INFLUENZA AU2032 A+B Antigen Rapid Test Kit Instructions

INFLUENZA AU2032 A+B Antigen Rapid Test Kit

Intended Use

The Influenza A+B Antigen Rapid Test Kit is a rapid visual immunoassay for the qualitative, presumptive detection of influenza A and B viral antigens form throat swabs and nasopharyngeal swab specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and type B virus Antigen infection.

Introduction

Influenza is a highly contagious, acute, viral infection of the respiratory tract. The causative agents of the disease are immunologically diverse, single-strand RNA viruses known as influenza viruses. There are three types of influenza viruses: A, B, and C. Type A viruses are the most prevalent and are associated with most serious epidemics. Type B viruses produce a disease that is generally milder than that caused by type A. Type C viruses have never been associated with a large epidemic of human disease. Both type A and B viruses can circulate simultaneously, but usually one type is dominant during a given season. Influenza antigens may be detected in clinical specimens by immunoassay. The Influenza A+B Test is a lateral-flow immunoassay using highly sensitive monoclonal antibodies that are specific for influenza antigens. The test is specific to influenza types A and B antigens with no known cross- reactivity to normal flora or other known respiratory pathogens.

Principle

The Influenza A+B Rapid Test Device detects influenza A and B viral antigens through visual interpretation of color development on the strip. Anti- influenza A and B antibodies are immobilized on the test region A and B of the membrane respectively. During testing, the extracted specimen reacts with anti- influenza A and B antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient influenza A and B viral antigens in the specimen, colored band(s) will form at the according test region of the membrane.

The presence of a colored band in the A and/or B region indicates a positive result for the particular viral antigens, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

Kit Contents

disposable

dropper, 1 desiccant)

Sample Diluent| 25 bottles
Collection Swaps| 25 sterile single use specimen collection swaps
Instruction Manual| 1 each

Storage and Stability

• The kit should be stored at 2~30°C, valid for 12months.
• The test must remain in the sealed pouch until use.
• Do not freeze.
• Care should be taken to protect components in this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.

Precautions

• Read this IFU carefully before use.
• Do not spill solution into the reaction zone.
• Do not use test if pouch is damaged.
• Do not use test kit after expiration date.
• Do not mix Sample Diluent Solution and Transfer Tubes from different lots.
• Do not open the Test Cassette foil pouch until ready to perform the test.
• Do not spill solution into the reaction zone.
• For professional use only.
• For in-vitro diagnostic use only.
• Do not touch the reaction zone of the device to avoid contamination.
• Avoid cross-contamination of samples by using a new specimen collection container and specimen collection tube for each sample.
• All patient samples should be treated as if capable of transmitting disease. Observe established precautions against microbiological hazards throughout testing and follow standard procedures for proper disposal of specimens.
• Do not use more than the required amount of liquid.
• Bring all reagents to room temperature (15~30°C) before use.
• Wear protective clothing such as laboratory coats, disposable gloves, and eye protection when testing.
• Evaluate the test result after 20 minutes and not beyond 30 minutes.
• Store and transport the test device always at 2~30°C.

Sample Collection and Storage

Prepare Materials
Open the package, take out the Influenza A+B Antigen test card in pouch, the Tube filled with the extraction buffer and the swab. When you are ready to proceed with the test, open the foil pouch of the Influenza A+B Antigen test card. Note: Failure to swab properly may cause false negative results

Nasopharyngeal Swab Collection Method:

1.  Remove the oropharyngeal swab from the pouch.
2.  Tilt patient’s head back 70 degrees. Gently and slowly insert the swab into one of patient’s 2. Tilt patient’s head back 70 degrees. Gently and slowly insert the swab into one of patient’s
3.  Slowly rotate 3-5 times the swab over the surface of the posterior nasopharynx.
4. Leave swab in place for several seconds to absorb secretions. Slowly remove the swab from the nostril while rotating it.

Anterior Nasal Swab Collection Method:

1. Remove the oropharyngeal swab from the pouch.
2. Insert the swab into one of patient’s nostrils up to 1 inch from the edge of the nostril.
3. Slowly roll the swab 5 times over the surface of the nostril. Using the same swab repeat this collection process in the other nostril. Take approximately 15 seconds to collect the specimen.
4. Slowly remove the swab from the nostril while rotating it.

