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BIOTEKE 5-in-1 Respiratory Antigen Rapid Test Kit

Views: 0     Author: BioTeke Corporation     Publish Time: 2026-01-23      Origin: Bioteke

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BIOTEKE 5-in-1 Respiratory Antigen Rapid Test Kit

BIOTEKE Respiratory 5-in-1 Antigen Rapid Test Kit


Fast, Multi-Pathogen Detection for Efficient Respiratory Disease Screening

Respiratory infections remain one of the most common causes of outpatient visits and public health screening worldwide. In clinical practice and large-scale screening scenarios, rapid, accurate, and easy-to-use diagnostic tools are essential for early differentiation of respiratory pathogens and timely decision-making.

The BIOTEKE Respiratory Tract 5-in-1 Antigen Rapid Test Kit is designed to meet these needs by enabling simultaneous qualitative detection of five common respiratory pathogens using a single test procedure. Developed for self-testing, professional use and distribution, this kit combines speed, convenience, and reliability, making it an ideal solution for clinics, hospitals, pharmacies, and medical device distributors.



What Is the BIOTEKE 5-in-1 Respiratory Antigen Rapid Test Kit?

The BIOTEKE 5-in-1 Respiratory Antigen Rapid Test Kit is an in vitro diagnostic (IVD) product based on immunochromatographic assay technology. It is intended for the qualitative detection of multiple respiratory pathogen antigens from human respiratory samples(anterior nasal swab).

By integrating multiple targets into one test format, the kit helps users, healthcare providers and screening organizations reduce testing time, lower operational complexity, and improve workflow efficiency, especially during respiratory infection seasons.



Key Features and Benefits

  • Multi-pathogen detection in one test
    Simultaneously screens for five respiratory pathogens, reducing the need for multiple single tests.

  • Rapid results
    Test results are available within a short time frame after sample application, supporting point-of-care decision-making.

  • Simple operation
    Designed for ease of use, with minimal hands-on time and no requirement for complex laboratory equipment.

  • Flexible sample types
    Compatible with commonly used respiratory samples such as anterior nasal swabs or pharyngeal swabs (refer to IFU for details).

  • Suitable for high-throughput screening
    Ideal for clinics, outpatient departments, pharmacies, and distribution to primary healthcare facilities.

  • B2B-friendly supply model
    Stable production capacity, clear MOQ, and OEM/ODM support for international distributors.



Target Pathogens Detected

The BIOTEKE Respiratory 5-in-1 Antigen Rapid Test Kit is designed to detect five clinically relevant respiratory pathogens that are commonly associated with acute respiratory tract infections: SARS-CoV-2, Influenza A virus, Influenza B virus, Respiratory syncytial virus(RSV), Adenovirus.

Note: The exact pathogen panel and performance characteristics should be confirmed according to the official Instructions for Use (IFU) and product datasheet.

This multi-target approach helps clinicians and screening personnel quickly differentiate respiratory infections, supporting appropriate follow-up testing or clinical management when necessary.



Intended Use and Application Scenarios

Intended Use
This product is intended for in vitro qualitative detection of respiratory pathogen antigens in human respiratory specimens. It is designed for self-testing and professional use in accordance with applicable local regulations.

Typical Application Scenarios

  • Hospitals and outpatient clinics

  • Community healthcare centers

  • Chain pharmacies and retail clinics

  • Disease screening programs

  • Medical laboratories (as a rapid screening tool)

  • Distributor portfolios targeting respiratory diagnostics


How It Works

Click to watch the video



Performance and Quality Assurance

BIOTEKE places strong emphasis on product consistency, quality control, and regulatory compliance throughout the manufacturing process.

  • Manufactured under a certified quality management system

  • Each batch undergoes internal quality control testing

  • Performance parameters such as sensitivity and specificity are validated and documented in the IFU

  • Designed to provide reliable and repeatable results when used according to instructions

For detailed analytical and clinical performance data, distributors and healthcare professionals are encouraged to download the official product datasheet or IFU.


Download the IFU 

    IFU 5 IN 1 CE3018.pdf



Regulatory Status and Compliance

  • Developed as an IVD medical device

  • Manufactured in compliance with international quality standards(ISO13485).

  • Relevant certifications and registrations (such as CE marking, IVDR certification) are available upon request

  • Documentation support provided for distributor registration and market access

Always ensure compliance with local regulatory requirements before importing, distributing, or using the product.


Explore the IVDR certification on EUDAMED(European Database on Medical Devices)https://ec.europa.eu/tools/eudamed/#/screen/certificates/f399036b-5dfc-4bdf-b434-9b75079abd7e


Why Choose BIOTEKE as Your IVD Partner?

With extensive experience in the in vitro diagnostics industry, BIOTEKE is a trusted manufacturer and supplier of rapid test kits and molecular diagnostic solutions.

Key Advantages for Distributors

  • Stable manufacturing capacity and reliable lead times

  • Minimum Order Quantity (MOQ) VARIABLE

  • OEM and ODM customization options available

  • Professional technical documentation support

  • Experience in global distribution and international trade

  • Responsive sales and after-sales support


Technical Overview (Summary)

Item Description
Test Method Immunochromatographic assay
Detection Type Qualitative
Sample Type Anterior nasal or pharyngeal swab
Targets 5 respiratory pathogens
Intended Use In vitro diagnostic
Result Time Within 15 minutes (refer to IFU)
Storage 2-30℃
MOQ 3600 boxes(Variable)
OEM/ODM Available

Frequently Asked Questions (FAQ)

Q1: Is this test suitable for home use?
Yes. The BIOTEKE 5-in-1 Respiratory Antigen Rapid Test Kit is intended for self-testing and professional use.

Q2: Can distributors request samples?
Yes. Samples may be available for qualified distributors upon request, subject to internal evaluation.

Q3: Does BIOTEKE support private labeling?
Yes. BIOTEKE offers OEM and ODM services, including customized packaging and branding, in accordance with regulatory requirements.

Q4: Is technical documentation provided?
Yes. Datasheets, IFU, certificates, and other supporting documents are available to assist with registration and distribution.

Q5: Does BIOTEKE have stock available? Or how long is the production cycle?

We only have a limited number of stock samples for customer evaluation. The production time for the product starts when the customer places an order. This helps ensure a long lifespan. The production cycle takes about 7 to 14 days.



Contact BIOTEKE for Pricing and Documentation

If you are a medical device distributor, wholesaler, or importer looking to expand your respiratory diagnostics portfolio, the BIOTEKE Respiratory Tract 5-in-1 Antigen Rapid Test Kit is a reliable and competitive option.


Request a quote


Download the product datasheet


Contact our sales team for distribution cooperation





Disclaimer

This product is intended for in vitro diagnostic use only. Product availability, regulatory status, and permitted applications may vary by country. Always follow local regulations and the official Instructions for Use.


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