Product Overview

The COVID-19/Flu/RSV/ADV/MP Antigen Combination Rapid Test (Swab) is an immunoassay that offers qualitative, visual readings. It's engineered to detect nucleocapsid protein antigens from SARS-CoV-2, Influenza A & B, Respiratory Syncytial Virus (RSV), Adenovirus (ADV), and Mycoplasma Pneumoniae (MP) all at once. This test utilizes nasal, nasopharyngeal, or oropharyngeal swab samples and is instrumental in facilitating the swift differential diagnosis of acute respiratory infections. It's exclusively meant for professional application.

Product Specification

Intended use	Detection of f influenza A&B viral, SARS-COV-2, Respiratory Syncytial Virus (RSV), Adenovirus (ADV),Mycoplasma Pneumoniae (MP)
Principle	Visual lmmunoassay
Storage	4-30°C
Shelf Life	36 Months
Reading Time	10~20 Minutes

Product Advantages

Multipathogen Screening: It can screen for six key respiratory pathogens in one go using a single device.

Quick Turnaround: Results are ready in just 10 minutes.

Ease of Use: The testing process is straightforward, with results that can be visually interpreted without ambiguity.

No Special Equipment: The test provides a visual readout, eliminating the need for any specialized instruments.

CE Certification: It complies with European regulatory requirements for In Vitro Diagnostic (IVD) devices.

Versatile Sample Handling: It works seamlessly with nasal, nasopharyngeal, and oropharyngeal swabs.

Ordering Information

Catalog No.	Product Name	Specimen	Format	Pack	Certification
FCRAM-6062	COVID-19/Flu/RSV/ADV/MP Antigen Combo Rapid Test (Swab)	Swab	Cassette	20Tests /Kit	CE

Operation Steps & Interpretation

1. Sample Collection

Nasal Swabbing: Gently insert the swab 2.5 cm into a nostril and roll it five times along the mucosa to gather mucus and cells. Repeat the process in the other nostril using the same swab.

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Nasopharyngeal Swabbing: Position the swab close to the floor of the nasal septum, then carefully advance it to the posterior nasopharynx. Rotate it several times, leave it in place briefly, and then withdraw it.

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Oropharyngeal Swabbing: Open your mouth wide. Take a sterile swab and insert it into your throat. Gently rub its soft tip over both tonsil pillars and the posterior oropharynx, taking care to avoid the tongue, teeth, and gums.

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2. Sample Preparation
Immerse the swab in the extraction buffer tube and rotate it 8 to 10 times against the tube's inner wall. Squeeze the swab to expel the liquid and then dispose of it.

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3. Testing
Dispense three drops of the extracted sample into the sample well marked "S".

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4.Result Interpretation

For Influenza A+B

Flu A Positive: Control line (C) + A line appear
Flu B Positive: Control line (C) + B line appear
Flu A+B Positive: Control line (C) + A line + B line all appear
Negative: Only the control line (C) is visible
Invalid: No control line (C) appears; or no lines appear at all

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For COVID-19/RSV/ADV/MP

Positive: Control line (C) + Test line (T) appear
Negative: Only the control line (C) is visible
Invalid: No control line (C) appears; or no lines appear at all

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FAQ

Q: Which pathogens can this test identify?

A: It can detect antigens from SARS-CoV-2 (COVID-19), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), Adenovirus (ADV), and Mycoplasma pneumoniae (MP).

Q: What sample types are suitable for this test?

A: The test accepts three sample types: nasopharyngeal swabs, nasal swabs, and oropharyngeal swabs.

Q: How should the test kit be preserved?

A: Store the kit at temperatures ranging from 4°C to 30°C and shield it from direct sunlight.

Q: Is it permissible to reuse test components like swabs or extraction tubes?

A: Absolutely not. The package insert clearly advises against reusing any components.

Q: What's the overall concordance rate of the test for pathogens such as Influenza A and RSV?

A: For Influenza A, the overall concordance rate varies from 98.77% to 99.58% across different sample types. For RSV, it ranges from 98.68% to 99.49% across sample types.

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