Interpretation of guidance for establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of high-risk human papillomaviruses issued by Food and Drug Administration of United States and China

R. M. Feng; W. Chen; Y. L. Qiao

doi:10.3760/cma.j.issn.0253-3766.2017.07.016

Interpretation of guidance for establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of high-risk human papillomaviruses issued by Food and Drug Administration of United States and China

R. M. Feng
, W. Chen
, Y. L. Qiao

Research output: Contribution to journal › Article › peer-review

2 Citations (Scopus)

Abstract

为促进人乳头瘤病毒(HPV)检测试剂盒临床功能验证设计的规范化，中国国家食品药品监督管理总局(CFDA)和美国国家食品药品监督管理总局(FDA)分别针对HPV检测试剂盒核酸检测的准确性验证和临床功能，包括不明意义非典型鳞状细胞(ASC－US)人群分流、联合筛查和初筛的有效性验证方面，从临床试验设计或评价等方面推荐了较为详细的指导原则。中美两国指导原则在研究设计、研究对象、样本量估计和统计分析等关键点的要求略有差异，但评价指标类似。按照CFDA指导原则要求，可采用横断面研究设计代替FDA建议的前瞻性设计进行ASC－US人群分流用途的验证；同时采用前瞻性研究设计，对同一个自然人群进行拟申报产品HPV和细胞学平行检测，通过至少3年细胞学随访，对初筛和联合筛查进行拟申报产品的临床有效性验证。.

Original language	English
Pages (from-to)	553-557
Number of pages	5
Journal	Zhonghua zhong liu za zhi [Chinese journal of oncology]
Volume	39
Issue number	7
DOIs	https://doi.org/10.3760/cma.j.issn.0253-3766.2017.07.016
Publication status	Published - 23 Jul 2017
Externally published	Yes

Keywords

Clinical performance evaluation
Evaluation of nucleic acid detection
Guidline
Human papillomavirus

Access to Document

10.3760/cma.j.issn.0253-3766.2017.07.016

Fingerprint

Dive into the research topics of 'Interpretation of guidance for establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of high-risk human papillomaviruses issued by Food and Drug Administration of United States and China'. Together they form a unique fingerprint.

Cite this

Feng, R. M., Chen, W., & Qiao, Y. L. (2017). Interpretation of guidance for establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of high-risk human papillomaviruses issued by Food and Drug Administration of United States and China. Zhonghua zhong liu za zhi [Chinese journal of oncology], 39(7), 553-557. https://doi.org/10.3760/cma.j.issn.0253-3766.2017.07.016

Feng, R. M. ; Chen, W. ; Qiao, Y. L. / Interpretation of guidance for establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of high-risk human papillomaviruses issued by Food and Drug Administration of United States and China. In: Zhonghua zhong liu za zhi [Chinese journal of oncology]. 2017 ; Vol. 39, No. 7. pp. 553-557.

@article{9cdb97fca761410e9fc3fe67ef4c5f89,

title = "Interpretation of guidance for establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of high-risk human papillomaviruses issued by Food and Drug Administration of United States and China",

abstract = "为促进人乳头瘤病毒(HPV)检测试剂盒临床功能验证设计的规范化，中国国家食品药品监督管理总局(CFDA)和美国国家食品药品监督管理总局(FDA)分别针对HPV检测试剂盒核酸检测的准确性验证和临床功能，包括不明意义非典型鳞状细胞(ASC－US)人群分流、联合筛查和初筛的有效性验证方面，从临床试验设计或评价等方面推荐了较为详细的指导原则。中美两国指导原则在研究设计、研究对象、样本量估计和统计分析等关键点的要求略有差异，但评价指标类似。按照CFDA指导原则要求，可采用横断面研究设计代替FDA建议的前瞻性设计进行ASC－US人群分流用途的验证；同时采用前瞻性研究设计，对同一个自然人群进行拟申报产品HPV和细胞学平行检测，通过至少3年细胞学随访，对初筛和联合筛查进行拟申报产品的临床有效性验证。.",

keywords = "Clinical performance evaluation, Evaluation of nucleic acid detection, Guidline, Human papillomavirus",

author = "Feng, \{R. M.\} and W. Chen and Qiao, \{Y. L.\}",

year = "2017",

month = jul,

day = "23",

doi = "10.3760/cma.j.issn.0253-3766.2017.07.016",

language = "English",

volume = "39",

pages = "553--557",

journal = "Zhonghua zhong liu za zhi [Chinese journal of oncology]",

issn = "0253-3766",

publisher = "Chinese Medical Journals Publishing House Co.Ltd",

number = "7",

}

Feng, RM, Chen, W & Qiao, YL 2017, 'Interpretation of guidance for establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of high-risk human papillomaviruses issued by Food and Drug Administration of United States and China', Zhonghua zhong liu za zhi [Chinese journal of oncology], vol. 39, no. 7, pp. 553-557. https://doi.org/10.3760/cma.j.issn.0253-3766.2017.07.016

