Fully Automated Molecular Diagnostic System “Simprova” for Simultaneous Testing of Multiple Items

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.

Clinical evaluation of fully automated molecular diagnostic system “Simprova” for influenza virus, respiratory syncytial virus, and human metapneumovirus

“…In conclusion, the newly developed LAMP-based POCT "Simprova" for IV, RSV, and hMPV demonstrated high sensitivity and high specificity in clinical specimens from patients with influenza-like illnesses. This Simprova-RV processed the entire step automatically; the test can be performed without skilled personnel in the POC setting by simply placing a pretreatment cartridge, a testing chip, and the sample in the machine 19 . In addition, positive results can be achieved faster than by rPCR testing, because of the use of an isothermal nucleic acid amplification method.…”

“…Simprova-RV was performed using a principal machine in which the pretreatment (extraction and purification of nucleic acid from the sample) part and the LAMP reaction and detection part were separated in this study. Simprova-RV was carried out as described previously 19 . In the pretreatment Purification Kit (Thermo Fisher Scientific) using 200 µL of UTM mixed with clinical specimens according to the manufacturer's instructions, with an elution of 50 µL.…”

“…Recently, we developed a loop-mediated isothermal amplification (LAMP)-based POCT "Simprova" for the detection of respiratory bacteria 19 . The results of the POCT for detecting respiratory bacteria are obtained within 35 min after specimen collection with high sensitivity and specificity.…”

Loop-Mediated Isothermal Amplification (LAMP): A Rapid, Sensitive, Specific, and Cost-Effective Point-of-Care Test for Coronaviruses in the Context of COVID-19 Pandemic

“…A recent study demonstrated the possibility to fully automate LAMP methods for the rapid and effortless molecular diagnosis [98], which may pave a way to the automation of RT-LAMP based COVID-19 diagnosis. In this system called "Simprova" (Developed by Eiken Chemical Co., Ltd.), a central unit that controls the entire system, a pretreatment unit that isolates and purifies nucleic acid from samples, and the LAMP component to detect and amplify nucleic acid sequences were all integrated.…”

The vision of point-of-care PCR tests for the COVID-19 pandemic and beyond

“…The Eiken Chemical Co. in Japan has developed a system for multiple testing that combines sample preparation with LAMP, and the optical detection of the results with RNA purification is based on magnetic force ( Fig. 4 A) [ 89 ]. It employed a microfluidic cartridge with 25 wells, allowing for multiplexed detection.…”