(Mico Biomed) Product Information Latest Version - 0706

Product Introduction
Contents
1. Company Profile
2. Product Specification
3. Certification
4. Others
About
Ever since MiCoBioMed was founded in We are striving to overcome the limits Since early 2020 we have been able to
2009, we have been focusing on one of existing devices and reagents with show unprecedented growth on the back
mission statement: healthcare for our Lab-On-A-Chip based technology of worldwide spread of COVID-19
everyone, everywhere. We work hard so we can carry out POCT (Point-Of- pandemic. Moreover, we have
knowing that molecular diagnostics is Care-Testing) quickly and accurately. successfully completed our IPO on
critical in achieving global health and KOSDAQ
happiness.
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Copyright all rights reserved by OOOOO
Product Portfolio
Molecular Diagnostics Immunological Diagnostics Biochemical Diagnostics
1. Veri-Q PREP M16 & Kits 1.Covid 19 IgGIgM Rapid Test
1. Blood Cholesterols
2.Covid 19 Antigen Rapid Test

2. Veri-Q PCR 316 & Kits
2. Blood Glucose
RT-qPCR S/W & Diagnostic Kits 3.ELISA & Immunoassay

1~300X More Sensitive
3. Veri-Q PCR LabChips & Case 3. Hemoglobin

nCoV-VM : COVID-19 Multiplex Detection kit (Open Kit - Compatible to PCR 316)
nCoV-VM 1) 100 tests / kit
2) Compatible instruments : CFX96, ABI® 7500, VERI-Q PCR316
3) 45 min for RT & 45 cycles qPCR
4) Expiry date 18months
Specification 5) Storage temperature -20±5°C
6) Detection ORF3a gene and N gene
7) Specificity RNAs from nasopharyngeal, oropharyngeal swab, or sputum specimens
Real time PCR Instrument Manufacturer
CFX 96 Bio-Rad
Compatible ABI 7500 ThermoFisher
Instruments
WHO
Veri-Q
EUL Mico BioMed
PCR 316

nCoV-VM : COVID-19 Multiplex Detection kit (Open Kit - Compatible to PCR 316)
-Performance Test
nCoV-VM
Analytical Sensitivity (LoD)
Analytical sensitivity (Limit of Detection;LoD) of nCoV VM defines each target gene as 95% detectable
concentration (copies/ mL ). This tests were replicated 24 times for each concentration using 3 instruments.
As a result of analyzing the analytical sensitivity is shown in the table below.
Instrument Specimens Sample preparation ORF3a N
Instrument Specimens Sample preparation ORF3a N
Nasopharyngeal swab 16TU-CV19 75.4 copies/mL 126.1 copies/mL
ABI7500 Saliva specimen 16TU-CV19 150 copies/mL 150 copies/mL
Saliva specimen Direct PCR method 600 copies/mL 600 copies/mL
Bio-Rad, CFX96 Saliva specimen 16TU-CV19 300 copies/mL 600 copies/mL
Veri-Q PCR316 (Model : QD-P100) Saliva specimen 16TU-CV19 600 copies/mL 300 copies/mL
Analytical Specificity (Cross-reactivity)

-The analytical specificity of the nCoV-VM was tested against 41 organisms including bacteria and virus that can be isolated from the reference
material DNA or RNA and cultured medium samples.
-Each isolated sample was tested at a concentration at least 5 x10^5 copies/reaction.
-It was confirmed that nCoV-VM, was specifically detected in positive control.
CoVFLU-VM : COVID-19 & Flu A/B Multiplex Detection kit (Open Kit - Compatible to PCR 316)
CoVFLU-VM 1) 100 tests / a kit

2) Compatible instruments for CFX96, ABI® 7500, VERI-Q PCR316
Specification 4) Expiry date 12months

5) Storage temperature -20±5°C
6) Detection ORF3a gene and N gene, Influenza A/B
CFX 96 Bio-Rad
Compatible ABI 7500 ThermoFisher

