As two kinds of products made through hybrid capture-chemiluminescence, nucleic acid test kits (DH2) for 14 high-risk Human Papillomavirus (HPV) and nucleic acid test kits (DH3) for Human Papillomavirus (HPV) branded in DALTONbio are products with intended use for cervical cancer's screening approved by NMPA, which are clearly applicable to "Cervical Cancer Primary Screening", "Cervical Cancer Combined Screening" and "ASC-US Population Triage". Additionally, the issuance of two certificates for cervical cancer's primary screening signifies that DALTON BioSciences possesses the first Hybrid Capture HPV Preliminary Screening (DH2) and the first Hybrid Capture HPV Typing Preliminary Screening (DH3) globally.

Based on Guidelines for Technical Review of Human Papillomavirus (HPV) Nucleic Acid Tests and Genotyping Reagents issued by NMPA in November 2015, DALTON BioSciences, together with clinical trial units designed a three-year follow-up clinical trial protocol. Since 2016, they have spearheaded the recruitment of millions of women and started a large-scale prospective clinical research. Finally, they were given registration change approvals of NMPA after making great efforts for seven years.

DH series nucleic acid test kits of Human Papillomavirus (HPV) branded in DALTONbio adopted the third-generation hybrid capture technology with exclusive independent intellectual property rights which designed specific RNA probes covering the entire HPV genome for each type of pathogen and proceeded with the HPV typing testing through innovative probes' combinations. This technology is highly sensitive and highly specific, and without the need for extraction as well as amplification of nucleic acid, through which the testing of high-through HPV is easy to take and the viral load can be indicated in a general laboratory. According to multiple research findings, targeting the testing for CIN2+ patients, hybrid capture is useful to avoid missed diagnosis caused by the loss of nucleic acids during extraction, the lack of L1 fragments of HPV in the sample, and the "amplification inhibition" during nucleic acid amplification. This technology is also helpful to avoid misdiagnosis arising from cross-contamination and other factors during the operation.

The nucleic acid test kits (DH3) of Human Papillomavirus (HPV) branded in DALTONbio are suitable for the HPV "2+12 typing" testing and the effective "cervical cancer risk" testing for HPV type 2 (HPV16, 18) as well as other 12 HPV types (HPV31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) which cause 70%-80% of cervical cancers. Consistent with the principle of "not over-typing" proposed in Guidance by NMPA completely, DH2 and DH3 can avoid secondary damages to patients as a result of "over-typing" in clinical applications.

With good reliability and reproducibility, two nucleic acid test kits (DH2&DH3) of Human Papillomavirus (HPV) branded in DALTONbio are trustworthy regarding negative predictive value which is up to 99.9% during the testing of HPV. In addition, following the principle of "Equal Risk, Equal Management" for cervical cancer, they meet all criteria for non-typing HPV nucleic acid testing (DH2) and typing HPV nucleic acid testing (DH3) recommended in Guidelines for Cervical Cancer Screening in China (I) and are available for the preliminary screening as well as combined screening of cervical cancer, and ASC-US population triage.

Two nucleic acid test kits (DH2&DH3) of Human Papillomavirus (HPV) branded in DALTONbio are HPV testing products for screening cervical cancer approved by NMPA and in conformity with national regulatory requirements. They are of great significance for ensuring women's health in China and contributing to cervical cancer's elimination globally.

Special announcement: This article is uploaded and published by the author on the new media platform of People's Daily named "People's Daily News", and only represents the author's views. People's Daily only provides a platform for information dissemination.