Our Multiple Real-Time PCR Kit for Detection of 2019-nCoV was designed and developed based on Real-Time RT-PCR unanimously recommended by 《Guidance for Diagnosis and Treatment of Novel Coronavirus Pneumonia (2nd version)》of National Health Commission and 《Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected Interim guidance 》(published in January 12th) of WHO.
Design of Target：
The triple targets, which cover ORF1ab gene, N gene and E gene of coronavirus, of the reagent kit were designed with reference to the decoding of novel coronavirus by WHO and National CDC.
① High Specificity: Three specific gene targets are covered by the combination of probes, making sure that the specific virus fragments can be accurately amplified.
② Enhanced Stability: The “two tubes and three groups” design increased the ability of resistance to interference, preventing the probes conducting non-specific amplification.
③ Increased Accuracy: False negative rate is dramatically decreased and prevented by the introduction of internal control in the process of PCR.
④ High Sensitivity: The sensitivity of our kit has reached the highest level of S6 with the limit of detection reaching 200 copies/ml among those products inspected by China Food and Drug Inspection and Research Institute.
⑤ Validation of Sufficient Clinical Data: The clinical trial of 562 cases conducted in Beijing Ditan Hospital, Beijing You‘an Hospital and CDC of Beijing demonstrated excellent effectiveness of our reagent kit.
⑥ Recognition by Front-line Clinicians: According to 《Comparison and analysis of the detection performance of six new coronavirus nucleic acid detection reagents》published in the journal of Chongqing Medicine by Chongqing’s Third People’s Hospital, the detection rate of X-ABT Biotech’s reagent kit has reached 100% with a more reasonable trend of Ct value.
⑦ Increased Efficiency and Reduced Contamination: The rates of human error and cross infection caused by manual operation can be reduced with the equipment of automatic nucleic acid extraction workshop, making the whole process of operation more efficient.
Compatible for real-time fluorescent PCR instruments such as ABI7500、Bio-Rad CFX96 ,CFX96 TOUCH、Hongshi slan96p and Roche Z480,etc.
The fluorescence amplification curve showed a typical S-shaped curve. The results of the control sample and the internal standard curve were in line with expectations, and there was no non-specific amplification.
Our procuct (Multiple Real-Time PCR Kit for Detection of 2019-nCoV) have attained the NMPA certification of medical device in February 27th, 2020. We have got ISO 13485:2012 quality system certification, and our production process and quality management are all in accordance with the European Union CE requirements. Our product can be supplied to EU market.