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Bioteke 4 In 1 COVID-19, Flu A+B, RSV Antigen Rapid Test Kit

  • COVID-19, Flu A&B, RSV combo test
  • Nasal swab samples
  • IVD CE Approved
  • For professional use
  • Wholesale supply
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  • ICA2114-8

  • Bioteke

Bioteke 4 In 1 COVID-19, Flu A+B, RSV Antigen Rapid Test Kit



Commercial Name: Multiple Respiratory Multipathogen Antigen Test Kit(Immunochromatographic Assay)



Intended Use


       This Bioteke 4 In 1 COVID-19, Flu A+B, RSV Antigen Rapid Test Kit is only used for the in vitro qualitative detection of COVID-19, Flu A+B, RSV from human anterior nasal swab specimens. 

       The kit is suitable for the auxiliary diagnosis of respiratory diseases, the results are for clinical reference only and cannot be used as the sole basis for diagnosis and exclusion decision. 

       This kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures.


Test Principle

       The Bioteke 4 In 1 COVID-19, Flu A+B, RSV Antigen Rapid Test Kit is immunochromatographic and uses double-antibody sandwich method to detect Influenza A virus/Influenza B virus /SARS-CoV-2/Respiratory syncytial virus antigen.

       During detection, the treated specimens are loaded into the sample wells of the test card. When the concentration of Influenza A virus/Influenza B virus/SARS-CoV-2/Respiratory syncytial virus antigen in specimen is higher than the minimum detection limit, the viral antigen will form complexes with labeled antibodies first. 

       Underchromatography, the complexes move forward along the nitrocellulose membrane till captured by precoated monoclonal antibody of Influenza A virus/Influenza B virus/SARS-CoV-2/Respiratory syncytial virus in detection zone on nitrocellulose film to form a red or blue reaction line on the detection zone, at this point the result is positive; Conversely, if there is no viral antigen or the concentration of antigen in specimen is below the minimum detection limit, no red/blue reaction line appears in the detection zone, at this point the result is negative.

       Regardless of whether the sample contains viral antigens or not, a dark blue reaction line will appear in the quality control zone (C), the dark blue reaction line that appears in the quality control zone (C) is the criterion for determining if the chromatography process is normal.


Specification
Components
Loading Quantity
1 test/kit
2 tests/kit 5 tests/kit 20 tests/kit 50 tests/kit
Test card 1pc
2pcs 5pcs 20pcs 50pcs
Samples extraction tube
1pc
2pcs 5pcs 20pcs 50pcs
Tube cap
1pc 2pcs 5pcs 20pcs 50pcs
Nasal swab 1pc 2pcs 5pcs 20pcs 50pcs
Waste bag 1pc 2pcs 5pcs 20pcs 50pcs

Note:

  1. The kits should be stored at 2~30℃.

  2. Valid for 24 months(After the QC passed).

  3. The test card should be used within 1 hour after opening the foil pouch.

  4. The swab samples should be tested immediately after collection.


Performance
  • Sensitivity 95%

  • Specificity 100%

  • Total coincidence rate 99%

There is no cross-reactivity with the following 50 types pathogens(Please refer to the user manual).



Qualifications

Product qualifications(By Dec.2nd,2022)

Multiple Respiratory multipathogen antigen test kit

 (immunochromatographic assay)

呼吸道多重病原体抗原检测试剂盒(乳胶微球免疫层析法)
CE Certification – CIBG Registration Letter CE 证书-CIBG 注册信
CE Certification –CIBG Registration Prove CE 证书-CIBG 网站注册证明
CE Certification–EC Declaration of Conformity CE 证书-EC 符合性声明
Export Qualified Suppliers 商务部出口白名单
Free sale certificate-Malaysia 自由销售证明-马来西亚
Free sale certificate-Mexico 自由销售证明-墨西哥
Free sale certificate-Indonesia 自由销售证明-印尼
Free sale certificate-Sri Lanka 自由销售证明-斯里兰卡
Free sale certificate-United Arab Emirates 自由销售证明-阿联酋
ISO 13485 Certificate ISO 13485 证书
ISO 9001 Certificate ISO 9001 证书
ISO 45001 Certificate ISO 45001职业健康安全管理体系认证证书
ISO 14001 Certificate ISO 14001环境管理体系认证证书
IPMS Certificate 知识产权管理体系认证证书


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