ABSTRACT
Point-of-care testing (POCT) is a test method performed on the sampling site or patient bedside. Accurate results can be achieved rapidly by the application of portable analytical instruments and compatible reagents. It has been widely used in the field of in vitro diagnosis (IVD). Paper-based microfluidics technology has great potential in developing POCT due to its advantages in low cost, simple operation, rapid detection, portable equipment, and unrestricted application conditions. In recent years, the development of paper-based microfluidic technology and its integration with various new technologies and methods have promoted the substantial development of POCT technology and methods. The classification and characteristic of the paper are summarized in this review. Paper-based microfluidic sample pretreatment methods, the flow control in the process of reaction and the signal detecting and analyzing methods for the testing results are introduced. The research progress of various kinds of microfluidic paper-based analytical devices (μPADs) toward POCT in recent years is reviewed. Finally, remaining problems and the future prospects in POCT application of paper-based microfluidics are discussed.
Subject(s)
Humans , Diagnostic Tests, Routine , Methods , Microfluidic Analytical Techniques , Paper , Point-of-Care TestingABSTRACT
Due to the automation of clinical test and analysis, work units like hospitals have reduced the demand for medical laboratory talents, which has increased the employment pressure of graduates. However, the demand for medical laboratory talents is in short supply with the development of the in-vitro diagnosis industry. Guided by the industry development and the employment demand, our school set up the development direction of "in-vitro diagnosis", combined medicine and engineering, established the corresponding curriculum system, adopted school-enterprise (institution) collaboration and explored the talent training mode of "special direction tutor system". In addition, we provided a special course of "Introduction to Medical Laboratory" to freshmen, helping them select direction and plan their career, and exploring how to cultivate medical and engineering compound applied undergraduate talents of medical laboratory major.
ABSTRACT
Due to the automation of clinical test and analysis,work units like hospitals have reduced the demand for medical laboratory talents,which has increased the employment pressure of graduates.However,the demand for medical laboratory talents is in short supply with the development of the in-vitro diagnosis industry.Guided by the industry development and the employment demand,our school set up the development direction of " in-vitro diagnosis ",combined medicine and engineering,established the corresponding curriculum system,adopted school-enterprise(institution)collaboration and explored the talent training mode of "special direction tutor system".In addition,we provided a special course of "Introduction to Medical Laboratory" to freshmen,helping them select direction and plan their career,and exploring how to cultivate medical and engineering compound applied undergraduate talents of medical laboratory major.
ABSTRACT
<p><b>OBJECTIVE</b>The quality of diagnostic products is closely related to people's health. The standards and standardization system are essential to IVD industry and supervision.</p><p><b>METHODS</b>Through a study of the standards of ISO, EU, the USA and China, a comparative analysis was carried out.</p><p><b>RESULTS</b>China's IVD standardization system is different from other organization in terms of standard quantity, type and content. The standardization system has its own characteristics, and conforms to the current industrial characteristics and regulatory needs.</p><p><b>CONCLUSIONS</b>Some suggestions are put forward to provide references for strengthening supervision of IVD products.</p>
ABSTRACT
Type Ⅰallergy is one type of allergic reaction mediated by IgE antibody .Simple, rapid and accurate allergen detection method can be used to identify the allergen of patients , which is of great significance for the prevention , diagnosis and treatment of allergic diseases . In this article , different techniques for in vitro diagnosis of allergen specific IgE antibodies in type Ⅰ allergic reactions were described , important factors affecting in vitro diagnosis of allergens were analyzed , and the future development trend of in vitro diagnosis of allergen specific IgE antibodies were prospected .In order to help clinicians to select more suitable in vitro detection methods in the process of in vitro diagnosis of type Ⅰallergy and to better understand the internal relationship between the allergen specific IgE detection report and clinical symptoms.
ABSTRACT
From the view-point of a front-line research team in clinical laboratory medicine , the advantages of microfluidic technology and its prospect in the field of in vitro diagnosis ( IVD) were reviewed in this paper. This paper introduces the application of microfluidics in molecular diagnosis , immune detection and microbial pathogen testing , showing the value of this technology in meeting challenges posed by clinical laboratory medicine .Opportunities and challenges of microfluidic IVD technology under the new situation were also discussed.The authors believe this technology will play a great role in promoting the improvement of clinical laboratory technology .
