GG Covid-19
GG COVID-19 QuadPlex RT-PCR
The GG QPlex COVID-19 RT-PCR Kit (Approved for export and use in Europe and Asia) was designed to detect open reading frame (ORF1ab), RdRP, and nucleoprotein (N) based on the genomic database of COVID-19. Reverse transcription and RT-PCR are carried out sequentially in the same tube.
GG COVID-19 Quadplex real time RT-PCR Assay is versatile, can be run on a variety of different equipments with a running time of ~1 hour (minus the RNA extraction time) and up to 95 specimens per run(depending on the Real Time PCR machine used), includes primers and dual-labeled hydrolysis (Taqman®) probes to be used in the in vitro qualitative detection of COVID-19 virus RNA isolated from clinical specimens including nasopharyngeal, oropharyngeal, and lower respiratory specimens such as sputum.
For the RdRP specific probe, the signal from the fluorescent dye (FAM) on the 5’ end is quenched by BHQ-1 on its 3’ end. For the N specific probe, the signal from the fluorescent dye (Texas Red) on the 5’ end is quenched by BHQ-2 on its 3’ end. For the Orf1ab specific probe, the signal from the fluorescent dye (Cy5) on the 5’ end is quenched by BHQ-1 on its 3’ end. For the internal control beta actin specific probe, the signal from the fluorescent dye (Cy5) on the 5’end is quenched by BHQ-1 on its 3’ end. Fluorescence intensity is monitored at each PCR cycle in corresponding channels at a threshold of 0.05.
For the RdRP specific probe, the signal from the fluorescent dye (FAM) on the 5’ end is quenched by BHQ-1 on its 3’ end. For the N specific probe, the signal from the fluorescent dye (Texas Red) on the 5’ end is quenched by BHQ-2 on its 3’ end. For the Orf1ab specific probe, the signal from the fluorescent dye (Cy5) on the 5’ end is quenched by BHQ-1 on its 3’ end. For the internal control beta actin specific probe, the signal from the fluorescent dye (Cy5) on the 5’end is quenched by BHQ-1 on its 3’ end. Fluorescence intensity is monitored at each PCR cycle in corresponding channels at a threshold of 0.05.
All components required for reaction are added during setup, and there is no need to add additional components once the reaction has been started, which is a very fast and will give satisfactory results in most cases.
The kit showed excellent performance (>95% sensitivity and specificity in detection of SARS-COV-2, great linearity (Correlation coefficient (R2) between threshold cycle (Ct) values and quantification values (log10) in each tested concentration ranged between 0.9929~0.9999), great sensitivity (LOD of 10 copies) and specificity (as proven by in silico analysis and wet testing) in clinical and performance evaluation carried out according to FDA EUA guidelines with clinical specimens and materials from BEI Resources (Manassas, VA, USA) and more. Refer to our Performance evaluation documents for information about our results, which were proven on multiple clinical specimens and FDA approved BEI materials.
Good Ag antigen test and PCR test work well on both Omicron and Delta variant specimens (>100-500 specimens verified) as well as clinical specimens with other variants and validated commercial controls.
GG QPlex COVID-19 PCR test kit works well on both Omicron and Delta variant specimens (>100-500 specimens verified)
Approved for use in Europe/Asia per CE/ISO (Inquire per email to see CE certificate)
NOT AUTHORIZED OR CLEARED FOR USE IN THE USA, investigational use only in the US
GG QPlex COVID-19 PCR test kit works well on both Omicron and Delta variant specimens (>100-500 specimens verified)
Approved for use in Europe/Asia per CE/ISO (Inquire per email to see CE certificate)
NOT AUTHORIZED OR CLEARED FOR USE IN THE USA, investigational use only in the US
This product contains Taq polymerase, reverse transcriptase, dNTPs, 2x reaction buffer, Hot Taq, specific primers and probes for detection except template RNA (from patient specimen) and RNA extraction kit. You just need to add distilled water and template RNA for RT-PCR and the RT-PCR is done in a single tube. Approved for use in Europe/Asia per CE/ISO and for research use in US.
GG COVID-19 Omicron & Delta Test Kit
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.
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.
There needs to be a test that will be able to tell if a newly infected individual with COVID-19 what kind of a COVID-19 variant the patient has 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 most recent COVID-19 variant strain and associated mutations are listed here.
For example, it has been shown that 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.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 XBB/EG.5.1. 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. The viral probes target areas that have not been shown to be mutated to date which show a clear advantage in detecting all the Omicron strains to date (23C, 23F, etc).
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.
