Clinical Performance at a Glance
Designed for Diagnostic Confidence
5 -in-1
Pathogens detected in a single test panel
15 min
Time to result from specimen application
≥98 %
Overall accuracy across all five detection targets
≥99 %
Overall specificity across all five detection targets
Detection Targets
Five Pathogens. One Cassette. One Decision.
SARS-CoV-2, Influenza A/B, RSV, and Adenovirus produce clinically indistinguishable symptoms. The BIOTEKE 5-in-1 Combo Test enables definitive differential diagnosis from a single patient contact — reducing unnecessary antibiotic prescriptions and enabling targeted treatment decisions.
SARS-CoV-2
Severe Acute Respiratory Syndrome Coronavirus 2 (COVID-19 causative agent)
Influenza A
Influenza Virus Type A — seasonal and pandemic strains including H1N1, H3N2
Influenza B
Influenza Virus Type B — Victoria and Yamagata lineages
RSV
Respiratory Syncytial Virus — Types A and B; high-risk for infants and elderly
Adenovirus
Human Adenovirus — multiple serotypes; respiratory, ocular and enteric disease
Product Overview
![BIOTEKE 5-in-1 respiratory antigen rapid test]( "BIOTEKE 5-in-1 respiratory antigen rapid test")
Multiple Respiratory Multipathogen
Antigen Test Kit
A CE-IVDR 2017/746 certified medical device for the simultaneous qualitative detection of five respiratory virus antigens from a single anterior nasal swab specimen — at the point of care, without laboratory infrastructure.
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✓Multiplex lateral flow immunoassay — five virus-specific antibody pairs detect and differentiate all target antigens simultaneously in one reaction zone.
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✓No instrumentation required — visual read in 15 minutes; suitable for point-of-care, emergency department, and community pharmacy settings.
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✓Reduces test cost per patient — one kit replaces up to five sequential rapid tests, lowering reagent spend and clinician time per episode.
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✓Stable 2–30°C — no cold-chain dependency during storage, enabling cost-effective distribution across diverse climates and logistics conditions.
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✓OEM and private-label ready — custom packaging, multi-language inserts, and private-label production for qualified distribution partners.
Request Product Datasheet 》
Testing Procedure
Simple 4-Step Protocol
Designed for primary care clinics, pharmacies, emergency departments, and field screening — no specialist laboratory training required.
Collect Specimen
Anterior nasal swab using the sterile swab included in the kit.
~30 sec
Prepare Sample
Insert swab into the extraction tube, stir 5 times, press against tube wall.
~30 sec
Apply to Panel
Dispense 3 drops of mixed sample into the specimen well on the test panel.
~30 sec
Read Results
Interpret the result window at 15 minutes. Coloured lines identify each positive pathogen.
~15 min
Technical Data
Product Specifications
| Specification | Details |
| Product Name | Multiple Respiratory Multipathogen Antigen Test Kit |
| Manufacturer | BioTeke Corporation(Wuxi) Co., Ltd |
| Intended Use | Simultaneous qualitative in vitro detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Adenovirus antigens in human anterior nasal swab specimens |
| Test Principle | Lateral Flow Immunoassay (LFIA) |
| Specimen Types | Anterior nasal swab (ANS) |
| Time to Result | 15-20 minutes |
| Regulatory Certification | CE marked under EU Regulation 2017/746 (IVDR), Class C In Vitro Diagnostic Medical Device |
| Quality Standard | ISO 13485:2016 certified manufacturing facility; GMP compliant |
| Storage Conditions | 2°C – 30°C; protect from direct sunlight and moisture. No refrigeration required during field deployment. |
| Shelf Life | 24 months from date of manufacture |
| Kit Contents | Test cassettes (sealed foil pouches), sterile swabs, extraction tubes & caps, Instructions for Use (IFU) |
| Pack Sizes | 1 test/kit (standard); bulk carton 360 kits/carton. Custom pack sizes available for B2B orders. |
Partnership Value
Why Distributors Choose BIOTEKE
IVDR-Ready for EU Entry
Full CE marking under Regulation 2017/746 eliminates notified body delays for market entry. Regulatory dossier and IFU available in 10+ languages for EU distribution partners.
OEM & Private Label
Custom branding, packaging design, and insert localization for qualified partners. Minimum order quantities negotiable. White-label registration support available.
Scalable Supply Chain
ISO 13485-certified GMP facility with capacity for large-volume tenders and seasonal demand peaks. Consistent lead times without quality compromise.
Regulatory Affairs Support
Dedicated scientific and regulatory team supporting local market registration, product training materials, and post-market surveillance requirements in your territory.
Multi-Market Portfolio
BIOTEKE respiratory products serve EU, MENA, Southeast Asia, and Latin American markets — consolidate your rapid diagnostic sourcing with one certified manufacturer.
Full Documentation Package
Complete technical file, clinical evaluation reports, CE certificate, and performance studies available under NDA to support your local regulatory submissions.
Common Questions
Frequently Asked Questions
![]() | What pathogens does the BIOTEKE 5-in-1 combo test detect? |
| The BIOTEKE Multiple Respiratory Multipathogen Antigen Test Kit simultaneously detects five respiratory pathogens from a single specimen: SARS-CoV-2, Influenza A (Flu A), Influenza B (Flu B), Respiratory Syncytial Virus (RSV), and Adenovirus(ADV). Each pathogen is identified independently via a dedicated detection zone on the lateral flow cassette. A control line (C) confirms the test has run correctly. |
![]() | Is the BIOTEKE 5-in-1 combo test CE marked under the EU 2017/746(IVDR)?
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| Yes, The BIOTEKE Multiple Respiratory Multipathogen Antigen Test Kit holds CE marking under EU Regulation 2017/746 (IVDR), classified as a Class C in vitro diagnostic medical device. This certification confirms compliance with the performance, safety, and clinical evidence requirements of the current EU IVDR framework. A copy of the CE certificate is available to registered distribution partners.
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![]() | What specimen types does the test accept? |
| The kit is validated for anterior nasal swab (ANS) specimens. Sterile swabs and extraction tubes are included in each kit — no additional collection materials are required.
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![]() | How does the cassette differentiate between all five pathogens? |
| The cassette is immunochromatographic and uses double-antibody sandwich method to detection the five respiratory pathogens. During detection, the treated specimens are loaded into the sample wells. When the concentration of the five pathogen antigen is higher than the minium detection limit, the viral antigen will form complexes with labeled antibodies first. Under chromatography, antigen-antibody complexes move forward along the nitrocellulose membrane till captured by pre-coated monoclonal antibodies.
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![]() | Can BIOTEKE offer OEM or private-label versions of the test kits?
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| Yes. BIOTEKE provides OEM and private-label production for qualified distribution partners, including custom outer packaging, multi-language insert translation (currently available in English, German, French, Spanish, Italian,, Portuguese, and Polish, etc.) OEM arrangements require a signed distribution agreement and are subject to minimum order quantities, which are discussed during the qualification process. |
B2B Partnership Inquiry
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