A Brief Discussion on the in Vitro Diagnostic Reagent Inspection Practice of Self-examination Management Regulations for Medical Device Registration / 中国医疗器械杂志

On October 21, 2021, the National Medical Products Administration issued and implemented the Self-examination Management Regulations for Medical Device Registration. The regulations clarify the specific requirements of the registration applicants in the process of self-examination, and put forward detailed requirements from the aspects of self-examination ability, self-examination report, declaration materials and responsibility requirements, so as to ensure the orderly development of the self-examination of medical device registration. Based on the actual verification work of in vitro diagnostic reagent, this study briefly discussed the understanding of the relevant contents of the regulations, aiming to provide some reference for enterprises and related supervision departments that have the requirement of registered self-examination.

Concordancia entre métodos diagnósticos de infección por SARS-CoV-2 en niños asistidos en el departamento de urgencias de un hospital pediátrico / Agreement between diagnostic methods for SARS-CoV-2 infection in children seen at the Emergency Department of a children's hospital

Introducción. Los inmunoensayos de detección rápida de antígenos (TRA) del SARS-CoV-2, son considerados adecuados para el diagnóstico en el punto de atención. El objetivo fue conocer la concordancia entre la reacción en cadena de la polimerasa en tiempo real con transcriptasa inversa (RT-qPCR, por su sigla en inglés) y los TRA en población pediátrica. Población y métodos. Se reclutaron todos los pacientes entre 1 mes y 17 años 11 meses de edad atendidos en la Unidad Febril de Urgencia de un hospital pediátrico entre el 11 de junio y el 3 de octubre de 2021. Se utilizó el TRA Panbio COVID-19 Ag® (Abbott Diagnostic) y, comométodo de referencia, la RT-qPCR (según el protocolo de los Centros para el Control y la Prevención de Enfermedades). Resultados. Se incluyeron 6491 pacientes. La prevalencia de COVID-19 fue del 2,8 %. El92,1 % de los sujetos presentaron síntomas. La sensibilidad, la especificidad y el índice kappa de concordancia para el TRA fueron del 71,0 %, 99,9 % y 0,813, respectivamente. El índice kappa yla sensibilidad del TRA fueron significativamentemayores en el grupo de 13 a 17 años (0,89 y 82,4 %,respectivamente) cuando se los comparó con los grupos de 0 a 5 y de 6 a 12 años. Esto podría deberse a la menor carga viral observada en los pacientes menores de 12 años. Conclusión. Si bien los TRA permiten acortar el tiempo de obtención de los resultados y mejorar la estrategia de aislamiento de pacientes con COVID-19, la sensibilidad en niños menores de 12 años o asintomáticos no se encontraría dentro de los rangos recomendados, sobre todo enperíodos de baja prevalencia de la enfermedad.

Introduction. Rapid antigen tests (RAgTs) for SARS-CoV-2 are considered adequate for diagnosis at the point of care. Our objective was to establish the agreement between reverse transcription-quantitative polymerase chain reaction (RT-qPCR) and RAgTs in the pediatric population. Population and methods. All patients aged 1 month to 17 years and 11 months seen at the Emergency Fever Unit of a children's hospital between 6-11-2021 and 10-3-2021 were recruited. The Panbio COVID-19 Ag® test (Abbott Diagnostic) was compared to the reference method RT-qPCR (as per the protocol suggested by the United States Centers for Disease Control and Prevention). Results. A total of 6491 patients were included. The prevalence of COVID-19 was 2.8%. Symptoms were observed in 92.1%. Sensitivity, specificity, and the kappa index of agreement for the RAgT were 71.0%, 99.9%, and 0.813, respectively. The kappa index and the RAgT sensitivity were significantly higher in the group aged 13­17 years (0.89 and 82.4%, respectively) compared to the groups aged 0­5 and 6­12 years. This may be due to the lower viral load observed in patients younger than 12 years. Conclusion. Although RAgTs shorten the time to result and improve the isolation strategy for COVID-19 patients, their sensitivity in children younger than 12 years or asymptomatic children is not within the recommended ranges, especially during periods of low disease prevalence.

HBV DNA load detected by two domestic fluorescent quantitative PCR reagents: a comparative analysis / 中国输血杂志

【Objective】 To compare the quantitative detection results of two domestic quantitative real-time PCR reagents in HBV-DNA detection. 【Methods】 A total of 306 serum samples form hepatitis B patients were selected for quantitative parallel detection of high-sensitiveity HBV-DNA using domestic reagent A and B, and the difference and consistency of the results were analyzed. 【Results】 1) The yielding rate of reagent A and B was 86.92% and 84.64%, respectively. The regression linear equation was Y=0.984 9x+ 0.154 9, R2=0.945 7, the correlation coefficient r=0.972 5, indicating the results by the two reagents had good correlation. 2) When the concentration was in the range of(20~1 000) IU/mL, the yielding rates of reagent A and B were 39.9% and 37.6%, respectively. 【Conclusion】 Reagent A is more suitable for post-treatment monitoring in patients with OBI and HBeAg(-), but also can be used to detect HBV pathogens in patients before operations or blood transfusions.

Analysis of Class II Common Problems in the Registration of / 中国医疗器械杂志

From the perspective of technical review, this paper made statistics on the supplement contents of

Analysis of Quality Management of in Vitro Diagnostic Reagent Clinical Trials / 中国医疗器械杂志

Clinical trial is an important step of in vitro diagnostic reagents research and development. Based on the Guiding Principles and the key points of inspect on the spot, combined with the actual work experience, the article focuses on the prominent problems in the whole process of in vitro diagnostic reagent clinical trials. It is helpful to improve the level of hospital drug clinical trial centre and the quality of in vitro diagnostic reagent clinical trials by analyzing the issues.

