RNA(PCR-Flu/Prob)CoV-19DetectionKit/96

General Descriptions:
The Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing) is a multiplexed real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in oropharyngeal swab, nasopharyngeal swab and sputum specimens collected from individuals who are suspected of COVID-19 by their healthcare provider. The kit is manually operated, and it is intended for use by clinical laboratory personnel specifically trained in PCR in level 2 biosafety laboratory. The Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing) 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 diagnosis procedures.

Technical specifications:
Technology: RT-PCR combined with fluorescent probe technique
Specimen Volume: YHXB No. 20170583 and YHXB No. 20150302) 200μl. QIAamp Viral RNA Mini Kit (l52906)140μL
Specimen Type: Throat swab, sputum and nasopharyngeal swab
Kit size: 96 tests

Manufacturer product reference:
Da An Gene Co., Ltd., DA0932

Items supplied with:
·PCR Detection reagents:
NC “ORF1ab/N” PCR reaction solution A.
-2x Specific primers, probes, tris(hydroxymethyl)aminomethane-hydrochloric acid buffer 900μl.
NC (ORF1ab/N) PCR reaction solution B.
-2x Hot start Taq DNA polymerase, c-MMLV enzyme, Rnasin, dNTPs, etc. 200 μl.
·Control
NC (ORF1ab/N) positive control.
-1x Pseudo viruses with target segments and internal control segments 400 μl.
-NC (ORF1ab/N) negative control.
-Pseudo virus containing target fragments, pseudo virus containing internal standard fragments
·1x IFU.

Items required, but not supplied:
·Extraction reagents:
- YHXB No. 20170583, YHXB No. 20150302 products manufactured by DAAN.
- QIAamp Viral RNA Mini Kit, 52906 by QIAGEN (Available for procurement through UNICEF as catalogue number S0003893)
·Applicable instruments:
- ABI 7500 Real-Time PCR Systems with V2.4 software (Applied Biosystems)
- LightCycler 480 II with V1.5 software (Roche)
·Others:
- Disposable gloves, shoe covers, hats, eye shields and personal protective equipment
- 1.5 mL microcentrifuge tubes (DNase/RNase free), RNase/DNase-free tips for pipettes, 8-tube strips for real-time PCR, 0.1 mL PCR tube 8-cap strips, white (LightCycler 480 II)
- Racks for 1.5mL microcentrifuge tubes, Benchtop centrifuge, Vortex mixer, Transparent Multi-well Plate 96 for Applied Biosystems 7500 Real-Time PCR System, Adjustable calibrated pipettes, Automatic Nucleic Acid Extractor used with YHXB No. 20170583 and YHXB No. 20150302)

Shelf life:
12 months from the date of manufacture.

Weight & volume:
Estimated weight: 0.042kg
Estimated Volume: 0.0002571m3 per kit.

Storage & transportation condition:
The kit must be stored at -20 ± 5°C. The reagent can be stored at 2-8°C for 7 days; the kit can be stored at 37°C for 3 days; repeated freezing and thawing should be avoided.

Packaging & labelling:
Primary packaging: All contents of RNA(PCR-Flu/Prob) CoV-19 Detection Kit of 96 tests
Secondary packaging: One kit RNA(PCR-Flu/Prob) CoV-19 Detection Kit/96 tests