FTD SARS-CoV-2, kit/32T

General descriptions:
FTD SARS-CoV-2 is a qualitative in vitro nucleic acid amplification test for the detection of severe respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acids in nasopharyngeal and oropharyngeal swabs of patients with signs and symptoms of SARS-CoV-2 infection in conjunction with clinical and epidemiological risk factors, who are suspected of COVID-19.

Technical specifications:
Technology: Real-time polymerase chain reaction (RT-PCR)
Kit size: 32 tests
Specimen Type: Nasopharyngeal and Oropharyngeal swabs
Specimen Volume: 200 µl
Time to result: 3-5 hrs depending on platform and quantity

Manufacturer product reference:
Siemens Healthcare GmbH, 11416300

Items supplied with:
•1 Vial, SCoV2 PP - Primer/probe- Mix (48 μL)
•1 Vial, SCoV2 PC - Positive control (150 μL)
•1 Vial, Negative Control (2000 μL)
•1 Vial, Internal Control (128 μL)
•1 Vial, 25x RT-PCR Enzyme mix (32 μL)
•1 Vial, 2x RT-PCR Buffer (400 μL)

Items required, but not supplied:
Instruments:
·FTD SARS-CoV-2 was validated with the Thermo Fisher Scientific Applied Biosystems® 7500 Real-Time PCR System and the NucliSENS® easyMAG® (bioMérieux).
Extraction Kit:
The following material and reagents are required for extraction with the NucliSENS easyMAG:
- NucliSENS easyMAG, Magnetic Silica Beads (280133).
- NucliSENS easyMAG, Lysis Buffer (280134).
- NucliSENS easyMAG, Extraction Buffer 1 (280130).
- NucliSENS easyMAG, Extraction Buffer 2 (280131).
- NucliSENS easyMAG, Extraction Buffer 3 (280132).
- NucliSENS easyMAG, Disposables (280135).
- Nuclease-free water.
General Lab Items:
•Adjustable micropipette capable of dispensing 1000 μL, 200 μL, 100 μL, 20 μL and 10 μL.
•Disposable, aerosol-resistant pipette tips, sterile-packaged.
•Disposable, powder-free gloves.
•Vortex mixer.
•Desktop centrifuge.
•Sample rack.
•Sample collection devices/material.
•Bleach/Microcide (or other product according to laboratory cleaning procedure).
•96-well PCR plates and plate sealers.
•Tubes.

Shelf life:
18 months from the date of manufacture.

Weight & volume:
Estimated weight: 0.053 kg
Estimated volume: 0.344 dm3

Storage & transportation condition:
Must be stored at -30°C to -10°C and shipped at 2-8 °C.

Packaging & labelling:
Primary packaging: All contents of FTD SARS-CoV-2 kit for 32 tests
Secondary packaging: One kit FTD SARS-CoV-2, kit/32 tests