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pcl

PRODUCT
Multi-immune source technology-based platform capable of diagnosing various diseases
COVID-19 Total Solutions
Molecular diagnosis MD series
PCLMDTM nCoV one step RT-PCR kit
MD01
MD01(One Tube One Gene)
PCL COVID19 Speed RT-PCR
MD02
MD02(One Tube Three Gene)
use • Molecular diagnostic reagent that detects the genes of COVID19 to diagnose infection of COVID19 In human oropharyngeal / nasopharyngeal specimens
MD01 MD02
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
• CE Certificate
• India
• Greece
• MFDS(KFDA)
• FIND Listed
• UNGM Supplier
Exporting to more than 12 countries​
PCLMD ABC multi RT-PCR Kit
MD03
1 tube for (Flu A/B + Covid-19)
use • Molecular diagnostic kit (RT-PCR) that detects RNA for the diagnosis of COVID-19 infection in human oropharyngeal / nasopharyngeal specimens​
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)
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
• 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)
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
Comparison between Gene Detection Methods
C Company POCT
(FDA EUA Approved)
PCL Speedy Bag
POCT
PCL 45min RT-PCR
Lab Machine
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
Swab + RNA Extraction kit + Specialized Equipment +Accessories ​
30-minute RT-PCR scan completed
Portable all-in-one bag
* The size and color of the bag are for reference
only and may be changed.