MOLECULAR MOUSE SYSTEM is a multiplex Real-Time PCR device intended for clinical laboratory professional users for in vitro diagnostic procedures (IVD) to be used with IVD MOLECULAR MOUSE cartridge panels containing specific reagents to detect multiple nucleic acid targets in processed biological samples.
MOLECULAR MOUSE instrument uses a dedicated software to perform an amplification reaction of targeted nucleic acid sequences using multiplex Real-Time PCR in a closed system. The software processes the raw data obtained from the instrument, provides qualitative results and emits a test report, after verification and/or validation by the user.
MOLECULAR MOUSE SYSTEM can be composed of one to six MOLECULAR MOUSE instruments plugged to a personal computer in which the MOLECULAR MOUSE software is installed. The software identifies and manages each instrument independently: it recognizes the cartridge identity, handles the analysis, collects and processes the raw data, stores the test analysis and finally generates the report.
The specifications to perform the test, including the targets list and the criteria for data interpretation are specified by the single IVD MOLECULAR MOUSE cartridge.
MOLECULAR MOUSE SYSTEM provides a results to support the diagnosis and is intended for combined use with other clinical and analytical results within a diagnostic evaluation defined and regulated by each specific laboratory.
The test cartridge is designed to be used exclusively with the MOLECULAR MOUSE SYSTEM (SI 1701.100/I) which allows the amplification and detection of specific nucleic acid using multiplex Real Time Polymerase Chain Reaction (PCR) assay. The MOLECULAR MOUSE SYSTEM consists of an instrument acting as a thermocycler and a closed software already installed on the PC, for running tests and monitoring results. For the analysis, the use of a single-use disposable cartridge, that houses the PCR reagents in freeze-dried form, is required. The specifications for performing the test (including the targets list and the criteria for data managing) are specified in the MM COVID-19 cartridge file. The system generates, analyses, stores and tracks the results information and the entire process takes about 1 hour. The test aims to identify specific nucleic acid sequences of SARS-CoV-2 (for ORF1ab, RdRp gene, N gene) including internal control, based on Reverse Transcriptase Real Time PCR. One test cartridge allows for analysis of three independent samples.
MOLECULAR MOUSE instrument uses a dedicated software to perform an amplification reaction of targeted nucleic acid sequences using multiplex Real-Time PCR in a closed system. The software processes the raw data obtained from the instrument, provides qualitative results and emits a test report, after verification and/or validation by the user.
MOLECULAR MOUSE SYSTEM can be composed of one to six MOLECULAR MOUSE instruments plugged to a personal computer in which the MOLECULAR MOUSE software is installed. The software identifies and manages each instrument independently: it recognizes the cartridge identity, handles the analysis, collects and processes the raw data, stores the test analysis and finally generates the report.
The specifications to perform the test, including the targets list and the criteria for data interpretation are specified by the single IVD MOLECULAR MOUSE cartridge.
MOLECULAR MOUSE SYSTEM provides a results to support the diagnosis and is intended for combined use with other clinical and analytical results within a diagnostic evaluation defined and regulated by each specific laboratory.
The test cartridge is designed to be used exclusively with the MOLECULAR MOUSE SYSTEM (SI 1701.100/I) which allows the amplification and detection of specific nucleic acid using multiplex Real Time Polymerase Chain Reaction (PCR) assay. The MOLECULAR MOUSE SYSTEM consists of an instrument acting as a thermocycler and a closed software already installed on the PC, for running tests and monitoring results. For the analysis, the use of a single-use disposable cartridge, that houses the PCR reagents in freeze-dried form, is required. The specifications for performing the test (including the targets list and the criteria for data managing) are specified in the MM COVID-19 cartridge file. The system generates, analyses, stores and tracks the results information and the entire process takes about 1 hour. The test aims to identify specific nucleic acid sequences of SARS-CoV-2 (for ORF1ab, RdRp gene, N gene) including internal control, based on Reverse Transcriptase Real Time PCR. One test cartridge allows for analysis of three independent samples.
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