Instruments
WHO
Veri-Q
EUL Mico BioMed
PCR 316
CoVFLU-VM : COVID-19 & Flu A/B Multiplex Detection kit (Open Kit - Compatible to PCR 316)
-Performance Test
CoVFLU-VM
Analytical sensitivity (Limit of Detection;LoD) of CoVFLU VM defines each target gene as 95% detectable
concentration (copies/ reactionak ). This tests were replicated 2 6 times for each concentration using 8
instruments. As a result of analyzing the analytical sensitivity is shown in the table below.
Instrument ORF3a gene N gene Influenza A Influenza B
Veri-Q PCR316 1,000 250 1,000 1.000
CFX96 500 124 250 250
ABI7500 500 125 500 250
ABI7500 Fast 250 125 500 250
Analytical Specificity
[Cross-reactivity]
-The analytical specificity of the CoVFLU-VM was tested against 42 organisms including bacteria and virus that can be isolated from the
reference material DNA or RNA and cultured medium samples.
-Each isolated sample was tested at a concentration at least 5 x10^5 copies/reaction.
-It was confirmed that CoVFLU-VM, was specifically detected in positive control.
[ Interfering substances]
-The PCR inhibition reaction of the CoVFLU-VM was tested against 4 interfering substances.
-As a result, the difference Ct value was ± 2, between the control and test group at each concentration.
Copyright-The PCR reaction
all reserved was not inhibited with these substances.
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nCoV-OM : COVID-19 Multiplex Detection kit (Open Kit)
nCoV-OM 1) 100 tests / kit
2) Compatible instruments : CFX96, ABI® 7500
6) Detection ORF3a gene and N gene (WHO Recommendation)
Standard Package: 100 tests/kit
Unit Size: 95 x 40 x 55 mm, 70 g 7) Specificity RNAs from nasopharyngeal, oropharyngeal swab, or sputum specimens
Compatible CFX 96 Bio-Rad
Instruments
ABI 7500 ThermoFisher

nCoV-OM
nCoV-OM : COVID-19 Multiplex Detection kit (Open Kit)
-Performance Test

Analytical sensitivity (Limit of Detection;LoD) of nCoV-OM defines each target gene as 95% detectable Unit Size: 95 x 40 x 55 mm, 70 g
concentration (copies/ml). This tests were replicated 24 times for each concentration using two instruments.
As a result of analyzing the analytical sensitivity is shown in the table below
Instrument ORF3a gene N gene

ABI7500 271 copies/ml 274 copies/ml
Bio-Rad, CFX96 75 copies/ml 126 copies/ml

- The analytical specificity of the nCoV-OM was tested against 42 organisms including bacteria and virus that can be isolated
from the reference material DNA or RNA and cultured medium samples.
- Each isolated sample was tested at a concentration at least 5 x10^5 copies/reaction.
- It was confirmed that nCoV-OM, was specifically detected in positive control.

nCoV-QM-N : COVID-19 Multiplex Detection kit (Close kit)
nCoV-QM-N 1) 100 tests / a kit
2) Compatible instruments for VERI-Q PCR316
Standard Package: 100 tests/kit 6) Detection ORF3a gene and N gene (WHO Recommendation)
Unit Size: 95 x 40 x 55 mm, 70 g
WHO
Compatible EUL Veri-Q
Mico BioMed
Instruments PCR 316

nCoV-QM-N : COVID-19 Multiplex Detection kit (Close kit) nCoV-QM-N
-Performance Test

Analytical sensitivity (Limit of Detection,LoD) of nCoV-QM-N defines each target gene as 95% Standard Package: 100 tests/kit
Unit Size: 95 x 40 x 55 mm, 70 g
detectable concentration (copies/ml). This tests were replicated 26 times for each concentration using 8
instruments. As a result of analyzing the analytical sensitivity is shown in the table below.
Veri-Q PCR316 (Model : QD-P100) 230copies/mL 159copies/mL

- The analytical specificity of the nCoV-QM-N was tested against 42 organisms including bacteria and virus that can be isolated
- Each isolated sample was tested at a concentration at least 5 x10^5 copies/reaction.
- It was confirmed that nCoV-QM-N, was specifically detected in positive control.

nCoV-QS : COVID-19 Detection kit (Close kit)
WHO
nCoV-QS 1) 50 tests / kit
EUL 2) Compatible instruments for VERI-Q PCR316
6) Detection ORF3a gene and N gene (WHO Recommendation)
Unit Size: 95 x 40 x 55 mm, 70 g 7) Specificity RNAs from nasopharyngeal, oropharyngeal swab, or sputum specimens
Compatible WHO
WHO
EUL
Instruments EUL
Veri-Q
Mico BioMed
PCR 316

