BioAid SARS-CoV-2 & Influenza A+B & RSV & ADV 5 in 1 Combo Antigen Rapid Test

The BioAid SARS-CoV-2 & Influenza A+B & RSV & ADV 5-in-1 Combo Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of protein antigens of SARS-CoV-2, influenza A, influenza B, Respiratory Syncytial Virus (RSV), and Adenoviruses (ADV). This test is for professional in vitro diagnostic use only.

Clinical signs and symptoms of respiratory viral infections caused by SARS-CoV-2, influenza viruses, RSV, and ADV can be similar. Test results allow for the simultaneous identification of protein antigens of SARS-CoV-2, influenza A virus, influenza B virus, Respiratory Syncytial Virus, and Adenoviruses, but do not differentiate between SARS-CoV and SARS-CoV-2, nor are they intended to detect influenza C antigens.

The viral antigens targeted by this test are generally detectable in nasal swab specimens collected during the acute phase of infection. Positive results indicate the presence of viral antigens; however, 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. The detected agent may not be the definitive cause of the disease. Individuals who test positive with the BioAid SARS-CoV-2 & Influenza A+B & RSV & ADV 5-in-1 Combo Antigen Rapid Test should self-isolate and seek follow-up care with their physician or healthcare provider, as additional testing may be necessary.

All negative results are presumptive, and confirmation with a molecular assay may be performed if necessary for patient management. Negative results do not rule out SARS-CoV-2, influenza A, influenza B, RSV, or ADV infection, and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolation and mask wearing.

Negative results should be interpreted in the context of an individual's recent exposures, medical history, and the presence of clinical signs and symptoms consistent with SARS-CoV-2, influenza A, influenza B, RSV, and ADV infection. Individuals who test negative but continue to experience SARS-CoV-2 and/or influenza-like symptoms including fever, cough, and/or shortness of breath may still be infected and should seek follow-up care with their physician or healthcare provider.

This is a qualitative membrane-based chromatographic immunoassay for the qualitative detection of nucleocapsid protein antigens of SARS-CoV-2, Influenza A+B, RSV, and ADV in human anterior nasal swab specimens.When processed specimens are added to the test cassette, SARS-CoV-2, Influenza A+B, RSV, and ADV antigens (if present) will react with antibody-coated particles specific to SARS-CoV-2, Influenza A, Influenza B, RSV, or ADV, which have been pre-coated on the test strip. The mixture then migrates upward along the membrane by capillary action.

As a procedural control, a colored line will always appear in the control line region, indicating that an appropriate volume of specimen has been added and proper membrane wicking has occurred.

1. Why is a 5-in-1 Respiratory Antigen Test Important?

Acute respiratory infections often present with very similar symptoms-such as fever, cough, and sore throat-but can be caused by different pathogens, including SARS-CoV-2 (COVID-19), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Adenovirus (ADV). These viruses require different management and treatment approaches. However, their clinical symptoms overlap significantly, making it difficult to identify the specific cause based on symptoms alone .

This 5-in-1 test is designed for simultaneous detection​ of these five major pathogens from a single sample. It enables rapid and accurate differentiation, which is crucial for prompt and appropriate clinical decision-making. This helps avoid diagnostic delays, supports targeted treatment, and aids in implementing correct infection control measures, especially in settings like emergency departments or during seasonal outbreaks .

2. Which Five Pathogens Does This Test Detect?

This rapid antigen test detects the following five common respiratory pathogens, which are major causes of community-acquired respiratory infections :

• SARS-CoV-2: The virus responsible for COVID-19.
• Influenza A & B: Viruses that cause seasonal flu. Influenza A is generally associated with more widespread outbreaks and severe illness.
• Respiratory Syncytial Virus (RSV): A leading cause of bronchiolitis and pneumonia in infants and young children.
• Adenovirus (ADV): A virus that can cause a range of illnesses, including respiratory infections (like the common cold, bronchitis, pneumonia), conjunctivitis, and gastrointestinal symptoms.

3. How Are These Viruses Spread, and What Symptoms Do They Cause?

These viruses primarily spread through respiratory droplets​ when an infected person coughs or sneezes, through direct contact​ with contaminated surfaces, and, in some cases, via aerosols​ in the air .

Infection with any of these viruses can lead to a set of common, non-specific symptoms, which is why clinical distinction is challenging :

• Fever or chills
• Cough
• Sore throat
• Runny or stuffy nose
• Fatigue and muscle aches

In severe cases, particularly for vulnerable individuals, any of these viruses can lead to serious complications such as pneumonia​ and bronchitis, requiring hospitalization .

4. Who Is This 5-in-1 Test Recommended For?

• This test is particularly suitable for the following groups and scenarios :
• Individuals with acute respiratory symptoms: To quickly identify the cause of infection and guide appropriate care.
• High-risk populations: Including infants, young children, the elderly, and individuals with weakened immune systems​ or chronic underlying conditions. These groups are more susceptible to severe illness, and early, accurate diagnosis is critical for their management.
• Clinical and public health settings: Such as hospital emergency rooms, clinics, and during outbreaks in communities or closed settings (e.g., nursing homes, schools) for rapid screening, patient triage, and effective infection prevention and control.

5. How Should the Test Results Be Interpreted?

A positive result​ for a specific virus indicates the presence of its antigens and suggests a current infection. This result should be discussed with a healthcare provider to determine the next steps for management and treatment.

A negative result​ means that the antigens for the targeted viruses were not detected in the sample at the time of testing. However, a negative result does not completely rule out infection. If the test is taken very early or late in the infection when the viral load is low, it may return a false negative. Therefore, if symptoms persist or worsen, retesting or confirmation with a more sensitive molecular method (like PCR) is recommended.

Note: Any visible faint red or pink line in the Test line region (CoV/A/B/T) and should be read as positive. If there is no colored
line in the Test line region (CoV, A, B and/or T) and a colored line in the Control line (C) region, then that test line (CoV, A, B
and/or T) should be read as negative.
If the Control (C) line is visible and any other line or multiple lines, no matter how faint, at "CoV", "A" , "B" and/or "T" appear, the
test is positive for that virus.
If the Control (C) line is visible, but the Test (CoV/A/B/T) line is not visible, the test is negative. The COVID-19, Flu A, Flu B,RSV
or ADV virus have not been detected.
If the Control (C) line is not visible, even if any other line is visible in the result window, the test is not valid. Re-test with a new
swab and a new test cassette. If the problem persists, do not use the test kit immediately and contact your local distributor.

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