TaqPathCOVID-19 CE-IVD RT-PCRKit,1000RXN

General description:
Minimum order quantity is 2000RXN.
TaqPath™ COVID-19 CE-IVD RT-PCR Kit contains the reagents and controls for a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19. TaqPath™ COVID-19 CE-IVD kit for use on Applied Biosystems 7500 Fast, 7500 Standard, 7500 Fast Dx and Quant Studio 5 Real-time PCR Systems. Testing with the TaqPath™ COVID-19 CE-IVD RT-PCR Kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

Technical specifications:
·The TaqPath™ COVID-19 CE-IVD RT-PCR Kit performance was established using nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage samples only. Other specimen types have not been evaluated and should not be tested with this assay.
·Samples must be collected, transported, and stored using appropriate procedures and conditions.

Manufacturer product reference: Thermo Fisher Scientific Inc., A48067

Items supplied with:
TaqPath™ COVID-19 CE-IVD RT-PCR Kit, 1000 reactions include the following components:
·TaqPath™ COVID-19 RT-PCR Kit (Catalogue # A48102)
-1 tube (1,500µL) x TaqPath™ COVID-19 Assay Multiplex-(Gene ORF1ab, N Protein, S Protein, MS2)
-10 tubes (1mL per tube) x MS2 Phage Control
·10 tubes (10µL per tube) x TaqPath™ COVID-19 Control (catalogue # A48105)
·10 tubes (250µL per tube) x TaqPath™ COVID-19 Control Dilution Buffer (Catalogue # A48099)
·1 bottle (10mL) x TaqPath™ 1-Step Multiplex Master Mix (No ROX) (Catalogue # A48111)
·Package insert
·Service and Support: For new instruments, installation and any repairs in the first year are free under warranty.

Items required, but not supplied:
Instruments/systems:
·Applied Biosystems™ 7500 Fast Dx RealTime PCR Instrument (used with SDS Software v1.4.1)
·Applied Biosystems™ 7500 Fast RealTime PCR Instrument (used with SDS Software v1.5.1 or 7500 Software v2.3)
·Applied Biosystems™ 7500 RealTime PCR Instrument (used with 7500 Software v2.3)
·Applied Biosystems™ QuantStudio™ 5 RealTime PCR Instrument, 384-well block, 0.1-mL block and 0.2-mL block (used with QuantStudio™ Design and Analysis Desktop Software v1.5.1)
·Applied Biosystems™ QuantStudio™ 5 Dx RealTime PCR Instrument (used with QuantStudio™ 5 Dx TD Software v1.0.2 or QuantStudio™ 5 Dx IVD Software v1.0.2)
·Applied Biosystems™ QuantStudio™ 7 Flex Real-Time PCR Instrument, 384–well block (used with QuantStudio™ RealTime PCR Software v1.3)
Other important items:
·Sample collection devices are required but not included in the kit and therefore must be purchased in sufficient quantities separately.

The following items are required to run the test but not supplied with the kit and can be purchased through UNICEF Supply Division separately:
·QuantStudio™ 5 Real-Time PCR System, 96-well, 0.1 mL, laptop or desktop-based. Catalogue # A28568 (laptop-based) or # 28573 (desktop-based).
·QuantStudio™ 5 Real-Time PCR System, 96-well, 0.2 mL, laptop or desktop-based. Catalogue # A28569 (laptop-based) or # 28574 (desktop-based).
·QuantStudio™ 5 Real-Time PCR System, 384-well, laptop or desktop-based. Catalogue # A28570 (laptop-based) or # 28575 (desktop-based).
·Magnetic Stand for Manual Extraction 96 well magnet stand. Catalog # AM10027.
·KingFisher™ Flex Purification System, KingFisher with 96 Deep-well Head. Catalog # 54000630.
·KingFisher 96 Tip Comb. Catalog # 97002534.
·KingFisher 96 deep-well plate, v-bottom, polypropylene. Catalog # 95040450.
·KingFisher 96 microplate (200μL) (for Flex, Apex and Presto). Catalog # 97002540.

Shelf life:
12 months from the date of manufacture.

Storage condition:
TaqPath™ COVID-19 RT-PCR Kit, TaqPath™ COVID-19 Control Dilution Buffer and TaqPath™ 1-Step Multiplex Master Mix (No ROX™) must be stored at –30°C to –10°C.
TaqPath™ COVID-19 Control must be stored at ≤ –70°C.