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