Abstract
Nucleic acid amplification-based diagnostics is known as one of the molecular diagnostic systems that allows higher sensitive detection of pathogens than test methods such as immunoassay. However, it has not been widely used because it is complicated to use and takes a long time to generate results. On the other hand, development of fully automated molecular diagnostic systems has been growing around the world as demand for such systems from physicians and laboratory technicians has increased. To meet this demand, we have developed the “Simprova” fully automated molecular diagnostic system, which takes advantage of LAMP (Loop-mediated Isothermal Amplification), a method Eiken Chemical Co., Ltd. invented. Simprova comprises a master unit that controls the entire system and a test unit that extracts and purifies nucleic acid from samples (pretreatment), and uses the LAMP method to detect and amplify nucleic acid. Users can obtain test results automatically by simply installing a pretreatment cartridge, a multi-well testing chip and the sample in the test unit. The multi-well testing chip has 25 reaction wells connected by channels and enables simultaneous testing of multiple targets with one sample. Turnaround time for one test is approximately 30 minutes. Since a conventional extraction and purification method using magnetic-bead separation is used for the pretreatment, nucleic acid can be extracted from serum, plasma, whole blood, urine, and sputum, for example. In addition, the system can perform random-access testing by connecting four test units to the master unit to realize near-the-patient testing. Simprova is therefore a robust and useful system for a wide variety of applications.
Highlights
Nucleic acid amplification-based diagnostics is known as one of the molecular diagnostic systems that allows higher sensitive detection of pathogens than test methods such as immunoassay
There was no statistically significant difference between the number of copies of S. pneumoniae, B. pertussis, C. pneumoniae and FluA extracted using the QUIAGEN extraction kit and by the Simprova protocol according to a t-test at the p = 0.05 level
We have developed a new fully-automated compact nucleic-acid-based diagnosis system “Simprova” taking advantage of loop-mediated isothermal amplification (LAMP)
Summary
Nucleic acid amplification-based diagnostics is known as one of the molecular diagnostic systems that allows higher sensitive detection of pathogens than test methods such as immunoassay. It has not been widely used because it is complicated to use and takes a long time to generate results. Nucleic acid-based diagnosis can be used to predict a disease possibility and determine a treatment effect through analysis of human genetic information and detection of abnormality of the genes. It identifies genes of pathogens such as virus and bacteria to determine the cause of a disease and can be used for determination of medical treatment and its effect. The LAMP method is commonly used at many clinical sites and research institutes because of its simplicity, high amplification efficiency and high specificity
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