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Influenza A+B Antigen Rapid Test Kit Later Flow Assay Diagnostic Rapid Test Kit

Basic Information
Place of Origin: China
Brand Name: Dewei
Certification: ISO, CE
Model Number: DWR-80IFAB
Minimum Order Quantity: 5000 units
Price: Negotiable
Packaging Details: 25test/box
Delivery Time: in 20 days
Payment Terms: L/C, T/T, Western Union
Supply Ability: 500,000pcs/day
Detail Information
Sample: Swab Type: Cassette
Certificate: ISO, CE Origin: China
Shelf Life: 24 Months Usage: Professional Use
Highlight:

Later Flow Assay Rapid Test Kit

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Influenza A+B Antigen Rapid Test Kit

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Diagnostic Rapid Test Kit


Product Description

Influenza A+B Antigen Rapid Test Kit (Later Flow Assay) Diagnostic Test Kit

 

 
【INTENDED USE】
This product is used for in vitro qualitative detection of influenza A and influenza B virus protein antigens in human swab test samples. The InfluenzaA+B antigen combined rapid test kit is designed to detect and identify influenza A and influenza B virus nucleoprotein antigens. Antigens can generally be detected in nasopharyngeal specimens during the acute infection
stage.
A positive result indicates the presence of viral antigens, but the clinical correlation with the patient’s medical history and other diagnostic information is necessary to determine the infection status. A positive result does not exclude bacterial infection or co-infection with other viruses.
A negative result does not exclude influenza A or influenza B infection, and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results must be combined with clinical observation, patient history and epidemiological information, and confirmed by molecular diagnostic analysis, and used for patient management when necessary. The InfluenzaA+B antigen combined rapid test kit is only for testing in medical institution. This product is for professional used only.
 
 
 
【INTRODUCTION】
Influenza is a contagious respiratory disease caused by influenza viruses. It can cause mild to severe diseases. The severe consequences of influenza infection can lead to hospitalization or death. Some people, such as the elderly, young children, and people with certain health conditions, are prone to severe flu complications. There are two main types of influenza viruses: type A and type B. The influenza A and B (human influenza viruses) that are usually spread among people are the cause of seasonal influenza epidemics every year.
 
 
【PRINCIPLE】
The rapid test of influenza A+B is a lateral flow chromatography detection method based on the principle of double antibody sandwich technology. The anti-influenza A and influenza B monoclonal antibodies combined with colloidal gold gold particles are used as the label, and gold is sprayed on the binding pad. During the test, the antigen and labeled antibody complexes are formed and migrated on the membrane by capillary action. If the specimen contains influenza A antigen, the complex will be captured by the pre-coated influenza A monoclonal antibody, forming a visible colored line in area A of the result window. If the specimen contains influenza B antigen, the complex will be captured by the precoated influenza B monoclonal antibody, forming a visible color line in the B area of the result window. The control line (C) is used for process control and should always appear if the test process is performed properly.

 

 

 
【CONTENTS】
Reagent cassette: The test kit includes the flu A+B test strip, which are fixed in a plastic device;
Swab (customized according to customer needs);
Extraction tube and Buffer;
Note: The components in the kits of different batch numbers cannot be used interchangeably.
Equipment and materials required for testing but not provided: timer, gloves, goggles.
 
 
 
【STORAGE AND STABILITY】
Store at 2~30℃. Freezing is prohibited.
Shelf life: 18 months when package is not open.
The reagent should be used as soon as possible within 1 hour after the aluminum foil bag is opened. Long-term exposure to the hot and humid environment will cause the product to deteriorate. It is recommended that the product be used immediately when the ambient temperature is higher than 30℃ or high humidity. See the label for the production date and expiration date.
 
 
【SAMPLE REQUIREMENT
Specimens obtained early in the onset of symptoms will contain the highest virus titer;
Compared with RT-PCR testing, specimens obtained 5 days after the onset of symptoms are more likely to produce Positive results; Insufficient specimen collection, improper specimen handling and/or transportation may produce false negative results; Do not return the nasal swab to the original swab packaging;
Freshly collected specimens should be processed as soon as possible, but no later than 1 hour after specimen collection;
The collected specimens can be stored at 2-8°C for no more than 24 hours;
Store at -70℃ for a long time, but avoid repeated freeze-thaw cycles; Improper sample handling, storage and transportation methods may produce false negative results.
 
 
 
【PRECAUTIONS】
1) This product is disposable, please use it within the validity period.
2) Do not use the aluminum foil bag if it is found to be damaged. Please use it as soon as possible after opening the aluminum foil bag.
3) All testing work must comply with the provisions of the Biosafety Code and strictly prevent cross-infection.
4) All samples and used articles should be treated as potential sources of infection.
5) It is recommended to use fresh samples, and never freeze-thaw samples repeatedly.
6) Compared with adults, children are more likely to spread the virus in a wider range and last longer. Therefore, the sensitivity of children's detection may be higher than that of adults.
7) For the detection reagent of influenza A virus or each subtype, when the antibody used is monoclonal, the slight change of epitope caused by small mutation of nucleotide sequence may lead to false negative result or decrease of analytical sensitivity of reagent.
8) When adding samples, add them vertically one by one to each sample hole to avoid insufficient sample volume due to bubbles, which will affect the interpretation of the product.
 
 
 
【OPERATION PROCEDURE
SAMPLE COLLECTION
This product can be equipped with disposable sampling swabs, sampling is as follows:
Nasal Sampling: Gently insert the swab head into the nasal cavity and scrape the cavity wall.
Immerse the swab head into sample solution and discard the tail of swab.
DETECTION
1. Insert the tip onto tube membrane, take out the tip after membrane’s puncture.
2. Collect the swab sample according to above instruction.
3. Roll the swab at least 6 times while pressing the head against the bottom and side of the extraction tube.
Leave the swab into the extraction tube for 1 minute.
Squeeze the tube by fingers from outside of the tube to immerse the swab. Remove the swab.
The extracted solution will be used as test sample.
4. Put the tip onto the tube, and take out its cap.
5. Add 2 drops of the mixed sample to each sample wells of the cassette and read the results in 15 minutes.
 
 
 
INTERPRETATION OF RESULTS
 
FluA Positive: 
One colored line appears at the control region (C), another colored line appears at the A test region, irregardless of the intensity of the test line.
 
Flu B Positive: 
One colored line appears at the control region (C), another colored line appears at the B test region, irregardless of the intensity of the test line.
 
Flu A & B Positive:
One colored line appears at the control region (C), and both the A and B lines appear at the test region, irregardless of the intensity of the test line.
 
Negative: 
One colored line appears at the control region (C), and no lines appear a the test region.
 
Invalid: 
If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.
 
 
 
 

For further operation or performance details, please refer to final instruction manual.

 

 

 

Contact Details
Bonnie He

Phone Number : +8613030247038

WhatsApp : +8615267039708