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There are two main methodologies that are suited to investigate COVID-19 infection, the RT-qPCR technology (molecular test) that detects the presence of the virus and the immunoassay technology (serological test) that detects antibodies produced in response to the coronavirus infection. Enzo Life Sciences is committed to providing our customers with the right tools and support for the development of an accurate and reliable test for COVID-19.

COVID-19 Diagnostic Solutions


COVID-19 Molecular Testing

AMPIPROBE® SARS-CoV-2 Test System





COVID-19 Serological Testing

SARS-CoV-2 IgG ELISA Kit




Passed Webinar

How to increase laboratory-based COVID-19 testing capacity

The COVID-19 pandemic is still a big threat for the United States. Diagnostic testing is critical to monitor and contain the disease; however, the increasing testing demand has created a shortage in laboratory-based molecular tests. In this webinar, we highlight the challenges faced by clinical laboratories in ramping up their testing capacity and provide potential solutions. Additionally, we discuss a case study on Enzo Clinical Labs and its ability in managing the COVID-19 clinical testing demand during the outbreak in New York.

Presented by: Albino Troilo
PhD, Sr. Marketing Manager at Enzo
Enzo

Topic: Clinical



COVID-19 Molecular Testing


AMPIPROBE® SARS-CoV-2 Test System


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:

  • Sensitivity*: 96.2%
  • Specificity*: 98.0%
  • Time to results: 192 samples in one shift
*Percent agreements between the AMPIPROBE® Test System and an FDA-approved EUA test performed on nasopharyngeal swabs




Figure 1. AMPIPROBE® SARS-CoV-2 Test System on the GENFLEX™ platform


Our AMPIPROBE® SARS-CoV-2 Test System is designed to also be used in modular settings according to customer needs and consistent with the FDA EUA-approved directions for use. Each of the workflow components can be combined with any equipment specifically listed in the directions for use.



AMPIXTRACT™ SARS-CoV-2 Extraction Kit



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.


Performance
  • Magnetic bead separation technology with proprietary buffer system
  • Isolation of high-quality RNA in ≺ 1 hour


Download our Flyer: Extraction Kit for SARS-CoV-2 - EUA




AMPIPROBE® SARS-CoV-2 Assay Kit



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.


Performance
  • Sensitivity*: 96.2%
  • Specificity*: 98.0%
  • Time to results: 192 samples in one shift
*Percent agreements between the AMPIPROBE® Test System and an FDA-approved EUA test performed on nasopharyngeal swabs

Cost-Effective
  • Low-cost alternative to other detection methods


Download our Flyer: Detection Kit for SARS-CoV-2 - EUA




AMPIPROBE® SARS-CoV-2 Controls



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
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®)
AMPIXTRACT™ SARS-CoV-2 Extraction Kit
AMPIPROBE® SARS-CoV-2 Assay Kit
AMPIPROBE® SARS-CoV-2 Controls

Figure 2. Summary of SARS-CoV-2 Reagents and Instruments Combination for COVID-19 Molecular Testing



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.





GENFLEX™ Platform



Our GENFLEX™ Platform is a high-throughput, automated, and scalable instrument for easy and accurate processing of common molecular diagnostic tests within a clinical production setting. Enzo has developed the specific reagents necessary for coronavirus detection that are compatible with this high-throughput platform. The AMPIPROBE® SARS-CoV-2 Test System combines the GENFLEX™ Platform with sample collection, extraction, and detection providing a flexible, yet accurate, approach for COVID-19 testing.









AMPIPROBE® SARS-CoV-2 Test System (RUO)

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
OR
  • Any open liquid handling platform
  • Any qPCR instrument





AMPIXTRACT™ SARS-CoV-2 Extraction Kit (RUO)

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
  • Magnetic bead separation technology with proprietary buffer system
  • Isolation of high-quality RNA in < 1 hour
  • > 99% recovery of extracted RNA from 350 μL sample
Easily Adaptable
  • Manual or automated processing
  • Compatible with common automated open platforms and RT-PCR kits
  • Flexible for 1.5 mL tubes or 96-well plates

AMPIXTRACT™ SARS-CoV-2 Extraction Kit


Download our Flyer: Extraction Kit for SARS-CoV-2 - RUO




AMPIPROBE® SARS-CoV-2 Assay Kit (RUO)

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.

Performance
  • Sensitivity: 98.1%
  • Clinical Specificity: 99.3%
  • Size: 96 tests
Easily Adaptable
  • Adaptable to both automated open platforms (including GENFLEX™) and manual processing
Cost-Effective
  • Low-cost alternative to other methods of viral load detection
AMPIPROBE® SARS-CoV-2 Assay Kit (RUO) was validated on the following RT-qPCR instruments:
  • QuantStudio® 5 (Applied Biosystems®)
  • Rotogene® (QIAGEN®)
  • qTOWER (Analytik Jena®)
Note: Extraction of RNA was performed either with the GENFLEX™ Platform using AMPIXTRACT™ SARS-CoV-2 Extraction Kit (RUO) or with QIAsymphony SP (Qiagen®) using QIAsymphony DSP Virus/Pathogen Midi Kit(Qiagen®)


Download our Flyer: Detection Kit for SARS-CoV-2 - RUO




AMPIPROBE® SARS-CoV-2 Controls (RUO)

The AMPIPROBE® SARS-CoV-2 Controls (RUO) are designed to be used during the qPCR detection of the SARS-CoV-2 virus.







Build Your Own COVID-19 Molecular Detection Assay

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.

  • Convenient one tube reaction (cDNA synthesis and qPCR in a single tube)
  • Thermostable and extremely active RTase
  • For dye-based and probe-based qPCR applications
  • Flexible: can be adapted to a variety of platforms
  • 200 and 1000 reactions formats available

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.




Complementary PCR Products




COVID-19 Serological Testing



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 patient’s 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 a patient’s immune response.




SARS-CoV-2 IgG ELISA Kit

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, it has been submitted to the FDA's Emergency Use Authorization (EUA) as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. 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

  • Clinical Specificity*: 96.5%
  • Clinical Sensitivity*: 100%
  • Time to results: < 2 hrs

Easily Adaptable
  • Adaptable to automated open platforms and to manual processing




Download our Flyer: Antibody Detection for SARS-CoV-2 - IVD



Download our Flyer: Antibody Detection for SARS-CoV-2 - RUO


*In a clinical study with a RT-PCR comparator. FDA’s independent review of this validation data is pending.

This test has been validated but FDA’s independent review of this validation is pending. This test is provided in compliance with FDA policy “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised).
Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.





Build Your Own SARS-CoV-2 IgG and IgM ELISA Kits


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.


COVID-19 and Coronavirus-Related Antigens


The right antigens are key in any immunogenic or serologic detection assay. We offer a variety of SARS-CoV-2 antigens as well as SARS-, MERS-CoV, and other coronaviral antigens to determine cross-reactivity or develop pan-coronavirus assays.




Complementary Products for ELISA Assay Development

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COVID-19 Literature

Brochures
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Product Flyers
Extraction Kit for SARS-CoV-2 - EUA
Product Flyers
Detection Kit for SARS-CoV-2 - EUA
Product Flyers
Antibody Detection for SARS-CoV-2 - IVD
Product Flyers
Extraction Kit for SARS-CoV-2 - RUO
Product Flyers
Detection Kit for SARS-CoV-2 - RUO
Product Flyers
Antibody Detection for SARS-CoV-2 - RUO

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