WHO
nCoV-QS
nCoV-QS : COVID-19 Detection kit (Close kit) EUL
-Performance Test

Analytical sensitivity (Limit of Detection;LoD) of nCoV-QS defines each target gene as95% detectable Unit Size: 95 x 40 x 55 mm, 70 g
concentration (copies/μL). This test was replicated 20 times for eachconcentration using two types of
equipment. As a result of analyzing the analyticalsensitivity, the limit of detection of ORF gene is 1.800 copies/
μLand the limit of detectionof N gene is 4.239 copies/ μL.
1.800 copies/uL 4.239 copies/uL

Veri-Q PCR316 (Model : QD-P100)
(5.399 copies/rxn) (12.718 copies/rxn)

- The analytical specificity of the nCoV-QS was tested against 42 organisms including bacteria and virus that can be isolated
- Each isolate d sample was tested at a concentration at least 5 x105copies/reaction.
- It was confirmed that nCoV-QS was specifically detected in positive control.

16TU-CV19 : PREP M16 Viral DNA/RNA Prep Kit (Close kit)
WHO
16TU-CV19 1) 100 tests / kit
EUL 2) Compatible instruments for Veri-Q PREP M16
3) Expiry date 18 months
Specification 4) 16TU-CV19 is a reagent kit for extraction of Viral DNA/RNA from Airway Sample (Sw
media, Sputum and ETC)
5) Stored at room temperature(15~25°C)
6) Airway clinical sample (Nasal swab media, Saliva and etc)
DNA & RNA extraction Instrument Manufacturer
Compatible WHO
WHO
EUL
WHO
EUL
Instruments EUL
Veri-Q
Mico BioMed
PREP M16

VERI-Q Instrument (Prep M16 & PCR 316)
G2 – 16TU 1) DNA/RNA Extraction for 5~30 min
WHO
2) 1~16 Sample tests
EUL
3) Compact size, 26x33x35cm dimension, 13.3 kg weight
Nucleic and 4) 100~500 ul Sample volume
Extraction Device 5) 50, 100, 150 ul Elution volume

6) 12V Dry or Car battery
7) 16 Spin column instrument
QD-P100 1) 30~55 min for RT & 45 cycles qPCR

WHO
EUL 2) 1~16 Channels on a LabChip (1~16 Sample tests)
3) FAM/HEX/TEX/CY5 4 Color Multiplex system
Gene Amplification
4) 8 ul Reaction volume
Device
5) On board printer
6) Room temperature optimal operating system, Optimal operating humidity (20~80%)
VERI-Q COVID-19 Rapid Test
MIS-COV-01 1) Reaction Principle: Chromatographic immunoassay
WHO 2) Sample Type: Serum/Plasma, Whole Blood (venous, capillary)
EUL
3) Test Results: Negative or Positive
4) Test time: Less than 20 minutes for standard test
COVID-19 5) Storage condition: 2ºC~30ºC
Antibody IgG/IgM 6) Sensitivity: 90.0%
7) Specificity: 97%
8) Pack size: 20 tests/box
MIS-COV-02 1) Reaction Principle: Chromatographic immunoassay

WHO 2) Sample Type: Nasal Swab or Nasopharyngeal Swab
EUL 3) Test Results: Negative or Positive
COVID-19 4) Test time: Less than 20 minutes for standard test

5) Storage condition: 2ºC~30ºC
Antigen
6) Sensitivity: 96.0%
7) Specificity: 100%
8) Pack size: 20 tests/box
VERI-Q Glucose / Hemoglobin analyzer
MGD-1002 1) Weight: 25g (without batteries)
WHO 2) Power: 1.5V Lithium Battery x 2
EUL
VERI-Q Balance 3) Measuring Range: 20~600mg/dL
4) Operation Temperature: 10 ~ 40℃
Glucose
5) Number of Measurement: 1,000 tests
Monitoring 6) Memory: 500 tests
System 7) Blood Sample: 0.5㎕, Capillary
8) Measuring Time: 5 Sec
1) Measurement Range: 0 ~ 27g/dL

MHD-2
WHO 2) Measurement Time: 2 Sec
EUL 3) Blood Sample: 4 ~ 7 µL Capillary / Venous whole blood
VERI-Q Hb Mate 4) Operation Temperature: 10 ~ 40℃

