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Novel coronavirus (2019-nCoV) nucleic acid detection kit (isothermal amplification method) clinical trial
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注册号:

Registration number:

ChiCTR2200060065 

最近更新日期:

Date of Last Refreshed on:

2022-05-20 

注册时间:

Date of Registration:

2022-05-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新型冠状病毒(2019-nCoV)核酸检测试剂盒(恒温扩增法)临床试验 

Public title:

Novel coronavirus (2019-nCoV) nucleic acid detection kit (isothermal amplification method) clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新型冠状病毒(2019-nCoV)核酸检测试剂盒(恒温扩增法)临床试验 

Scientific title:

Novel coronavirus (2019-nCoV) nucleic acid detection kit (isothermal amplification method) clinical trial 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

陈英 

研究负责人:

李为民 

Applicant:

Chenying 

Study leader:

Liweimin 

申请注册联系人电话:

Applicant telephone:

028-85422851 

研究负责人电话:

Study leader's telephone:

18980601009 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

hxlcyjglb@163.com 

研究负责人电子邮件:

Study leader's E-mail:

weimi003@yahoo.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

四川大学华西医院 

研究负责人通讯地址:

四川大学华西医院 

Applicant address:

#37 Guoxue Alley, Wuhou District, Chengdu, Sichuan Province, P.R.China  

Study leader's address:

#37 Guoxue Alley, Wuhou District, Chengdu, Sichuan Province, P.R.China  

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

四川大学华西医院 

Applicant's institution:

#37 Guoxue Alley, Wuhou District, Chengdu, Sichuan Province, P.R.China  

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2022年临床试验(器械)审42号 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

四川大学华西医院临床试验伦理审查委员会 

Name of the ethic committee:

Ethics Committee on Clinical Trial, West China Hospital of Sichuan University  

伦理委员会批准日期:

Date of approved by ethic committee:

2022-05-16 

伦理委员会联系人:

左泽锦 

Contact Name of the ethic committee:

zuozejin 

伦理委员会联系地址:

四川省成都市武侯区国学巷37号老八教412  

Contact Address of the ethic committee:

#37 Guoxue Alley, Wuhou District, Chengdu, Sichuan Province, P.R.China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

四川大学华西医院 

Primary sponsor:

Chengdu, Sichuan Province, P.R.China 

研究实施负责(组长)单位地址:

四川省成都市武侯区国学巷37号 

Primary sponsor's address:

#37 Guoxue Alley, Wuhou District, Chengdu, Sichuan Province, P.R.China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川省

市(区县):

成都市

Country:

CHINA

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

四川省成都市武侯区国学巷37号

Institution
hospital:

West China Hospital of Sichuan University

Address:

#37 Guoxue Alley, Wuhou District, Chengdu, Sichuan Province, P.R.China

国家:

中国

省(直辖市):

四川省

市(区县):

成都市

Country:

CHINA

Province:

Sichuan

City:

Chengdu

单位(医院):

成都万众壹芯生物科技有限公司

具体地址:

四川省成都市高新区科园南路88号7栋5层501号

Institution
hospital:

Chengdu One-chip Biotechnology Co., Ltd.

Address:

No. 501, 5th Floor, Building 7, No. 88, Keyuan South Road, High-tech Zone, Chengdu, Sichuan Province

经费或物资来源:

成都万众壹芯生物科技有限公司 

Source(s) of funding:

Chengdu One-chip Biotechnology Co., Ltd. 

研究疾病:

2019-nCoV 

Target disease:

2019-nCoV 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

诊断试验新技术临床试验 

Study phase:

Diagnostic New Technique Clincal Study 

研究目的:

本次通过采用考核试剂与已上市新型冠状病毒(2019-nCoV)核酸检测试剂盒(荧光PCR法)的检测结果进行比较研究,并比较专业人员及非专业人员使用考核试剂对疑似患者的检测结果,同时针对非专业人员进行可用性评价及结果判读评价,以确定试剂盒是否能满足预期用途。 

Objectives of Study:

A comparative study was carried out using the assessment reagents and the test results of the marketed new coronavirus (2019-nCoV) nucleic acid detection kit (fluorescent PCR method), and the detection results of suspected patients using assessment reagents by professionals and non-professionals were compared. Non-professionals conduct usability evaluation and result interpretation evaluation to determine whether the kit is suitable for the intended use. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

