Bioteke Corporation Influenza A and Influenza B Rapid Antigen Test Kit

As an excellent manufacturer of immunochromatographic diagnostic reagents, the influenza A and B rapid antigen test kit is one of our proud products. This product is mainly designed for rapid family testing, aiming to provide efficient, accurate, reliable and economical influenza rapid testing solutions to meet market demand.

---

A. Test Principle

The kit is immunochromatographic and uses double-antibody sandwich method to detect Influenza A virus and Influenza B 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 antigen in specimen is higher than the minimum detection limit,the viral antigen will form complexes with labeled antibodies first.Under chromatography,the complexes move forward along the nitrocellulose membrane till captured by pre-coated monoclonal antibody of Influenza A virus/Influenza B virus in detection zone on nitrocellulose film Flu A/Flu B to form a red/red/red reaction line on the detection zone,at this point the result is positive;conversely,ifthere is no viral antigen or the concentration of antigen in specimen is below the minimum detection limit,no red 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 red reaction line will appear in the quality control zone (C),the red reaction line that appears in the quality control zone (C)is the criterion for determining if the chromatography process is normal.

---

B. Advantages

• Dual testing: Detects both influenza A and influenza B simultaneously to ensure comprehensive testing to meet the needs of different flu seasons.

• Rapid testing: Only 3 drops sample are needed,and accurate results can be obtained within 15 minutes (20 seconds at the fastest) to assist in treatment decision-making.

• High Accuracy: After testing, this product has a test accuracy of over 99%, providing reliable results.

• User-Friendly: Designed for ease of use, it is suitable for a wide range of end users, including home and laboratory.

• Quality certification: CE and ISO13485 certifications ensure high standards and reliability, and high user trust.

• High production capacity: Monthly supply capacity can reach 5 million boxes, with stable supply to meet large-scale procurement needs.

---

C. Operation Instructions & Result Interpretation

---

D.Specification

Components	Main Ingredients	Loading quantity
Test card	Test strip contain specific Flu A/B virus-monoclonal antibody,Anti-mouse igG polyclonal antibody	1 test/kit	2 tests/kit	20 tests/kit
Sample extraction tube		1pc	2pcs	20pcs
Tube cap		1pc	2pcs	20pcs
Anterior nosal swab		1pc	2pcs	20pcs
Waste bag		1pc	2pcs	20pcs

Note: 

1. Test card are sealed together with desiccant in the aluminum foil pouch.

2. Do not mix use different batches of test cards and sample tube.

3. Storage condition and shelf life:The test card and sample extraction tube should be stored at 2℃-30℃,valid for 24 months.Test cards should be used as soon as possible within 1 hour after opening the foil pouch.The bottle of sample extraction tube should be capped immediately after use and stored at 2℃-30℃,please use it within the validity period.

4. Date of manufactureand expiration:See package label for details.

---

E. Product Qualification（by Sept.13th,2023）

CE Certification - AEMPS Registration Letter

CE Certification - AEMPS Registration Prove

CE Certification - EC Declaration of Conformity

CE Certification - EAR Certificate of Notification

ISO 9001 Certificate

ISO 45001 Certificate

ISO 13485 Certificate

ISO 14001 Certificate

IPMS Certificate

{"json":"[{\"downloadUrl\":\"//rlrorwxhojnqll5p-static.micyjz.com/attachment/iijlKBqrmqRlkSmlijkoloSR7ww7fgzb73r/Summary-of-qualifications-in-Fecal-Occult-Blood-FOB-Rapid-Test-Kit-immunochromatographic-assay.zip?dp=1\",\"encodeFileId\":\"neUKfvGgONFE\",\"fileId\":6614354,\"fileName\":\"Summary of Qualifications \",\"fileType\":\"zip\",\"photoUrlNormal\":\"//jororwxhojnqll5p-static.micyjz.com/static/assets/widget/images/downloadNew/zip.svg\",\"pname\":\"Summary of Qualifications \",\"name\":\"Summary of Qualifications \"}]","type":"1"}

{"json":"[{\"downloadUrl\":\"//inrorwxhojnqll5p-static.micyjz.com/Influenza+AB+Manual-aidlmBprKqqlmSRnknqmppqim.pdf?dp=1\",\"encodeFileId\":\"zIUKfQJtnSCj\",\"fileId\":6948824,\"fileName\":\"Influenza AB Manual.pdf\",\"fileType\":\"pdf\",\"photoUrlNormal\":\"//rlrorwxhojnqll5p-static.micyjz.com/static/assets/widget/images/downloadNew/pdf.svg\",\"pname\":\"Influenza AB Manual.pdf\",\"name\":\"Influenza AB Manual.pdf\"}]","type":"1"}