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Main

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
ABI 7500 21.6 copies/rxn 21.9 copies/rxn

Clinical Evaluation

nCoV-QM
Comparative Assay Total
Positive Negative
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
nCoV-OM Positive 65 0 65
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)