SARS-CoV-2 IgM IgG Antibody Rapid Assay kit by Colloidal Gold Method

Product catalog summary

Company Overview
Beijing Origingene-tech Biotechnology Co., Ltd., established in July 2018 with a registered capital of 20 million yuan, is a high-tech company that integrates research and development, production, sales, and service. The company has developed a first-class platform for in vitro diagnosis registration and industrial transformation in China. Located in Beijing Zhong Guan Cun Science Park, the company has a total construction area of 2000 square meters, with a production workshop of about 1000 square meters built according to medical equipment production quality standards. It includes two production lines for molecular and immune diagnostic products, with an annual output capacity of 10 million diagnostic reagents.

Facilities and Capabilities
The company's R&D and quality testing laboratories are designed according to PCR lab standards, featuring separate rooms for reagent preparation, sample handling, PCR amplification, and product analysis. Each room is equipped with buffer rooms and independent ventilation systems. The company boasts a professional R&D team, advanced equipment, and automated production lines. It collaborates with domestic and international universities and research institutions, integrating expertise in genetics, immunology, optics, electrochemistry, microfluidics, and biological instruments to develop new products.

Product Specifications
The SARS-CoV-2 IgM/IgG Antibody Rapid Assay Kit uses chromatographic immunoassay technology for the qualitative detection of SARS-CoV-2 IgM/IgG in blood. It is packaged in sets of 10 tests per box, with 54 boxes per carton. Each test includes an alcohol pad, disposable blood collection needle, medicine dropper, colloidal gold test paper card, and diluent dropper.

Advantages
The test is fast, providing results in 15 minutes, convenient as it requires no instruments, highly sensitive by detecting both IgM and IgG, and highly specific with no cross-reaction with common pathogens.

Clinical Performance
The clinical sensitivity of the test is 91% (95% CI: 86.06% - 96.60%), and the clinical specificity is 99% (95% CI: 98.0% - 99.7%). The positive predictive value is 93%, and the negative predictive value is 98%. No cross-reactivity was observed with common pathogens such as SARS virus, coronavirus OC43, influenza viruses, adenovirus, Staphylococcus aureus, or Klebsiella pneumoniae.

Interference and Certification
Potential interfering substances such as α-lnterferon, Zanamivir, Ribavirin, and others do not affect the test results. The SARS-CoV-2 IgM/IgG test kit has received CE certification.

Catalog excerpts

SARS-CoV-2 IgM IgG Antibody Rapid Assay kit by Colloidal Gold Method-1

5* * * «■ 8rl!i3W«lgM/lgG ISiMiSKRI^ (Kttfe'S) SARS-CoV-2 IgM/IgG Antibody Rapid Assay Kit by Colloidal Gold Method

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SARS-CoV-2 IgM IgG Antibody Rapid Assay kit by Colloidal Gold Method-2

BEIJING ORIGINGENE-TECH BIOTECHNOLOGY CO.,LTD.

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SARS-CoV-2 IgM IgG Antibody Rapid Assay kit by Colloidal Gold Method-3

Packing Information Intended Use&Advantages mmutt Qualification Certificate

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SARS-CoV-2 IgM IgG Antibody Rapid Assay kit by Colloidal Gold Method-4

北京源景泰科生物科技有限公司成立于2018年7月，注册资本2000万元,是集研发、生产、销售及服务为一体的高科技公司，搭建了中国一流的体外诊断注册和产业转化平台。公司位于北京市中关村科技园区通州园联东U谷，总建筑面积2000平方米，按照《医疗器械生产质量管理规范》及《医疗器械生产质量管理规范附录体外诊断试剂》要求建设了约 1000平方米生产厂房,其中十

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SARS-CoV-2 IgM IgG Antibody Rapid Assay kit by Colloidal Gold Method-5

Founded in July 2018 with a registered capitalof 20 million yuan, Beijing Origingene-tech biotechnology co., ltd. is ahigh-tech company integrating R&D, production, sales and service, and hasbuilt a first-class in vitro diagnosis registration and industrialtransformation platform in China. Company is located in Beijing Zhong Guan Cun science park, tongzhou Lian Dong U Gu, a total construction area of 2000 squaremeters, according to the 《medical equipment production and the quality control standard》" and " 《medical equipment production and the quality control standard for theappendix in vitro...

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SARS-CoV-2 IgM IgG Antibody Rapid Assay kit by Colloidal Gold Method-6

BEIJING ORIGINGENE-TECH BIOTECHNOLOGY CO.,LTD. SARS-CoV-2 IgM/IgG Antibody Rapid Assay Kit by Colloidal Gold Method 10 packed in 10 sets 152g / pack (^) 183 X 116 X 70(mm) 54packs in 1 carton box 9.5kg / box (ffi) 705 X 445 X 505 (mm)

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SARS-CoV-2 IgM IgG Antibody Rapid Assay kit by Colloidal Gold Method-7

单人份测试包含酒精棉片 Alcohol pad 一次性使用采血针头 Disposable blood collection needle 滴管 medicine dropper 胶体金试纸卡

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SARS-CoV-2 IgM IgG Antibody Rapid Assay kit by Colloidal Gold Method-8

用途源景泰科生产的新型冠状病毒（SARSCoV-2）IgM/IgG抗体快速检测试剂盒使用免疫层析技术同时检测患者全血中的新型冠状病毒IgM/IgG. The SARS-CoV-2IgM/IgG Antibody Rapid Assay Kit is a chromato

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SARS-CoV-2 IgM IgG Antibody Rapid Assay kit by Colloidal Gold Method-9

优点快速，仅需15分钟判读结果； Fast, read the result in 15 minutes only. 简便，无需设备； Convenient, no instrument needed. 高敏，同时检测IgM和IgG; High sensitivity, IgM and IgG joineddetection. 特异，与常见病原体无交叉反应。 Hi

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SARS-CoV-2 IgM IgG Antibody Rapid Assay kit by Colloidal Gold Method-10

BEIJING ORIGINGENE-TECH BIOTECHNOLOGY CO.,LTD. Reactivity and cross reactivity 与SARS病毒、冠状病毒OC43、冠状病毒HKU1、流感病毒 A型、流感病毒B型、腺病毒、金黄色葡萄球菌、肺炎克雷伯菌等常见病原体无交叉。 The cross-reactivitywas evaluated using specimen samples known to co

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SARS-CoV-2 IgM IgG Antibody Rapid Assay kit by Colloidal Gold Method-11

Possible interfering substances 临床样本中可能存在的α-lnterferon、Zanamivir、Ribavirin、 Oseltamivir、Peramivit、Lopinavir、Lopinavir、Lopinavir、Arbidol、 Levofloxacin、Azithromycin、Cefatriaxone、Meropenem、 Tobramycin、Histamine Dihydrochloride、Phenylephrine、 Oxymetazoline、Beclomethasone、Dexamethasone、Flunisolide、 Triamcinolone acetonide、Budesonide、Mometasone、 Fluticasone等物质对本试剂盒检测无干扰。 Some substances in clinicalsamples don’t interfere with the kit， including α-lnterferon、Zanamivir、Ribavirin、Oseltamivir、 Peramivit、Lopinavir、Lopinavir、Lopinavir、Arbidol、 Levofloxacin、Azithromycin、Cefatriaxone、Meropenem、 Tobramycin、Histamine...

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