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    COVID-19
    Monkeypox virus
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COVID-19 Nucleic Acid Test

Specifications:

Intended Use

This product is used for the qualitative detection of SARS-CoV-2 (COVID-19) the S and Ngenes in the throat swab and sputum sample. This kit is applicable to qualitatively test of the novel coronavirus(COVID-19,also known as SARS-CoV-2) in a suspected case of pneumonia infected with a Novel Coronavirus,a suspected case of a cluster,other patients who need to be diagnosed with a novel coronavirus infectin or differential diagnosis.

 

Principle

This kit uses One-Step Real-Time PCR and TaqMan-MGB fluorescent probe technology. Primers and probes are designed in the highly conserved regions of the S and N gene sequences of COVID-19, and human RNase P gene as internal control. This kit has been validated on samples extracted from sputum, nasopharyngeal and throat swabs. Three fluorescent reporters are incorporated into this test: FAM measures the COVID-19 S gene; VIC measures the COVID-19 N gene; CY5 measures human RNase P gene as internal control.

 

Sample requirements

The nucleic acids extraction in throat swabs or and sputum sample from individual suspected of COVID-19 infection by their health provider is required for the detection. Specimen collection should avoid possible contamination in collection, storage, and transportation. Samples can be inactivated at 56 for 30 minutes. Following extraction, RNA samples should be used immediately or stored at -70C for use later. Avoid and minimize repeated sample freezing and thawing.

 

Performance Characteristics

Analytical sensitivity (limit of detection) is defined as the lowest concentration at which the detection rate of at least 95% for 20 samples. The analytical sensitivity of the assay was determined by analyzing a dilution series of in vitro transcribe (Pseudovirus) RNA from 20 to 500 copies/mL for S gene and N gene. The testing was carried out in either 5-replicates (for concentrations200 copies/mL) or 10-replicates (for concentrations<200 copies/mL).

 

Storage and validity

The kit reagents should be stored at -2010 in the dark in a freezer. When properly stored, the reagents are stable for 12 months when sealed and 2 months after initial use. Avoid and reduce repeated freezing and thawing. The reagents should be discarded after 5 times of freezing and thawing. If reagents will be used intermittently, it is suggested to keep the reagents frozen in aliquots.





 
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