INTENDED USE

The QuadSure COVID-19 & Flu A/B & RSV 4-in-1 Rapid Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B,and respiratory syncytial virus (RSV). Testing is limited to Research Use Only (RUO) with nasal swab specimens from individuals aged 6 months or older. This test is only used for individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first six (6) days of symptom onset. Results are for the identification and differentiation of SARS-CoV-2, influenza A virus, influenza B, and RSV virus protein antigens, but do not differentiate between SARS-CoV and SARS-CoV-2 viruses and are not intended to detect influenza C antigens.

The viral antigens targeted by this test are generally detectable from specimens collected using nasal swabs 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. The agent detected may not be the definitive cause of disease. Individuals who test positive with the QuadSure COVID-19 & Flu A/B & RSV 4-in-1 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, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2, influenza A, influenza B, and RSV infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions such as isolating from others and wearing masks. Negative results should be considered in the context of an individual’s recent exposures, history, and the presence of clinical signs and symptoms consistent with SARS-CoV-2, influenza A, influenza B, and RSV infection. Individuals who test negative and continue to experience SARS-CoV-2 and/or influenza, and/or RSV-like symptoms of fever, cough, and/or shortness of breath may still have SARS-CoV-2, and/or influenza, and/or RSV infection and should seek follow-up care with their physician or healthcare provider.

KIT CONTENTS

Coronaviruses are enveloped RNA viruses that are found broadly among humans, other mammals, and birds. The viruses are known to cause mild symptoms, but sometimes severe respiratory, enteric, hepatic, and neurological diseases can occur. Seven coronavirus species are known to cause human disease, four of which (229E, OC43, NL63 and HKU-1) are quite prevalent and can cause mild cold symptoms, especially in immunocompetent people. There are three other strains that are known to cause severe acute respiratory disease. These strains include severe acute respiratory syndrome coronavirus (SARS-CoV), Middle East respiratory syndrome coronavirus (MERS-CoV), and the 2019 Novel Coronavirus (COVID-19). These strains are all zoonotic in origin and have been linked to sometimes fatal respiratory illness. The prevalence of SARS and MERS has been quite low in recent years; the Novel Coronavirus (COVID-19) was recently identified in December 2019. The main manifestations of illness include fever, fatigue, and dry cough. Nasal congestion, runny nose, sore throat, myalgia, and diarrhea are found in a few cases. Most epidemiological studies suggest a 1–14-day incubation period. The median incubation period is estimated at 5.1 days, with most developing symptoms before 11.5 days. Infected but asymptomatic people can also be an infectious source.

Along with the common cold, influenza is one of the most common acute respiratory infections, producing symptoms such as headache, chills, dry cough, body aches, and fever. It affects 5%-20% of the United States population annually, resulting in more than 200,000 hospitalizations and 36,000 deaths. The influenza A virus is typically more prevalent and is associated with the most serious influenza epidemics, while influenza B infections usually present with milder symptoms. Diagnosis is difficult because the initial symptoms can be similar to those caused by other infectious agents. Considering that the influenza virus is highly contagious, accurate diagnosis and prompt treatment of patients can have a positive effect on public health. Accurate diagnosis and the ability to distinguish between A or B antigens can also help reduce the inappropriate use of antibiotics and gives the physician the opportunity to prescribe an antiviral therapy. Initiation of antiviral therapy should begin as soon as possible after onset, ideally within 48 hours of the appearance of symptoms, as treatment may reduce the duration of symptoms.

Respiratory syncytial virus (RSV) belongs to the Pneumovirus genus of the Paramyxoviridae family. It can be transmitted through the air and through close contact, mainly causing lower respiratory tract infections such as bronchiolitis and pneumonia in infants under 6 months old, and upper respiratory tract infections such as rhinitis and colds in older children and adults. Clinically, patients with respiratory syncytial virus infection can present with fever, nasal congestion, dyspnea, and even respiratory failure or heart failure when the symptoms are severe, requiring active treatment. The QuadSure COVID-19 & Flu A/B & RSV 4-in-1 Rapid Test can provide rapid detection of SARS-CoV-2, influenza A, influenza B, and/or RSV viral antigens from symptomatic patients.

PRINCIPLE OF PROCEDURE

The QuadSure COVID-19 & Flu A/B & RSV 4-in-1 Rapid Test is a sandwich immunochromatographic assay that uses antibodies to detect nucleocapsid proteins from SARS-CoV-2, influenza A, influenza B, and RSV in nasal swab specimens.

When the extracted specimen is added to the sample well, it is absorbed into the device and moves along the test strip by capillary action. It then mixes with latex beads coated with antibodies specific to SARS-CoV-2, influenza A, influenza B, and RSV nucleocapsid proteins. These antibody-coated latex beads flow across a pre-coated membrane.

If the COVID-19 antigen level in the specimen is at or above the detection limit, the antigen binds to the latex beads and is captured by antibodies immobilized in the test region of the device, producing a colored test band that indicates a positive result. If the antigen level is below the detection limit, there is no visible colored band in the test region, indicating a negative result. The same process applies to the detection of influenza A, influenza B, and RSV antigens. This test cannot differentiate between RSV A and RSV B antigens.

To ensure the test works correctly, a blue line will appear in the Control Region (C) if enough sample volume has been added and the test has been performed properly. This blue line appears due to the binding of the antibody-coated latex beads to a secondary antibody immobilized in the Control Region (C). The test device does not use biotin-streptavidin/avidin chemistry for coupling reagents and is not intended for use with viral transport media.

KIT CONTENTS

The test kit contains:

• 25 Individually sealed pouches, each pouch contains 1 test card and 1 desiccant
• 25 Extraction Tubes With Buffer
• 25 Sterile Nasal Swabs
• Test Tube Rack (1)
• Instructions for Use (1)
• Quick Reference Instructions (1)