control group).The long-axis diameter (LA),short-axis diameter (SA) and cross-sectional area (CSA) of the median nerve were measured.The receiver operating characteristic curve of the median nerve ultrasonic measurement results was established,and the area under the curve (AUC) was calculated.The diagnostic efficiency of each index for PTS was compared with the surgical results as a reference. Results The PTS group showed larger LA[(5.02±0.50) mm vs.(3.89±0.41) mm;t=4.38,P=0.013],SA[(2.55±0.46) mm vs.(1.70±0.41) mm;t=5.19,P=0.009],and CSA[(11.13±3.72) mm2 vs.(6.88±2.68) mm2;t=8.42,P=0.008] of the median nerve than the control group.The AUC of CSA,SA,and LA was 94.3% (95%CI=0.912-0.972,Z=3.586,P=0.001),77.7% (95%CI=0.734-0.815,Z=2.855, P=0.006),and 78.8% (95%CI=0.752-0.821,Z=3.091,P=0.004),respectively.With 8.63 mm2 as the cutoff value,the sensitivity and specificity of CSA in diagnosing PTS were 93.3% and 90.0%,respectively. Conclusion High-frequency ultrasound is a practical method for diagnosing PTS,and the CSA of median nerve has a high diagnostic value.


Subject(s)
Humans , Forearm/innervation , Muscle, Skeletal/innervation , Median Nerve/diagnostic imaging , Ultrasonography/methods , Sensitivity and Specificity
15.
Article in Chinese | WPRIM | ID: wpr-971312

ABSTRACT

Objective To rapidly screen patients with novel coronavirus pneumonia (COVID-19) infection including asymptomatic ones. Method Established a rapid detection test kit, and evaluated analytical and clinical performance of it. Result The minimum limit of detection of the reagent was 9.75×102 TCID50/mL; there was no cross-reaction and interference in the high-concentration samples of 29 common respiratory pathogens tested. The diagnostic sensitivity of clinical samples was 98.56%, specificity was 99.00%, and the total coincidence rate was 98.85%; the consistency test Kappa value is 0.974 5. The stratified analysis of positive samples with different Ct values showed that the coincidence rate within each stratum was greater than 95%. Conclusion This COVID-19 antigen test kit with excellent detection performance, fast detection speed, and portable operation. It can be used as a supplementary method for existing nucleic acid detection methods for early screening of new coronavirus.


Subject(s)
Humans , COVID-19 , COVID-19 Testing , Sensitivity and Specificity , SARS-CoV-2
16.
Article in Chinese | WPRIM | ID: wpr-971176

ABSTRACT

Non-small cell lung cancer (NSCLC) can be detected with enlarged lymph nodes on imaging, but their benignity and malignancy are difficult to determine directly, making it difficult to stage the tumor and design radiotherapy target volumes. The clinical diagnosis of malignant lymph nodes is often based on the short diameter of lymph nodes ≥1 cm or the maximum standard uptake value ≥2.5, but the sensitivity and specificity of these criteria are too low to meet the clinical needs. In recent years, many advances have been made in diagnosing benign and malignant lymph nodes using other imaging parameters, and with the development of radiomics, deep learning and other technologies, models of mining the image information of enlarged lymph node regions further improve the diagnostic accuracy. The purpose of this paper is to review recent advances in imaging-based diagnosis of benign and malignant enlarged lymph nodes in NSCLC for more accurate and noninvasive assessment of lymph node status in clinical practice.
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Subject(s)
Humans , Carcinoma, Non-Small-Cell Lung/pathology , Diagnostic Imaging , Lung Neoplasms/pathology , Lymph Nodes/pathology , Sensitivity and Specificity
17.
Article in Chinese | WPRIM | ID: wpr-970938

ABSTRACT

Objective: To explore the etiological diagnostic value of metagenomic next-generation sequencing (mNGS) in peritoneal dialysis (PD)-related peritonitis. Methods: The study was a retrospective cohort study. The clinical data of patients with PD-related peritonitis who were treated and underwent microbial cultivation and mNGS test at the same time from June 2020 to July 2021 in the Affiliated Drum Tower Hospital, Medical School of Nanjing University were analyzed. The positive rate, detection time and consistency between mNGS test and traditional microbial culture were compared. Results: A total of 18 patients with age of (50.4±15.4) years old and median dialysis time of 34.0 (12.4, 62.0) months were enrolled in the study, including 11 males and 7 females. Pathogenic microorganisms were isolated in 17 patients by mNGS test, with a positive rate of 17/18, which was higher than 13/18 of microbial culture, but the difference was not statistically significant (P=0.219). Both mNGS test and microbial culture isolated positive pathogenic bacteria in 12 patients, and mNGS test isolated the same types of pathogenic bacteria as microbial cultivation did in 11 patients. In five patients with negative microbial culture, mNGS test also isolated pathogenic microorganisms, including 3 cases of Staphylococcus epidermidis, 1 case of Mycobacterium tuberculosis and 1 case of Ureaplasma urealyticum. In 1 patient, microbial culture isolated pathogenic bacteria (Escherichia coli) whereas mNGS test did not. The detection time of mNGS was 25.0 (24.0, 27.0) h, which was significantly shorter than 89.0 (72.8, 122.0) h of microbial culture (Z=3.726, P<0.001). Conclusions: mNGS test can improve the detection rate of pathogenic microorganisms in PD-related peritonitis and greatly shorten the detection time, and has good consistency with microbial culture. mNGS may provide a new approach for pathogen identification of PD-related peritonitis, especially refractory peritonitis.


