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Download our GENFLEX® Molecular System Brochure |
| EXPANDED FLEXIBILITY | HIGH-THROUGHPUT | TURN-AROUND TIME | ||
| Use with any sample collection device | 96 samples per run | 5 hours for first 96 samples |
| CAPACITY | COST-EFFECTIVE | |||
| 384 samples per day
Over 1,000 samples per day by adding two additional instruments |
Affordable platform and reagents |
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| Any Sample Collection Device | Reagent Loading | PCR Plate Loading | Automated Data Interpretation |
| Automatic Barcode Reading | Sample Extraction & PCR Setup | Real-time PCR |
The nucleic acid extraction is performed with magnetic beads-based extraction reagents, such as our AMPIXTRACT® Extraction Reagents Kit or third party reagents, in a 96 well format. Following the extraction, the extracted nucleic acid is then combined with PCR reagents in another 96 well plate for qPCR analysis. The pipetting arm is able to prepare up to 5 different 96 well PCR plates allowing for higher throughput and multiplexing.
GENFLEX® Molecular System uses air displacement pipetting to achieve superior measurement accuracy. The 8 channels pipette and tips are designed to fit precisely together using the CO-RE (Compressed O-Ring Expansion) technology. This creates a tight seal with precise tip alignment to eliminate tip distortion and ensure the highest accuracy during liquid handling steps. Additionally, anti-droplet control and liquid level detection technologies further safeguard sample and results integrity.
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The Quant Studio 5 real time PCR (Thermo Fisher) with its 5 channels and 96 well format ensure high quality and fast nucleic acid amplification and detection.
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Our pipetting module is controlled by the integrated and intuitive software, which enables users to control their system without compromising on requirements. Additionally, the software is completely integration friendly. It allows for basic process programming, or create time-saving custom templates for future processes, and for third party components to be added to the system without limiting functionality.
DataAssist™ Software is a free, easy-to-use data analysis tool that utilizes the Comparative Ct (ΔΔCt) method to rapidly and accurately quantitate relative gene expression across a large number of genes and samples.
The data analysis procedure is simple and straightforward. Raw data can be imported from up to hundreds of plates, and analysis settings including selection of normalization controls and method (single or multiple control genes) can be changed according to customer needs. The software provides instant response and fast calculation, allows normalization using multiple reference genes, and provides analysis results in content-rich tables and scalable graphic charts that are easily exported.
GENFLEX® Molecular System is a versatile and flexible solution and can support different applications, including the possibility of developing Laboratory Developed Tests (LDTs).
In development *Viral Load (HCV, HIV, HBV) |
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Automated data analysis and LIS connectivity for accurate specimen management and tracking |
The AMPIPROBE® SARS-CoV-2 Test System is a multiplex assay system based on real-time reverse transcription polymerase chain reaction (rRT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 virus in upper respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
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The AMPIPROBE® SARS-CoV-2 Test System is for use on the automated GENFLEX™ Molecular System under Emergency Use Authorization (EUA).
*Percent agreements between the AMPIPROBE® Test System and an FDA-approved EUA test performed on nasopharyngeal swabs |
GENFLEX® Molecular System |
The AMPIPROBE® SARS-CoV-2 Test System is comprised of the AMPIXTRACT® SARS-CoV-2 Extraction Kit, the AMPIPROBE® SARS-CoV-2 Assay Kit and the AMPIPROBE SARS-CoV-2 Controls Kit.
| AUTOMATED PROCESS | EXPANDED FLEXIBILITY | HIGH-THROUGHPUT | ||
| Sample processing, sample amplification and detection, clinical report | Use with any upper respiratory specimens | 96 samples per run including controls |
| TURN-AROUND TIME | CAPACITY | COST- EFFECTIVE | ||
| Results within 1 hour and 15 minutes after extraction | Over 1,000 samples per day by connecting multiple instruments | Affordable platform and reagents |
The AMPIPROBE® SARS-CoV-2 Test System is a multiplex assay system based on real-time reverse transcription polymerase chain reaction (rRT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal, oropharyngeal swab specimens and nasopharyngeal wash/aspirate or nasal aspirate specimens) collected from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The AMPIPROBE® SARS-CoV-2 Test System is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.
The AMPIPROBE® SARS-CoV-2 Test System is only for use under the Food and Drug Administration’s Emergency Use Authorization.
This test has not been FDA cleared or approved;
This test has been authorized by FDA under an EUA for use by authorized laboratories;
This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens;
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
All product names, logos, and brands are the property of their respective owners.
| Instrument W x H x D | 65.5 in x 35.6 in x 39.6 in |
| Work area W x H x D | 47.8 in x 7.6 in x 18.3 in |
| Weight | 319.6 lbs |
| Voltage | 100 VAC |
| Frequency | 50/60 Hz |
| Operating temperature range | 15°C – 35°C (relative humidity 30% - 85% with no condensation |
| Sample capacity (wells) | 96 |
| Reaction volume | 10 – 100 μL |
| Excitation source | Bright white LED |
| Optical detection | 6 decoupled filters |
| Excitation/detection range | 450 – 680 nm/500 – 730 nm |
| Maximum block ramp rate | 6.5°C/sec |
| Average sample ramp rate | 3.66°C/sec |
| Temperature uniformity | 0.4°C |
| Temperature accuracy | 0.25°C |
| Compatible dyes | FAM/SYBR Green, VIC/JOE/HEX/TET, ABY/NED/TAMRA/Cy3, JUN, ROX/ Texas Red, Mustang Purple™, Cy® 5/ LIZ™, Cy® 5.5 |
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