The AMPIPROBE® SARS-CoV-2 Test System, which 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, 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. The AMPIPROBE SARS-CoV-2 Test System has been authorized by FDA under an Emergency Use Authorization (EUA). It is adaptable to different extraction methodologies and throughput including our proprietary GENFLEX® Platform, QIAsymphony® SP, and manual workflow.
Performance:
The AMPIXTRACT™ SARS-CoV-2 Extraction Kit is part of our AMPIPROBE® SARS-CoV-2 Test System. It is designed for the isolation and purification of SARS-CoV-2 RNA virus from upper respiratory specimen (such as nasal, mid-turbinate, nasopharyngeal, oropharyngeal swab specimens and nasopharyngeal wash/aspirate or nasal aspirate specimens). Its magnetic bead separation technology enables high-quality purification of nucleic acids that are free of proteins, nucleases, and other impurities. The purified nucleic acids are ready for direct use in downstream applications, such as amplification and qualitative detection of SARS-CoV-2 virus.
RNA isolation can be performed with the AMPIXTRACT™ SARS-CoV-2 Extraction Kit either manually or via an automated process using Enzo’s GENFLEX® platform.
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Performance
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The AMPIPROBE® SARS-CoV-2 Assay Kit is part of our AMPIPROBE® SARS-CoV-2 Test System and it is a multiplex assay designed for the detection of SARS-CoV-2 virus. It contains two primer/ probe sets specific to different SARS-CoV-2 genomic regions and primers/probes for internal control and negative control, human RNase P. It is adaptable to different extraction methodologies and throughput including our proprietary GENFLEX® Platform, QIAsymphony® SP, and manual workflow.
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Performance
Cost-Effective
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The AMPIPROBE® SARS-CoV-2 Controls is part of our AMPIPROBE® SARS-CoV-2 Test System and is intended to be used in combination with AMPIPROBE® SARS-CoV-2 Assay kit and AMPIXTRACT™ SARS-CoV-2 Extraction Kit during the PCR process. The AMPIPROBE® SARS-CoV-2 Controls Kit contains a positive RNA control that is specific to the SARS-CoV-2 genomic regions targeted by the assay as well as human RNase P, a negative RNA control that contains target to human RNase P, and a no-template control (NTC).
| High Throughput Solution |
FDA's EUA authorized Kits |
GENFLEX® platform
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AMPIXTRACT™ SARS-CoV-2 Extraction Kit AMPIPROBE® SARS-CoV-2 Assay Kit AMPIPROBE® SARS-CoV-2 Controls |
| Mid to Low Throughput Solution |
FDA's EUA authorized Kits |
| QIAsymphony SP (Qiagen®) + QuantStudio® 5 (Applied Biosystems®)  |
QIAsymphony DSP Virus/Pathogene Midi Kit (Qiagen®) AMPIPROBE® SARS-CoV-2 Assay Kit AMPIPROBE® SARS-CoV-2 Controls |
| Mid to Low Throughput Solution |
FDA's EUA authorized Kits |
Manual + QuantStudio® 5 (Applied Biosystems®)
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AMPIXTRACT™ SARS-CoV-2 Extraction Kit AMPIPROBE® SARS-CoV-2 Assay Kit AMPIPROBE® SARS-CoV-2 Controls |
Emergency Authorization Use Only
In Vitro Diagnostic (IVD) Use Only
Prescription/Rx Use Only
The AMPIPROBE® SARS-CoV-2 Test System has not been FDA cleared or approved; the test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, to perform high complexity tests.
The AMPIPROBE® SARS-CoV-2 Test System has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
The AMPIPROBE® SARS-CoV-2 Test System is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests 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.
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Our SARS-CoV-2 Test System is designed to also be used in open modular settings according to customer needs. Each of the workflow components can be combined with any open platforms or used in manual settings.
| GENFLEX® platform
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Our AMPIXTRACT™ SARS-CoV-2 Extraction Kit (RUO) is designed for isolating viral RNA from nasopharyngeal samples. The isolated RNA is pure and ready for your downstream application including direct input to the target amplification process through RT-PCR methods. The flexible kit design is easily adapted to both automated, high-throughput and manual processing.
Performance
Our AMPIPROBE® SARS-CoV-2 Assay Kit (RUO) is a multiplexed assay designed for the detection of the SARS-CoV-2 virus. It contains two primer/probe sets specific to different SARS-CoV-2 genomic regions and primers/probes for internal control and negative control, human RNase P. This kit is intended to be used in combination with general RNA extraction kits, including AMPIXTRACT™ SARS-CoV-2 Extraction Kit (RUO) and generic qPCR instruments. This assay can also be used in manual settings or with open automated platforms such as the GENFLEX® Automated Instrument (please contact us for more information) or any other open platforms available on the market for the liquid handling process of RNA extraction and PCR set up.
PerformanceThe AMPIPROBE® SARS-CoV-2 Controls (RUO) are designed to be used during the qPCR detection of the SARS-CoV-2 virus.
Another alternative solution for our customers is the ability to build their own molecular detection kit by combining our reagents for RT-PCR with primers of their choice.
Our AMPIGENE® 1-Step RT-PCR Kit uses the latest developments in reverse transcriptase (RT) technology and buffer chemistry for efficient cDNA synthesis and PCR in a single tube. An optimized buffer system allows efficient amplification, and proprietary enhancers prevent the formation of primer dimers, to increase sensitivity and specificity.
We offer this product as a dye-based kit or as a probe-based kit. In both cases, our customers are only required to provide specific SARS-CoV-2 primers or SARS-CoV-2 labelled probes, respectively, to build a complete COVID-19 detection kit.
While molecular tests serve as the frontline diagnostic tool to monitor SARS-CoV-2 active infections, serological tests are used to detect antibodies that are being produced by the immune system in response to the viral infection. Due to the delay between infection, symptomatic onset, and presence of antibodies, serological tests serve to diagnose past infections and assess an immune response.
Our SARS-CoV-2 IgG ELISA Kit is an Enzyme-Linked Immunosorbent Assay (ELISA) designed for the qualitative detection of IgG antibodies specific to SARS-CoV-2 in human serum samples.
Formatted in a 96-well microplate (12 x 8 well strips), the assay is easily adapted for either automated open platforms or manual workflows.
Designed for accurate and sensitive detection, the indirect ELISA has a two-step binding process involving a specific SARS-CoV-2 antigen and an HRP conjugated anti-human IgG secondary antibody.
Performance
| Enzyme-linked immunosorbent assay (ELISA) is one of the most reliable methods for detecting blood-borne anti-SARS-CoV-2 antibodies of both IgM and IgG subclasses, which the body may have generated to fight the disease. Here, we highlight a list of COVID-19 related antigens and buffers that are needed for the development of ELISAs that detect anti-COVID-19 antibodies. |  |
Coronavirus Antibodies
COVID-19 and Coronavirus Related Proteins
Products Related to Coronavirus Biology
COVID-19 and Coronavirus Related Proteins
Coronavirus Antibodies
Drug Discovery
Small Molecules Therapeutics
Antiviral Response
Inflammation and Immune Response Monitoring
MAPK Signaling Pathway Monitoring
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