COVID-19 & Flu A/B Combo Rapid Antigen Test: CLIA-Waived, Triple Detection with 15-Minute Results

Features

• Detects COVID-19, Flu A, and Flu B in one test
• Just one nasal swab checks for all three viruses
• Get fast results in just 15 minutes
• CLIA-waived for easy, on-the-spot testing
• Lateral flow tech makes antigen testing simple and convenient
• Best used within five days of symptoms starting
• 90.2% positive agreement for COVID-19
• 90.0% positive agreement for Flu A
• 91.2% positive agreement for Flu B
• Long shelf life—up to 16 months
• Store at room temperature for easy inventory management
• Optional controls help you check for quality assurance
• Each test cassette is individually sealed for convenience and safety
• Pre-filled extraction tubes make processing samples quick and easy
• Comes in a box of 25 tests

Description

The Healgen COVID-19/Flu A&B Antigen Combo Rapid Test makes it easy to check for COVID-19, Flu A, and Flu B—all with one nasal swab. Results are ready in just 15 minutes, so you can make quick decisions about care. Designed for use within five days of symptoms starting, this CLIA-waived test is perfect for clinics, urgent care, and doctor’s offices. The combined test means less hassle and faster answers for patients with respiratory symptoms.

This test offers strong performance—showing over 90% positive agreement for COVID-19, Flu A, and Flu B. It’s easy to store at room temperature and lasts up to 16 months, so you can keep your supplies ready throughout the year. Each box comes with everything you need for 25 tests: individually sealed cassettes, sterile nasal swabs, pre-filled extraction tubes, tube tips, holders, and clear instructions. Optional quality controls are available to help you keep your testing process consistent. With its fast results and reliable performance, this kit helps healthcare providers quickly identify what’s causing a patient’s symptoms and take the right next steps.

Specifications

• Manufacturer: Healgen
• Product Type: COVID-19/Flu A&B Antigen Combo Rapid Test Cassette
• Test Method: Lateral Flow Immunochromatographic Assay
• Target Analytes: SARS-CoV-2, Influenza A, And Influenza B Antigens
• Specimen Type: Nasal Swab
• Time To Results: Approximately 15 Minutes
• Intended Testing Window: Within Five Days Of Symptom Onset
• Regulatory Status: FDA Emergency Use Authorization (EUA)
• CLIA Classification: Waived
• COVID-19 Positive Percent Agreement: 90.2%
• Influenza A Positive Percent Agreement: 90.0%
• Influenza B Positive Percent Agreement: 91.2%
• Shelf Life: Up To 16 Months
• Storage Temperature: 2°C To 30°C (36°F To 86°F)
• Quantity: 25 Tests Per Box

Box Contents

• 25 Individually Sealed Test Cassettes
• 25 Sterile Nasal Swabs
• 25 Pre-Filled Extraction Tubes
• 25 Extraction Tube Tips
• 2 Tube Holders
• Instruction Sheet For Healthcare Providers
• Fact Sheets For Healthcare Providers And Patients
• Quick Reference Guide (QRG)

Important Regulatory Information

This product has not been FDA cleared or approved, but it has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories. It is only authorized for the detection of SARS-CoV-2, Influenza A, and Influenza B antigens and should not be used for detection of any other pathogens.

Testing Information: Testing must be performed according to the manufacturer's current Instructions for Use, including repeat testing requirements. Negative results do not rule out infection and should be evaluated alongside clinical findings and patient history.

Licensing requirements may vary by state or locality. Please verify regulations prior to purchase.