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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 Molecular Testing


AMPIPROBE® SARS-CoV-2 Test System

The AMPIPROBE® SARS-CoV-2 Assay is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test 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, to perform high complexity tests.





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



AMPICOLLECT™ Saline, Normal

AMPICOLLECT™ Saline, Normal is for sample collection of upper respiratory specimens such as nasal, mid-turbinate, nasopharyngeal, oropharyngeal swab specimens and nasopharyngeal wash/aspirate or nasal aspirate specimens. Alternatively, for sample collection of upper respiratory specimens, Viral or Universal Transport Medium can be used. For a complete list of sample collection allowed by FDA, visit their website.






AMPIXTRACT™ SARS-CoV-2 Extraction Kit

Our AMPIXTRACT™ SARS-CoV-2 Extraction Kit is designed for isolating viral RNA from upper respiratory specimens. It utilizes magnetic-particle technology for automated isolation and purification of nucleic acids from upper respiratory specimens. The isolated RNA is pure and ready for your downstream application including direct input to the target amplification process through RT-PCR methods. This kit is intended to be used with the GENFLEX™ platform. Alternatively, sample extraction could be performed following our manual protocol in combination with the AMPIPROBE® SARS-CoV-2 Assay Kit and QuantStudio™ 5 Real-Time PCR (Applied Biosystems™).


Performance
  • Magnetic bead-based separation technology with proprietary buffer system
  • Isolation of high-quality RNA in ≺ 1 hour
  • ≻ 99% recovery of extracted RNA from 350 μL sample





AMPIPROBE® SARS-CoV-2 Assay Kit

Our AMPIPROBE® SARS-CoV-2 Assay Kit is a multiplexed real-time RT-PCR assay that contains two primer and probe sets to detect two regions in the SARS-CoV-2 nucleocapsid (N) gene and one primer and probe set to detect human RNase P (RP) in a clinical sample. RNA isolated from upper respiratory specimens (such as nasopharyngeal swabs) is reverse transcribed to cDNA and subsequently amplified using the Applied Biosystems QuantStudio® 5 (QS5), which is part of the GENFLEX™ platform. During the amplification process, the probe anneals to a specific target sequence located between the forward and reverse primers. During the extension phase of the PCR cycle, the 5’ nuclease activity of Taq polymerase degrades the bound probe, causing the reporter dye (FAM, Hex or Quasar 670) to separate from the quencher dye (BHQ1 or BHQ2), generating a fluorescent signal. Fluorescence intensity is monitored at each PCR cycle by the thermocycler. Controls for the qPCR are included in the AMPIPROBE® SARS-CoV-2 Controls kit.


Performance
  • Clinical Sensitivity: 98.1%
  • Clinical Specificity: 99.3%
  • Size: 96 tests
Cost-Effective
  • Low-cost alternative to other methods of viral load detection





AMPIPROBE® SARS-CoV-2 Controls

The AMPIPROBE® SARS-CoV-2 Controls 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). This kit is intended to be used with the AMPIPROBE® SARS-CoV-2 Assay Kit.






Instruments Kits
GENFLEX™ platform
AMPIXTRACT™ SARS-CoV-2 Extraction Kit
AMPIPROBE® SARS-CoV-2 Assay Kit
AMPIPROBE® SARS-CoV-2 Controls

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

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



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).
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.
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.





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

Our AMPIPROBE® SARS-CoV-2 Test System is also designed to be used also as in a modular setting. The extraction and the detection components, AMPIXTRACT™ SARS-CoV-2 Extraction Kit and AMPIPROBE® SARS-CoV-2 Assay Kit, can be purchased as stand-alone products and be implemented in a manual or open automated process. This modular option gives you the freedom to assemble the COVID-19 testing workflow according to your needs.


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.

High Performance
  • Magnetic bead-based 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

Magnetic Bead Procedure

AMPIXTRACT™ SARS-CoV-2 Extraction Kit





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.

High Performance
  • Clinical Sensitivity: 98.1%
  • Clinical Specifity: 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®)





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






*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

COVID-19 Characterization

Coronavirus Antibodies
COVID-19 and Coronavirus Related Proteins
Products Related to Coronavirus Biology



COVID-19 Therapeutic Development

COVID-19 and Coronavirus Related Proteins
Coronavirus Antibodies
Drug Discovery
Small Molecules Therapeutics
Antiviral Response
Inflammation and Immune Response Monitoring
MAPK Signaling Pathway Monitoring
Scale up Production



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