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SARS-CoV-2 (Coronavirus) Detection Workflow for research use only

Fri 11 Sep, 2020

Overview of the SARS-CoV-2 (Coronavirus) Detection Process

In December 2019 the novel SARS-CoV-2 (formerly named 2019-nCoV) was identified in Wuhan, the capital of China’s province Hubei. Based on its rapid spreading with more than 105,000,000 confirmed cases by beginning of February 2021 the World Health Organization declared the outbreak a public health emergency of international concern.

Important facts:

  • SARS-CoV-2: (+) ss-RNA virus
  • Related to SARS-CoV and MERS-CoV
  • Detection based on basis of PCR

Analytik Jena offers a broad product portfolio in the field of nucleic acid extraction and PCR or real-time PCR with both extraction kits and the necessary equipment. For research purposes for the detection of SARS-CoV-2 the following workflow is suggested.

1. Sample Collection

In principle, respiratory material such as nasopharyngeal and oropharyngeal swabs are suitable for the detection of respiratory pathogens. For more detailed information, recommendations of the WHO or other institutions should be observed.
Serum can also be used for serological tests, acute and convalescence samples.

2. Nucleic Acid Extraction

Analytik Jena offers a choice of extraction platforms and related extraction kits for extraction of viral RNA from swabs, cell free body fluids (e.g. serum, plasma, cerebrospinal fluid) and more. The product line innuPREP AniPath allows the simultanous extraction of both bacterial and viral DNA and/or RNA from respective starting materials. A detailed overview is shown in the table below.

HandlingSample throughputExtraction platformExtraction kit
NameKey features
ManualLow-Up to 12 samples / 25 mininnuPREP Virus TS RNA Kit
innuPREP Virus DNA/RNA Kit

 

Automated

MiddleInnuPure C16 touchUp to 16 samples / 31 - 84 min
Extraction platform only

innuPREP AniPath DNA/RNA Kit - IPC16, non-filled
innuPREP AniPath DNA/RNA Kit - IPC16
innuPREP Virus DNA/RNA Kit - IPC16, non-filled
innuPREP Virus DNA/RNA Kit - IPC16

HighCyBio FeliXUp to 96 samples / 62 - 73 min
Extraction platform + liquid handling
(e.g. preparation of PCR)

innuPREP AniPath DNA/RNA Kit – FX*
innuPREP Virus TS RNA Kit 2.0 - FX
innuPREP Virus DNA/RNA Kit - FX

HighKingFisher FlexUp to 96 samples / 60 min
Extraction platform only		innuPREP AniPath DNA/RNA Kit - KFFLX
innuPREP RNA Virus PLUS Kit – KFFLX

* Release planned for mid 2021

3. Amplification and Detection

Molecular assays to detect SARS-CoV-2 have been developed and are accessible through the homepage of the WHO. Furthermore, several commercial kits based on real-time PCR
are available. The table below shows all available detection kits which are tested on qTOWER³ and/or qTOWER³ 84.

