SARS-CoV-2 Testing Workflow

New 2019-nCoV Coronavirus RNA Purification and Identification Method

Ultrafast and Reliable Isolation of Coronavirus SARS-CoV-2 RNA and Subsequent Analysis

PerkinElmer chemagen has developed a SARS-CoV-2 RNA isolation kit named chemagic Viral DNA/RNA 300 Kit H96 (cat # CMG-1033-S) for automated isolation from 300 µl of below listed sample materials using the chemagic™ 360 instrument (cat. # 2024-0020) equipped with a chemagic 96 Rod Head Set (cat. # CMG-370). The isolation process takes only 18 min with a ultrafast protocol, 31 min with a short protocol and 60 minutes with a regular protocol. The eluted viral RNA is ready for subsequent analysis via RT-PCR.

Coronavirus PCR testing workflow

New ultrafast protocol for viral RNA isolation

Isolate viral SARS-CoV-2 RNA in only 18 min with similar performance in qPCR! Download the new ultrafast protocol version and contact us to update your chemagic™ 360 instrument!

 

SARS-CoV-2 Detection Workflow

SARS-CoV-2 Detection Workflow

Coronavirus Sample Preparation

1. Sample collection with nasal or oropharyngeal swabs. 300 µl saliva, sputum, BAL, serum or plasma are common sample materials, too.
2. Nucleic Acid Purification (NAP) using chemagen Technology instruments

Optional: The addition of a homogenization step simplifies the further processing for some sample materials such as saliva. Read more

Detection

3a. Reverse Transcription of  RNA to cDNA
3b. RT-PCR Detection of SARS-CoV-2 specific genes

RUO SARS-CoV-2 RNA Isolation

Catalog No.Kit NameInstrumentInputRUO Sample TypeFormatPreps/kitProtocols
CMG-1033-Schemagic™
Viral DNA/RNA 300 Kit H96		chemagic™ 360/MSM I
instrument		up to 300 µlOropharyngeal swab,
nasopharyngeal
swab, saliva		96 well960Ultrafast - 18 min
Short - 31 min
Regular - 60 min

For research use only. Not for use in diagnostic procedures.

RUO kit for SARS-CoV-2 qPCR

Catalog No.Kit NameInstrumentInputRUO Sample TypeDetection OfFormatPreps/kit
SARS-CoV-2-PCR-RUOPerkinElmer® SARS-CoV-2 Nucleic Acid Kit (RUO)Third party Real-Time PCR cycler400 µlOropharyngeal swab, nasopharyngeal swabSARS-CoV-2dependent on thermo cycler used48

For research use only. Not for use in diagnostic procedures.

FDA EUA authorized Kit for qPCR

Catalog No.Kit nameInstrumentInputFDA EUA Sample TypeDetection OfPoolingPreps/kit
2019-nCoV-PCR-AUSPerkinElmer® NewCoronavirus Nucleic Acid Detection KitThird party Real-Time PCR cycler300 µlOropharyngeal swab, nasopharyngeal swab, anterior nasal swabSARS-CoV-2Yes, up to 5 individuals48

For emergency use authorization only. Products may not be licensed in accordance with the laws in all countries. Please check with your local representative for availability.

CE-IVD Kits for SARS-CoV-2 qPCR

Catalog No.Kit NameInstrumentInputIVD-CE Sample TypeDetection OfPoolingPreps/kit
SDX-56392PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel AssayThird party Real-Time PCR cycler300 µlNasopharyngeal swab, oropharyngeal swabSARS-CoV-2, influenza A, influenza B, respiratory syncytial virus (RSV)No96
Covid-19-PCR-AUS-CPerkinElmer® SARS-CoV-2 Real-time RT-PCR AssayThird party Real-Time PCR cycler400 µlNasopharyngeal swab, oropharyngeal swab, SalivaSARS-CoV-2Yes, up to 5 individuals48
3501-0010PerkinElmer® SARS-CoV-2 RT-qPCR Reagent KitThird party Real-Time PCR cycler300 µlNasopharyngeal swab, oropharyngeal swabSARS-CoV-2No96
MP 2606-0100EURORealTime™ SARS-CoV-2*Third party Real-Time PCR cycler300 µlThroat swabsSARS-CoV-2No100

Products may not be licensed in accordance with the laws in all countries, such as the United States and Canada. Please check with your local representative for availability.

