Allplex 2019-nCoV Assay, kit/124RXN

General description:
Allplex 2019-nCoV Assay is an in vitro diagnostic (IVD) real-time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the qualitative detection of SARS-CoV 2 viral nucleic acids in human nasopharyngeal swab, oropharyngeal swab, anterior nasal swab, mid-turbinate and sputum specimens from individuals who are suspected of COVID-19.

Technical specifications:
Principle: Reverse transcriptase polymerase chain reaction
Test format: RT- PCR Kit
Kit size: 124 reactions
Specimen type: Nasopharyngeal swab, Oropharyngeal swab, anterior nasal swab, mid-turbinate
and Sputum specimens
Specimen Volume: 8ul (Extracted Nucleic Acid)
Time to result: 1hr50 min

Manufacturer product reference:
Seegene Inc., RP10252W

Items supplied with:
·1 Vial, 2019-nCoV MOM (620 μL)
·1 Vial, Real-time One-step Enzyme (200 μL)
·1 Vial. 5X Real-time One-step Buffer (500 μL)
·1 Vial, 2019-nCoV Positive Control (80 μL)
·1 Vial, RP-V IC (Exogenous Internal Control) (1,000 μL)
·1 Vial, RNase-free Water (Ultrapure quality, PCR-grade RNase-free Water provided for: 1. Negative Control (NC) for PCR control and 2. RT-PCR Mastermix) (1,000 μL)
·1, IFU

Items required, but not supplied:
Instruments and software for amplification and analysis:
·CFX96 Real-time PCR Detection System-IVD (Bio-Rad); or CFX96 Touch Real-Time PCR Detection System (Bio-Rad);
·CFX Manager Software V3.1; or CFX Maestro Software V1
·Seegene Viewer Software V3.20 for analysis and interpretation of result. (Distribution by Seegene Technologies (CA, US), support@seegenetech.com)
Instruments and software for nucleic acid extraction:
·Microlab STARlet IVD (Cat. No. 173000-075, Hamilton Co.); or Seegene STARlet (Cat. No. 65415-03, Seegene Inc.)
·STARMag 96 X 4 Universal Cartridge Kit (Cat. No. 744300.4.UC384, Seegene Inc.) STARMag 96 X 4 Universal Cartridge Kit is used for testing on either the Microlab or Seegene STARlet.
·Seegene Launcher V6. (Distribution by Seegene Technologies (CA, US), support@seegenetech.com)
Other important items:
·Hard-Shell 96-Well PCR Plate, low profile, thin wall, skirted, white/white (Code: HSP9655, Bio-Rad)
·Optical Flat 8-Cap Strips (Code: TCS0803, Bio-Rad)
·Permanent Clear Heat Seal (Cat. No. 1814035, Bio-Rad) and PX1 PCR plate sealer (auto-sealer, Cat. No. 181-4000, Bio-Rad). The above Permanent Clear Heat Seal and the PX1 PCR Plate Sealer must be used when running the Allplex assay.
General lab items:
·Disposable powder free gloves (latex or nitrile)
·Pipettes and sterile pipettes tips
·1.5ml micro centrifuge tubes
·Desktop centrifuge for 1.5 ml microtube and 96 well plate
·Vortes mixer
·Clean bench
·Ice

Shelf life:
8 months from manufacturing date.

Storage & transportation condition:
Must be stored at -20°C and shipped at 2 - 8 °C.

Weight & volume:
Estimated weight: 0.04 Kg
Estimated volume: 0.38 dm³

Packaging & labelling:
Primary packaging: All contents of Allplex 2019-nCoV Assay for 124 reactions
Secondary packaging: One Kit Allplex 2019-nCoV Assay, kit/124 reactions.