GeneFinder COVID-19 PlusRealAmp Kit/100T

General description:
GeneFinder COVID-19 Plus RealAmp Kit is a real-time reverse transcription-PCR assay for the qualitative detection of SARS-CoV-2 nucleic acids in nasopharyngeal, oropharyngeal, nasal, and mid-turbinate nasal swab specimens, bronchoalveolar lavage fluid (BAL), and sputum from individuals who are suspected of COVID-19 by their healthcare provider.
The GeneFinder COVID-19 Plus RealAmp Kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

Technical specifications:
Technology: real-time reverse transcription-PCR
Specimen type: Alveolar lavage fluid, throat swab, sputum.
Time of Result: About 120 min.
Analytical Sensitivity: Confirmed as 10 copies / reaction for all target genes (RdRp, E, N gene).
Analytical Specificity: Other corona viruses and 19 viral pathogens and mycopplasma were included in the evaluation. No cross reaction indicated.

Manufacturer product reference: OSANG Healthcare Co., Ltd, IFMR-45

Items supplied with:
·1 x COVID-19 Plus Reaction Mixture vial (1,050 μL)
·1 x COVID-19 Plus Probe Mixture vial (550 μL)
·1 x COVID-19 Plus Positive Control vial (50 μL)
·1 x COVID-19 Plus Negative Control vial (50 μL)
·1 x IFU

Items required, but not supplied:
·Instruments:
- Applied Biosystems 7500 Real-Time PCR Instrument (ABI 7500)
- Applied Biosystems, 7500 Fast Real-Time PCR Instrument (ABI 7500 Fast), or
- CFX96 Real-Time PCR Instrument (CFX96)
·Extraction kits:
- QIAamp viral RNA Mini Kit (QIAGEN)
- DNA and Viral NA Small Volume Kit (Roche MagNA Pure 96) extraction kits
·Other important items:
- DNAZapTM solutions (ThermoFisher Scientific, Cat.no: AM9890) or equivalent
- Molecular Grade Water, Nuclease-free
·General lab items:
- Racks for 1.5 mL microcentrifuge tubes
- Pipettes (1- 20 μL, 20-200 μL, 200-1,000 μL)
- Pipettes tips with aerosol barrier (RNase, DNase-free)
- Powder-free gloves (disposable)
- Vortex mixer or equivalent
- 1.5 ml tube
- PCR tube or 96 well plate
- Bench microcentrifuge

Shelf Life:
12 months from the date of manufacture.

Weight & Volume:
Estimated Weight: 0.04 kg
Estimated Volume: 0.00042m3

Storage & transportation condition:
Must be stored at -20°C and shipped at ambient temperature.

Packaging & labelling:
Primary packaging: All content of GeneFinder COVID-19 Plus RealAmp kit for 100 tests
Secondary packaging: One kit GeneFinder COVID-19 Plus RealAmp kit/100 tests