诊断试验诊断准确性 

Study design:

Diagnostic test for accuracy 

纳入标准:

a.年龄:不限; b.性别:不限; c.具有可溯源临床诊断背景、性别、年龄等病例信息; d.新型冠状病毒肺炎疑似患者; e. 受试者必须在试验前对本研究知情同意,并自愿或由其监护人签署了书面的知情同意书。 

Inclusion criteria

a. Age: no limit; b. Gender: no limit; c. With traceable clinical diagnosis background, gender, age and other case information; d. Suspected patients with novel coronavirus pneumonia; e. Subjects must give informed consent to this study before the trial, and voluntarily or signed a written informed consent form by their guardian. 

排除标准:

a.病例信息(性别、年龄、临床诊断背景信息和其他人口学资料等)不完整; b.样本保存条件不符合说明书要求; c.样本疑似被污染; d.研究者认为受试者存在任何不宜参加此试验的其它因素。 

Exclusion criteria:

a. Incomplete case information (sex, age, background information on clinical diagnosis and other demographic data, etc.); b. The storage conditions of the samples do not meet the requirements of the instructions; c. The sample is suspected to be contaminated; d. The investigators considered that the subjects had any other factors that made them inappropriate to participate in this trial. 

研究实施时间:

Study execute time:

From2022-05-16To 2022-12-31 

征募观察对象时间:

Recruiting time:

From2022-05-16To 2022-12-31 

诊断措施:

Diagnostic measures:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

荧光PCR法

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

fluorescent PCR

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

新型冠状病毒(2019-nCoV)核酸检测试剂盒(恒温扩增法)

Index test:

Novel coronavirus (2019-nCoV) nucleic acid detection kit (isothermal amplification method).

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

新冠疑似病例

例数:

Sample size:

500

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Suspected cases of 2019-nCoV

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川省 

市(区县):

成都市 

Country:

CHINA 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川大学华西医院 

单位级别:

三甲医院 

Institution
hospital:

West China Hospital of Sichuan University  

Level of the institution:

Grade III Class A hospital  

国家:

中国 

省(直辖市):

四川省 

市(区县):

广安市 

Country:

CHINA 

Province:

Sichuan 

City:

Guang‘’an 

单位(医院):

广安市人民医院 

单位级别:

三甲医院 

Institution
hospital:

Guang'an Peoples Hospital  

Level of the institution:

Grade III Class A hospital 

国家:

中国 

省(直辖市):

四川省 

市(区县):

成都市 

Country:

CHINA 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

成都市公共卫生临床医疗中心 

单位级别:

三甲医院 

Institution
hospital:

Public Health Clinical Center of Chengdu  

Level of the institution:

Grade III Class A hospital 

国家:

中国 

省(直辖市):

上海市 

市(区县):

 

Country:

CHINA 

Province:

Shanghai 

City:

 

单位(医院):

上海市公共卫生临床中心 

单位级别:

三甲医院 

Institution
hospital:

Public Health Clinical Center of Shanghai  

Level of the institution:

Grade III Class A hospital 

国家:

中国 

省(直辖市):

四川省 

市(区县):

成都市 

Country:

CHINA 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

核工业四一六医院 

单位级别:

三甲医院 

Institution
hospital:

Nuclear Industry 416 Hospital  

Level of the institution:

Grade III Class A hospita 

测量指标:

Outcomes:

指标中文名:

新型冠状病毒检测结果

指标类型:

主要指标 

Outcome:

2019-nCoV test results

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

阳性符合率

指标类型:

主要指标 

Outcome:

PPA

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

阴性符合率

指标类型:

主要指标 

Outcome:

NPA

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总符合率

指标类型:

主要指标 

Outcome:

OPA

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Kappa

指标类型:

主要指标 

Outcome:

Kappa

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

鼻或咽拭子

组织:

Sample Name:

nasal or throat swab

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 0 years
最大 Max age 100 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

不适用

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

Blinding:

是否共享原始数据:

IPD sharing

No

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

no

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

病历

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

medical records

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2022-05-16
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