RealStar YF Virus RT-PCR Kit 1.0,kit/96T

General description:
The RealStar Yellow Fever Virus RT-PCR Kit 1.0 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection of yellow fever virus specific RNA.

Technical specifications:
Analytical sensitivity: 0.69 copies/μl (95% confidence interval (CI): 0.41 - 1.56 copies/μl)
Analytical specificity: The analytical specificity of the RealStar Yellow Fever Virus RT-PCR Kit 1.0 was evaluated by testing a panel of genomic RNA/DNA extracted from viruses related to YFV and other pathogens causing similar symptoms. The RealStar Yellow Fever Virus RT-PCR Kit 1.0 did not cross-react with any of those pathogens.
Clinical sensitivity: 100% with 95% CI (73.5-100) %
Clinical specificity: 100% with 95% CI (92.1-100) %
Specimen type: Serum, plasma

Manufacturer product reference: Altona Diagnostics GmbH, 671013

Items supplied with:
·Master A (60μl/Vial), 8 vials
·Master B (180μl/Vial), 8 vials
·Internal Control (1000μl/Vial), 1 vial
·Positive Control (250μl/Vial), 1 vial
·Water (PCR grade) (500μl/Vial), 1 vial

Items required, but not supplied:
·Appropriate real-time PCR instrument: The kit was developed and validates to be used with the following real-time PCR instruments.
-Mx 3005P™ QPCR System (Stratagene)
-VERSANT® kPCR Molecular System AD (Siemens Healthcare Diagnostics)
-ABI Prism® 7500 SDS (Applied Biosystems)
-ABI Prism® 7500 Fast SDS (Applied Biosystems)
-LightCycler® 480 Instrument II (Roche)
-Rotor-Gene® 6000 (Corbett Research)
-Rotor-Gene® Q5/6 plex Platform (QIAGEN)
-CFX96™ Real-Time PCR Detection System (Bio-Rad)
-CFX96™ Deep Well Real-Time PCR Detection System (Bio-Rad)

··Appropriate nucleic acid extraction system or kit: The following kits and systems are suitable for nucleic acid extraction.
-QIAamp® Viral RNA Mini Kit (QIAGEN) – (UNICEF Number: S0004079 YF Dx-QIAamp Viral RNA Mini Kit, 250RXN)
This is the only extraction kit that has been validated with this test by the WHO. All other extraction kits mentioned below have not been validated for this test. Therefore, any country wishing to use those kits must conduct its own validation process.
-QIAsymphony® (QIAGEN)
-NucliSENS® easyMag® (bioMérieux)
-MagNA Pure 96 System (Roche)
-m2000sp (Abbott)
-Maxwell® 16 IVD Instrument (Promega)
-VERSANT® kPCR Molecular System SP (Siemens Healthcare)

·General lab items:
-Desktop centrifuge with a rotor for 2 ml reaction tubes
-Centrifuge with a rotor for microtiter plates, if using 96 well reaction plates
-Vortex mixer
-Appropriate 96 well reaction plates or reaction tubes with corresponding
(optical) closing material
-Pipettes (adjustable)
-Pipette tips with filters (disposable)
-Powder-free gloves (disposable)

Shelf life:
12 months from the date of manufacturing; do not use beyond its expiry date.

Weight and volume:
Estimated weight: 0.1kg
Estimated volume: 0.756dm³

Storage and transportation condition:
·The kit should be stored between -25°C and -15°C upon arrival.
·It is shipped on dry ice (-20°C). The components of the kit should arrive frozen. If one or more components are not frozen upon receipt, or if tubes have been compromised during shipment, contact Altona Diagnostics GmbH for assistance
·Repeated thawing and freezing of Master reagents (more than twice) should be avoided, as this might affect the performance of the assay. The reagents should be frozen in aliquots, if they are to be used intermittently.
·Storage between +2°C and +8°C should not exceed a period of two hours.
·Protect Master A and Master B from light.

MSDS:
Dry-ice shipment; UN 1845, class 9, carbon dioxide, solid (dry ice)