Oropharyngeal Swab Collection Method:

1. Remove the oropharyngeal swab from the pouch.
2. Tilt patient’s head back 70 degrees
3.  Insert swab into the oral cavity without touching the gums, teeth, and tongue (A tongue depressor may be used.) Swab the posterior pharyngeal wall using a rotatory motion.
4. Withdraw the swab from the oral cavity.

Sample Treatment:

• Dip the swab after sample collection into the sample diluent solution tube, make the solution fully permeate the swab
• Rotate and squeeze the swab 5 times, then pull out the swab, and take the remained liquid as the sample to be tested.

Assay Procedure:

• Apply 3 full drops of the sample diluent solution (90-100ul) vertically into the sample well of the test cassette.
• The results are observed after 20 minutes and sowed on clinical significance after 20 minutes.

Interpretation of Results

Note
The intensity of the color in test regions may vary depending on the concentration of antigen present in the sample. The antigen level cannot be determined by this qualitative test. Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.

Quality Control

Internal Control:
This test contains a built-in control feature, the (C) band. The (C) line develops after adding specimen and sample diluent. Otherwise, review the whole procedure and repeat test with a new device.

External Control:
External controls are not supplied with this kit. It is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
Good Laboratory
Practice recommends using the external controls, positive and negative, to assure the proper performing of the assay, in particularly, under the following circumstances:

• New operator uses the kit, prior to performing testing of specimens.
• A new lot of test kit is used.
• A new shipment of kits is used.
• The temperature used during storage of the kit fall outside of 2°C -30°C.
• The temperature of the test area falls outside of 15°C -30°C.

Limitations of the Test

1. The Influenza A+B Antigen Rapid test kit (Nasal swab test) is for in vitro diagnostic use only. This test should be used for the detection of Influenza A+B antigens in human Nasal swab specimens.
2. The Influenza A+B Antigen Rapid test kit (Nasal swab test) will only indicate the presence to Influenza A+B in the specimen and should not be used as the sole criteria for the diagnosis of SARS-CoV-2 and Influenza A+B infections.
3. If the symptom persists, while the result from Influenza A+B Antigen Rapid test kit (Nasal swab test) is negative or non-reactive result, it is recommended to re-sample the patient few hours later.
4. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
5. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of Influenza A+B infection.
6. The potential impacts of vaccines, antiviral therapeutics, antibiotics, chemotherapeutic or immunosuppressant drugs have not been evaluated in the test.
7. Due to inherent differences between methodologies, it is highly recommended that, prior to switching from one technology to the next, method correlation studies are undertaken to qualify technology differences. One hundred percent agreement between the results should not be expected due to differences between technologies.
8. Performance has only been established with the specimen types listed in the Intended Use. Other specimen types have not been evaluated and should not be used with this assay.

Notice

1. Must strictly follow the instructions for operation and interpretation of the results.
2.  The product is qualitatively tested, and the result cannot be used as a quantitative basis. should be tested using reagents within the validity period.
3. The reagent, straw for single person one-time use, cannot be reused.
4.  Because the sample titer is different, the red lines of the test line will show different shades of color, all of which indicate positive results. The depth of the test line color cannot be used as the basis for determining the antigen in the sample.
5. The samples stored at low temperature should be balanced to room temperature and fully mixed before testing.
6. Samples and waste must be treated as a potential source of infection and the desiccant in the foil bag is not edible.

Who we are
Attogene is a biotechnology company located in Austin, Texas. Our focus is to enhance health and wellness by offering and developing customer focused Life Science Products domestically and internationally.

Our mission is to:

• Enhance detection technologies
• Enable rapid responses
• Enable impactful research discoveries

Contact Us
3913 Todd Lane, Suite 310 Austin, TX 78744
Phone: 512- 333-1330 Email : sales@attogene.com Web : www.attogene.com AU2032_V1_20220927

Documents / Resources

| INFLUENZA AU2032 A+B Antigen Rapid Test Kit [pdf] Instructions
AU2032, A B Antigen Rapid Test Kit, Rapid Test Kit, A B Antigen Test Kit, Test Kit
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References

• Home Update - Attogene

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