ABSTRACT
OBJECTIVE: To discuss essential points in performance evaluation and clinical trial of respiratory multi-pathogen nucleic acid assay, providing constructive suggestions for product research and development as well as regulatory registration. METHODS: Based on the features and intended use of the assay, requirements of national food and drug regulatory division and personal experiences in examining IVD products to demonstrate essential points and approaches in performance evaluation and clinical trial by illustrating examples. RESULTS: The verification of the limit of detection, analytical specificity, precision and the enterprise references were included in the performance evaluation. The total number of samples and the number of positive sample, genotype, reference products and statistical analysis etc. were included in the clinical trial study. CONCLUSION: The performance evaluation and the clinical trial study are an important part of the estimation of product performance. They are an important way to assess the safety and effectiveness of the product before the product goes into the market and also an important part of the technical review in the product registration. Applicants should take full account of scientific and comprehensive evaluation methods in product development and registration process, and based on the product characteristics and intended use to verify the product adequately.
ABSTRACT
OBJETIVO: Identificar se os pontos de corte de sensibilidade anunciados por três testes de gravidez na urina são compatíveis com os anunciados pelo fabricante e descrever os seus desempenhos diagnósticos. MÉTODOS: A urina de um voluntário masculino foi usada para diluir β-hCG recombinante em concentrações definidas de 0; 6,25; 12,5; 25; 50; e 100 mUI/mL. As amostras foram codificadas e cegamente analisadas para a positividade em três diferentes lotes dos testes hCG Strip Test Plus®, BioEasy® e Visitect Pregnancy®. O tamanho da amostra foi calculado para um erro alfa de 5 por cento, com um poder de 99 por cento. RESULTADOS: As três marcas apresentaram sensibilidade de 100 por cento na detecção do β-hCG nos três lotes analisados, com 100 por cento de valor preditivo negativo, usando somente controles negativos e amostras com concentrações iguais ou superiores ao limite do teste (n = 180/marca). A acurácia dos testes foi 83 por cento (BioEasy®), 84 por cento (Visitect®) e 91 por cento (Strip Test Plus®). O Strip Test Plus® apresentou o melhor desempenho para a razão de probabilidade positiva (52,5), enquanto que o produto Visitect® teve a melhor razão de probabilidade negativa (zero). CONCLUSÃO: Os três produtos analisados têm a sensibilidade dos pontos de corte anunciados. O produto Strip Test Plus® tem o melhor desempenho para identificar concentrações urinárias de β-hCG > 12,5 mUI/mL, consequentemente, confirmando gravidez, enquanto que o Visitect® tem o melhor desempenho para descartar a presença de β-hCG na urina (probabilidade pós-teste negativo: zero).
OBJECTIVE: To identify whether cutoff for sensitivity advertised by three pregnancy tests in urine are compatible to those reported by the manufacturer and to describe their diagnostic performance. METHODS: The urine of a male volunteer was used to dilute recombinant β-hCG at defined concentrations of 0, 6.25, 12.5, 25, 50, and 100 mIU/mL. The tubes containing each of the concentrations were coded and blindly assessed for positivity in three different lots of hCG tests: Strip Test Plus®, BioEasy®, and Visitect Pregnancy®. The sample size was calculated for an alpha error of 5 percent, with a power of 99 percent. RESULTS: All three brands, in their three lots analyzed, had 100 percent of sensitivity for detecting β-hCG, with 100 percent negative predictive value, using only negative controls and samples with concentrations equal or higher than the test cutoff (n = 180/brand). The accuracy of the tests was 83 percent (BioEasy®), 84 percent(Visitect®) and 91 percent (Strip Test Plus®). Strip Test Plus® had the best positive likelihood ratio (52.5), while Visitect® had the best negative likelihood ratio (zero). CONCLUSION: The three brands have adequate sensitivity for the advertised cutoffs. The Strip Test Plus® test had the best performance to identify urinary concentrations of β-hCG > 12.5 mIU/mL, and consequently, to confirm pregnancy, while Visitect® had the best performance to exclude β-hCG in urine (negative post-test probability: zero).