General description:

STANDARD M nCoV Real-Time Detection kit is used for identification and
detection of novel

coronavirus (2019-nCoV) ORF1ab (RdRp) gene and E gene in human
nasopharyngeal swab,

oropharyngeal swab, and sputum specimens using reverse transcription
(RT) real-time

PCR.

Technical specifications:

Principle: TaqMan probe real-time fluorescent PCR technology

Test format: RT-PCR Instruments

Kit size: 96 Tests

Specimen type: Nasopharyngeal swab, Oropharyngeal swab, Sputum
specimens

Specimen volume: 10µl

Time to result: 120 min

Clinical sensitivity: 100%

Clinical specificity: 100%

Manufacturer product reference:

SD Biosensor, M-NCOV-01

Items supplied with:

2 vials x 2019-nCoV Reaction Solution (750µL)

1 vial x RTase Mix (630µL)

1 vial x 2019-nCoV Positive control (600µL)

1 vial x Negative control (600µL)

1 vial x Internal control A (525µL)

1 vial x ROX (55µL)

1x IFU

Items required, but not supplied:

·Instruments:

- LightCycler 480 (Roche).

- CFX96™ Dx System (Bio-Rad),

- Applied Biosystems 7500 Real-Time PCR Instrument System (Thermo Fisher
Scientific).

- Applied Biosystems 7500 Fast Real-Time PCR Instrument System (Thermo
Fisher Scientific).

·Extraction Kits:

- QIAamp Viral RNA Mini Kit, Qiagen (cat.no. 52904) is recommended by
the manufacturer

Other important items:

- Sterilized (DNase, RNase free) micro centrifuge tube (1.5ml).

- Thermal cycler.

- 0.2ml PCR strips, plate (DNase, RNase free) and cap or sealing film
for each Real-time PCR equipment.

·General Lab Items:

- Disposable latex gloves

- Sterilized filtered pipette tips.

- Pipettes.

- Vortex mixer.

- Desktop centrifuge.

- Clean bench.

- Flake or snow type ice.

- PPE (Personal Protective Equipment).

- Biohazard waste container.

Shelf life:

12 months from manufacturing date.

Storage & transportation condition:

The kit should be stored in a sealed place at -25°C (-13℉) to -15°C
(5℉).

Kit materials are stable until expiration date printed on the outer
packaging.

Freeze-thaw times no more than 5 times.

Packaging & labelling:

Primary packaging: All contents of STANDARD M nCoV Real-Time Detection
kit of 96T

Secondary packaging: One Kit STANDARD M nCoV Real-Time Detection kit/96T

Weight & volume:

Estimated weight: 0.045 kg

Estimated volume: 0.234 dm³