[Product Name]

Freeze-dried Zaire Ebola Virus Nucleic Acid Detection Kit (Fluorescence PCR)

[Packaging Size]

20 tests/kit, 50 tests/kit

[Intended Use]

This kit is suitable for qualitative detection of Zaire Ebola virus nucleic acid in serum or plasma samples of patients suspected of Zaire Ebola virus (ZEBOV) infection, and provides an auxiliary means for diagnosis of patients with Zaire Ebola virus infection. The test results should be combined with the clinical diagnosis, and the final diagnosis should be comprehensively considered in close combination with other clinical indicators.

Ebola virus belongs to Filoviridae, which is an unsegmented single-stranded negative-strand RNA virus. Viruses are long filaments with an average virion length of 1000nm and a diameter of about 100nm.

The Ebola virus genome is an unsegmented negative-strand RNA with a size of 18.9kb, encoding 7 structural proteins and 1 non-structural protein. Ebola virus can be divided into types like Zaire, Sudan, Bundibugyo, Tai Forest and Reston. Among them, Zaire type and Sudan type have been reported to cause many people’s deaths from infection. EHF (Ebola Hemorrhagic Fever) is an acute hemorrhagic infectious disease caused by the Ebola virus. Humans are mainly infected by contact with body fluids, secretions and excreta of patients or infected animals, and the clinical manifestations are mainly protruding fever, bleeding and multiple organ damage. EHF has a high mortality rate of 50%-90%. At present, the methods of Ebola virus diagnosis are mainly laboratory tests, including two aspects: etiological detection and serological detection. Etiological detection includes detecting viral antigens in blood samples by ELISA, detecting nucleic acids by amplification methods like RT-PCR, etc., and using cells Vero, Hela, etc. for virus isolation and culture. Serological detection includes detecting Serum specific IgM antibodies by capture ELISA, and detecting Serum specific IgG antibodies by ELISA, immunofluorescence, etc..

[Main Components]

Note: Components of different batches cannot be interchanged.

[Storage Conditions and Shelf-life]

1. Unopened kits: Should be stored stored at a temperature not higher than 30°C and protected from light, and the shelf life is 12 months.
2. The freeze-dried reaction buffer should be tested by RT-PCR immediately after being reconstituted. Otherwise, it should be stored at -25°C to -15°C away from light, and the shelf life is 1 week and avoid the repeated freezing and thawing (should be limited within two cycles).
3. The freeze-dried positive control should be stored at -25°C to -15°C after being reconstituted, and the shelf life is 1 week and avoid the repeated freezing and thawing (should be limited within two cycles).
4. Transport condition: Can be transported stably for 1 month below 37°C.
5. See the packaging label for the production date, production batch number and expiration date.

[Applicable Instruments]

QuantStudio®5 Real-Time PCR Systems, SLAN-96P Real-Time PCR Systems (Shanghai Hongshi Medical Technology Co., Ltd.), LightCycler®480 Real-Time PCR system, LineGene 9600 Plus Real-Time PCR Detection System(FQD-96A, Bioer technology), MA-6000 Real-Time Quantitative Thermal Cycler (Suzhou Molarray Co., Ltd.), BioRad CFX96 Real-Time PCR System, and BioRad CFX Opus 96 Real-Time PCR System.