There needs to be a test that will be able to tell if a newly infected individual with COVID-19 what kind of a COVID-19 variant the patient has 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 most recent COVID-19 variant strain and associated mutations are listed here.
For example, it has been shown that 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.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 XBB/EG.5.1. 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. The viral probes target areas that have not been shown to be mutated to date which show a clear advantage in detecting all the Omicron strains to date (23C, 23F, etc).
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.
Product Information
- ALL of Cellgenemedix’s COVID-19 products have been validated in multiple variants with clinical samples and verified commercial controls.
- Good Ag antigen test and PCR test work well on both Omicron and Delta variant specimens (>100-500 specimens verified) as well as multiple other variantas and validated commercial controls.
- Approved for use in Europe/Asia per CE/ISO (Inquire per email to see CE certificate)
- NOT AUTHORIZED OR CLEARED FOR USE IN THE USA (ISO certified)
Good Ag COVID-19 Antigen test (Home Test)
The “Good Ag COVID-19 Antigen test (GG-CAG-01/02/03)” is a lateral flow assay for home use (OTC) and professionals (POC) for rapid antigen testing of COVID-19 which can detect as little as 0.1-0.01ng/ml N (Nucleocapsid) antigen of SARS-Cov-2 in nasal/nasopharyngeal/oral/ oropharyngeal swab/sputum/saliva specimens with higher analytical sensitivity than most if not all the commercially available antigen kits (LOD 10-20 time lower). It shows higher clinical performance (sensitivity 85-95% and specificity 100% in reference to real time PCR assay) that allows home testing to detect SARS-Cov-2 within 15-20 minutes without need of additional instrument.
Please refer to Sample collection guide for specific instructions on how to collect the samples. The Good Ag COVID-19 Antigen test is special in that it targets conserved (non-mutated to date, especially both in Delta and Omicron) areas of the NP (nucleoprotein) of the SARS-CoV-2 genome. It uses USPTO-/international patented technology to detect these areas of COVID-19 antigen, thus creating strong, reliable results even in people with mutant strains of coronavirus.
The Good Ag COVID-19 Antigen test was demonstrated at near patient or Point of Care (POC) testing that non-laboratory personnel can perform the test accurately in the intended use environment. In addition, the robust use of the Good Ag COVID-19 Antigen test for self-administered (OTC) or Point of Care (POC) testing was demonstrated by clinical studies.
Please refer to Sample collection guide for specific instructions on how to collect the samples. The Good Ag COVID-19 Antigen test is special in that it targets conserved (non-mutated to date, especially both in Delta and Omicron) areas of the NP (nucleoprotein) of the SARS-CoV-2 genome. It uses USPTO-/international patented technology to detect these areas of COVID-19 antigen, thus creating strong, reliable results even in people with mutant strains of coronavirus.
The Good Ag COVID-19 Antigen test was demonstrated at near patient or Point of Care (POC) testing that non-laboratory personnel can perform the test accurately in the intended use environment. In addition, the robust use of the Good Ag COVID-19 Antigen test for self-administered (OTC) or Point of Care (POC) testing was demonstrated by clinical studies.
- Higher analytical sensitivity than other commercial antigen kits (LOD 10-20 time lower)
- Higher clinical performance (sensitivity 85-95% and specificity >95% in reference to real time PCR assay)
- Both batch / individual test available (GG-CAG-01 and 03: batch of 25/GG CAG-02: 1)
- Allow home testing to detect SARS-Cov-2 within 20 minutes without need of additional instrument
- One of the best tools to screen/diagnose COV-19 in the public (Home test, Point of care test)
- Cost effective
For investigational use only: please contact the Technical Support at +1-862-621-6960 (Available Hours: Mon. to Fri.: 9 a.m. – 6 p.m.) or cellgenemedix@cellgenemedix.com (24/7 available) before testing patient specimens.
Attached below is the IFU for Good Ag COVID-19 rapid test.
NOT AUTHORIZED OR CLEARED FOR USE IN THE USA; For investigational use only.
CE + ISO approved for clinical use in Europe and Asia
Attached below is the IFU for Good Ag COVID-19 rapid test.
NOT AUTHORIZED OR CLEARED FOR USE IN THE USA; For investigational use only.
