NeoPlex COVID-19 Detection Kit/96T

General descriptions:
NeoPlex COVID-19 Detection Kit is a multiplex in vitro real-time PCR assay intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens (such as nasopharyngeal, oropharyngeal, mid-turbinate, and nasal swabs) and lower respiratory specimens (such as sputum, tracheal aspirates, and bronchoalveolar lavage) from individuals suspected of COVID-19 by their healthcare provider. The NeoPlex COVID-19 Detection Kit is intended for use by qualified, trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time RT-PCR and in vitro diagnostic procedures.

Technical specifications:
Technology: Real Time reverse transcription Polymerase chain reaction (rRT-PRC).
Kit size: 96 tests
Specimen Type: upper respiratory specimen (such as nasopharyngeal, oropharyngeal, mid-turbinate or nasal swab) or lower respiratory specimen (such as sputum BAL, or tracheal aspirate)
Specimen Volume: RNA 5µl for detecting SARS-CoV-2
Time to result: 2h 5min

Manufacturer product reference:
GeneMatrix Inc., NR05A

Items supplied with:
·1 Vial, COVID-19 PPM (500uL) - RdRp (Primer/Probe), N (Primer/Probe), IC (Primer/Probe) and Tris EDTA Buffer Solution
·1 Vial, One-step Master Mix (500uL)
·1 Vial, COVID-19 Positive Control (100uL) - RdRp IVT RNA (100 copies/rxn), N IVT RNA (100 copies/rxn), IC IVT RNA (100 copies/rxn)
·1 Vial, DW - RNase-free water, No template control (1mL)
·1, IFU

Items required, but not supplied:
PCR instrument and software:
·Applied Biosystems™ 7500 Fast Dx Real-Time PCR Instrument with SDS software version 1.4
Extraction kit:
·QIAamp DSP Viral RNA Mini Kit (QIAGEN, Cat No.61904).
Other important items:
·MicroAmp™ Optical 8-Tube Strip, 0.2-mL (Cat No. 4316567).
·MicroAmp™ Optical 8-Cap Strip (Cat No. 4323032).
General lab items:
·Pipettes in variable sizes.
·Aerosol barrier pipette tips.
·Micro Centrifuge.
·Vortex mixer.
·Disposable powder-free gloves.


Shelf life:
11 months from the date of manufacture.

Weight & volume:
Estimated weight: 0.027 Kg
Estimated volume: 0.3 dm3

Storage & transportation condition:
Must be stored at less than or equal to -20 °C and shipped on dry ice.
Temperature during operation: room temperature (15-25°C)

Packaging & labelling:
Primary packaging: All contents of Neoplex COVID-19 Detection Kit for 96 tests
Secondary packaging: One kit Neoplex COVID-19 Detection Kit/96 tests