Healgen COVID-19/Flu A&B Ag Combo Rapid Test Cassette

COVID-19-Flu A-Flu B

Point of origin: EUA 240010 FDA ISO13485
Testing item: COVID-19/Flu A&B Ag
Throughput: 10-15min
Application scenarios: clinic,hospital,family
Sample: blood

The COVID-19/Flu A&B Ag Combo Rapid Test is a rapid immunochromatographic assay designed to qualitatively detect antigens from SARS-CoV-2 (the virus causing COVID-19), Influenza A, and Influenza B in human respiratory specimens. This test is intended for professional use to aid in the diagnosis of infections caused by these viruses.

Key Features

Rapid Results: Provides results within minutes, allowing for quick diagnosis and timely decision-making.
Multiplex Testing: Simultaneously detects and differentiates between SARS-CoV-2, Influenza A, and Influenza B.
Ease of Use: Simple procedure that can be performed with minimal training.
Specimen Types: Uses nasopharyngeal or nasal swabs.

Materials Provided

COVID-19/Flu A&B Ag Combo Rapid Test Cassettes
Sterile swabs for sample collection
Buffer solution
Dropper or pipette for sample application
Package insert with instructions for use

Test Procedure

Sample Collection: Collect nasopharyngeal or nasal swab specimens using the provided sterile swabs.
Sample Preparation: Place the swab into the buffer solution to extract the viral antigens.
Application: Apply a specified number of drops of the prepared sample onto the test cassette.
Incubation: Allow the test to run for the recommended time (typically 10-20 minutes).
Interpretation: Read the results based on the appearance of colored lines on the test cassette.

Interpretation of Results

Positive for SARS-CoV-2: Appearance of a control line (C) and a test line (T) for COVID-19.
Positive for Influenza A: Appearance of a control line (C) and a test line (T) for Influenza A.
Positive for Influenza B: Appearance of a control line (C) and a test line (T) for Influenza B.
Negative: Appearance of only the control line (C) with no test lines.
Invalid: Absence of the control line (C) regardless of the presence of test lines, indicating a procedural error or faulty test.

Product Description
Performance Parameters

Clinical Applications

Diagnosis: Rapidly differentiates between COVID-19 and Influenza A/B, which is crucial during flu season or when symptoms overlap.
Outbreak Management: Helps in the timely identification and isolation of infected individuals to prevent the spread of these contagious diseases.
Public Health Surveillance: Assists in monitoring the prevalence of COVID-19 and influenza infections within communities.

Benefits

Quick and Accurate: Provides fast results with high specificity and sensitivity.
Cost-Effective: Reduces the need for multiple separate tests, saving time and resources.
Convenient: Suitable for use in various settings such as clinics, hospitals, and point-of-care facilities.

By providing rapid and reliable results, the COVID-19/Flu A&B Ag Combo Rapid Test plays a crucial role in the effective management and control of respiratory infections caused by these viruses.