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Jung Moon, M.D. M.M.S., Pathologist, Cellgenemedix. © Vita Studio

GG Omicron and Delta PCR Testing for Clinical Triage of COVID Patients

Published on January 07, 2022

The Delta and Omicron variants are driving a “dual surge” in Covid-related infections all over the world, with daily US cases reaching an all-time high with more than 600 million cases in the world and over 5.49 million deaths to date, according to health officials. The current trend in the Coronavirus pandemic has led to an interesting phenomenon that may be called a “twin pandemic”, where the Delta variant continues to primarily ravage unvaccinated people, even as Omicron also targets people who are partially immune—either from previous infection or incomplete vaccination. “Even if Omicron variant causes less severe disease, our modelers predict hospital surges for CA,” wrote California Public Health Officer and Director Dr. Tomás Aragón on Twitter. “Omicron is so contagious that it finds unvaccinated/non-immune people who are most vulnerable for hospitalizations and deaths.” The Centers for Disease Control and Prevention revised estimates on their prevalence last week; Omicron is estimated to account for 59% of all infections and Delta 41% of infections.

The Omicron and Delta variants in the last 4 weeks have demonstrated different characteristics such as increased severity of infection, especially lower respiratory infection and complications/death rate in Delta variant while Omicron variant is more infectious, more likely to invade the upper respiratory tract, and better at circumventing vaccinated peoples’ immunity than the Delta variant. (Danish study conducted by researchers at University of Copenhagen, Statistics Denmark and Statens Serum Institut (SSI)).

“This leads us to theorize; there needs to be a test that will be able to tell if a newly infected individual with COVID-19 has the Delta variant or the Omicron variant, as the clinician who sees the COVID-19 patient firsthand should be able to triage the COVID-19 patient in regards to disease severity, underlying disease status, and the variant status.” Jung Moon M.D. (licensed US and Korean MD, Pathologist, Cellgenemedix) says, “GG COVID-19 Omicron and Delta kit (Cellgenemedix, South Korea, currently on investigational use in Europe and Asia and unavailable in the USA) is a cost-effective diagnostic tool optimized for rapid diagnosis of Omicron/Omicron stealth, Delta, and SARS CoV-2 infection, and is expected to be a useful tool in the control and surveillance as well as accurate diagnosis of SARS-CoV-2 in the new, antigen shift era of COVID-19 pandemic.”

“Accurate diagnosis of SARS-CoV-2 as well as differentiation of Delta and Omicron variants is crucial in the decision making of high-risk patients, especially when deciding whether they should be considered for in-patient care versus outpatient follow-up. GG COVID-19 Omicron and Delta kit is the first of its kind for rapid (90 minutes from RNA extraction to results) POC diagnosis of Omicron and Delta as well as SARS CoV-2 infection. While it is screening for the variants and cannot replace sequencing as far as the gold standard of diagnosis, the analytical sensitivity and specificity is high in our studies and the cost of this test is known to be similar to or slightly more expensive than the previous Real Time RT-PCR test for diagnosis of COVID-19. Also, the ability to screen tens of thousands of patients per lab in one setting is something that sequencing can never do, but real-time PCR can do”

Dr Moon also added that “The GG Omicron and Delta kit is applicable to most real time PCR machines used all over the world such as Applied Biosystems 7500 (Thermo Fisher Scientific), Rotor-Gene Q 5-plex HRM (Qiagen, Hilden, Germany), CFX96 Touch Real-Time PCR Detection System (Bio-Rad, Hercules, CA, USA) and comes with associated software compatible with all three machines. It also has the ability detect Stealth Omicron (BA.2, 3) which may not be detected in certain Omicron diagnostic methods and has the potential to detect future mixed delta and omicron type which may well be a problem in the future”

“A new super-variant could be created if Omicron and Delta infect someone at the same time” Dr. Paul Burton, one of Moderna’s bosses, has warned. Covid infections normally only involve one mutant strain, but in extremely rare cases two can strike at the same time. If these also infect the same cell, they may be able to swap DNA and combine to make a new version of the virus. He warned the high numbers of Delta and Omicron cases currently circulating in Britain made this more likely.

“In this case, The GG Omicron and Delta kit may play a key role in disease control and treatment and needs to be applied as soon as possible in as many countries as possible”, Dr. Moon says. “GG COVID-19 Omicron and Delta kit is a one-step, single tube, multiplex real time reverse transcription PCR assay utilizing hydrolysis probes (TaqMan probes) and primers for N protein as well as hot spot mutations of spike protein that allow discrimination of each type. 2 lab personnel may test 400-1600 patient specimens per day using any of the most common Real time RT-PCR machines. Thus, this reagent kit has the capacity to test hundreds of thousands of patient specimens per day and guide clinical decisions daily.”

GG COVID-19 Omicron and Delta kit. Cellgenemedix LLC.

GG COVID-19 Omicron and Delta kit. Cellgenemedix LLC. © Jung Moon

Newsroom Editor