Company nameAssay nameCE-IVD/ FDA EUA*Dye/ configuration/ target
Assays detecting SARS-CoV-2
Altona DiagnosticRealStar® SARS-CoV-2 RT-PCR Kit 1.0 RUO-FAM: Color Module 1 (E gene)
VIC: Color module 2 (IC)
Cy5: Color module 5 (S gene)
BGI GenomicsReal-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV-FAM: Color Module 1 (N-CoV)
VIC/HEX: Color Module 2 (IC)
EuroImmunEuroRealTime SARS-CoV-2CE IVD (qTOWER3)FAM: Color Module 1 (ORF1ab and N gene)
HEX: Color Module 2 (IC)
Fosun Pharma USAFosun COVID-19 RT-PCR Detection Kit-FAM: Color Module 1 (ORF1ab)
HEX: Color Module 2 (N gene)
ROX: Color Module 4 (E gene)
Cy5: Color Module 5 (IC)
IDEXXWater SARS-CoV-2 RT-PCR Test-FAM:  Color Module 1 (N1 and N2)
HEX: Color Module 2 (IC)
IngentixViroReal® Kit SARS-CoV-2 & SARSCE IVD (qTOWER3)FAM: Color Module 1 (RdRp)
Cy5: Color Module 5 (IC)
Inno-Train Diagnostik GmbHCovid-19 FluoGene QCE IVD (qTOWER3)FAM: Color Module 1 (N1 gene)
VIC/JOE: Color Module 2 (M gene)
ROX: Color Module 4 (IC)
MikrogenampliCube Coronavirus SARS-CoV-2-FAM: Color Module 1 (E gene)
HEX: Color Module 2 (ORF1a)
Cy5: Color Module 5 (IC)
ampliCube Coronavirus Panel-FAM: Color Module 1 (MERS-CoV)
HEX: Color Module 2 (SARS-CoV,SARS-CoV-2, Bat SARS-like CoV)
ROX: Color Module 4 (HCoV)
Cy5: Color Module 5 (IC)
Perkin ElmerSARS-CoV-2 RT-qPCR Reagent kitCE IVD (qTOWER3)FAM: Color Module 1 (N gene)
HEX: Color Module 2 (ORF1ab)
Cy5: Color Module 5 (IC)
New Coronavirus Nucleic Acid Detection KitFDA EUA (qTOWER3)
FDA EUA (qTOWER3 84)		FAM: Color Module 1 (N gene)
ROX: Color Module 4 (ORF1ab)
HEX: Color module 2 (IC)
PrimerDesignCoronavirus (COVID-19) FAM: Color Module 1 (RdRp)
VIC: Color module 2 (IC)
Procomcure BiotechPhoenixDx® SARS-CoV-2 IVDCE IVD (qTOWER3)FAM: Color Module 1 (E gene)
FAM: Color Module 1 (RdRp)
R-BiopharmRIDA®GENE SARS-CoV-2 RUO-FAM: Color Module 1 (E gene)
VIC: Color module 2 (IC)
RTA LaboratoriesDiagnovital SARS-CoV-2 MultiplexFDA EUA (qTOWER3) pendingFAM: Color Module 1 (N gene, ORF1ab)
HEX: Color Module 2 (IC)
SeegeneAllplex™ 2019-nCoV Assay-FAM: Color Module 1 (E gene)
HEX: Color Module 2 (IC)
ROX: Color Module 4 (RdRP gene)
Cy5: Color Module 5 (N gene)
Shimadzu2019 Novel Coronavirus Detection Kit -FAM: Color Module 1 (N1 gene)
ROX: Color Module 4 (N2 gene)
Cy5: Color Module 5 (IC)
Siemens healthineers / 
Fast-Track Diagnostic		FTD SARS-CoV-2 Assay (RUO)-FAM: Color Module 1 (ORF1ab and N gene)
Cy5: Color Module 5 (IC)
SolGentDiaPlexQ Novel Coronavirus (2019-nCOV) Detection Kit-FAM: Color Module 1 (N gene)
VIC: Color Module 2 (ORF1a)
Texas Red: Color Module 4 (IC)
TIB MOLBIOLTIB MOLBIOL LightMix® Modular SARS-CoV-2 (COVID19) RdRP -FAM: Color Module 1 (RdRP gene)
Cy5: Color module 5 (IC)
TIB MOLBIOL LightMix® Modular SARS-CoV.2 (COVID19) E gene -FAM: Color Module 1 (E gene)
Cy5: Color module 5 (IC)
Wells BiocareGENE™ COVID-19 RT-PCR kit-FAM:  Color Module 1 (N gene)
ROX: Color Module 4 (IC)
Cy5: Color Module 5 (RdRp)
careGENE™ N-Cov RT-PCR Kit-FAM:  Color Module 1 (E gene)
ROX: Color Module 4 (IC)
Assays detecting SARS-CoV-2 mutations
TIB MOLBIOLTIB MOLBIOl VirSNiP SARS-CoV-2 Spike 501Y-FAM: Color Module 1 (SARS Spike 501Y)
Inno-Train Diagnostik GmbHCovid-19 FluoGene Q N501Y (RUO)-

