GG COVID-19 Omicron/Delta PCR study Proposal
Creators: name: Moon, Jung Joo
Publisher: name: Zenodo
Year: 2022
Subjects: covid variant test

description: Most U.S. doctors have no way to determine which variant of the coronavirus a patient is carrying, a distinction that could mean the difference between life and death. 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. High-risk patients carrying the Delta variant could benefit greatly from two particular monoclonal antibody treatments shown to reduce hospitalization and death. But those medications would most likely do nothing for patients with Omicron, who would only respond to a third antibody treatment that is in very short supply. Delta patients benefit most from the antibody drugs made by Regeneron (casirivimab and imdevimab) and Eli Lilly (Bamlanivimab), while Omicron patients benefit from antibodies from GlaxoSmithKline and Vir Biotechnology (sotrovimab (VIR-7831)). GG COVID-19 Omicron and Delta kit (Cellgenemedix, USA) is a cost effective diagnostic tool optimized for rapid (90 minutes from RNA extraction to results) POC diagnosis of Omicron and Delta as well as SARS CoV-2 infection. We have achieved CE mark and this was made from a ISO 13485 certified facility. GG COVID-19 Omicron and Delta kit is a cost effective diagnostic tool optimized 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 accuracy, 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. This is also due to the fact that single PCR has to be done and if the PCR doesn't come out (specimen quality, etc), sequencing cannot be done. However, due to the amplification properties of re-time PCR, GG COVID-19 Omicron and Delta kit is able to detect most covid-19 infections and whether it is Delta, Omicron, or neither. GG COVID-19 Omicron and Delta kit also has the ability to detect Stealth Omicron (BA.2) and has the potential to detect future mixed delta and omicron type which may well be a problem in the future. Development of a cost-efffective PCR variant test that costs as little as or less than the conventional PCR test and can be run in multiple PCR machines frequently equipped in small-to medium sized labs around USA may be a solution to partially solve the disparity of covid test and variant test in specific will hopefully be resolved by better quality accurate variant testing. Beyond the direct health impacts of the virus, the pandemic has taken a disproportionate toll on the financial security and mental health and well-being of people of color, low-income people, LGBT people, and other underserved groups as shown in Figure below. Despite being disproportionately affected by the pandemic, as of today, Black and Hispanic people were less likely than White people to have received a COVID-19 test. Addressing disparities in health and health care is important not only from and social justice and equity standpoint, but also for improving the nation’s overall health and economic prosperity. While sequencing technologies may be the gold standard for COVID-19 variant test, its limitations include low throughput and high cost, making multigene panels laborious and expensive. This is not adequate for medicare/medicaid and makes it unpractical for standard of care for minority populations. Therefore, we propose that GG COVID-19 Omicron and Delta kit could be a cost-effective was to diagnose COVID-19 variants in the minority population. In addition, we are proposing that labs within and outside of USA collaborate with us in our Cellgenemedix Good Ag Rapid COVID-19 Antigen Test &amp; GG COVID-19 Omicron/Delta PCR study which is conducted in various clinical sites in USA and Korea currently. Study proposal PURPOSE: Participating laboratories will run positive and negative samples COVID-19 clinical samples from real-time PCR platform using probes/primers from Cellgenemedix to accurately identify variants of the COVID19 virus using a PCR method on CFX96/ABI7500/Rotorgene Q platform. METHODS: 1. Previous samples that were tested on FD A approved PCR test on real-time PCR platform for Covid19 . 2. Probes/Primers supplied from CellGenmedix 3. Samples both positive and negative are extracted using a FDA-approved extractor using the small volume Total nucleic acid kits 4. Run protocol will be provided 5. Results are recorded on a excel file provided by Cellgnemedix 6. Validation of results will be performed by sending in the samples after running the PCR test for sequencing in Korean authorized labs. CONTROLS: 1. All samples are extracted with an internal control 2. External controls from Cellgenemedix and Twist Bioscience will be run Below is an abstract we submitted around the performance test of this 'GG COVID-19 Omicron and Delta kit'. Background. We are facing a global new era of the COVID-19 pandemic by omicron variant with multiple mutations. This raises concern about the accuracy of conventional RTqPCR assays, many of which have been developed before in detecting SARS-CoV-2. We may need to develop a new RTqPCR assay appropriate for the omicron variant. Materials and Methods. We herein have developed 2 types of new RTqPCR assays which detect G142D/del143-145 of S which is specific to omicron variant (S142-145 assay), 452 and 478 of S (S452/478 assay), N or 69/70, and internal control (IC) to make a new single tube, quadplex RTqPCR assay of COVID-19 ('GG COVID-19 Omicron and Delta kit'). Analytical performance was analyzed with Twist/BEI controls. Clinical performance analysis was done as a multi-center study between South Korea and USA with specimens from New Jersey, collected between August 2021 and February 2022. Result: 400 left over samples of nasopharygeal swabs including 149 SARS-CoV-2 positive sample were collected and tested on January 2022 out of which 148 were due to omicron variant and 1 delta variant, respectively. S142-145 assay was superior to conventional assay (sensitivity 100% vs 00.0 to 00.0%, mean Ct value 25.0 vs 30.4 to 31.3). GG COVID-19 Omicron and Delta kit showed higher sensitivity than conventional RTqPCR (100% vs 95.4%) and 100% specificity in detecting SARS-CoV-2 and could differentiate all of omicron variants. 330 samples including 125 SARS-CoV-2 positive samples were collected between September-October 2021 and also tested, out of which 78 were due to delta variant. All of 78 delta variant were correctly detected by 'GG COVID-19 Omicron and Delta kit’. Conclusion: These results indicate that our GG COVID-19 Omicron and Delta kit may be more sensitive than conventional PCR assays in detecting some variants of SARS-CoV-2 due to target design. ALL of Cellgenemedix’s COVID-19 products have been validated in multiple variants with clinical samples and commercial and verified commercial control materials and Good Ag antigen test and PCR test work well on both Omicron and Delta variant specimens (&gt;100-500 specimens verified) as well as multiple other variants and validated commercial controls. -------------------------------------------- CONFIDENTIALITY NOTICE: This communication with its contents may contain confidential and/or legally privileged information. It is solely for the use of the intended recipient(s). Unauthorized interception, review, use or disclosure is prohibited and may violate applicable laws including the Electronic Communications Privacy Act. If you are not the intended recipient, please contact the sender and destroy all copies of the communication. Contents and any attached file are intellectual property of Cellgenemedix. Corp This product has not been approved the F DA approval in the USA and is Investigational use only in the USA. The performance characteristics of this product have not been established by the F D A to date. However, this product has achieved CE mark approval for European and Asian market and was made from a ISO 13485 certified facility for high level immunology testing. The technology is patent pending in various patent offices around the world.