The chemagic™ Viral DNA/ RNA 300 Kit H96 (cat. # CMG-1033-S) and the chemagic™ 360 instrument are recommended for the isolation of nucleic acids for use with the PerkinElmer® SARS-CoV-2 Real-time RT-PCR assay or PerkinElmer® SARS-CoV-2 RT-qPCR Reagent Kit.
* The EURORealTime™ SARS-CoV-2 has been validated for CE-IVD registration with the Prepito® Viral DNA/RNA200 Kit (cat. # CMG-2015) with an input volume of 300 µl on the chemagic™ Prepito® instrument.
Find here more products from Euroimmun for Coronavirus Testing.

Detection of COVID-19 Variants of Concern (VOCs)

According to the WHO there are four variants as being of global concern and requiring heightened tracking and analysis. These are the variants B.1.1.7,  B. 1.351, P.1, and B.1.617. The variants show mutations in the glycoprotein S gene. As PerkinElmer SARS-CoV-2 RT-PCR assays were designed to identify SARS-CoV-2 ORF 1ab and N genes, the mutations in the VOCs do not affect the detection of SARS-CoV-2 by PerkinElmer RT-PCR assays. .

The observation of SARS-CoV-2 variants necessitates to take a deeper look on positive SARS-CoV-2 results as the observed variants seems to spread faster and/or may cause more severe diseases. Therefore, PerkinElmer provides two solutions for SARS-CoV-2 variant detection:

For research use only. Not for use in diagnostic procedures.

 

References

MacKay, M.J., Hooker, A.C., Afshinnekoo, E. et al. The COVID-19 XPRIZE and the need for scalable, fast, and widespread testing. Nat Biotechnol (2020).

FDA, “SARS-CoV-2 Reference Panel Comparative Data” (15th September, 2020)

Sahajpal, N. S., Mondal, A. K., Njau, A., Ananth, S., Jones, K., Ahluwalia, P. K., Ahluwalia, M., Jilani, Y., Chaubey, A., Hegde, M., Kota, V., Rojiani, A., & Kolhe, R. (2020). Proposal of RT-PCR–Based Mass Population Screening for Severe Acute Respiratory Syndrome Coronavirus 2 (Coronavirus Disease 2019). J Mol Diagn  22(10), 1294-1299. (2020)

Pillay, S., Giandhari, J., Tegally, H., Wilkinson, E., Chimukangara, B., Lessells, R., Moosa, Y., Mattison, S., Gazy, I., Fish, M., Singh, L., Khanyile, K. S., San, J. E., Fonseca, V., Giovanetti, M., Alcantara, L. C., Jr, & de Oliveira, T. (2020). Whole Genome Sequencing of SARS-CoV-2: Adapting Illumina Protocols for Quick and Accurate Outbreak Investigation during a Pandemic. Genes, 11(8), 949. (2020)

Senok, A., Alsuwaidi, H., Atrah, Y., Al Ayedi, O., Al Zahid, J., Han, A., Al Marzooqi, A., Al Heialy, S., Altrabulsi, B., AbdelWareth, L., Idaghdour, Y., Ali, R., Loney, T., & Alsheikh-Ali, A. . Saliva as an Alternative Specimen for Molecular COVID-19 Testing in Community Settings and Population-Based Screening. Infection and drug resistance, 13, 3393–3399. (2020)

Instruments Used in the Coronavirus Detection Workflow

Catalog No.Product NameApplication
2024-0020chemagic™ 360 instrumentProcessing of 96 x 300 µl COVID-19 associated sample materials within 60 minutes
CMG-370chemagic™ 96 Rod Head SetFacilitates processing of 96 samples in parallel on a chemagic™ 360 instrument
variable, please inquire
JANUS® G3 workstationFor sample handling and qPCR set up

Customer Testimonials

We are using PerkinElmer model chemagic™ 360 (Automated Nucleic Acid Extraction system) installed in our laboratory for COVID-19 testing. We are running 32 min. short protocol (recently updated by the PerkinElmer Team) and getting good result with our RT PCR. Due to this short protocol we are able to run approx. 4000 samples / day with two instruments, The instrument supplied has been functioning well, satisfying the requirements of our applications and meeting our expectations for quality and reliability of the data generated.

Department of Microbiology, Government of Rajasthan, S.M.S. Medical School, Jaipur

We had good earlier experience with the PerkinElmer chemagic 360 nucleic acid extraction system and found it to be highly versatile, filling many existing and future needs in our operations. When the viral extraction kit and RT-PCR kit became available it was a natural choice to adopt the complete workflow from a single, reliable and local supplier.

Biopsense, Jyväskylä, Finland

Protocol Download

Protocol Download

For research use only. Not for use in diagnostic procedures.