Image Credit: NIH
With the coronavirus disease 2019 (COVID-19) pandemic ongoing, millions of testing kits are needed internationally every single day. Here, we see how LGC, Biosearch Technologies, a leading provider of tools and technologies for genetic analysis, is helping respond to this demand, assisted by evaporation technology from SP Genevac.
A rapid response from the scientific community
The emergence of the novel coronavirus caused by the SARS-CoV-2 viral strain was swiftly followed by the development of tests from hundreds of labs around the globe, at a pace not witnessed in previous pandemics.
In February, the US Food and Drug Administration (FDA) lifted restrictions on labs and companies developing their own tests for the SARS-CoV-2 virus, leading to a rapid rise in the number of tests performed. This has proven necessary, as in the USA between 5 and 20 million tests per day could be needed for effective widespread population testing. While the world awaits a vaccine, testing for infections remains the most powerful tool for containing the virus.
How can we test for COVID-19?
There are two primary types of tests for COVID-19: a viral test and an antibody test. The most commonly used type is a viral test that employs Reverse Transcription Polymerase Chain Reaction (RT-PCR) to look for active infection with SARS-CoV-2. This is usually taken from a sample at the back of the nose or throat. By contrast, antibody tests can pick up current or past infections through the detection of a person’s immune response to the virus via a blood sample. Antibody tests take longer to develop than PCR tests, which were quickly available once the genetic sequence of SARS-CoV-2 was published.
PCR is a long-established and widely used approach for genetic analysis. In the case of an RNA virus-like SARS-CoV-2, a DNA copy of the genetic material is made. This is then massively amplified through the addition of enzymes, master mix, probes, and primers. Primers are oligonucleotide sequences that hybridize to target sequences on the single-stranded DNA during this amplification to initiate copying and allow probes to a couple, clear, and release the reporting fluorophore. Viral genes targeted so far include the N, E, and RdRP genes. Probes are fluorescently labeled oligonucleotide sequences that hybridize with target sequences of DNA while it is being copied, at which point, light is emitted. The more of a target sequence copied, the more hybridization will take place, and the greater the light emission. This can be detected and measured to determine if the SARS-CoV-2 is present in the sample.
Stepping up to the challenge
One global brand that has been responding to the demand for COVID-19 testing is LGC, Biosearch Technologies. The brand provides tools and technology for genetic testing, usually catering to agrigenomic and molecular diagnostics customers. Their portfolio includes products for sample preparation, amplification, cloning and expression, next-generation sequencing, custom oligonucleotide synthesis, and nucleic acid chemistry reagents. Biosearch Technologies has experience of operating in pandemics, having previously scaled up their oligonucleotide manufacturing during the 2009 swine flu (H1N1) outbreak.
Image Credit: LGC, Biosearch Technologies
During COVID-19, they have been expediting the production of oligonucleotides and other critical components including RNA viral purification kits, master mix, and enzymes for 1-step RT-qPCR. They are also an acceptable commercial supplier of the 2019-nCoV CDC-qualified probe and primer kits, in accordance with CDC's Emergency Use Authorization (EUA). The kits include FAM-BHQ probes and primers targeting N1, N2, and RNase P signatures as required by protocols provided by the CDC. Oligos are delivered dried and shipped at ambient temperature.
They also deliver large scale probes and primers using sequences designated by the Charité protocol enabling anywhere up to 100,000 tests per order. Custom, bulk oligonucleotides based on customer-supplied sequences are also available. Through their past experience of pandemics and by prioritizing COVID-19-related orders, Biosearch Technologies is helping its customers in the mission to address COVID-19 testing goals.
One of LGC, Biosearch Technologies' bottlenecks in their oligo production workflow from synthesis to customer distribution is the drying process. The output from the synthesis labs and purification group can far outweigh the aliquoting, loading, and drying workflow, which causes slowdowns upstream.
Not only is scaling up the production of these probes and primers critical to achieving testing capacity, but they must also be accurate and reliable. The organization is harnessing SP Genevac technology, to help them rapidly produce probes and primers to the high standards needed in this critical situation. SP Genevac technology has the capacity equivalent 3-4 times that of other dryers in use within the production workflow, with roughly equivalent drying time. This capacity also allows production to dry other products concurrently with the COVID-19 oligos, ensuring that there is no backlog of non-COVID oligos for other customers.
Biosearch Technologies use the SP Genevac HT S3i evaporator to dry down the probes and primers for SARS-CoV-2 detection and custom orders. If the oligos are not perfectly dried, the water left in the samples can cause damage to the probes and primers over time. Therefore, it is important the oligos are dried effectively prior to shipping. Freeze drying is also an alternative way to achieve desired dryness if long term storage is required. The SP Genevac HT S3i has a number of features that help ensure this process is both rapid and reliable.
Through parallel capacity, the model facilitates high-throughput evaporation, preventing bottlenecks in test kit component production. But it also carries a number of patented technologies to ensure this speed is not at the expense of accuracy. This includes SP Genevac’s SampleGuard temperature control, to preserve sample integrity, and Dri-Pure anti-bumping sample protection, which guarantees against contamination and sample loss. Having a dual functionality to dry and freeze dry samples brings a unique feature to this oligo synthesis application.
Why is testing so important?
In its simplest terms, testing for COVID-19 is essential because it is the only way to confirm a case of the infection; symptoms alone are insufficient. But beyond that, there are a range of reasons why testing is critical in dealing with a pandemic.
Testing is the only means available to understand the pandemic and the transmission of the virus. From a research perspective, it can also shed light on how the virus affects different populations of people.
As around the world, entire regions and industries are effectively shut down, it is vitally important to know whether these interventions are successfully preventing viral transmission. However, increased testing will also be needed if these stringent measures, with their huge impact on the economy, can be eased and allow uninfected individuals to return to work.
On an individual basis, a confirmation of COVID-19 infection, particularly if detected early, allows for quarantining, and contact tracing, both considered important measures for containing the virus. With no vaccine yet available, this strategy is the only viable option for bringing the epidemic under control. Testing is also able to reveal the infection in asymptomatic carriers, around 50% of those infected, who are thought to play a significant role in spreading the disease.
SP Scientific would like to acknowledge the valuable assistance provided by LGC, Biosearch Technologies.
References and Further Reading
About SP Scientific Products
SP Scientific is the synergistic collection of well-known, well-established, and highly regarded scientific equipment brands — VirTis, FTS Systems, Hotpack, Hull, Genevac, PennTech, and most recently i-Dositecno — joined to create one of the largest and most experienced companies in freeze-drying/lyophilization, production fill-finish lines, centrifugal evaporation and concentration, temperature control/thermal management, glassware washers and controlled environments.
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