SARS-CoV-2 & Influenza A+B & RSV & ADV & HMPV 6 in 1 Combo Antigen Rapid Test

The BioAid SARS-CoV-2 & Influenza A+B & RSV & ADV & HMPV 6-in-1 Combo Antigen Rapid Test (hereinafter referred to as "the Test") is a lateral flow immunoassay intended for the qualitative detection and differentiation of protein antigens of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus, influenza B virus, Respiratory Syncytial Virus (RSV), Adenoviruses (ADV), and Human Metapneumovirus (HMPV). 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, ADV, and HMPV are often similar. The Test results can simultaneously identify the protein antigens of SARS-CoV-2, influenza A virus, influenza B virus, RSV, and ADV. However, it does not differentiate between SARS-CoV and SARS-CoV-2, nor is it intended to detect influenza C virus antigens.

The viral antigens targeted by the Test are generally detectable in nasal swab specimens collected during the acute phase of infection. A positive result indicates the presence of viral antigens; however, clinical correlation with the patient's medical history and other diagnostic information is required to determine the infection status.

Positive results do not rule out bacterial infection or co-infection with other viruses, and the detected agent(s) may not be the definitive cause of the disease. Individuals who test positive with the Test should self-isolate and seek follow-up care from their physician or healthcare provider, as additional testing may be necessary.

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

Negative results should be interpreted in the context of an individual's recent exposure history, medical history, and the presence of clinical signs and symptoms consistent with infections caused by the above-mentioned viruses. Individuals who test negative but continue to experience SARS-CoV-2 and/or influenza-like symptoms (e.g., fever, cough, and/or shortness of breath) may still be infected and should seek follow-up care from their physician or healthcare provider.

The Test is a qualitative membrane-based chromatographic immunoassay designed for the qualitative detection of nucleocapsid protein antigens of SARS-CoV-2, influenza A+B, RSV, ADV, and HMPV in human anterior nasal swab specimens. After the specimen is processed and added to the test cassette, any viral antigens present in the specimen will react with the antibody-coated particles (pre-coated on the test strip) specific to SARS-CoV-2, influenza A, influenza B, RSV, or ADV. The mixture then migrates upward along the membrane by capillary action. As a process control, a colored line will always appear in the control line region, indicating that an appropriate volume of specimen has been added and normal membrane wicking has occurred.

1. Why is a 6-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, Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), Adenovirus (ADV), and Human Metapneumovirus (HMPV). These viruses require different management approaches, but their clinical symptoms overlap significantly, making it difficult to identify the specific cause based on symptoms alone .

This 6-in-1 test is designed for the simultaneous detection of these six 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 when these viruses often co-circulate .

2. Which Six Pathogens Does This Test Detect?

This rapid antigen test detects the following six 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.
• 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, conjunctivitis, and gastrointestinal symptoms.
• Human Metapneumovirus (HMPV): A common virus that causes symptoms similar to RSV, leading to upper and lower respiratory tract infections.

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 6-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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