Description
Rapid Influenza A & B Detection for Point-of-Care Clinical Testing
Support confident clinical decision-making during influenza season with the Medline Influenza A & B Rapid Antigen Test, a convenient, CLIA-waived diagnostic assay designed for the qualitative detection of influenza A and influenza B antigens in anterior nasal swab specimens.
Engineered for efficient healthcare workflows, this rapid cassette-based testing system provides results in approximately 10 minutes, enabling healthcare professionals to evaluate suspected influenza infections without relying on lengthy laboratory turnaround times.
The compact testing format combines straightforward specimen collection, limited hands-on procedures, and easy-to-interpret results. It is suitable for professional point-of-care environments operating within the applicable regulatory requirements and the manufacturer's instructions for use.
Features & benefits
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Dual influenza detection: Qualitative identification of influenza A and B viral antigens.
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Rapid turnaround: Results in approximately 10 minutes.
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CLIA-waived testing: Suitable for facilities authorized to perform the waived test according to applicable requirements.
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Anterior nasal swab collection: Convenient specimen collection method.
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Cassette-based platform: No large laboratory analyzer required.
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High-volume availability: Choose a 25-test box or an 18-box case containing 450 tests.
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Professional applications: Clinics, physician practices, urgent care facilities, occupational health programs, and other qualifying testing environments.
Published performance characteristics
|
Diagnostic measure |
Reported performance |
|---|---|
|
Influenza A positive percent agreement |
92.4% |
|
Influenza B positive percent agreement |
91.4% |
|
Influenza A negative percent agreement |
100% |
|
Influenza B negative percent agreement |
100% |
|
Result time |
10 minutes |
Figures are reproduced from the supplier information shown. Performance depends on the evaluation conditions, patient population, specimen quality, and instructions for use. A negative antigen test does not conclusively exclude influenza infection.
Product specifications
|
Attribute |
Specification |
|---|---|
|
Product name |
Medline Flu A & B Rapid Antigen Cassette Test |
|
MPN |
MPH1825FLU |
|
Test methodology |
Rapid antigen immunoassay |
|
Target analytes |
Influenza A and B |
|
Specimen |
Anterior nasal swab |
|
Test format |
Cassette |
|
Tests per box |
25 |
|
Boxes per case |
18 |
|
Tests per case |
450 |
|
CLIA complexity |
Waived |
|
FDA clearance reference |
K251563 |
|
U.S. FDA product classification |
Influenza A/B Virology |
|
UNSPSC |
41116144 |
|
Latex information |
Not made with natural rubber latex, per supplier listing |
|
Single-use |
Yes |
|
Intended market |
Professional healthcare / clinical testing |
For in vitro diagnostic use. Intended for use only as specified in the current manufacturer's labeling. Not represented as an over-the-counter home self-test. Negative results do not exclude influenza infection and should be interpreted in conjunction with clinical observations, patient history, and other diagnostic information. Testing facilities must comply with applicable CLIA and other regulatory requirements.
The FDA lists this Medline assay under clearance K251563 with a waived complexity designation.
