Smart Detect SARS-CoV-2 rRT-PCR Kit/48T

General description:
Smart Detect SARS-CoV-2 rRT-PCR Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) in human nasopharyngeal swab, anterior nasal swab and mid-turbinate nasal swab specimens. It is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time RT-PCR and in vitro diagnostic procedures.

Technical specifications:
Technology: RT PCR
Kit size: 48 tests
Sample type: nasopharyngeal or nasal swab
Clinical sensitivity: 100%
Clinical specificity: 96.70%

Manufacturer product reference: InBios International, Inc., COV2-E

Items supplied with:
2 x Positive Control (PC), 200μL
1 x No Template Control (NTC), 1000μL
2 x Extraction Control (EC), 1.2mL
1 x Primer/Probe Mix

Items required, but not supplied:
Instruments:
·7500 Fast Dx Real-time PCR Systems with SDS software version 1.4 software (Applied Biosystems)
·CFX96 Touch Real-Time PCR Detection System (Bio-Rad) with CFX Maestro Software (Bio-Rad)
Extraction kits:
·QIAamp Viral RNA Mini Kit, Qiagen, Cat.no. 52904/52906 is an extraction kit recommended by the test manufacturer.
Other important items:
·TaqPath™ 1-Step RT-qPCR Master Mix, CG (Life Technologies, catalog # A15299 and/or A15300) is a Master Mix recommended by the test manufacturer.
General lab items:
·Vortex, Microcentrifuge (with rotor for 1.5-2 mL tubes), DNase/RNase free microcentrifuge tubes (1.5-2 mL), Calibrated DNase/RNase-free pipettes of varying sizes (2 or 10 μL, 200 μL, 1000 μL), DNase/RNase-free aerosol barrier pipette tips of varying sizes, Cold block(s) or ice, Ethanol (96-100%), Ethanol (70%), 10% bleach, DNAZap PCR DNA Degradation Solutions(Ambion, catalog # AM9890) or equivalent, RNase AWAY Decontamination Reagent (Invitrogen, catalog # 10328011) or equivalent, Disposable powder-free gloves, Aerosol barrier pipette tips, 7500 Fast Dx Real-Time PCR Instrument (Applied Biosystems), Sequence Detection System (SDS) Software, version 1.4 (Applied Biosystems), MicroAmp™ Fast Optical 96-Well Reaction Plate with Barcode, 0.1 mL (Applied Biosystems, catalog # 4346906 or 4366932)*, MicroAmp™ Optical Adhesive Film (Applied Biosystems, catalog # 4360954 or 4311971)*, MicroAmp™ Fast 8-Tube Strips, 0.1 mL (Applied Biosystems, catalog # 4358293)*, MicroAmp™ Optical 8-Cap Strips (Applied Biosystems, catalog # 4323032)*, CFX96 Touch Real-Time PCR Detection System (Bio-Rad), CFX Maestro Software (Bio-Rad), Microseal 'B' Adhesive Seals (Bio-Rad, catalog #MSB1001), Hard-Shell 96-Well PCR Plates, low profile, thin wall, skirted, green/clear (Bio-Rad, catalog #HSP9641)*, 0.2 ml Flat PCR Tube 8-Cap Strips, optical, ultraclear (Bio-Rad, catalog #TCS0803)*
*Either 8-tube PCR strips or 96-well PCR plates may be used.

Shelf life:
12 months from the date of manufacture.

Storage & transportation condition:
Must be stored at Store at -20°C or below.

Weight and volume:
Estimated weight: 0.032kg
Estimated volume: 0.62dm3

Packaging & labelling:
Primary packaging: All contents of Smart Detect SARS-CoV-2 rRT-PCR, kit of 48 tests
Secondary packaging: One kit Smart Detect SARS-CoV-2 rRT-PCR, kit/48 tests