Subject(s)
Female , Male , Humans , Adult , Middle Aged , Aged , Retrospective Studies , Peritoneal Dialysis/adverse effects , High-Throughput Nucleotide Sequencing , Peritonitis/diagnosis , Sensitivity and Specificity
18.
Chinese Journal of Pathology ; (12): 142-146, 2023.
Article in Chinese | WPRIM | ID: wpr-970148

ABSTRACT

Objective: To explore the feasibility and application value of intraoperative direct immunohistochemical (IHC) staining in improving the diagnosis accuracy in difficult cases of bronchiolar adenoma (BA). Methods: Nineteen cases with single or multiple pulmonary ground-glass nodules or solid nodules indicated by imaging in Cancer Hospital of Chinese Academy of Medical Sciences from January to July 2021 and with difficulty in differential diagnosis at frozen HE sections were selected. In the experimental group, direct IHC staining of cytokeratin 5/6 (CK5/6) and p63 was performed on frozen sections to assist the differentiation of BA from in situ/micro-invasive adenocarcinoma/adenocarcinoma/invasive mucinous adenocarcinoma. In the control group, two pathologists performed routine frozen HE section diagnosis on these 19 cases. The diagnostic results of paraffin sections were used as the gold standard. The sensitivity and specificity of BA diagnosis, consistency with paraffin diagnosis and time used for frozen diagnosis were compared between the experimental group and the control group. Results: The basal cells of BA were highlighted by CK5/6 and p63 staining. There were no basal cells in the in situ/microinvasive adenocarcinoma/adenocarcinoma/invasive mucinous adenocarcinoma. In the experimental group, the sensitivity and specificity with aid of direct IHC staining for BA were 100% and 86.7%, respectively, and the Kappa value of frozen and paraffin diagnosis was 0.732, and these were significantly higher than those in the control group (P<0.05). The average time consumption in the experimental group (32.4 min) was only 7 min longer than that in the control group (25.4 min). Conclusions: Direct IHC staining can improve the accuracy of BA diagnosis intraoperatively and reduce the risk of misdiagnosis, but require significantly longer time. Thus frozen direct IHC staining should be restricted to cases with difficulty in differentiating benign from malignant diseases, especially when the surgical modalities differ based on the frozen diagnosis.


Subject(s)
Humans , Paraffin , Sensitivity and Specificity , Adenocarcinoma in Situ , Adenoma/diagnosis , Adenocarcinoma, Mucinous/surgery , Frozen Sections/methods
19.
Article in Chinese | WPRIM | ID: wpr-969877

ABSTRACT

Objective: To establish a rapid and specific quantitative real-time PCR (qPCR) method for the detection of SARS-CoV-2 subgenomic nucleocapsid RNA (SgN) in patients with COVID-19 or environmental samples. Methods: The qPCR assay was established by designing specific primers and TaqMan probe based on the SARS-CoV-2 genomic sequence in Global Initiative of Sharing All Influenza Data (GISAID) database. The reaction conditions were optimized by using different annealing temperature, different primers and probe concentrations and the standard curve was established. Further, the specificity, sensitivity and repeatability were also assessed. The established SgN and genomic RNA (gRNA) qPCR assays were both applied to detect 21 environmental samples and 351 clinical samples containing 48 recovered patients. In the specimens with both positive gRNA and positive SgN, 25 specimens were inoculated on cells. Results: The primers and probes of SgN had good specificity for SARS-CoV-2. The minimum detection limit of the preliminarily established qPCR detection method for SgN was 1.5×102 copies/ml, with a coefficient of variation less than 1%. The positive rate of gRNA in 372 samples was 97.04% (361/372). The positive rates of SgN in positive environmental samples and positive clinical samples were 36.84% (7/19) and 49.42% (169/342), respectively. The positive rate and copy number of SgN in Wild strain were lower than those of SARS-CoV-2 Delta strain. Among the 25 SgN positive samples, 12 samples within 5 days of sampling time were all isolated with virus; 13 samples sampled for more than 12 days had no cytopathic effect. Conclusion: A qPCR method for the detection of SARS-CoV-2 SgN has been successfully established. The sensitivity, specificity and repeatability of this method are good.


Subject(s)
Humans , SARS-CoV-2/genetics , COVID-19/diagnosis , Subgenomic RNA , Real-Time Polymerase Chain Reaction/methods , RNA, Viral/genetics , Sensitivity and Specificity , Nucleocapsid/chemistry , COVID-19 Testing
20.
Article in Chinese | WPRIM | ID: wpr-969835

ABSTRACT

The laboratory diagnostic strategy for human immunodeficiency virus (HIV) is a process to accurately detect HIV patients through a combination of available HIV tests. Laboratory tests for HIV infection are mainly serological antibody and antigen testing and HIV RNA testing. With the update of testing reagents, the sensitivity and specificity have improved substantially and the window period of detection has shortened, but there is a risk of false positives. Various guidelines have recommended different diagnostic strategies for different target populations and different prevalence regions to guide patients to confirm the diagnosis and receive standardized antiretroviral therapy as early as possible. How to refer to the diagnostic strategies, reduce false positives and shorten the window period while increasing the detection rate is an urgent issue for laboratories to address. This article describes the characteristics and advantages and disadvantages of testing methods related to HIV infection from the perspective of laboratory diagnostic strategies, as well as the impact of the development of treatments on diagnostic strategies, in order to provide theoretical support for the practical application of HIV diagnostic strategies.


Subject(s)
Humans , HIV , HIV Infections/diagnosis , Sensitivity and Specificity , Clinical Laboratory Techniques/methods , Quality Control
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