Shenzhen Yilifang biotechnology Co., ltd.
Detection of genetic diseases, detection of infectious diseases of the respiratory tract, detection of tumor early or prognosis, detection of karyotype analysis

SARS-CoV-2 Nucleic Acid detection Kit(Real-time PCR)

【Background】

     In 2020, an unexpected outbreak swept the world. The main pathogen causing the outbreak is SARS-CoV-2, a new virus that researchers first identified in Wuhan province, China, in late 2019, and was named by the World Health Organization on January 12, 2020. It is a pathogen that mainly causes respiratory and intestinal diseases.
The epidemic coincided with the Spring Festival in 2020, and the development was very fierce and spread widely. As an industrial national high-tech enterprise for the detection and development of respiratory pathogens, our company joined the "battle" as soon as possible and quickly organized the strongest R & D force to succeed Develop high-sensitivity detection kits to fight against viruses and help the frontline fight against epidemics!

【Clinical Manifestations】

Based on the current epidemiological survey, the incubation period for 2019-nCoV is generally 3-7 days, with a maximum of 14 days. The clinical manifestations of the virus infection are: fever, fatigue, respiratory symptoms are mainly dry cough, and dyspnea gradually develops; severe cases present with acute respiratory distress syndrome, septic shock, metabolic acidosis and coagulation that are difficult to treat; some patients have mild onset symptoms but no fever; most patients have a good prognosis, and a few patients are in critical condition or even die. The disease caused by the virus can be manifested as simple infection, mild pneumonia, severe pneumonia, ARDS, sepsis, and septic shock. According to the severity of clinical syndrome, it is divided into mild, moderate and severe, the latter including severe pneumonia, ARDS, sepsis and septic shock.

【Product Features】

Based on real-time fluorescent PCR technology, the results are produced within 1.5 hours.

The reaction system of this kit contains a dU-UNG enzyme anti-pollution system to avoid false positive results; the system contains internal standards to avoid false negative results.

Taking the highly conserved regions of the ORF1ab and N genes in the genome of the new coronavirus (2019-nCoV) as target regions, specific primers and fluorescent probes were designed to perform PCR amplification to ensure the accuracy of the product.

【Product performances】

Sensitivity

1.0x103copies/mL

Linear range

1.0x103copies/mL ~ 1.0x 109copies/mL

Accuracy

100% in enterprise references

Precision

Coefficient of variation (CV) ≤5% within and between batches

Specificity

No cross-reaction with coronavirus (NL63, HKU1, 229E, OC43), influenza A virus, influenza B virus, respiratory syncytial virus, adenovirus, mycoplasma pneumonia, and bordetella pertussis.

Interference

Not affect by Interferon (α-2b≤180 μg/mL), Hydroxymezoline hydrochloride spray(≤150 μg /mL), Budesonide nasal spray(≤256 g /mL), Erythromycin(≤50 mg/mL), Roxithromycin (≤7.5 mg/mL), Azithromycin (≤100mg/mL).

【Product Information】
Applicable Samples: pharyngeal swab, sputum, alveolar lavage fluid

Technical Principle:Real-time PCR

Packing: 24 tests/kit, 48 tests/kit, 96 tests/kit

Applicable instruments:ABI 7500,ABI 7300,Roche480,Roche96, etc.