Objective: The objective of the study is to verify the clinical validity of the following kits with the comparative experimental analysis and evaluate whether their performance can meet the clinical requirements, i.e....Objective: The objective of the study is to verify the clinical validity of the following kits with the comparative experimental analysis and evaluate whether their performance can meet the clinical requirements, i.e. Class III in vitro diagnostic reagent “Herpes Simplex Virus (HSV) Type II Nucleic Acid Detection Kit (PCR-Fluorescence Probe Method)” of Daan Gene Co., Ltd. (Daan kit for short) and “Herpes Simplex Virus (HSV) Type II Nucleic Acid Detection Kit (Fluorescence PCR Method)” of Wuhan Biot Gene Co., Ltd. (Biot kit for short). Method: In the study process, the samples were divided into positive and negative groups according to the control test results, and the clinical application performance of Daan kit and Biot kit was evaluated by comparing their test results. Results: The results show that two kits indicate the same test results, i.e. 26 positive and 107 negative samples in a total of 133 male urethral discharge samples, and 32 positive and 238 negative samples in a total of 270 female cervical secretion samples. Conclusion: It can be concluded from the clinical test that Daan and Biot Herpes Simplex Virus (HSV) Type II Nuc- leic Acid Test Kits are reliable, accurate, safe, convenient for use, stable and high-value in the clinical application.展开更多
The on-going global pandemic of coronavirus disease 2019(COVID-19)caused by a novel coronavirus called severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)has been underway for about 11 months.Through November ...The on-going global pandemic of coronavirus disease 2019(COVID-19)caused by a novel coronavirus called severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)has been underway for about 11 months.Through November 20,2020,51 detection kits for SARS-CoV-2 nucleic acids(24 kits),antibodies(25 kits),or antigens(2 kits)have been approved by the National Medical Products Administration of China(NMPA).Convenient and reliable SARS-CoV-2 detection assays are urgently needed worldwide for strategic control of the pandemic.In this review,the detection kits approved in China are summarised and the three types of tests,namely nucleic acid,serological and antigen detection,which are available for the detection of COVID-19 are discussed in detail.The development of novel detection kits will lay the foundation for the control and prevention of the COVID-19 pandemic globally.展开更多
To develop a national reference panel for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)antigen detection kit and establish a quality standard.The cultures of SARS-CoV-2 and other pathogens were collected...To develop a national reference panel for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)antigen detection kit and establish a quality standard.The cultures of SARS-CoV-2 and other pathogens were collected to establish a national reference panel for SARS-CoV-2 antigen detection.The stability and homogeneity of the reference panel were evaluated.Based on World Health Organization(WHO)guidance and nucleic acid quantitative results,a quality standard reference panel was established.Currently,three generations of SARS-CoV-2 antigen national reference materials with batch numbers 370095–202001,370095–202202,and 370095–202203 have been successfully established.These national reference panels comprised 8 positive samples,20 negative samples,1 repetitive sample,and 1 lower detection limit sample.The stability and homogeneity of the reference panel meet the requirements.The quality standards are as follows:the positive and negative coincidence rates are 8/8 and 20/20,respectively.The 10 test results of the medium and low-concentration repetitive reference materials should be positive,and the color rendering should be uniform(or the coefficient of variance should not be higher than 20.0%).The lower detection limit should be at least 5×105 U/mL(equivalent to copies/mL),and higher concentrations above the lower detection limit must be positive.A national reference panel for the SARS-CoV-2 antigen detection kit has been established.As the standard of SARS-CoV-2 antigen reagents,the reference panel has played a crucial role in the pre-marketing quality evaluation and post-marketing quality supervision in China.展开更多
文摘Objective: The objective of the study is to verify the clinical validity of the following kits with the comparative experimental analysis and evaluate whether their performance can meet the clinical requirements, i.e. Class III in vitro diagnostic reagent “Herpes Simplex Virus (HSV) Type II Nucleic Acid Detection Kit (PCR-Fluorescence Probe Method)” of Daan Gene Co., Ltd. (Daan kit for short) and “Herpes Simplex Virus (HSV) Type II Nucleic Acid Detection Kit (Fluorescence PCR Method)” of Wuhan Biot Gene Co., Ltd. (Biot kit for short). Method: In the study process, the samples were divided into positive and negative groups according to the control test results, and the clinical application performance of Daan kit and Biot kit was evaluated by comparing their test results. Results: The results show that two kits indicate the same test results, i.e. 26 positive and 107 negative samples in a total of 133 male urethral discharge samples, and 32 positive and 238 negative samples in a total of 270 female cervical secretion samples. Conclusion: It can be concluded from the clinical test that Daan and Biot Herpes Simplex Virus (HSV) Type II Nuc- leic Acid Test Kits are reliable, accurate, safe, convenient for use, stable and high-value in the clinical application.
基金supported by the National Key Program for Infectious Disease of China(2018ZX10101002)the National Key Research and Development Program of China(2016YFD0500301,2020YFC0840900)。
文摘The on-going global pandemic of coronavirus disease 2019(COVID-19)caused by a novel coronavirus called severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)has been underway for about 11 months.Through November 20,2020,51 detection kits for SARS-CoV-2 nucleic acids(24 kits),antibodies(25 kits),or antigens(2 kits)have been approved by the National Medical Products Administration of China(NMPA).Convenient and reliable SARS-CoV-2 detection assays are urgently needed worldwide for strategic control of the pandemic.In this review,the detection kits approved in China are summarised and the three types of tests,namely nucleic acid,serological and antigen detection,which are available for the detection of COVID-19 are discussed in detail.The development of novel detection kits will lay the foundation for the control and prevention of the COVID-19 pandemic globally.
基金supported by the National Key Research and Development Program of China (2021YFC2400904)the National Science and Technology Major Project of China (2018ZX10102001).
文摘To develop a national reference panel for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)antigen detection kit and establish a quality standard.The cultures of SARS-CoV-2 and other pathogens were collected to establish a national reference panel for SARS-CoV-2 antigen detection.The stability and homogeneity of the reference panel were evaluated.Based on World Health Organization(WHO)guidance and nucleic acid quantitative results,a quality standard reference panel was established.Currently,three generations of SARS-CoV-2 antigen national reference materials with batch numbers 370095–202001,370095–202202,and 370095–202203 have been successfully established.These national reference panels comprised 8 positive samples,20 negative samples,1 repetitive sample,and 1 lower detection limit sample.The stability and homogeneity of the reference panel meet the requirements.The quality standards are as follows:the positive and negative coincidence rates are 8/8 and 20/20,respectively.The 10 test results of the medium and low-concentration repetitive reference materials should be positive,and the color rendering should be uniform(or the coefficient of variance should not be higher than 20.0%).The lower detection limit should be at least 5×105 U/mL(equivalent to copies/mL),and higher concentrations above the lower detection limit must be positive.A national reference panel for the SARS-CoV-2 antigen detection kit has been established.As the standard of SARS-CoV-2 antigen reagents,the reference panel has played a crucial role in the pre-marketing quality evaluation and post-marketing quality supervision in China.
