WELLlifeItem # 100874MPN WV01P0002

COVID-19/Influenza A&B Test 25/Bx

In Stock

WELLlife™ COVID-19/Influenza A&B Rapid Test

This rapid lateral-flow immunoassay kit for institutional use simultaneously detects and differentiates SARS-CoV-2, Influenza A and Influenza B antigens from a single anterior nasal swab specimen in symptomatic individuals.

Includes: (25) Test Cassettes, (25) Prefilled Extraction Buffer Tubes, (25) Sterile Swabs, Positive Control, Negative Control, Tube Holder, IFU
Differentiate between SARS-COV-2, Influenza A, and Influenza B infections with an easy nasal swab
Has a broader detection window within five (5) days of symptom onset.
Cassette Format
Nasal Swab
10 Minute Results
510(k) cleared
25/Bx

Manufacturer: WELLlife
Number Of Tests: 25 Tests
Sold By: Case of 25
Storage Condition: 36°F-86°F (2°C-30°C)
Test Type: Cassete
Time to Results: 10 Minutes

How does the performance of the WELLlife COVID-19/Influenza A&B Rapid Test compare to PCR tests in a clinical setting?

The WELLlife COVID-19/Influenza A&B Rapid Test, being a rapid lateral-flow immunoassay, generally offers quicker results but may not match the sensitivity and specificity of PCR tests, which are considered the gold standard for viral detection. [Manufacturer Info][Industry Standards]

What are the implications of this test being FDA Emergency Use Authorized rather than cleared or approved?

The FDA Emergency Use Authorization indicates that the WELLlife COVID-19/Influenza A&B Rapid Test is permitted temporarily during specific circumstances like public health emergencies, and may not have undergone the same full review process as FDA-approved or cleared tests. [Industry Standards]

How easy is it to use the test for someone who isn't familiar with medical devices, like a school nurse or small clinic staff?

The WELLlife COVID-19/Influenza A&B Test is designed for ease of use with pre-filled extraction buffer tubes and clear instructions, making it accessible for individuals like school nurses or staff at small clinics with minimal training. [Manufacturer Info]

Could you explain the steps involved in performing the test and how results are interpreted?

To perform the test, collect a nasal swab sample, insert the swab into the pre-filled buffer tube, then apply the sample to the test cassette; results appear within 10 minutes, showing different lines to indicate the presence of COVID-19, Influenza A, or B. [Manufacturer Info]

What storage conditions are optimal for maintaining the effectiveness of these test kits?

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