FAM: Color Module 1 (N1 gene)
VIC/JOE: Color Module 2 (M gene)
ROX: Color Module 4 (IC)
Cy5: Color Module 5 (S N501Y)

Assays detecting SARS-CoV-2 and Influenza viruses
EuroImmunEURORealTime SARS-CoV-2/Influenza A/BCE IVD (qTOWER3)FAM: Color Module 1 (ORF1ab and N gene)
ROX: Color Module 4 (Influenza A)
Cy5: Color Module 5 (Influenza B)
HEX: Color Module 2 (IC)
IngentixViroReal® Kit SARS Coronavirus & Influenza A/BCE IVD (qTOWER3)FAM: Color Module 1 (SARS)
VIC: Color module 2 (Influenza A/B)
Cy5: Color Module 5 (IC)
MikrogenampliCube Respiratoty Flu & SARS-CoV-2-FAM: Color Module 1 (Influenza-A)
HEX: Color Module 2 (Influenza-B)
ROX: Color Module 4 (ORF1a)
Cy5: Color Module 5 (IC)
Cy5.5: Color Module 6 (E gene)
R-BiopharmRIDA®GENE Flu & SARS-CoV-2 RUO-FAM: Color Module 1 (Influenza A/B)
VIC: Color Module 2 (ICR)
ROX: Color Module 4 (E gene)
Cy5: Color Module 5 (RdRp gene)

*Please note that products of Analytik Jena GmbH listed here are not explicitly marked as CE IVD and are exclusively intended for research purposes. The validation of the kits was performed by the assay manufacturers themselves on qTOWER devices and was subsequently CE IVD or FDA EUA certified.

The PCR set up can be pipetted by a liquid handling platform like CyBio FeliX . Using PCR workstations or cabinets increases maximum safety and minimizes contamination risks. Single
components such as qPCR Master Mixes and Reverse Transcription MasterMix are available via Analytik Jena as well. In general all Real-time PCR-based assays can be established on the qTOWER3 real-time thermal cycler family provided by Analytik Jena or similar. Information on further commercial qPCR assays for SARS-CoV-2 detection with confirmed compatibility on qTOWER3 devices is available on request.

Downloads

Flyer Workflow detection of SARS-CoV-2 (English)

Open PDF

Implementation of SARS-CoV-2 (Coronavirus) detection assays from TIB MOLBIOL on qTOWER³ for research use

Open PDF

Web Seminar Biofoundries and SARS-CoV-2 diagnostics

Learn more: Web Seminar Biofoundries and SARS-CoV-2 Diagnostics

Feedback

Comments (21)

  • Abhimanyu Pandey –

    thank you
    Reply

    • Analytik Jena AG –

      You are welcome!
      Reply

  • Mustakim,MD,Clin.Path –

    Thank you,I am User Analytic Jenna PCR labkesda Soppeng From South Celebes Indonesia.
    Reply

  • Florian Werner –

    We have also validated our Kylt SARS-CoV-2 Kits on the qTower 384. Very satisfied with the performance and results. (https://www.kylt.eu/de/products/show/more/454)
    Reply

  • Bhuneshwar Behra –

    Thank you
    Reply

  • Sunil Prasad Lekhak –

    Dear Sir/Madam

    We are trading company in Nepal, specialized in Molecular Diagnostic lab.
    Currently we are looking for Fully automated Nucleic acid extraction system and liquid handling system.
    I am very much interested in your CyBio Felix system.

    Could you please send me technical specifications and Distributor Price for Nepal.

    Looking forward to your reply.

