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Freeze-dried Human Respiratory Syncytial Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification)

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Freeze-dried Human Respiratory Syncytial Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification)

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Introduction

Generic name: Freeze-dried Human Respiratory Syncytial Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification)
[Packaging Size] 48 tests/kit
[Intended Use]

This kit is used for in vitro qualitative detection of Human respiratory syncytial virus (HRSV) nucleic acid in throat swab samples.
Human respiratory syncytial virus (HRSV), HRSV belongs to the Pneumoviridae and Orthopneumirus genus, a non-segmental single-stranded negative-stranded RNA virus. HRSV mainly causes respiratory tract infection and has become one of the main causes of hospitalization for respiratory tract infections in infants and children under 5 years old, and one of the main pathogens of severe respiratory diseases in adults, the elderly and immunocompromised patients. The test results of this kit are not the sole indicator for the diagnosis of respiratory syncytial virus infection in patients. It must be combined with the clinical symptoms of the patient and other laboratory test data to correctly determine the infection or colonization of the pathogen, and formulate a reasonable treatment plan to make the treatment safe and effective.

[Test Principles]

This kit adopts Enzymatic Probe Isothermal Amplification (EPIA), and designs specific primers and RNA base-containing probes (rProbe) for the highly conserved region of Human respiratory syncytial virus, and adds Bst enzyme and RNaseH enzyme at the same time, in which the left and right ends of the RNA base of rProbe are labeled with fluorescent groups and quencher, respectively. Use the DNA polymerase activity and strand displacement activity of Bst enzyme to amplify the target to be tested at a constant temperature, the RNaseH enzyme can cleave the RNA bases on the target-probe hybrid chain, so that the fluorescent group and quencher of rProbe are separated thereby fluorescing. In addition, the left fragment of the residual rProbe RNA base can be used as a primer to further extend to form a product, which further accumulates the product. The fluorescent signal is continuously accumulated with the formation of the product, thereby realizing the detection of the target nucleic acid.

In the system, the recombinant pine chloroplast gene pseudovirus is used as an exogenous internal control, as the quality control of reagent and operation itself, to avoid false negative.

[Storage Conditions and Shelf-life]

1. Unopened kit: It should be stored at no higher than 30°C and protected from light, and the shelf-life is 12 months.
2. It should be tested immediately after the freeze-dried positive control and internal control are reconstituted. The remaining positive control and internal control should be stored below -15°C away from light, and the shelf-time is 1 week and the repeated freezing and thawing should be avoided (no more than 2 cycles).
3. Transportation conditions: It can be transported stably for 1 month below 37°C.
4. See the packaging label for the production date, production batch number and expiry date.

[Applicable Instruments]

Applied Biosystems 7500 Real-Time PCR Systems, SLAN-96P Real-Time PCR Systems (Shanghai Hongshi Medical Technology Co., Ltd.), LightCycler®480 Real-Time PCR system, Real-time Fluorescence Constant Temperature Detection System Easy Amp HWTS1600.

[Requirements for Samples]

1. Sample Collection
Freshly collected throat swabs.
Sample collection of throat swab:
Use polyester fiber head swab to wipe the posterior uvula, posterior pharyngeal wall and bilateral tonsils repeatedly with moderate force, and avoid touching the tongue. Take out the rear sampling tube, break the plastic handle on the contact part of the hand, soak the swab in the sampling solution, and tighten the tube cap. It has been proved that throat swab samples can be preserved in preservation solutions such as saline or Hank’s solution.
2. Precautions for sample collection: Avoid contamination during sample collection, storage and transfer.
Sample safety: All samples are considered to be potentially infectious, and operations are performed in accordance with relevant national standards.
3. Storage
The samples to be tested have to be frozen for storage, stored below -15°C for no more than 1 week, and frozen below -70°C for long-term storage. The extraction of frozen samples to be tested should be carried out after the samples have been thawed completely and mixed well, and the repeated freezing and thawing should be avoided.

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