Understanding COVID-19 Mutations and the Ability of DTPM’s COVID-19 Assay to Detect Them

DTPM's COVID-19 RT-PCR Testing Assay works for all current known COVID-19 strainsThe Origin of the COVID-19

COVID-19 was first reported in mid-December 2019 in Wuhan China. The acute respiratory syndrome virus (SARS-CoV-2) is a single-stranded RNA beta-coronavirus. This virus causes a serious disease known as Coronavirus Disease 2019 (COVID-19), which has spread in over 210 countries, with 91 Million overall confirmed cases and 800,000 current confirmed cases. More than 50.4 Million have recovered, and almost 1.9 Million deaths reported worldwide as of January 9, 2021. Geographical demographics of the virus have been observed and are likely affecting the fatality rate and the initial spread of the virus depending on the measures each location is taking to limit exposure.

SARS-CoV-2 Mutations Explained

Mutations of any virus are expected so as researchers and scientists studied SARS-CoV-2, they developed accurate tests and vaccines, planning for future strains. Different strains can be more contagious and can mutate depending on demographic location. Research has currently shown that the number of mutations is relatively low and that overall, no continent differs significantly from the average mutation rate. There are currently less than 10 variants of SARS-CoV-2.

The original L strain that was first detected in Wuhan China has essentially disappeared. At the beginning of 2020, the initial L strain mutated into Strain S (variant ORF8-L84S). Later, as the virus began to spread, Strain S mutated into the Strain V(variant of the ORF3a coding protein NS3-G251) and Strain G(variant of the spike protein S-D614G) strains. The G strain mutated into GR, GH, and GV which are currently the most prominent strains in North America now.  Another less talked about strain is called the O strain which is a collection of mutations that can’t be categorized into any other particular strain.

One of the most recent strains of SARS-CoV-2 (known as 20B/501Y.V1, VOC 202012/01, or B.1.1.7 lineage) found in The United Kingdom, is called VUI (Variant Under Investigation) and contains mutations in a gene called “Spike” which is associated with binding to human cells. These mutations appear to make the UK variant more contagious but most recent data shows that the mortality does not appear to be higher in the VUI / UK strain.

What does this Mean for COVID-19 Testing?

DTPM currently has an FDA EUA authorized COVID-19 Test for use in your laboratory. Our carefully designed DTPM-COVID-19 RT-PCR COVID-19 assay includes forward and reverse primers, and a probe, positive controls, and Taq/RT are included with the assay.

The DTPM-COVID-19 RT-PCR Assay currently detects all known SARS-CoV-2 strains. Our assay was designed to a conserved domain of the SARS-CoV-2 pathogen. Although the virus is mutating, none of the currently recognized variants are located at the locus of the primers and probe contained in the DTPM assay.

Why The DTPM-COVID-19 RT-PCR Assay is Unique

What Makes our Assay Unique?

  • Superior Bioinformatics
  • The assay is specifically optimized to the SARS-CoV-2 Pathogen
  • Utilizes RT-PCR to increase sensitivity and identify live pathogens
  • Speed:  a 45 minute PCR run time
  • Proprietary Endogenous Control
  • Compatible with multiple collection methods

Instrumentation and Extraction

  • The DTPM Covid-19 assay has EUA approval for the Quant Studio 5
  • The extraction methods are available in multiple formats from 24 to 192 samples

Accuracy and Quick Results

Now you can provide patients with the quickest and most accurate results possible to allow the healthcare provider to provide an accurate diagnosis:

  • Expedited Patient Results
  • Unmatched accuracy of PCR
  • Simple Collection
  • Direct access to experienced scientific staff
  • Personal customer service experience

What is the DTPM PCR Testing Process Look Like?

DTPM's COVID-19 Testing Process explained in infographic formLooking into the Future of COVID-19

Speculation surrounding mutations and new strains is complicated and researchers Scientists are currently doing all they can to identify new variants and educate the public on significant changes within the mutations including, geographic location, how contagious it can be, and if it impacts the fatality rate. Currently, all known strains are detected using the DTPM COVID-19 test. DTPM’s current statement to our clients and future clients is as follows:

Our team has evaluated the known and published sequence information publicly available. At this time, no known mutations appear to impact the ability of our assay to detect the presence of SARS-CoV-2 RNA. We will continue to evaluate new information as it becomes available and will provide updates should we determine there is an incompatibility observed.

To learn more about DTPM COVID-19 testing, visit https://dtpm.com/coronavirus-assay/