Our COVID strategy
- ALL of Cellgenemedix’s COVID-19 products have been validated in multiple variants with clinical Omicron and Delta samples and verified commercial controls.
- GG COVID-19 Omicron & Delta PCR test works well on Omicron and Delta variant specimens (>100-500 specimens verified), as well as multiple other verified control materials
- CE + ISO approved for use in Europe and Asia(Inquire per email to see CE certificate
- NOT AUTHORIZED OR CLEARED FOR USE IN THE USA
Case numbers outpace surveillance efforts. Efforts to track the evolution of SARS-CoV-2 have lagged far behind case numbers, but are improving. Simply put, detecting SARS-CoV-2 is cheap. But detecting SARS-CoV-2 variants? That’s much more expensive.
Recently (November 24, 2021), a new concern mutant, Omicron Corona 19 virus(BA.1) was reported in South Africa, which has 32 mutations with more mutations than Delta in the spike protein is becoming Omicron mutation is rapidly spreading to most countries and have huge clinical impact. The world is in dire need of a diagnostic kit that can diagnose COVID-19 infection while simultaneously diagnosing omicron and delta mutations, report automatic analysis, and quickly and accurately test multiple samples.
There are a few ways to detect SARS-CoV-2 variants. One method uses sequencing to sequence all the genetic material found in a clinical sample – viral and human. While comprehensive, the sequencing of the human genetic material is costly and unnecessary. It also requires that the sample is sequenced to a higher depth for accurate detection, given the viral genetic material is a very small proportion of the total sample. An alternative method is targeted NGS sequencing which may save time and money.
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)). Differentiation of Delta and Omicron variants is also 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.
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 and for this PCR testing such as GG COVID-19 Omicron and Delta kit has to be introduced as soon as possible.
The GG COVID-19 variant Kit (GG-VOC1-01/2) allows differentiation of the Alpha (B.1.1.7), Beta (B.1.351)/ Gamma (P.1), Delta (B.1.617.2.) Kappa (B.1.617.1), Lambda (C.37), Eta (B.1.525)/Mu (B.1.621) and Omicron (B.1.1.529) as well as differentiation of Omicron stealth (BA.2) and Deltacron through Real-time RT-PCR in 1 -3 tubes.
While both targeted sequencing and RT-PCR approaches enable viral evolution tracking, GG COVID-19 variant Kit offers a clear advantage: it can save time and money and is easy to use. This allows the assay to remain robust in the face of continual viral evolution.
While both targeted sequencing and RT-PCR approaches enable viral evolution tracking, GG Delta/Omicron variant Kit offers a clear advantage: it can save time and money and is easy to use. This allows the assay to remain robust in the face of continual viral evolution.
Cellgenmedix’s RT-PCR for SARS-CoV-2 variant testing has multiple probes targeting different regions of the viral genome, and has the capacity to detect all the variants of concern and interest in a very cost-effective format. Probes for each new loci is guaranteed to be developed within 2 weeks. It is known that the price of this kit will not be different from the existing PCR kit that simply identifies COVID-19.
Cellgenemedix has developed the world’s first real-time PCR kit for testing of the presence of COVID-19 at the same time as screening in whether the COVID-19 type is Delta or Omicron or neither. The “GG COVID-19 Omicron and Delta test kit” by Cellgenemedix-patented quadplex test kit (UNAVAILABLE in USA, CE MARK and AVAILABLE for sale in Asia and EUROPE) with 4 channels in one tube; a control gene (IC), N of COVID-19 virus (SARS-CoV-2), SARS-CoV-2 Spike protein “omicron” type mutation (del 143/144/145), and Spike “delta” type mutation (T478K and L452R), all simultaneously confirmed with a fluorescent probe (PROBE). The Real-time PCR test is performed to check at the same time. This product comes out in 2 forms (100T/200T) and can also be detect all stealth-type Omicron (BA.2) and uses its own technology applied for international patents.
Cellgenmedix’s highly sensitive COVID-19 Variant Of Concern RT-PCR test assay is the first in the world to detect all 5 SARS-CoV-2 variants in 1 tube. Since COVID-19 pandemic started more than two years ago, RT-PCR has been the go-to method for detecting SARS-CoV-2 infection because it offers high sensitivity for a relatively low cost. However, the continued emergence of variants like those originating from the Alpha (B.1.1.7), Beta (B.1.351)/ Gamma (P.1), Delta (B.1.617.2.) and Omicron (B.1.1.529) threatens to make diagnostic tests more prone to failure and sequencing has been the gold standard for the detection of clinically significant COVID-19 variants.
|Test Principle||One-step real-time RT-PCR (TaqMan®-based detection|
|Targets||NP gene and S gene region of SARS-CoV-2 (COVID-19), 3 mutation hot-spots|
|Number of Tests||100T I Kit|
200T I Kit
300T I Kit
|Time to Result||1.5 hr ~ 2 hr|
|Specimen Type||sputum, nasopharyngeal or oropharyngeal swabs, nasal swabs|
|Instrument Required||RNA Extraction kit|
Real-time PCR instrument*
|Kit Storage||<-15 °C, avoid repeated freezing and thawing of kit contents|
|Compatibility||• Bio-Rad CFX96|
• Applied Biosystems Real-Time Real time PCR Instrument System (Thermo Fisher Scientific) ABI 7500
• Roche Rotorgene
The lab has to be able to perform the following steps:
1. Rna extraction from patient specimen with RNA extraction kits such as QIAamp Viral RNA Mini Kit. (available all over USA, not in short supply)
2. Run Reverse transcription and Real Time PCR GG PCR reagents on your pre-existing machines
3. Report results according to SOP (additional machines may contact manufacturer for questions):
(1) Applied Biosystems 7500 Real Time PCR System (Thermo Fisher Scientific, Waltham, MA, USA)
(2) CFX96 Touch Real Time PCR Detection System (Bio-Rad, Hercules, CA, USA)
(3) Rotor Gene Q 5 Plex (QIAGEN, Hilden, Germany)
(4) LineGene 9600 Plus real-time PCR detection system (Biosan, Riga, Latvisa)