Enzo’s mission is to provide low-cost alternative solutions to the diagnostic market. Our AMPIPROBE® platform uses novel PCR design to enable the quantification of nucleic acids for clinically relevant targets. Incorporating our IP into the AMPIPROBE® assays allows Enzo to offer a low-cost option for nucleic acid detection in a price sensitive market.
AMPIPROBE® assays are easily adaptable for laboratory use and cost-effective, without compromising on quality and performance. Compatible on open PCR platforms, AMPIPROBE® assays can be validated on existing instrumentation, eliminating the need for capital expenditures.
Enzo's AMPIPROBE® Technology
AMPIPROBE® is a proprietary technology that incorporates probe detection in primer design. It employs a combination of fluorescent reporter-labeled primers and quencher-labeled primers to amplify DNA, akin to traditional qPCR.
When free in solution, fluorescent primers generate a signal. However, as the primers are incorporated into amplified DNA, the quencher and the fluorophore are brought within close proximity and exhibit Forster resonance energy transfer (FRET). This causes a logarithmic decay of signal with respect to the number of amplification cycles of DNA.
Once the signal decays to a defined threshold, a value is generated with respect to the corresponding cycle. The threshold cycle is indicative of the amount of target RNA or DNA in the sample.
The AMPIPROBE® HCV assay kit is Enzo’s landmark AMPIPROBE® assay for the quantitation of HCV viral load. It has been validated and approved by the New York State Department of Health to be used as a laboratory developed test to quantitatively measure HCV viral load.
COVID-19 Molecular Testing
AMPIPROBE® SARS-CoV-2 Test System
AMPIPROBE® SARS-CoV-2 Test System on the GENFLEX® platform
Our AMPIPROBE® SARS-CoV-2 Test System is a complete workflow designed for the qualitative detection of nucleic acids from SARS-CoV-2 virus. It has been authorized by FDA under an Emergency Use Authorization (EUA).
Components:
AMPICOLLECT™ for sample collection*
AMPIXTRACT® SARS-CoV-2 Extraction Kit for sample processing - nucleic acid extraction from patient specimens
AMPIPROBE® SARS-CoV-2 Assay Kit and Controls for amplification and detection
GENFLEX® automated high-throughput platform
* Note: AMPICOLLECT™ sample collection is not required by the FDA but it is manufactured by Enzo to offer a complete integrated solution with EUA authorized products. It is equivalent to sample collection offered by competing brands.
Key features:
Accurate
Clinical Sensitivity: 98.1%
Clinical Specificity: 99.3%
Low-cost alternative to competitors’ workflows
Flexible solution:
AMPIXTRACT® SARS-CoV-2 Extraction Kit and AMPIPROBE® SARS-CoV-2 Assay kit and Controls can be adapted to any open platforms or to manual settings
GENFLEX® platform is an automated open system for molecular testing
Disclaimer:
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.
The AMPIPROBE® Women’s Health Panel is a highly sensitive and specific multiplex nucleic acid amplification assay developed with Enzo’s proprietary technology. It allows for the detection of 16 pathogens, including Bacterial Vaginosis (BV), Trichomoniasis (TV), Vulvovaginal Candidiasis (VVC), Ureaplasma and Mycoplasma (UMM), as well as sexually transmitted infections such as Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). Designed to be flexible, the AMPIPROBE® Women’s Health Panel consist of 5 different assays that can be performed either singularly or in a panel, according to customer need. Additionally, all the assays are adaptable to automated platforms, such as the Enzo’s GENFLEX™ Molecular System or any open platforms available, or to manual settings.
Ureaplasma spp. Mycoplasma genitalium Mycoplasma hominis
AMPIPROBE® HCV Assay Kit
The AMPIPROBE® HCV assay kit is Enzo’s landmark AMPIPROBE® assay for the quantitation of HCV viral load. It has been validated and approved by the New York State Department of Health to be used as a laboratory developed test to quantitatively measure HCV viral load.
Key Benefits:
Sensitive quantitation of HCV viral load
LOD Serum = 5.5 IU/mL
LOD Plasma = 7.9 IU/mL
Low-cost alternative to other methods of viral load detection
Compatible with most open qPCR platforms
Complete set of controls including:
High, Medium and Low quantitation controls
Internal sample extraction control
Negative sample control
Smaller sample input allows remaining extracted samples to be used in other tests
