VS SARS-CoV-2 6x8wellstrips LP, kit/48T

General Descriptions:
VIASURE SARS-CoV-2 RT- PCR Detection Kit is designed for the specific identification and differentiation of 2019 Novel Coronavirus (SARS-CoV-2) in respiratory samples from patients with signs and symptoms of COVID-19 infection. This test is intended for use as an aid in the diagnosis of SARS-CoV-2 in combination with clinical and epidemiological risk factors. This test is indented for use by professional users only.

Technical specifications:
Technology: Real Time PCR
Test Format: 6 x 8-well strips (Low Profile)
Specimen Volume: 5 µl
Specimen Type: RNA extracted from respiratory samples (nasopharyngeal swab and oropharyngeal swab)
Kit size: 48 tests
Result Time/output: ≤ 3 hours/Qualitative

Manufacturer product reference:
Certest Biotec, VS-NCO206L

Items supplied with:
·6 x SARS-CoV-2 8-well strips
·1 x Rehydration Buffer Vial (1.8ml)
·1 x SARS-CoV-2 Positive Control Vial
·1 x Negative control Vial (1ml)
·1 x Water RNAse/DNAse free Vial (1ml)
·6 x Tear-off 8-cap strips
1x IFU
2Instruments:
- Applied Biosystems 7500 Fast Real-Time PCR System,
- Applied Biosystems StepOne™ Real-Time PCR System,
- Bio-Rad CFX96™ Real-Time PCR System,
- Agilent Technologies AriaMx Real-Time PCR System,
- DNA-Technology Detection DTprime Real-time Detection Thermal Cycler,
- DNA-Technology DTlite Real-Time PCR System,
- Rotor-Gene® Q (Qiagen),
- SmartCycler (Cepheid),
- Roche Molecular Diagnostics Cobas z480 Analyzer,
- VIASURE 48 Real Time PCR System.
- VIASURE 96 Real Time PCR System.
3Extraction kits:
- Viasure RNA-DNA Extraction kit (VIASURE),
- Maxwell 16 Viral Total Nucleic Acid Purification Kit, using the Maxwell 16 instrument (Promega),
- Total Nucleic Acid Isolation (TNAI) Kit, using COBAS AmpliPrep (ROCHE),
- MagDEA Dx SV kit, using the magLEAD 12gC instrument (Precision System Science Co.),
- MagCore Viral Nucleic Acid Extraction kit, using the MagCore HF16 automated Nucleic Acid Extractor System,
- EZ1 Virus Mini Kit, using EZ1 instrument (Qiagen),
- mSample Preparation Systems RNA, using the Abbott m2000 RealTime System (Abbott Molecular)
4Other important items:
- Loading block (for use with Qiagen/Corbett Rotor-Gene instruments)
·General lab items:
- Centrifuge for 1.5 mL tubes and PCR-well strips or 96-well plate (if available)
- Vortex
- Micropipettes (0.5-20 μL, 20-200 μL)
- Filter tips
- Powder-free disposable gloves

Items required, but not supplied:
·Real Time PCR instrument (thermocycler): The test kit has been validated on these equipments:
- Applied Biosystems 7500 Fast Real-Time PCR System,
- Applied Biosystems StepOne™ Real-Time PCR System,
- Bio-Rad CFX96™ Real-Time PCR System,
- Agilent Technologies AriaMx Real-Time PCR System,
- DNA-Technology Detection DTprime Real-time Detection Thermal Cycler ,
- DNA-Technology DTlite Real-Time PCR System,
- Rotor-Gene Q (Qiagen),
- SmartCycler (Cepheid),
- Roche Molecular Diagnostics Cobas z480 Analyzer,
- VIASURE 48 Real Time PCR System,
- VIASURE 96 Real Time PCR System
·RNA extraction kit: The test kit has been validated on these extraction kits:
- Viasure RNA-DNA Extraction kit (VIASURE), recommended,
- Maxwell 16 Viral Total Nucleic Acid Purification Kit, using the Maxwell 16 instrument (Promega),
- Total Nucleic Acid Isolation (TNAI) Kit, using COBAS AmpliPrep (ROCHE) ,
- MagDEA Dx SV kit, using the magLEAD 12gC instrument (Precision System Science Co.),
- MagCore Viral Nucleic Acid Extraction kit, using the MagCore HF16 automated Nucleic Acid Extractor System,
- EZ1 Virus Mini Kit, using EZ1 instrument (Qiagen),
- mSample Preparation Systems RNA, using the Abbott m2000 RealTime System (Abbott Molecular)
·Loading block (for use with Qiagen/Corbett Rotor-Gene instruments)
·Centrifuge for 1.5 mL tubes and PCR-well strips or 96-well plate (if available)
·Vortex
·Micropipettes (0.5-20 μL, 20-200 μL)
·Filter tips
·Powder-free disposable gloves

Shelf life:
24 months from the date of manufacture

Weight & volume:
Estimated weight: 0.190 Kg
Estimated volume: 2.6 dm3

Storage & transportation condition:
Must be shipped and stored at 2-40°C.

Packaging & labelling:
Primary packaging: All contents of VIASURE SARS-CoV-2 6x8 well strips LP, kit of 48 tests
Secondary packaging: One kit VIASURE SARS-CoV-2 6x8 well strips LP, kit/48 tests