TaqPathCOVID-19 CE-IVD RT-PCRKit,1000RXN
Minimum order quantity is 2000RXN.
TaqPath™ COVID-19 CE-IVD RT-PCR Kit contains the reagents and controlsfor a real-time reverse transcription polymerase chain reaction (RT-PCR)test intended for the qualitative detection of nucleic acid fromSARS-CoV-2 in nasopharyngeal swab, nasopharyngeal aspirate, andbronchoalveolar lavage (BAL) specimens from individuals suspected ofCOVID-19. TaqPath™ COVID-19 CE-IVD kit for use on Applied Biosystems7500 Fast, 7500 Standard, 7500 Fast Dx and Quant Studio 5 Real-time PCRSystems. Testing with the TaqPath™ COVID-19 CE-IVD RT-PCR Kit isintended for use by qualified and trained clinical laboratory personnelspecifically instructed and trained in the techniques of real-time PCRand in vitro diagnostic procedures.
·The TaqPath™ COVID-19 CE-IVD RT-PCR Kit performance was establishedusing nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolarlavage samples only. Other specimen types have not been evaluated andshould not be tested with this assay.
·Samples must be collected, transported, and stored using appropriateprocedures and conditions.
Manufacturer product reference: Thermo Fisher Scientific Inc.,A48067
Items supplied with:
TaqPath™ COVID-19 CE-IVD RT-PCR Kit, 1000 reactions include thefollowing components:
·TaqPath™ COVID-19 RT-PCR Kit (Catalogue # A48102)
-1 tube (1,500µL) x TaqPath™ COVID-19 Assay Multiplex-(Gene ORF1ab, NProtein, 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)
·Service and Support: For new instruments, installation and anyrepairs in the first year are free under warranty.
Items required, but not supplied:
·Applied Biosystems™ 7500 Fast Dx RealTime PCR Instrument (used withSDS Software v1.4.1)
·Applied Biosystems™ 7500 Fast RealTime PCR Instrument (used with SDSSoftware v1.5.1 or 7500 Software v2.3)
·Applied Biosystems™ 7500 RealTime PCR Instrument (used with 7500Software v2.3)
·Applied Biosystems™ QuantStudio™ 5 RealTime PCR Instrument, 384-wellblock, 0.1-mL block and 0.2-mL block (used with QuantStudio™ Design andAnalysis Desktop Software v1.5.1)
·Applied Biosystems™ QuantStudio™ 5 Dx RealTime PCR Instrument (usedwith QuantStudio™ 5 Dx TD Software v1.0.2 or QuantStudio™ 5 Dx IVDSoftware 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 kitand therefore must be purchased in sufficient quantities separately.
The following items are required to run the test but not suppliedwith the kit and can be purchased through UNICEF Supply Divisionseparately:
·QuantStudio™ 5 Real-Time PCR System, 96-well, 0.1 mL, laptop ordesktop-based. Catalogue # A28568 (laptop-based) or # 28573(desktop-based).
·QuantStudio™ 5 Real-Time PCR System, 96-well, 0.2 mL, laptop ordesktop-based. Catalogue # A28569 (laptop-based) or # 28574(desktop-based).
·QuantStudio™ 5 Real-Time PCR System, 384-well, laptop ordesktop-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-wellHead. 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.
12 months from the date of manufacture.
TaqPath™ COVID-19 RT-PCR Kit, TaqPath™ COVID-19 Control Dilution Bufferand 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.