Respiratory Adenovirus Antigen Rapid Test

Respiratory Adenovirus Antigen Rapid Test Cassette is a lateral flow chromatographic

immunoassay for the qualitative detection of adenovirus antigen in nasal swab,nasopharyngeal swab, and oropharyngeal swab specimens directly from individuals who are suspected of adenovirus infection by their healthcare provider.Results are for the identification of adenovirus antigen. This antigen is generally detectable in upper respiratory samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude adenovirus infection and should not be used as the sole basis for treatment or other patient management decisions. The Respiratory Adenovirus Antigen Rapid Test Cassette is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings.

Adenoviruses are extremely common viruses that infect humans at any time of year.

Adenovirus infections are often asymptomatic but can cause mild to severe illness. The illnesses can range from the common cold to pneumonia, croup, and bronchitis. People with weakened immune systems, chronic respiratory, or cardiac disease are at high risk for developing severe illness from an adenovirus infection.Adenoviruses are usually spread from an infected person to others through close personal contact, such as touching or shaking hands; coughing and sneezing; touching an object or surface with adenoviruses on it, then touching your mouth, nose, or eyes before washing your hands.

Anti-adenovirus antibody is conjugated with colored particles and pre-treated on the label pad and another Anti-adenovirus antibody is pre-coated on the membrane. When specimens are processed and added to the test cassette, adenovirus antigen, if present in the specimen, will react with the Anti-adenovirus antibody-coated particles. The mixture then migrates upward on the membrane by capillary action. The antigen-conjugate complexes migrate across the test cassette to the reaction area and are captured by a line of antibody bound on the membrane.Test results are interpreted visually at 15-30 minutes based on the presence or absence of visually colored lines.

To serve as a procedure control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

1.What is Adenovirus ?

Adenovirus is a group of non-enveloped double-stranded DNA viruses belonging to the family Adenoviridae. With over 100 serotypes​ identified, they are classified into subgroups A-G based on genetic and immunological characteristics. Adenoviruses are highly stable in the environment due to their lack of a lipid envelope, resisting many disinfectants and surviving for extended periods on surfaces.

Key Features:

• Icosahedral structure (70–100 nm diameter) with surface proteins (hexon, penton, fiber) determining serotype specificity.
• Infect multiple organs, including respiratory tract, eyes, gastrointestinal tract, and urinary system.
• Can remain latent in lymphoid tissues and reactivate in immunocompromised individuals.

2.How does Adenovirus spread?

Transmission occurs through multiple routes, making adenoviruses highly contagious :

• Respiratory Droplets: Coughing or sneezing releases viral particles
• Contact Transmission: Direct contact with infected persons or contaminated surfaces (e.g., touching eyes, nose, or mouth with unwashed hands) .
• Fecal-Oral Route: Especially common with serotypes causing gastroenteritis (e.g., types 40/41) .
• aterborne Transmission: Poorly chlorinated swimming pools can lead to outbreaks of conjunctivitis or pharyngoconjunctival fever .
• Atypical Shedding: Recovered individuals, especially immunocompromised patients, may shed the virus for weeks without symptoms .

3.What are the symptoms of Adenovirus and severe Adenovirus?

Most infections are mild and self-limiting, but severity depends on serotype and host immunity .

• Common Symptoms Respiratory:Cold-like symptoms (runny nose, sore throat, cough), fever, bronchitis .
• Ocular: Pink eye (conjunctivitis), often with redness, watery discharge, and light sensitivity .
• Gastrointestinal: Diarrhea, vomiting, abdominal pain (especially in children).

Severe Adenovirus Infections​ High-risk groups (infants, immunocompromised individuals, or those with chronic conditions) may develop:

• Pneumonia: Can progress to acute respiratory distress syndrome (ARDS), with a mortality rate of 27–45% in outbreaks.
• Systemic Disease: Hepatitis, meningitis, encephalitis, or hemorrhagic cystitis.
• Prolonged Complications: Bronchiectasis or lung damage in severe pediatric cases.

Allow the test and extraction buffer to reach room temperature (15- 30 ℃) prior to testing.

1. Use an extraction buffer tube for each specimen to be tested and label each extraction tube appropriately.

2. Unscrew the dropper cap from the extraction buffer tube without squeezing.

3. Insert the swab into the tube and swirl it for 30 seconds. Then rotate the swab at least 5 times while squeezing the sides of the tube. Take care to avoid splashing contents out of the tube.

4. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.

5. Screw the dropper cap firmly onto the extraction buffer tube containing the sample. Mix thoroughly by swirling or flicking the bottom of the tube.

6. Remove the test cassette from the foil pouch and use it as soon as possible.

7. Place the test cassette on a flat and clean surface.

8. Add the processed specimen to the sample well of the test cassette.

a. Unscrew the small cap from the dropper tip.

b. Invert the extraction buffer tube with the dropper tip pointing downwards and hold it vertically.

c. Gently squeeze the tube, dispensing 4 drops of the processed specimen into the sample well.

9. Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not read the result after 30 minutes.

NEGATIVE: Only one colored control line appears in the control region (C). No apparent colored line appears in the test line region (T). This means that no adenovirus antigen was detected.
POSITIVE:* Two distinct colored lines appear. One line in the control line region (C) and the other line in the test line region (T). This means that the presence of adenovirus antigen was detected.

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