Since the coronavirus outbreak in China, 7 PCR assays and one software have been approved by the China National Medical Products Administration (NMPA) within one month.
However, the PCR techniques are time-consuming and required for central lab processing. The China Ministry of Science and Technology (MOST) issued a guideline to promote the development and the approval of the rapid assay on February 8th.
Three types of assays and devices are mentioned:
1. On-site rapid IVD device and assay
Aim: to provide rapid diagnostic approach for confirmation and release the current pressure of confirmation of diagnosis.
The whole process shall be less than 1.5 hours, the analysis sensitivity shall be less than 300 copies per ml. Comparing to the traditional PCR assay, the sensitivity shall not be less than 95% and the specificity shall not be less than 99%. The false negative due to mutation can be covered.
The product development shall be done within a week, the product prototype shall be given to the third-party testing for performance evaluation within two weeks and the medical device approval shall be achieved within a month.
2. Antigen rapid IVD assay
Aim: to provide faster diagnostic approach independent from device and location for Suspected patient screening and asymptomatic infection.
The whole process shall not be more than 30 minutes. The sensitivity of the antigen rapid IVD assay shall be more than 80% of the PCR assay. No obvious cross-reactivity to common coronaviruses.
The product development shall be done within two weeks. The product prototype shall be given to the third-party testing for performance evaluation within three weeks and the medical device approval shall be achieved within one and half month.
3. Antibody rapid IVD assay
Aim: to provide fast and high-throughput diagnostic approach of the blood samples of the suspected patient
The assay may examine the full blood. The whole process shall not be more than 30 minutes The IgM antibody assay shall reach a sensitivity of 70% in confirmed patients. IgG and all antibody assay shall reach a sensitivity of 90% in recovering patients. No obvious cross-reactivity to the serum of patients with common coronaviruses.
The product development shall be done within a week, the product prototype shall be given to the third-party testing for performance evaluation within two weeks and the medical device approval shall be achieved within a month.
The application of MOST projects is limited to registered legal entities in China. Overseas companies that are interested in the application must set up either a Chinese subsidiary or have a Chinese corporation partner for submission.