Product Overview

The COVID-19/Flu/RSV Antigen Combination Rapid Test (Swab) serves as a swift visual immunoassay designed for the qualitative and presumptive identification of nucleocapsid protein antigens from influenza A and B viruses, SARS-CoV-2, and Respiratory Syncytial Virus (RSV) in samples obtained via nasal, nasopharyngeal, or oropharyngeal swabs. Its primary purpose is to assist in the rapid differential diagnosis of acute infections caused by these viruses.

Product Specification

Intended use	Detection of influenza A&B viral, SARS-COV-2, Respiratory Syncytial Virus (RSV)
Principle	Visual Immunoassay
Storage	4-30°C
Shelf Life	36 Months
Reading Time	10~15 Minutes

Product Advantages

Multi-target Detection: This test can qualitatively identify nucleocapsid protein antigens of SARS-CoV-2, Influenza A, Influenza B, and RSV in a single run, facilitating prompt differential diagnosis of acute respiratory infections.

Broad Specimen Adaptability: It is compatible with nasal, nasopharyngeal, and oropharyngeal swabs, offering versatility in sample collection methods.

Swift Outcomes: Results are visually discernible within 10-15 minutes, enabling prompt clinical decision-making.

Excellent Performance: Compared to RT-PCR, it exhibits high relative sensitivity (e.g., 97.32%-97.87% for SARS-CoV-2 across various specimens) and relative specificity (100% for SARS-CoV-2 across specimens), with an overall concordance rate surpassing 98%.

Stable Storage Conditions: Unused test kits remain stable at temperatures ranging from 4°C to 30°C until their expiration date, eliminating the need for freezing and simplifying storage and transportation.

Detection of Both Viable and Non-viable Particles: It can detect both live and inactive viral particles, enhancing its diagnostic value.

Ordering Information

Catalog No.

Product Name

Specimen

Format

Pack

Certification

FCR-6042

COVID-19/Flu/RSV

Antigen Combo Rapid Test(Swab)

Nasopharyngeal secretion

Cassette

25Tests /Kit

Product Usage Steps

1.Specimen Collection

Nasal Swab: Request that the patient clears their nose beforehand. Gently insert the swab 2.5 cm into one nostril, rotate it five times along the nasal mucosa, and then repeat the process in the other nostril before withdrawing the swab.

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Nasopharyngeal Swab: Have the patient tilt their head back. Insert the swab through the nostril with more secretions, advancing it gently along the floor of the nasal septum to the posterior nasopharynx. Rotate the swab several times, hold it for a few seconds, and then carefully remove it.

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Oropharyngeal Swab: Ask the patient to open their mouth wide. Gently rub the swab tip over both tonsillar pillars and the posterior oropharynx, taking care to avoid contact with the tongue, teeth, or gums.

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2. Specimen Preparation

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3.Assay Procedure
Open the test device pouch, place three drops of the extracted specimen into the sample well (S), and start the timer. Observe the results between 10-15 minutes; do not interpret the results after 20 minutes have elapsed.

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FAQ

Q: Can this test serve as the sole basis for diagnosis?

A: No, it is intended to aid in differential diagnosis. Clinical correlation with the patient's history and other diagnostic data is necessary to confirm the infection status.

Q: What does a negative result imply?

A: A negative result suggests that no detectable antigen is present above the test's threshold, but it does not definitively exclude infection. If symptoms persist, further testing, such as molecular assays, may be warranted.

Q: Does this test exhibit cross-reactivity with other microorganisms?

A: No, cross-reactivity studies have confirmed that it does not react with common pathogens like adenovirus, rhinovirus, Streptococcus pneumoniae, and others mentioned in the package insert.

Q: Who is authorized to perform this test?

A: It is designed for use by medical professionals or trained individuals who are proficient in conducting rapid lateral flow tests.

Q: Why might the sensitivity vary between children and adults?

A: Children tend to shed viruses for extended periods, which may result in higher sensitivity in pediatric samples compared to those from adults.

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