GenesigCOVID-19 CEIVD RTPCRAssay,kit/96T

General description:
Primerdesign Ltd COVID-19 genesig Real-Time PCR assay is intended to be used to achieve qualitative detection of COVID-19 viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum from patients in association with a CE IVD extraction system. The kit is intended for use by laboratory trained personnel.

Technical specifications:
Technology: RT PCR
Kit size: 96 tests
Sample type: Nasopharyngeal swabs, oropharyngeal swabs and sputum
Clinical sensitivity: 98%
Clinical specificity: 100%

Manufacturer product reference: Primerdesign Ltd., Z-Path COVID-19-CE

Items supplied with:
·2 x oasig Lyophilised qPCR OneStep Master Mix, 525μL
·2 x COVID-19 Primer & Probe Mix, 110μL
·2 x Master Mix Resuspension buffer, 600μL
·2 x Kit Resuspension buffer, 1500μL
·1 x Water RNase/DNase Free, 500μL
·1 x COVID-19 Positive control template, 600μL
·2 x RNA Internal extraction control, 1000μL

Items required, but not supplied:
PCR Instruments and software:
·Applied Biosystem® 7500 Real-Time PCR System, software version 2.3; product code: 4351104 (Thermo Fisher Scientific)
·CFX96 Maestro, software version 1.1, product code: 1855201,1855195 (Bio-Rad)
·LightCycler 480 II, software version 1.5, product code: 05015278001 (Roche)
Extraction kits:
·GXT DNA/RNA Extraction Kit VER 2.0 (IFU-120102-10) by HAIN Lifescience GmbH is an extraction kit recommended by the test manufacturer.
Other important items:
·Depending on the Real-Time PCR instrument to be used: White Roche LightCycler 480 Multiwell plate 96, White Bio-Rad CFX96 Multiwell plate 96, or Transparent Applied Biosystems 7500 Real-Time PCR System Multiwell Plate 96
General lab items:
·PCR hood
·Benchtop centrifuge
·Vortex mixer
·Adjustable pipettes
·Pipette tips with filters
·Disposable gloves
·1.5mL microcentrifuge tubes for extraction

Shelf life:
18 months from the date of manufacture.

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

Packaging & labelling:
Primary packaging: All contents of genesigCOVID-19 CEIVD RT-PCR Assay, kit of 96 tests
Secondary packaging: One kit genesigCOVID-19 CEIVD RT-PCR Assay, kit/96tests