万 泰生物技术      http://testkit.bz/in       by: Vic       6-2020
**北京万泰:  生产  "胶体金产品"(rapid test)...北京总部生产并销售。(WanTai-Beijing)
                      胶体金(rapid test),北京万泰是在出口白名单上, 出口没有问题。
**厦门万泰:  生产  "发光产品",  厦门万泰是北京万泰的子公司
(Innodx-Xiamen)

电话:+86-592-680 7333 传 真:+86-592-680 7377 邮 箱:service@innodx.com    400- 650 5969    DownLoad::  ARTG   CE   CO   ISO9   ISO1   BECA


Leading the Way in Infectious Disease Diagnostics

We are committed to providing innovative solutions for diagnosing infectious diseases and aim to increase the availability of high-quality vaccines in order to combat infectious diseases globally. We have developed ELISA and PCR kits, and rapid tests for infectious diseases including Hepatitis E – a disease we are committed to combat using Hecolin®, the world’s first vaccine for Hepatitis E, developed by our subsidiary Innovax.

Along with the spreading global pandemic of COVID-19, countries around the world have been struggling to diagnose and control this disease in time.
Xiamen University and Wantai have jointly developed innovative, highly sensitive and specific serological and molecular assays for testing of Covid-19.


厦门万泰凯瑞生物技术有限公司,是万泰生物药业股份有限公司的全资子公司,专注于全自动管式化学发光免疫诊断试剂生物活性 原料的研发、
生产和销售。万泰凯瑞以“科学为本,关注健康”为理念,致力于将生物技术成果转化为优质产品服务于社会大众。现有员工总人数近200人。 

《全 省首个新冠病毒抗体检测试剂盒上市!29分钟出结果!产自海沧!》
               2020-03-07 15:37 来源:澎湃新闻·澎湃号·政务

由海沧生物医药基地的   厦门万泰凯瑞生物技术有限公司    与厦大共同研制的
福建省首个新冠病毒抗体 检测试剂盒    已于昨天(3月6日)获批上市啦!

国内外首个获批的  双抗原夹心法 总抗体检测试剂    通过抽血来检测
29分钟就能出结果!新型冠状病毒(2019-nCoV)抗体检测试剂盒   (化学发光微粒子免疫检测法)通过纳米顺磁颗粒与化学发光结合的免疫分析技术。

采用双抗原夹心原理,配套全自动化学发光仪,通过检测化学发光反应信号,定性检测人血清或血浆中新型冠状病毒(2019-nCoV)抗体。

***抗体检测与核酸检测的区别就是:

*核酸检测
直接检测病毒,对于样品采集要求很高,如果未能获得满意的下呼吸道标 本,用通常的鼻咽拭子标本进行检测的灵敏度不够高。
对于设施、技术等要求比较高,例如,检验员要穿密不透风的防护服,对着病毒进行数个小时的病原检测,熟练的检验人员一天的检测量只有300-400人份。
工作人员将采集的标本装进全自动化设备进行批量抗体检测。

*抗体检测
检测人体血液中感染病毒后产生的特异性免疫反应产物(抗体),采用一般的血清或血浆标本(可以通过抽血来检测),
而且可以29分钟检测出结果,每小时可以检测200人份。
总体来说    这款抗体检测试剂盒具有       灵敏度高、特异性好、    随到随检、全自动高通量等优点

抗体检测可以取代核酸检测呢?   答案是 :NO
近期很多地方开始实行复工复产的行动,我建议复工人员在上班之前必须要接受一次双检测:核酸的检测   和  IgM(抗体)检测,
这两个检测结果能证明没有被感染,可以正常参与工作。

** 钟南山
二者因为检测原理不同    实际上是一种有效互补的关系

来听听万泰凯瑞研发部经理    宋浏伟博士是怎么说的吧:
对于来自高危国家或地区的   入境人员、高流行区复工复学的人群等

联合核酸和抗体检测   可以提高带毒者的发现率   以及时进行隔离观察   减少社会传播风险

月产能超过100万人份   据万泰凯瑞总经理孙旭东介 绍   该产品的研发从1月15日启动   历时49天获批上市      目前月产能超过100万人份

我们与厦大此次合作研发这款产品,从研发、申报到上市,在这么短时间内就完成了。要感谢国家科技部应急攻关项目、
省科技厅、省药监局、厦门稽查办、厦门市市场监督管理局、厦门市科技局以及海沧区等政府部门的大力支持!

此前,该团队研制的这种新冠系列检测试剂,已向武汉同济医院、武汉协和医院、火神山医院、雷神山医院、湖北省疾控中心、
中南医院、仙桃市人民医院、深圳三院和浙大附一院等医院捐赠近9万人份,用于临床试用和临床评价。

厦门万泰凯瑞生物技术有限公司(innoDx),是万泰生物药业股份有限公司的全资子公司,
目前已建立拥有自主知识产权的生物活性原料、吖啶酯化学发光检测技术及试剂等一系列科研平台,平台具有简单、快速、线性范围宽、灵敏度高等特点,
基于此研发的试剂各检测性能达到或优于国际主流公司的水平,是国内吖啶酯直接化学发光领先品牌。 

  万泰是最早进入白名单,  FDA Xiamen上,boson和我们都一样的,都是在出口白名单上 
目前出口了7百万人份, 所以我也不清楚哪些是bill gates的采购

万泰的传染病历史更长久,市场更广一些,产品质量我们是总抗,灵敏度更高
但是对于新冠产品我个人认为还是要选择质量好的,毕竟一旦扩散会不可控制












Along with the spreading global pandemic of Novel Coronavirus, countries around the world have been struggling to diagnose and control this disease in time. Xiamen University and Wantai have jointly developed a series of innovative, highly sensitive and specific serological and molecular assays for testing of Covid-19. Together our tests offer total testing solution for Covid-19 diagnosis with results in just 75-minutes. Download Wantai COVID-19 Diagnostics Test Introduction Brochure.

