Detects five respiratory viruses from an anterior nasal swab in ~15 minutes. IVDR CE self-test certified. See IFU for intended use, performance and limitations.
Accurate and sensitive antigen detection for the ongoing monitoring of COVID-19, including variants, directly from nasal or nasopharyngeal swabs.
Flu A
Detects active infection from seasonal and pandemic flu A strains with rapid antigen response. Enables early isolation and treatment decisions.
Flu B
Identifies influenza B variants swiftly to differentiate co-circulating flu outbreaks and reduce misdiagnosis with other respiratory pathogens.
RSV
Rapid detection of respiratory syncytial virus infections, critical for pediatric and geriatric populations where timely diagnosis prevents complications.
ADV
Screens for common adenovirus respiratory infections that often mimic influenza, supporting better clinical differentiation and management.
Most simple and convenient way to use – in just one swab!
Always follow the Instructions for Use (IFU). Training available upon request.
MAK-5 outperforms similar tests with great accuracy
Sensitivity
High Sensitivity Detects even low viral antigen levels with validated sensitivity above 95 %, minimizing false negatives across all five pathogens.
Specificity
Exceptional Specificity Proven accuracy above 98 %, ensuring reliable differentiation between similar respiratory infections and reducing false positives.
Time to Result
Rapid Results Clear, easy-to-read outcomes in 15 minutes — enabling faster clinical decisions and improved patient management vs. alternative methods.
Validated under CE-IVDR standards for professional and OTC applications.
Intended Use & Specifications
Specimen: Anterior nasal swab
Readout: Lateral flow immunoassay
Storage: As per IFU
Shelf life: See label
Operating temp: See IFU
Certification: IVDR CE self-test (CE ####)
Packaging: Box contents listed below
Disposal: Per local regulations
Availability: EU/SEA (contact us)
What’s included in the MAK-5?
Test Cassettes
Individually packed, ready-to-use rapid antigen strips pre-coated for five-pathogen detection.
Extraction Buffer
Optimized reagent ensuring stable antigen release and consistent performance.
Swabs
High-absorbency, individually sealed, suitable for nasal or nasopharyngeal collection.
IFU
Step-by-step illustrated guide ensuring correct handling and interpretation.
MAK-5 identifies five major respiratory pathogens — Influenza A & B, SARS-CoV-2, RSV, and Adenovirus — in a single test.
How should results be interpreted?
Follow the IFU result guide; faint lines should be interpreted per IFU instructions.
What sample types can be used?
MAK-5 supports nasal and nasopharyngeal swab samples.
How long does the test take?
Results are typically available within 15 minutes after sample application.
What is the test’s regulatory status?
MAK-5 is CE-marked (IVDR compliant) and validated for professional and OTC (over-the-counter) use in select markets.
What is the storage temperature range?
Store between 2°C and 30°C; no refrigeration required during standard handling.
What is the sensitivity and specificity?
Validated sensitivity and specificity exceed 95% for all five pathogens under controlled clinical evaluation.
Can MAK-5 detect co-infections?
Yes, it simultaneously identifies multiple positive pathogens in one sample.
Is special equipment required?
No external reader or instrument is needed — results are visually interpretable.
What is the shelf life of the kit?
Unopened kits are stable for 18–24 months from production date.
Who can perform the test?
Healthcare professionals, clinics, pharmacies, and (in OTC-approved regions like Europe) self-testing individuals following the included IFU (“home-use”).