5) Power: AAA Battery (3ea.)
6) Storage condition: 10 ~ 40ºC

VERI-Q Multi Analyzer
WHO
EUL
MMD-1 1) All6 in 1: Total Cholesterol, Triglycerides, HDL, Glucose, Hemoglobin, LDL

2) Power: 1.5V Lithium Battery x 3
VERI-Q Multi 3) Size: 13 x 7 x 2 (cm)
Meter 4) Type: Photometric
5) Operation Temperature: 10 ~ 40℃
6) Number of Measurement: 1,000 tests
7) Memory: 1,000 tests
8) Blood Sample: 15㎕ x 3, Capillary
9) Measuring Time: Max 180 Sec
10) CV: TC <5%, TG <5%, HDL <7%

VERI-Q SARS-CoV-2 Neutralizing Ab ELISA Kit
eCoV-CN
1) Intended for the qualitative detection of neutralization antibody to SARS-CoV-2 in human serum or plasma
2) Identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection
3) Reaction Principle: qualitative blocking ELISA
4) Sample Type: human serum or plasma (EDTA, heparin, citrate)
5) Test Results: qualitative (Negative or Positive)
6) Test time: 60 minutes for standard test
7) Storage condition: 2ºC~8ºC
8) Sensitivity: 94.4%, Specificity: 100%
9) Pack size: 96 tests/kit
Vaccinated People Recovering

COVID-19 Patients
Other Kits
* Developing or approval stages.
Clinical and Animal Food Pathogen
Norovirus GI Kit AAT & A.acidocaldarius Detection Kit Vibrio Cholerae Kit
HBV
Norovirus GII Kit Salmonella spp. Kit Vibrio Vulnificus Kit
HBV <Kit Components> Enterotoxigenic, E.coli (ETEC-LT) Kit Listeria monocytogenes Kit
HCV Subtypes
Enterotoxigenic, E.coli (ETEC-ST) Kit Staphylococcus aureus Kit
HIV Subtypes
Enteropathogenic E.coli (EPEC) Kit Bacillus cereus Kit
MTB
Enteroinvasive E.coli (EIEC) Kit Enterohemorrhagic E.coli (EHEC-stx1) Kit
MTB/NTM
Enteroaggregative E.coli (EAEC) Kit Enterohemorrhagic E.coli (EHEC-stx2) Kit
MTB/MDR
TAB(Alicyclobacillus spp.) Detection Kit Yersinia enterocolitica Kit
STD (GC/NG)
TAB(A. acidoterrestris) Detection Kit Shigella spp. Kit
HPV (16/18)
TAB(A. acidocaldarius) Detection Kit Clostridium perfringens Kit
Influenza (A/B/RSV)
EHEC stx 1 & 2 Kit Campylobacter jejuni Kit
Avian Influenza Virus (M/HS)
Norovirus GI &GII Kit Campylobacter coli Kit
Avian Influenza Virus (H7)
Alicyclobacillus spp. & AAT Detection Kit Vibrio parahaemolyticus Kit
African Swine Fever Virus
Tropical Fever
Coxiella burnetii Brucella suis Vaccinia virus Clostridium botulinum neurotoxin Rnase P
Bacillus anthracis Brucella spp. Clostridium botulinum neurotoxin type F Crimean-congo haemorrhagic
Rickettsia powazekii Francisella tularensis subsp. type A Rift valley fever virus fever virus
Yersimia pestis Tularensis (A) Monkeypox virus Ricinus communis
TG, typhus group Clostridium botulinum Clostridium botulinum neurotoxin Yellow fever virus
Burkholderia pseudomallei Francisella tularensis subsp. type B Ebola virus Targets included in Fever Panel
Brucella abortus Holartica (B) Varicella zoster virus Hantaan virus 1. Malaria (Pan/Pf/Pv). 8. Samonella typhi
2. Zika 9. Creamian-congo haemoligic fever
Burkholderia mallei Vibrio cholera Clostridium botulinum neurotoxin Marburg virus 3. Dengue 10. Brucella
Brucella melitensis Francisella tularensis subsp. type E 16S rRNA 4. Chikungunya 11. Hepatitis E
Francisella tularensis Novicida (C) Variola virus Lassa virus 5. Oriental Tsutsugamushi 12. Bartonella
6. Richettsia 13. Burkholderia
Copyright all reserved by pptplug.co.kr 7. Leptospira 14. Streptococcus pneumonia
Approval Status
EU EUL
Product Model Description Korea FDA
CE WHO EUL FDA EUA
Open Kit
nCoV-VM Approved
(Compatible to PCR 316)
Open Kit
CoVFLU-VM Approved
(Compatible to PCR 316)
PCR Reagent nCoV-OM Open Kit Approved Approved
nCoV-QM-N Close Kit Approved Approved
nCoV-QS Close Kit Approved Approved Approved
PREP Reagent 16TU-CV19 Prep Kit Approved Approved Approved Approved
PCR 316 Amplification Machine Approved Approved Approved Approved