Wantai SARS-CoV-2 Diagnostic Kits:      SARS-CoV-2
1
Total Ab ELISA
1

SARS-CoV-2 Total Ab ELISA   Download Brochure

WANTAI SARS-CoV-2 Ab ELISA detects total antibody as indicative of an immune response to SARS-CoV-2 in patients suspected of previous SARS-CoV-2 infection, or for the detection of seroconversion in patients following known recent SARS-CoV-2 infection. The test may also be used to aid in the diagnosis of acute or past SARS-CoV-2 infection in conjunction with other tests and clinical information. The prevalence of SARS-CoV-2 infection in the area where testing has occurred should be considered when interpreting positive test results. The test should not be used as the sole basis for diagnosis.

Performance evaluations (click on the links to open each study report)

The kit detects TOTAL ANTIBODIES (IgG, IgM and IgA) against S1-RBD and it has been extensively evaluated and validated in Europe. In the Netherlands, Erasmus Medical Center showed sensitivity of 98% (100% >14days), Sanquin Blood Bank calculated PPV of 99%, 88%, and 72% in areas with prevalence of 4-10%, 2-4%, and <2% and the RIVM National Institute for Public Health reports sensitivity of 97.7% (>10 days) ~ 99.5% (>14 days) . Statens Serum Institut in Denmark showed sensitivity of 71% (7~13days) ~ 100% (10days) and the Medizinische Universität Wien in Austria calculated sensitivity of 92~100%. Over 98% agreement with automated immunoassays has been demonstrated during a study conducted by the University Hospital in Padova, Italy.

Very high specificity (>98%) has been shown in all clinical studies.

FIND results are expected soon.  

2
IgM ELISA
2
SARS-CoV-2 lgM ELISA

SARS-CoV-2 lgM ELISA    Download Brochure

Wantai SARS-CoV-2 lgM ELISA is an enzyme-linked immunosorbent assay for the qualitative detection of lgM-class antibodies to SARS-CoV-19 virus in human serum or plasma. It is intended for testing of patients suspected of recent infection with the SARS-CoV-2 virus. The test should not be used as the sole basis for diagnosis. The test is based on antibody-capture method.

Performance evaluations (click on the links to open each study report)

The Medizinische Universität Wien in Austria reported sensitivity of 92% (6 ~10days) to 100% after day 11 post disease onset, and 97% specificity of the kit.

FIND results are expected soon.

3
Rapid Test
3
SARS-CoV-2 Rapid Test

Rapid Test for Total Antibody to SARS-CoV-2 -   Click to Download Brochure

! IMPORTANT : THIS PRODUCT IS INTENDED FOR PROFESSIONAL USE ONLY, NOT FOR SELF-TESTING OR TESTING AT HOME !

WANTAI SARS-CoV-2 Ab Rapid Test is a 15minutes test that detects total antibody as indicative of an immune response to SARS-CoV-2 in patients suspected of previous SARS-CoV-2 infection, or for the detection of seroconversion in patients following known recent SARS-CoV-2 infection. The kit is based on double antigen "sandwich" method and it detects TOTAL ANTIBODIES against S1-RBD. The test may also be used to aid in the diagnosis of acute or past SARS-CoV-2 infection in conjunction with other tests and clinical information. The prevalence of SARS-CoV-2 infection in the area where testing has occurred should be considered when interpreting positive test results. The test should not be used as the sole basis for diagnosis.

Performance evaluations (click on the links to open each study report) :

In a limited validations, the RIVM National Institute for Public Health in the Netherlands, and the Ministry of Health in the Czech Republic both reported sensitivity and specificity of 100%. In Austria, the Medizinische Universität Wien calculated sensitivity of 80% (6-10days) and 100% (>11days) respectively, and the University of Innsbruck reported sensitivity of 95.7% (100% >14days) and specificity of 100%.

FIND and Doherty Institute evaluation results are expected soon.

View our how to operate video. Click Here >>>

4
RT-PCR
4
SARS-CoV-2 RT-PCR

SARS-CoV-2  RT-PCR

Wantai SARS-CoV-2  RT-PCR Kit is a Nucleic Acid Detection kit for the detection of Severe Acute Respiratory Syndrome Coronavirus (PCR – Fluorescence Probing).




<>Matthew  International Business Development Department
Beijing Wantai Biological Pharmacy Enterprise Co.,Ltd  
No.31 Kexueyuan Road, Changping District, Beijing 102206, China
<>T: +86-10-59528944 | F: +86-10-89705849 | M: +86-18401483975  WhatsApp: +86-18401483975<>E:  lvziqian@ystwt.com     W: www.ystwt.cn