Interpretation of guidance for establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of high-risk human papillomaviruses issued by Food and Drug Administration of United States and China. / Feng, R. M.; Chen, W.; Qiao, Y. L.
In: Zhonghua zhong liu za zhi [Chinese journal of oncology], Vol. 39, No. 7, 23.07.2017, p. 553-557.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Interpretation of guidance for establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of high-risk human papillomaviruses issued by Food and Drug Administration of United States and China

AU - Feng, R. M.

AU - Chen, W.

AU - Qiao, Y. L.

PY - 2017/7/23

Y1 - 2017/7/23

N2 - 为促进人乳头瘤病毒(HPV)检测试剂盒临床功能验证设计的规范化，中国国家食品药品监督管理总局(CFDA)和美国国家食品药品监督管理总局(FDA)分别针对HPV检测试剂盒核酸检测的准确性验证和临床功能，包括不明意义非典型鳞状细胞(ASC－US)人群分流、联合筛查和初筛的有效性验证方面，从临床试验设计或评价等方面推荐了较为详细的指导原则。中美两国指导原则在研究设计、研究对象、样本量估计和统计分析等关键点的要求略有差异，但评价指标类似。按照CFDA指导原则要求，可采用横断面研究设计代替FDA建议的前瞻性设计进行ASC－US人群分流用途的验证；同时采用前瞻性研究设计，对同一个自然人群进行拟申报产品HPV和细胞学平行检测，通过至少3年细胞学随访，对初筛和联合筛查进行拟申报产品的临床有效性验证。.

AB - 为促进人乳头瘤病毒(HPV)检测试剂盒临床功能验证设计的规范化，中国国家食品药品监督管理总局(CFDA)和美国国家食品药品监督管理总局(FDA)分别针对HPV检测试剂盒核酸检测的准确性验证和临床功能，包括不明意义非典型鳞状细胞(ASC－US)人群分流、联合筛查和初筛的有效性验证方面，从临床试验设计或评价等方面推荐了较为详细的指导原则。中美两国指导原则在研究设计、研究对象、样本量估计和统计分析等关键点的要求略有差异，但评价指标类似。按照CFDA指导原则要求，可采用横断面研究设计代替FDA建议的前瞻性设计进行ASC－US人群分流用途的验证；同时采用前瞻性研究设计，对同一个自然人群进行拟申报产品HPV和细胞学平行检测，通过至少3年细胞学随访，对初筛和联合筛查进行拟申报产品的临床有效性验证。.

KW - Clinical performance evaluation

KW - Evaluation of nucleic acid detection

KW - Guidline

KW - Human papillomavirus

UR - https://www.scopus.com/pages/publications/85056507285

U2 - 10.3760/cma.j.issn.0253-3766.2017.07.016

DO - 10.3760/cma.j.issn.0253-3766.2017.07.016

M3 - Article

C2 - 28728306

AN - SCOPUS:85056507285

SN - 0253-3766

VL - 39

SP - 553

EP - 557

JO - Zhonghua zhong liu za zhi [Chinese journal of oncology]

JF - Zhonghua zhong liu za zhi [Chinese journal of oncology]

IS - 7

ER -

Feng RM, Chen W, Qiao YL. Interpretation of guidance for establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of high-risk human papillomaviruses issued by Food and Drug Administration of United States and China. Zhonghua zhong liu za zhi [Chinese journal of oncology]. 2017 Jul 23;39(7):553-557. doi: 10.3760/cma.j.issn.0253-3766.2017.07.016

Interpretation of guidance for establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of high-risk human papillomaviruses issued by Food and Drug Administration of United States and China

Abstract

Keywords

Access to Document

Other files and links

Fingerprint

Cite this