Usefulness of Carbohydrate Antigen 19-9 Test in Healthy People and Necessity of Medical Follow-up in Individuals with Elevated Carbohydrate Antigen 19-9 Level / 가정의학회지

BACKGROUND: Carbohydrate antigen 19-9 (CA 19-9) is a tumor marker whose level is elevated in many types of cancers and other benign conditions. CA 19-9 levels are frequently found to be elevated in individuals during general health examinations. This study aimed to investigate the clinical characteristics of such individuals and to determine the need for medical follow-up. METHODS: We investigated individuals who underwent a health inspection, including a serum CA 19-9 test, at our center. Their CA 19-9 levels, age, sex, body mass index (BMI), and personal and past histories were investigated. Additionally, subgroup analyses were performed for those who underwent follow-up study for the elevated CA 19-9 levels. RESULTS: Of 58,498 subjects, 581 (1.0%) had elevated CA 19-9 levels. Multivariate analyses revealed that older age, female sex, lower BMI, and diabetes were independent predisposing factors for elevated CA 19-9 level. A subgroup analysis revealed that the causative conditions were identified in 129 of 351 subjects (36.8%). Among them, the causative conditions in 31 subjects (8.8%, including four cases of cancer and 15 of benign tumors) were not detected at the initial check-up and were found during the follow-up period. CONCLUSION: The use of CA 19-9 as a marker for cancer in healthy individuals is inappropriate. However, medical follow-up in individuals with elevated CA 19-9 levels may be useful because some causative diseases may be detected during follow-up.

Cases Study on Ethical Issues in Clinical Trials of In Vitro Diagnostic Reagent / 中国医学伦理学

From the interest of subjects in clinical trials,this paper analyzed the ethical issues of the following cases.It included that the standard operating procedures of the clinical trial were contrary to the programs;the clinical trials failed because of statistical problems;unnecessary duplication blood increased the damage to subjects.It is recommend that relative researchers of the clinical trials of in vitro diagnostic reagent should grasp the scientificity and ethicality,improve the quality of clinical trials and effectively protect the rights and interests of subjects.

Utilidad de la técnica genotypemtbdrplus para el diagnóstico de tuberculosis pulmonar / Utility of the genotype mtbdrplus technique for pulmonary tuberculosis diagnosis

Introducción: es necesario identificar de forma simple y rápida el bacilo Mycobacterium tuberculosis (MTB) para la instauración temprana de tratamiento efectivo y de medidas decontrol que prevengan la transmisión de la enfermedad.Objetivos: evaluar la utilidad de la prueba Genotype MTBDRplus para la identificación de M. tuberculosisen muestras respiratorias de pacientes atendidos en el Hospital Universitario San Vicentede Paúl Fundación entre junio y agosto de 2010.Materiales y métodos: las muestras respiratorias fueron colectadas de 100 pacientes atendidosen el Hospital, a las cuales se les realizó baciloscopia, cultivo en medio Ogawa Kudoh y PCR por la prueba comercial Genotype MTBDRplus. La sensibilidady especificidad de la PCR fue determinada tomandocomo referencia el cultivo en Ogawa Kudoh.Resultados: la sensibilidad, especificidad, valor predictivopositivo y valor predictivo negativo fueron 86,7 %, 93,7 %, 72,2 % y 97,4 % respectivamente. La sensibilidaden muestras con baciloscopia positiva fue 100 % y de 60 % en muestras con baciloscopia negativa. La medianadel tiempo para el reporte por PCR fue 14 días, comparadocon los 60 días requeridos por el cultivo (p=0,000).Conclusiones: La prueba de PCR Genotype MTBDRpluses una buena opción para la detección rápida de M. tuberculosisen muestras respiratorias con baciloscopia positiva.

Introduction: For the early establishment ofeffective treatment and control measures to prevent disease transmission it´s necessary tohave simple and fast diagnostic tools to identify M. tuberculosis (MTB) bacilli.Objetives: In this study, the usefulness of the Genotype MTBDRplus assay for identifying M. tuberculosisin respiratory specimens from patientsat Hospital Universitario San Vicente de Paúl (HUSVP) was evaluated.Materials and methods: Respiratory specimens were collected from 100 patients treated atthe HUSVP to which smear, culture in Ogawa Kudoh medium and commercial Polymerase ChainReaction (PCR) Genotype MTBDRplus assay were performed. The sensitivity and specificity of PCRwere determined in reference to the culture in Ogawa Kudoh.Results: The sensitivity, specificity, positive predictivevalue and negative predictive value were 86.7 %, 93.7 %, 72.2 % and 97.4 % respectively. Sensitivity in smear-positive samples was 100 %,and 60 % in smear-negative samples. The median time for results reporting using PCR was 14 days compared with the 60 days required by the culture (p=0.000).Conclusions: Genotype MTBDRplus is a good choice for rapid detection of M. tuberculosis in smear positive respiratory specimens.

Development and characterization of stable cell lines constitutively expressing the porcine reproductive and respiratory syndrome virus nucleocapsid protein

Despite global efforts to control porcine reproductive and respiratory syndrome virus (PRRSV) infection, the virus continues to cause economic problems in the swine industry worldwide. In this study, we attempted to generate and characterize a panel of stable BHK cell lines that constitutively express the nucleocapsid (N) protein of type 1 or type 2 PRRSV. The established BHK cell lines were found to react well with N-specific antibodies as well as the hyperimmune serum of pigs raised against each genotype of PRRSV. Taken together, the data implicate a potential usefulness for the newly generated stable cell lines as a diagnostic reagent for PRRSV serology.