(주)미코바이오메드

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We have two types of real-time PCR kits: a closed kit using MiCo BioMed’s LabChip-type real-time PCR

and an open kit using universal tube-type ones

Closed System

Veri-Q PREP M16
Veri-Q PCR316
nCoV-QM

RNA Extraction

Optimized Extractor

Veri-Q PREP M16 (MiCo BioMed)

Optimized Extraction Kits

Veri-Q PREP M16-16TU-CV19 kit (7A133, MiCo BioMed)

Veri-Q ManuPrep Viral DNA/RNA kit (7A231, MiCo BioMed)

Real-time PCR

Optimized Real-time PCR

Veri-Q PCR 316 (MiCo BioMed)

Optimized Real-time PCR Kit

Veri-Q™ COVID-19 Multiplex Assay kit (nCoV-QM, MiCo BioMed)

Open System

QiaCube
Veri-Q PREP M16
ABI 7500
Bio-Rad
nCoV-OM

RNA Extraction

Optimized Extractor

QiaCube (Qiagen)

Veri-Q PREP M16 (MiCo BioMed)

Optimized Extraction Kits

QIAamp MinElute Virus Spin kit (57704, Qiagen)

Veri-Q PREP M16-16TU-CV19 kit (7A133, MiCo BioMed)

Veri-Q ManuPrep Viral DNA/RNA kit (7A231, MiCo BioMed)

Real-time PCR

Optimized Real-time PCR

Applied Biosystems™ 7500 (ABI 7500) Real-Time PCR System (Thermo Fisher)
CFX Connect Real-time PCR Detection System (Bio-Rad)

Optimized Real-time PCR Kit

Veri-Q™ COVID-19 Multiplex Assay kit (nCoV-OM, MiCo BioMed)

Performance Data

Analytical Sensitivity

nCoV-QM

nCoV-OM

Limit of Detection

Kits	Real-time PCR	ORF3a gene	N gene
nCoV-QM	Veri-Q PCR 316	8.9 copies/rxn	9.0 copies/rxn
nCoV-OM	CFX96	6.0 copies/rxn	10.1 copies/rxn
nCoV-OM	ABI 7500	21.6 copies/rxn	21.9 copies/rxn

Clinical Evaluation

nCoV-QM

		Comparative Assay		Total
		Positive	Negative	Total
nCoV-QM	Positive	63	0	63
	Potential positive	1	0	1
	Negative	1	93	94
Total		65	93	158

- Positive Percent Agreement (PPA):96.9 %[95% CI: 89.3, 99.6]

- Negative Percent Agreement (NPA):100 %[95% CI: 96.1, 100]

- Overall Percent Agreement (OPA):98.7 %[95% CI: 95.5, 99.8]

- Kappa: 0.97[95% CI: 0.94, 1]

nCoV-OM

		Comparative Assay		Total
		Positive	Negative	Total
nCoV-OM	Positive	65	0	65
nCoV-OM	Negative	0	93	93
Total		65	93	158

- Positive Percent Agreement (PPA):100 %[95% CI: 94.5,100]

- Negative Percent Agreement (NPA):100 %[95% CI: 96.1, 100]

- Overall Percent Agreement (OPA):100 %[95% CI: 97.7, 100]

- Kappa: 1[95% CI: 1, 1]

Other Features

Specimen: nasopharyngeal or oropharyngeal swabs
Target genes: ORF3a & N genes
Kit unit: 100 tests per kit (95 X 40 X 55 mm / 70 g)
Running time for real-time PCR

- nCoV-QM: ~55 min using Veri-Q PCR 316 (MiCo BioMed)

- nCoV-OM: ~80 min using ABI (Thermo Fisher) or CFX96 (BioRad)