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ICA2114-8
BioTeke
A. Product Name
Multiple Respiratory Multipathogen Antigen Test Kit (immunochromatagraphic assay)
B. Test Items
Sars-Cov-2/Covid-19
Influenza A/Flu A
Influenza B/Flu B
Respiratory Syncytial Virus/RSV
Bioteke 4 In 1 Test Kit
Components
Test Panel
C. Advantages
Superior performance and high accuracy.
The multi-color system is more conducive to the interpretation of inspector and can help reduce the chance of misjudgment.
Two-way chromatography, one sampling, multiple detections.Operators' detection steps will be simpler.
Automation degree is high, and the production efficiency is several times higher than that of other enterprises.
Lower cost.
The product form is flexible.Multiple inspections can be combined according to customers' requirements.
D. Operation Procedure
E. Interpretation of Results
【Positive】
SARS-CoV-2 positive:Two coloured lines appear in the RSV/COVID-19 test window.A dark blue/purple line is in the (C) section and a red line is in the (COMD-19) section.
Respiratory Syncytial virus(RSV) positive:Two coloured lines appear in the RSV/COVID-19 test window. A dark blue/purple line is in the (C) section and a blue line is in the (RSV) section.
InfluenzaA(Flu A) positive:Two coloured lines appears in the Flu A/Flu B test window. A dark blue/purple line is in the (C) section and a red line is in the (Flu A) section.
Influenza B(Flu B) positive:Two coloured lines appears in the Flu A/Flu B test window. A dark blue/purple line is in the (C) section and a blue line is in the (Flu B) section.
Multiple positive:Two coloured (C) lines appear in two separate windows. If the other line appears,the corresponding pathogen is positive.
Note: A positive result means that you are likely to be infected with COVD-19/Respiratory syncytial virus /influenza A/influenza B. Test results should always be considered in the context of clinical observations and epidemiological data when making final diagnoses and patient management decisions.
【Negative】
In the Influenza A virus/Influenza B virus /SARS-CoV-2/Respiratory syncytial virus detecion window,two dark blue/purple lines appear in the (C)section and no line appears in the detection area (flu B/flu A/COVD-19/RSV).It indicates that Influenza A virus,Influenza B virus,SARS-CoV-2 or Respiratory syncytial virus was not detected in the sample.However,a negative result does not exdude the absence of Influenza A virus,Influenza B virus, SARS-CoV-2,Respiratory syncytial virus infection and should not be used as the sole basis for treatment or patient management decisions.
Negative results should be considered in the context of the individuals recent exposure history,medical history and the presence of clinical signs and symptoms consistent with Influenza A virus,Infuenza B virus,SARS-CoV-2 and Respiratory syncytial virus,and confirmed by PCR test as necessary for patient management.
【Invalid】
If any of the control (C) lines do not appear,the test is considered invalid.
An invalid test result means that your test has encountered an error and the results cannot be interpreted.You will need to retest using a new test card.
F. Product Qualifications
| 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） | |
| EU HSC Common List | 欧盟抗原检测卡通用清单 |
| Malaysia Registration | 马来西亚注册 |
| 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 |
These antigen tests are included under “Category A” of the EU common list:
| Prospective clinical field study |
| Study in Poland.Sample size : 103 positive ,325 negative .Sensitivity:90.29% ; specificity:99.04% |
A. Product Name
Multiple Respiratory Multipathogen Antigen Test Kit (immunochromatagraphic assay)
B. Test Items
Sars-Cov-2/Covid-19
Influenza A/Flu A
Influenza B/Flu B
Respiratory Syncytial Virus/RSV
Bioteke 4 In 1 Test Kit
Components
Test Panel
C. Advantages
Superior performance and high accuracy.
The multi-color system is more conducive to the interpretation of inspector and can help reduce the chance of misjudgment.
Two-way chromatography, one sampling, multiple detections.Operators' detection steps will be simpler.
Automation degree is high, and the production efficiency is several times higher than that of other enterprises.
Lower cost.
The product form is flexible.Multiple inspections can be combined according to customers' requirements.
D. Operation Procedure
E. Interpretation of Results
【Positive】
SARS-CoV-2 positive:Two coloured lines appear in the RSV/COVID-19 test window.A dark blue/purple line is in the (C) section and a red line is in the (COMD-19) section.
Respiratory Syncytial virus(RSV) positive:Two coloured lines appear in the RSV/COVID-19 test window. A dark blue/purple line is in the (C) section and a blue line is in the (RSV) section.
InfluenzaA(Flu A) positive:Two coloured lines appears in the Flu A/Flu B test window. A dark blue/purple line is in the (C) section and a red line is in the (Flu A) section.
Influenza B(Flu B) positive:Two coloured lines appears in the Flu A/Flu B test window. A dark blue/purple line is in the (C) section and a blue line is in the (Flu B) section.
Multiple positive:Two coloured (C) lines appear in two separate windows. If the other line appears,the corresponding pathogen is positive.
Note: A positive result means that you are likely to be infected with COVD-19/Respiratory syncytial virus /influenza A/influenza B. Test results should always be considered in the context of clinical observations and epidemiological data when making final diagnoses and patient management decisions.
【Negative】
In the Influenza A virus/Influenza B virus /SARS-CoV-2/Respiratory syncytial virus detecion window,two dark blue/purple lines appear in the (C)section and no line appears in the detection area (flu B/flu A/COVD-19/RSV).It indicates that Influenza A virus,Influenza B virus,SARS-CoV-2 or Respiratory syncytial virus was not detected in the sample.However,a negative result does not exdude the absence of Influenza A virus,Influenza B virus, SARS-CoV-2,Respiratory syncytial virus infection and should not be used as the sole basis for treatment or patient management decisions.
Negative results should be considered in the context of the individuals recent exposure history,medical history and the presence of clinical signs and symptoms consistent with Influenza A virus,Infuenza B virus,SARS-CoV-2 and Respiratory syncytial virus,and confirmed by PCR test as necessary for patient management.
【Invalid】
If any of the control (C) lines do not appear,the test is considered invalid.
An invalid test result means that your test has encountered an error and the results cannot be interpreted.You will need to retest using a new test card.
F. Product Qualifications
| 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） | |
| EU HSC Common List | 欧盟抗原检测卡通用清单 |
| Malaysia Registration | 马来西亚注册 |
| 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 |
These antigen tests are included under “Category A” of the EU common list:
| Prospective clinical field study |
| Study in Poland.Sample size : 103 positive ,325 negative .Sensitivity:90.29% ; specificity:99.04% |