    Sunil Prasad Lekhak

    Life Sciences Solutions Pvt. Ltd.
    Reply

    • Analytik Jena AG –

      Thank you for your inquiry. We have forwarded your request to our sales team which will contact you as soon as possible.
      Reply

  • Jazz –

    I Am looking into doing research for covid kit for salmon , poultry etc sample, can I ask if your kit suitable for animal sample ? What is the price to run a covid test? If the test including extraction and regained as well? Can you quote both ? What is the lead time and shelf life of this ?
    Reply

    • Analytik Jena AG –

      Thank you for your inquiry. Our sales team will contact you shortly to answer your questions.
      Reply

  • Mario Schwarzkopf –

    Hallo, ich Interessiere mich auch für ein Kit mit dem schnellstmöglich das Virus nachgewiese, bzw. ausgeschlossen werden kann. Ich bräuchte alle Gerätschaften, die Notwendig wären um dies für eine Mobile Prüfung zu nutzen. Würde mich über nähere Informationen und Preise freuen.

    Beste Grüße
    :Schwarzkopf
    Reply

    • Analytik Jena AG –

      Hallo Herr Schwarzkopf, wir haben Ihre Anfrage an unser Sales-Team weitergeleitet, welches die genauen Einsatzzwecke und Gegenheiten mit Ihnen abklären wird.
      Reply

  • Sara Sánchez –

    Cordial saludo,

    Quisiera saber si hay un proceso de validación con el kit comercial Molecutech Real Time COVID-19 el cual nos puedan compartir. O si hay opción de hacer una capacitación virtual para la interpretación de los resultados de las corridas realizadas con el qTower 3 y el Kit de Molecutech.
    Reply

    • Analytik Jena AG –

      Dear Mrs. Sánchez, right now the kit isn't validated on qTOWER3 yet. Please contact our application specialists at support-ls@analytik-jena.com. I'm sure that you will find an appropriate solution for your setup together.
      Reply

  • Mudhafar –

    Are SARS-CoV-2 (Coronavirus) Kits from Analyticgena Working with Applied Biosystem 7500 fast Device?
    Reply

    • Analytik Jena AG –

      Analytik Jena offers various nucleic acid extraction kits which can be used for the purification of viral RNA such as the SARS-CoV-2. For the subsequent detection via RT real time PCR on the one hand the PCR assay amplifying SARS-CoV-2-specific targets via distinct fluorescent dyes or probes is required. Such SARS-CoV-2 assays are not part of Analytik Jena's product portfolio. On the other hand a real time cycler is needed (which is offered by AJ). The PCR Assay and real time cyclers have to be compatible. The sample preparation via nucleic acid extraction does not affect the real time cycler so it is no problem to do nucleic acid extraction with kits by Analytik Jena and PCR with any cyler such as the Applied Biosystem 7500 fast Device .
      Reply

  • Michael –

    What cell free body fluid is the “liquor” part? That is from your web site above:

    2. Nucleic Acid Extraction
    Analytik Jena offers a choice of extraction platforms and related extraction kits for extraction of viral RNA from swabs, cell free body fluids (e.g. serum, plasma, liquor) and more.
    Reply

    • Analytik Jena AG –

      The aforementioned body fluid is cerebrospinal fluid. Thank you for the hint! We have corrected the text passage.
      Reply

  • Mary –

    Dear Sir/ Madam,

    We are using the KH medical etraction and detection kits for COVID-19 Virus. We already have the qTower2.0 at our institute but it seems not to give good amplification/ detection curves in the same. should we upgrade it or what could be the problem?
    Reply

    • Analytik Jena AG –

      Dear Mary, thank you for reaching out to us. The qTOWER2 should be able to help with your COVID-19 detection. Maybe a software update is all that is necessary. Our Life Science support staff has been contacted to assist you in solving this problem.
      Reply

  • Hue Anh –

    Dear Sir/ Madam,
    For testing Seegene's Allplex™ 2019-nCoV Assay on qTower3, Is color compensation required? If yes, Can I use AJ's Color compensation kit?

    Thanks!
    Reply

    • Analytik Jena GmbH –

      For reliable results with AllplexTM 2019-nCoV Assay by Seegene a color compensation with the Standard 2 matrix from qPCRsoft 4.1 or qPCRsoft384 1.2 is required.
      Reply

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