CE + ISO approved for clinical use in Europe and Asia
Instructions for use
Sample requirements for COVID-19 PCR and Target population
Sample Requirements
The type of specimen(s) required:
nasopharyngeal, nasal, oropharyngeal swab, lower respiratory specimen, saliva
nasopharyngeal, nasal, oropharyngeal swab, lower respiratory specimen, saliva
INFORMATIONS AND INSTRUCTIONS
Only synthetic fiber (Dacron or flocked) swabs with plastic shafts are preferred for molecular testing. Do not use calcium alginate swabs or swabs with wooden shafts, as they may contain substances that inactivate some viruses and inhibit PCR testing. Place swabs immediately into sterile tubes containing 3 ml of viral transport media. For initial testing, collecting nasopharyngeal swab specimens are preferred (refer to following instructions)
Self-collected nasal swabs may be taken as below for Home-use Good Ag COVID-19 rapid antigen testing.
Self-collected nasal swabs may be taken as below for Home-use Good Ag COVID-19 rapid antigen testing.
Transfer in 4 ºC condition and deep freeze at -70 ºC if it takes longer than 48 hours. In case of Good Ag COVID-19 Antigen test (Point of care), follow the instructions as included in the kit.
| Specimen Type | Nasopharyngeal Swab or Oropharyngeal swab collected according to standard technique and immediately placed in 1-3 mL of transport media. |
| Minimum Sample Volume | 0.3 mL (300 μL) |
| Transport and Storage | Samples should be processed and tested with the BioFire COVID-19 Test as soon as possible. |
| If storage is required, samples can be held: | |
| •At room temperature for up to 4 hours (15-25ºC) | |
| •Refrigerated for up to 2 days (2-8ºC) | |
| •Frozen (≤-15ºC or ≤-70ºC) for up to 30 days |
Refer to: InterimGuidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-nCoV/guidelines-clinical-specimens.html
Refer to Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-nCoV/lab-biosafety-guidelines.html
The target population
PUI(Person under investigation);
patients who meet CDC COVID-19 clinical criteria (e.g., signs and symptoms associated COVID-19 infection) in conjunction with CDC COVID-19 epidemiological criteria (e.g., history of residence in or travel to a geographic region with active COVID-19 transmission at the time of travel, or other epidemiologic criteria for which COVID-19 testing may be indicated)
The COVID-19 RNA is generally detectable during the acute phase of infection. Positive results are indicative of the presence of COVID-19 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of disease.
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Negative results do not preclude COVID-19 infection and should not be used as the sole basis for patient treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The COVID-19 RNA is generally detectable during the acute phase of infection. Positive results are indicative of the presence of COVID-19 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of disease.
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Negative results do not preclude COVID-19 infection and should not be used as the sole basis for patient treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
Lower respiratory specimens
Lower respiratory tract specimens
(1)Bronchoalveolar lavage, tracheal aspirate
-2 to 3 mL should be collected in a sterile, leak-proof, screw-cap sputum collection cup or sterile, dry container.
(2)Sputum
-The patient should rinse his or her mouth with water and then expectorate deep cough sputum directly into a 50-mL sterile, leak-proof, screw-cap sputum collection cup or sterile, dry container containing 3 ml of sampling solution.If the sputum is not collected in the sampling solution, 2-3 ml of the sampling solution can be added into the tube before testing in the laboratory.
Refer to below for specifics. Sputum is a relatively hard specimen to process, and as GG COVID-19 Real Time RT-PCR kit has been approved for use in sputum specimens, this leaves more flexibility for the lab. This is because the specimen may be collected by a non-medical individual, if submitted to the laboratory directly within the designated timeframe.
[embeddoc url=”https://cellgenemedix.com/wp-content/uploads/2020/05/Sample-Processing.pdf” download=”all”]
Refer to: Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-nCoV/guidelines-clinical- specimens.html
Refer to Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19) https://www.cdc.gov/coronavirus/2019-nCoV/lab-biosafety-guidelines.html
Purchase and Delivery
Antigen tests can be delivered within a week. Delivery fees upon request. Investigational use only.
PCR and other reagents may be delivered within a week all over the world. Delivery fees upon request. Investigational use only except in Europe or Asia where the CE and ISO mark is acquired and sales especially wholesale is available upon request.
Test kitts that are in Korea can delivered by FEDEX/DHL within 72 hours (Seoul-around the world) inside box filled with dry ice. Delivery fees may range from 50 dollars to more. Investigational use only. NOT AVAILABLE IN THE US, approved for export and use in Europe and Asia.
PCR and other reagents may be delivered within a week all over the world. Delivery fees upon request. Investigational use only except in Europe or Asia where the CE and ISO mark is acquired and sales especially wholesale is available upon request.
Test kitts that are in Korea can delivered by FEDEX/DHL within 72 hours (Seoul-around the world) inside box filled with dry ice. Delivery fees may range from 50 dollars to more. Investigational use only. NOT AVAILABLE IN THE US, approved for export and use in Europe and Asia.