CFDA Approved COVID-19 RT-PCR Test

Principle: Real-time fluorescence PCR technology and hydrolysis probe technology are used to achieve qualitative detection of ORF1ab and N genes at the nucleic acid level of one or more pathogens in the same reaction tube. The instrument software system automatically draws real-time amplification curves to achieve instant results Judge.

ORF 1ab gene: FAM channel; N gene: VIC channel

Test result judgment:

Positive: The test result of the sample to be tested is Ct≤35, the curve is S -shaped and there is a significant exponential growth period, and both channels must meet the above conditions at the same time;

Negative: Ct > 38 or not detected in all channels, the result is judged negative;

More Testing: One channel results Ct ≤ 35, and the other channel results 35 < Ct ≤ 38. At this time, the sample should be tested repeatedly. For example, the Ct value is still in the range of 35-38, and the curve is standard S -shaped and obvious. During the exponential growth period, it is judged as positive, otherwise it is judged as negative.

Detection time: 75-110 minutes

Test samples: whole blood, plasma, serum, throat swabs Advantages: high sensitivity and strong specificity

Disadvantages: low temperature transportation, long detection time, and high requirements for experimental conditions.

Reagent composition: RT-PCR reaction solution, enzyme mixed solution, new coronavirus (2019) reaction solution, positive control, negative control.

Minimum detection limit: 1 × 10 3 copies / ml;

Linear detection range: 2 × 10 3 ~ 1 × 10 8 copies / ml;

Specificity: other pathogens with the same infection site or similar and common symptoms (coronavirus 229E , coronavirus OC43 , coronavirus HKU1 , coronavirus NL63 , influenza A virus, influenza B virus, parainfluenza virus , Adenovirus, respiratory syncytial virus, metapneumovirus, boca virus, rhinovirus, Mycoplasma pneumoniae, Chlamydia pneumoniae, Streptococcus pneumoniae, Klebsiella pneumoniae, Legionella, Staphylococcus aureus, Mycobacterium tuberculosis, influenza Haemophilus, Acinetobacter baumannii) and human leukocytes have no cross-reactive total nucleic acids. Precision: The coefficient of variation of the detection precision reference is less than 5%.