use | • Molecular diagnostic reagent that detects the genes of COVID19 to diagnose infection of COVID19 In human oropharyngeal / nasopharyngeal specimens |
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MD01 | MD02 | |
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Analysis Targets | N Gene | N genes, E Genes, IC |
time | 45 minutes (0.1 or 0.2ml tube) from RNA to Result |
|
Raw materials | Use of high-quality raw materials from thermofischers | |
Sensitivity | Superior sensitivity 7-43 times more sensitive than other clinically proven products | |
Usability | Easy to use with One Tube | |
compatibility | ABI AB 7500 Real-time PCR, ABI Quant Studio, Rotor-gene Stratagene Bio-Rad Chroma 4 BioRad CFX96 Analytik Jena qTOWER3 Bioneer Tianlong Gentier Roche |
Certification and supply countries |
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• CE Certificate
• India
• Greece
• MFDS(KFDA)
• FIND Listed
• UNGM Supplier
Exporting to more than 12 countries
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use | • Molecular diagnostic kit (RT-PCR) that detects RNA for the diagnosis of COVID-19 infection in human oropharyngeal / nasopharyngeal specimens |
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• One step RT-PCR kit for the qualitative detection of
SARS-CoV-2 + Influenza A + B RNAs in One tube -SARS-CoV-2 N gene(FAM) -Influenza A gene(Cy5) -Influenza B(Cy5.5) Multiplex Detection • Premium Quality Raw Material (ThemoFisher Master Mix for Fast Virus Detection) |
Components | Details | Volume (100 RXN) |
|
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1 | Master mix |
Enzyme mix for one-step RT-PCR |
500 μl |
2 |
Primer+Probe Mixture |
Primer/Probe mix for covid19, influenza A,B and IC |
200 μl |
3 | Positive Control |
Cloned plasmid DNAs of for covid19, influenza A,B and IC |
100 μl |
4 | DW | RNase-free water | 1 ml |
Performance Summary |
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• detection limit: SARS-CoV-2 : 10 copies/rxn Influenza A : 5 copies/rxn Influenza B : 10 copies/rxn • clinical sensitivity: 100% (95% CI: 65.66% to100.00%) • clinical specificity: 100% (95% CI: 65.66% to 100.00%) • Cross-Reactivity : No cross-reactivity is detected with the following pathogens over 106 copies/rxn; Human coronavirus 229E, OC43, HKU1 and NL63,SARScoronavirus, MERS-coronavirus, Adenovirus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Influenza A virus (H1N1), Influenza B virus, Enterovirus D68, Respiratory syncytial virus A, Respiratory syncytial virus B, Rhinovirus, Haemophilus influenzae, Legionella pneumophila, Bordetella pertussis, Mycoplasma pneumoniae and pooled nasal |
package | RNA Releasing Reagent+ MD01 or MD02 |
NA01+ MD01 or MD02 |
PCL Speedy Bag (NA01+MD01+Specialized Equipment) |
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Product Photos | ||||
1 | Sample collection |
10 minutes | 10minutes | 10 minutes |
2 | RNA Extraction |
40~70 minutes | ||
3 | RT-PCR (Analysis) |
45 minutes | 45 minutes | 20minutes |
Equipment used | General Purpose Devices | General Purpose Devices | Specialized Equipment | |
Total inspection time | 95~125 minutes in total | Total 55 minutes | 30 minutes in total |
C Company POCT (FDA EUA Approved) |
PCL Speedy Bag POCT |
PCL 45min RT-PCR Lab Machine |
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Steps | 1 | 2 | 3 |
RT-PCR time | 30m | 30m | 45min |
From Swab to Result time | 30m | 30m | 60min |
Sensitivity | 80~90% | 90~100% | 90~100% |
# of Samples Tested one Process | 1 | 8 | 94 |
LOD (Ct Value) | <30 | <40 | <40 |