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High-throughput, low-cost molecular testing for SARS-CoV-2 using Mass Spec.

B: One to watch

Agena Bioscience® has developed a cost-effective assay for the detection of SARS-CoV-2 virus on the MassARRAY® System. The high-throughput MassARRAY System enables laboratories to process approximately 6000-7000 samples per day with a single instrument of compact footprint (0.71m2) - reducing the burden on operator resources, equipment service and maintenance and IT interfacing costs per test. The Sars-Cov-2 assay provides a robust alternative to test for the presence of SARS-CoV-2 virus in human samples. This single well assay utilizes a one-step RT-PCR reaction to reverse transcribe viral RNA into cDNA and amplify the nucleic acid material in the same reaction. The reaction products are then analysed using a MALDI-TOF Mass Spectrometer with integrated analysis software for automatic results calling. This new biochemistry is shown to work robustly with an input containing as few as 10 genome copy number equivalents (GCE) of the SARS-CoV-2 virus in the reaction.

Have you validated this method, if so, how and what were the results of the validation?

Update: Agena Bioscience recently gained Emergency Use Authorisation (EUA) for iPLEX Pro SARS-CoV-2 Panel, from the U.S. Food and Drug Administration for in vitro diagnostic use. Details about this test can be found on the following Weblink: Whilst this panel is only available for diagnostics use in the USA a CE-IVD certification is in process to be finalized later in June 2020. 

Analytical Sensitivity & Specificity Studies:

Two 96-well plates containing a total of 100 samples were processed to determine analytical sensitivity and specificity. The results show that the SARS-CoV-2 Panel (RUO) achieves 100% sensitivity and specificity with a limit of detection of 10 viral copies. See attached white paper for further details.

Accuracy Study:

An external clinical laboratory was used to determine accuracy by comparing results with an established TaqMan based assay. Samples that were positive or negative on the alternative platform were tested using the SARS-CoV-2 Panel (RUO) on the MassARRAY System with Chip Prep Module 96. Results for the 50 samples tested showed 100% concordance with expected results.

Limit of Detection

Guidelines from the U.S. Food & Drug Administration (FDA) were followed to determine the LOD for the assay.1 SARS-CoV-2 dilutions of 0, 5, 10, 20, 100, 1000, and 10,000 GCE in a background of 100 ng of human RNA were used as input for the RT-PCR reaction. Results showed that the LOD of the assay was 10 viral copies added to RT-PCR reaction.

An input of 3 μL of RNA was used for the RT-PCR reaction, therefore indicating that the sensitivity of the assay is as low as 3 copies of SARS-CoV-2 per μL of input RNA.

How quickly could this be deployed and what are the dependencies?

The MassARRAY platform for SARS-CoV-2 testing can be deployed immediately with robust supply chain as all required materials are provided by Agena Bioscience.

What is the likely production volume?​

2 million tests per month with the ability to ramp beyond that.

What are the risks and barriers to using this at scale?

None identified. The MassARRAY system is bench-top, compact, high-throughput and easily scalable to meet the highest of daily testing demands.

Who are you already partnering with on this?

We are partnering with several clinical labs in the USA and EU countries such as UK, Germany, Austria, and Portugal.

edited on Jul 30, 2020 by Carlo Bottari
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Bev Matthews Jun 8, 2020

Hello Carlo, your solution has been review and the champions would like to hear more about this approach when you have new information to share. Please do post back on hear when you are ready. Many thanks Bev

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Carlo Bottari Jun 8, 2020

Hello Bev, that's great. We are very much excited and looking forward to providing updates on our approach for SARS-CoV-2 testing on the MassARRAY. Thanks. Best regards, Carlo

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Bev Matthews Jun 8, 2020

Status label added: B: One to watch

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