The Rapid Antigen Test for Avian Influenza (H5N1) is a chromatographic immunoassay intended for the visual qualitative detection or machine read quantitative detection of antigens of H5N1 in samples. H5N1 Avian Influenza is a highly contagious viral disease that can affect birds, livestock, cats, dogs, rodents and may also cause serious illness and death in humans. This RDT detects H5N1 Avian Influenza antigens, and is a valuable tool for veterinarians and livestock producers to help identify infected animals and control the spread of the virus. H5N1 is characterized by a range of clinical symptoms in birds including respiratory distress, drop in egg production, swelling of the head, neck, and eyes, and high mortality rates in severe cases. Prevention measures include strict biosecurity measures, quarantine, and vaccination.
This user-friendly and reliable H5N1 Rapid Antigen Test has been designed to assist veterinarians, animal health professionals, and farmers in quickly identifying H5N1-infected birds, allowing for prompt action to limit the spread of the virus and minimize its economic impact.
This test utilizes a lateral flow immunoassay, employing dye-labeled particles that bind to H5N1 antigens in the sample. The appearance of a colored line on the test strip indicates the presence of H5N1 antigens. A nitrocellulose membrane is immobilized with a monoclonal antibody against the Avian influenza antigen. Another anti-Avian influenza Ag monoclonal antibody is conjugated to colloidal gold particles. This conjugate is placed on a polyester pad as a conjugate pad. When the test is in assay buffer containing specimens, the solubilized conjugate migrates with the sample by passive diffusion and both the conjugate and sample come into contact with the anti-Avian influenza antibody that it absorbed onto the nitrocellulose.
Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results should be considered in the context of recent exposures, history and the presence of clinical signs and symptoms. The Rapid Antigen Test for H5N1 is intended for use by medical professionals or trained operators who are proficient in performing tests and trained clinical laboratory personnel.
Each box contains 50 test kits. Each test kit contains:
The following materials are provided with the RDT for Avian Influenza:
Materials Required but not Provided:
Storage And Disposal
The product should be stored at 2-30°C. Do not freeze or overheat the test kit or kit reagents. Kit contents are stable until the expiration date printed on each test kit. The indicators must be kept in the foil pouch until use. Dispose of used contents in accordance with federal, state, and local requirements.
Before use, check the expiration date of the packaging. If the kit is past its expiration date, do not use. Confirm that all components needed are in the kit.
Various collection methods are available for sampling H5N1, with each approach tailored to specific scenarios. The Sterile Wood Abrasive Collector, known as SWAC, offers versatility in this regard. For live humans and mammals, the SWAC can collect epithelial cells potentially harboring replication-competent virus particles through nostril sampling. In the case of small birds and rodents, the SWAC is inserted into the oropharyngeal region to gather viral particles ensconced in mucus. Cloacal swabs are utilized by inserting a swab into the cloaca, the convergence point of the digestive, urinary, and reproductive tracts, to collect fecal matter. During necropsy, tissue samples can be procured from organs like the lungs, trachea, and intestines. The choice of collection method hinges on the intended purpose and the bird’s condition.
Inadequate or inappropriate sample collection, storage, and transport may yield false test results. The training in specimen collection is highly recommended because of the importance of specimen quality.
Obtain the sterile SWAC. Make sure the SWAC head does not touch anything until sample collection.
Insert the SWAC into the mouth of the animal being tested. Keep the SWAC near the cheek in the mouth. Rotate the SWAC 5 times to collect saliva.
Stand up the Spacket, and tear it open. Be careful not to spill the liquid reagent inside.
Put the SWAC into the Spacket. Roll the swab 5 times. Leave the SWAC in the Spacket for 1 minute before inserting the test indicator.
While the SWAC remains in the Spacket, place the test indicator into the Spacket with the sample pad going down. Leave the test indicator in the Spacket for 10 minutes. Use the assaya timerDx to keep track of the test time.
Take out the test indicator and read the result at 10 minutes. Do not read the result after 20 minutes. The test indicator may also be read by the intelligent analyzer eXpress (iaX-2101) after 10 minutes.
Positive Indicator Line Legend
At 10 minutes, the appearance of the Control Line and Test Line on the Test Indicator, indicates a positive result for the presence of antigens for H5N1. Positive test results only mean antigens for H5N1 exist in the specimen
At 10 minutes, the appearance of only Control Line indicates a negative result for the presence of antigens for H5N1.
If at 10 minutes, the Control Line does not appear, even if a Test Line appears in the indicator, the result is considered invalid. If the test is invalid, a new test should be performed with a new patient sample and a new Test Indicator.
Two internal procedural controls are needed to confirm correct assay procedure and active kit components. One of two is a line appearing in the “Control Line” area in every run of the test to assess validity of the test. Another one is a clear background serving as an internal negative control. The background color should be white and not interfere with the reading of the test result. If the background color interferes with the reading, it is recommended to repeat the test.
Result Interpretation with the iaX-2101
Please refer to the full iaX-2101 Instructions for Use for complete instructions on how to operate the IaX.
Place the test indicator into the iaX-2101, with the barcode pointing in.
GREEN – (NEGATIVE)
YELLOW ! (INVALID)
RED + (POSITIVE)
Warnings & Precautions
The RDT for H5N1 has been evaluated for sensitivity and specificity using a panel of known H5N1-positive and H5N1-negative chicken samples. The test was found to have a sensitivity of 99% and a specificity of 98%.
Adverse Events Reporting
Use this link to report any adverse events: assaya.com/ae
Catalog Number (REF): AKIT-H5N1-AG-01
50 pcs per box (Carton of 50 test kits)
In Vitro Diagnostic Medical Device
No Direct Sunlight
Do not expose to water
Consult Package Insert
Do not reuse
Contains sufficient for <50> tests
Do not use if package is damaged