RADI COVID-19 Detection Kit/100T

General description:
The RADI COVID-19 Detection Kit is an in vitro diagnostic medical device, based on Realtime RT-PCR technology utilizing reverse-transcriptase (RT) reaction to convert RNA into complementary DNA (cDNA). It is intended for the presumptive qualitative detection of nucleic acid from the COVID-19 in upper and lower respiratory specimens. The RADI COVID-19 Detection Kit is a molecular in vitro diagnostic test that aids in the detection and diagnosis COVID-19 and in based on widely used nucleic acid amplification technology. The assay is for use by a laboratory professional trained to use real-time PCR in a laboratory.

Technical specifications:
Principle: Reverse transcriptase polymerase chain reaction
Kit size: 100 tests
Specimen Type: Upper and lower respiratory specimens such as nasopharyngeal or oropharyngeal swabs and sputum.
Specimen Volume: 15µl extracted RNA
Time to result: 80 minutes for PCR.

Manufacturer product reference: KH Medical Co., Ltd., RV008

Items supplied with:
•1 x Primer & Probe mixture (500μL)
•1 x 3X RT MasterMix (1,000μL)
•1 x Positive control (300μL)
•1 x RNase free water (1,000μL)
•1 x COVID-19 Extraction Control (1,000μL)
•1 x IFU

Items required, but not supplied:
·RT-PCR Instruments:
- CFX96 Real-Time PCR Detection System, Bio-Rad.
- Applied Biosystems7500Real-Time PCR System, ThermoFisher.
·Extraction Kits:
- RADI PREP Swab and Stool DNA/RNA KIT (Ref. MP002), KH Medical (Available for procurement through UNICEF SD as S0003895)
- RADI PREP Plus RADI PREP Plus (Ref. KM001), KH Medical
- QIAmp Viral RNA Mini Kit, Qiagen (Available for procurement through UNICEF SD as S0003893)
·General Lab Items:
- Micropipettes
- Sterilized pipette tips with filter barriers
- Centrifuge, Vortex mixer
- Disposable powder-free gloves
- Consumables relating the RT-PCR

Shelf life:
8 months from the date of manufacture.

Weight & volume:
Estimated weight: 32g / 1 kit.
Estimated volume: 90 X 60 X 21.5mm / 1kit (box).

Storage & transportation condition:
All components should be stored at-25°C to-15°C upon arrival. Exposure time at Room temperature should not exceed 30 minutes.
The test kit must be shipped on dry ice.

Packaging & labelling:
Primary packaging: All contents of RADI COVID-19 Detection Kit for 100 tests.
Secondary packaging: One kit RADI COVID-19 Detection Kit/100 tests.