Instrument
PREP M16 Extraction Machine Approved Approved Approved Approved
MIS-COV-01 Antibody IgG/IgM Approved Approved

Rapid Test Kit
MIS-COV-02 Antigen Approved Approved
ELISA eCov-CN Neutralizing Antibody Approved Approved

Country Registration
GHANA FDA BRAZIL FDA
WHO
EUL
INDIA FDA PHILIPPINE FDA
WHO
EUL
* Processing on WHO EUL, UK, France,

Copyright all reserved by pptplug.co.kr MEXICO FDA Oman, Qatar, Argentina, Indonesia, Colombia and so on.
Others
CE Free Sales ISO 13485

THANK YOU
Contact Information
salesbio@micobiomed.com

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Product Introduction

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2.Covid 19 Antigen Rapid Test

RT-qPCR S/W & Diagnostic Kits 3.ELISA & Immunoassay

Copyright all reserved by pptplug.co.kr

Real time PCR Instrument Manufacturer

Compatible ABI 7500 ThermoFisher

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Nasopharyngeal swab 16TU-CV19 75.4 copies/mL 126.1 copies/mL

ABI7500 Saliva specimen 16TU-CV19 150 copies/mL 150 copies/mL

Saliva specimen Direct PCR method 600 copies/mL 600 copies/mL

Nasopharyngeal swab 16TU-CV19 270.6 copies/mL 273.8 copies/mL

Bio-Rad, CFX96 Saliva specimen 16TU-CV19 300 copies/mL 600 copies/mL

Saliva specimen Direct PCR method 1600 copies/mL 1600 copies/mL

Nasopharyngeal swab 16TU-CV19 297.8 copies/mL 301.1 copies/mL

Saliva specimen Direct PCR method 2400 copies/mL 2400 copies/mL

Analytical Specificity (Cross-reactivity)

CoVFLU-VM 1) 100 tests / a kit

Specification 4) Expiry date 12months

Real time PCR Instrument Manufacturer

Compatible ABI 7500 ThermoFisher

Real time PCR Instrument Manufacturer

Compatible CFX 96 Bio-Rad

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Analytical Sensitivity (LoD)

Instrument ORF3a gene N gene

Analytical Specificity (Cross-reactivity)

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Real time PCR Instrument Manufacturer

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Analytical Sensitivity (LoD)

Veri-Q PCR316 (Model : QD-P100) 230copies/mL 159copies/mL

Analytical Specificity (Cross-reactivity)

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Real time PCR Instrument Manufacturer

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Analytical Sensitivity (LoD)

1.800 copies/uL 4.239 copies/uL

Analytical Specificity (Cross-reactivity)

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DNA & RNA extraction Instrument Manufacturer

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Nucleic and 4) 100~500 ul Sample volume

Extraction Device 5) 50, 100, 150 ul Elution volume

QD-P100 1) 30~55 min for RT & 45 cycles qPCR

MIS-COV-02 1) Reaction Principle: Chromatographic immunoassay

COVID-19 4) Test time: Less than 20 minutes for standard test

1) Measurement Range: 0 ~ 27g/dL

VERI-Q Hb Mate 4) Operation Temperature: 10 ~ 40℃

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MMD-1 1) All6 in 1: Total Cholesterol, Triglycerides, HDL, Glucose, Hemoglobin, LDL

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Vaccinated People Recovering

PCR Reagent nCoV-OM Open Kit Approved Approved

nCoV-QM-N Close Kit Approved Approved

nCoV-QS Close Kit Approved Approved Approved

PREP Reagent 16TU-CV19 Prep Kit Approved Approved Approved Approved

PCR 316 Amplification Machine Approved Approved Approved Approved

MIS-COV-01 Antibody IgG/IgM Approved Approved