CE IVDR Class C self-test for lay-user application. Suitable for OTC-oriented channels. Detects five respiratory viruses from an anterior nasal swab in ~15 minutes. See IFU for intended use, performance and limitations.
Why 5-in-1 Respiratory Testing Matters
01
Beyond COVID + Flu
Many respiratory symptoms are not caused by COVID-19 or influenza. Broader testing reduces the blind spots and improve treatments. For easy patient home-/self-testing
02
RSV Included
RSV is a major seasonal respiratory pathogen and can be clinically relevant in children, older adults and vulnerable groups. ECDC highlighted RSV activity together with influenza during the 2024/2025 winter season in the EU/EEA.
03
Adenovirus Included
Adenovirus is frequently overlooked in respiratory testing despite causing symptoms that can resemble bacterial infections. Including Adenovirus in the MAK-5 panel helps close an important diagnostic gap, supporting better differentiation of viral respiratory illnesses and helping avoid unnecessary assumptions about bacterial causes.
What pathogens does MAK-5 detect?
SARS-CoV-2
Rapid antigen detection of SARS-CoV-2 to support respiratory self-testing and differentiation from other common respiratory pathogens.
Flu A
Detects Influenza A antigen as part of a combined respiratory panel, supporting faster awareness during flu seasons and mixed outbreaks.
Flu B
Identifies influenza B variants swiftly to differentiate co-circulating flu outbreaks and reduce misdiagnosis with other respiratory pathogens.
RSV
Detects RSV antigen, relevant for children, older adults and vulnerable groups where respiratory infections may require closer attention.
ADV
Screens for common adenovirus respiratory infections that often mimic influenza or bacterial infections, supporting better clinical differentiation and treatment.
One Sample Well. Five Results.
MAK-5 is designed for simplicity. Thanks to its patented bidirectional flow technology, one prepared sample is added into a single sample well and distributed across the test card for detection of all five target pathogens: SARS-CoV-2, Influenza A, Influenza B, RSV and Adenovirus.
This reduces handling steps compared with multi-well test designs and helps minimize user error — an important advantage for home users, elderly users, pharmacies and OTC-oriented distribution.
Most simple and convenient way to use – in just one swab!
Always follow the Instructions for Use (IFU). Training available upon request.
Intended Use & Specifications
Specimen: Anterior nasal swab
Readout: Lateral flow immunoassay
Storage condition: 2~30℃ (as per IFU)
Shelf life: 24 months (see label)
Certification: IVDR CE Class C self-test, ISO13485
Disposal: Per local regulations
Availability: Europe, SEA & AUNZ (contact us)
MAK-5 outperforms similar tests with great accuracy
Sensitivity
High Sensitivity Validated clinical performance across all five target pathogens, with high sensitivity.
Specificity
Exceptional Specificity Proven high accuracy 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.
CE-IVDR Class C self-test for lay-user application. Suitable for OTC-oriented channels, pharmacies, retail and home-testing programs where permitted by local regulation.
MAK-5 Technical Information
Regulatory note: MAK-5 is positioned as consumer self-test and OTC-ready. Market access, sales channels and claims depend on local registration requirements.
Item
MAK-5
Product Type
Respiratory multipathogen antigen rapid test
Use Type
Self-test and OTC-ready
Pathogens
SARS-CoV-2, Flu A, Flu B, RSV, ADV
Technology
Immunochromatographic antigen assay
Sample Type
Anterior nasal swab
Result Time
Within approx. 15 minutes
Format
Cassette
Storage
2–30°C
Packaging
1 test/kit, 20 tests/kit
Certification / Status
CE-marked IVDR for self-test usage ISO 13485 manufacturer quality system
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.
Study Experience
VACCELERATE Europe
MAK-5 was used in two German VACCELERATE pilot studies published among others in Frontiers in Public Health to evaluate self-testing for five respiratory viruses in adult volunteers as well as senior citizens in particular.
Self-testing enables real-time reporting
During one winter season, 1,429 participants communicated self-testing results. Among symptomatic participants, SARS-CoV-2, RSV and Influenza A were the most frequently detected pathogens. The study concluded that self-testing enabled real-time reporting of five endemic acute respiratory infection pathogens in a citizen-science setting.
Key Points
German/EU VACCELERATE volunteer registry studies
Five respiratory pathogens monitored
Published in Frontiers in Public Health and Clinical Microbiology and Infection CMI
Supports real-world relevance of multipathogen self-testing
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 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?
MAK-5 is supported by clinical performance data across all five target pathogens. Please refer to the IFU, datasheet and performance documentation for pathogen-specific sensitivity and specificity values.
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?
MAK-5 is designed as a CE IVDR self-test for lay users. It may also be used in suitable healthcare, pharmacy or workplace settings where permitted by local regulation and applicable procedures.
