Innovation drives our continued success. At Singclean Medical, our dedicated R&D team relentlessly pursues advancements in materials and technology. Each year, we invest over 10% of our revenue into research and development to stay ahead of evolving market needs and deliver cutting-edge solutions to our customers. In 2022, we established the Singclean IVD Business Unit, focused on the research, production, and quality control of in vitro diagnostic (IVD) products. Our mission is to support comprehensive disease detection and help individuals gain a deeper understanding of their health.
Monkeypox Virus Test Kit
R & D Strength
Quality Certified
Our factory is certified with CE, ISO 13485, NMPA, and other international standards. We operate with advanced production equipment and processes that fully comply with global regulatory requirements.
Global Supply and Honor
We offer comprehensive ODM and OEM services. Our products have been sold in over 60 countries and regions, earning the trust of more than 330 global partners. Our sales network now spans more than 120 countries and regions worldwide.

Introduction of Singclean In Vitro Diagnostic products
Surgiclean® lnfectious Disease Test including Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence PCR), Monkeypox Virus Antigen Test Kit, Monkeypox Virus IgG/IgM Test Kit, FLU A/B Antigen Test Kit, HBsAg Test kit, HIV-1/2 Antibody Urine Assay Kit.
Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence PCR)
Application
The Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence PCR) is designed for the detection of monkeypox virus nucleic acid in serum and pustular or vesicular rash specimens from individuals suspected of monkeypox infection. By specifically targeting nucleic acid fragments of the monkeypox virus, this kit enables rapid and accurate identification, making it ideal for the quick diagnosis of diseases associated with monkeypox virus infection.

Principle
Singclean Monkeypox Virus Nucleic Acid Detection Kit utilizes polymerase chain reaction (PCR) with fluorescent probe technology, employing specific primers designed based on the nucleic acid sequence of the monkeypox virus to amplify targeted nucleic acid fragments. A highly specific probe binds to the corresponding fragment and is hydrolyzed by exonuclease activity, generating a detectable fluorescence signal. The real-time amplification curve is produced based on the correlation between the fluorescence signal and the number of amplification cycles, enabling accurate and efficient detection.

Monkeypox virus Antigen Test Kit
Application
The Monkeypox Virus Antigen Test Kit (Immunochromatography) is a solid-phase immunochromatographic assay designed for the rapid and qualitative detection of monkeypox virus antigens in human body fluids. This test provides a preliminary screening result and should not be used as the sole basis for diagnosis. Any reactive specimen must be confirmed using alternative testing methods in conjunction with clinical evaluation.

Principle
The Monkeypox Virus Antigen Test Kit (Immunochromatography) is a colloidal gold-based immunochromatographic assay designed to detect monkeypox virus antigens in human samples.
The test utilizes a nitrocellulose strip coated with monkeypox virus antibodies at the test line (T) and goat anti-mouse IgG at the control line (C). The conjugate pad contains colloidal gold-labeled monkeypox virus antibodies and mouse IgG-gold conjugates. When the sample mixed with buffer is added to the sample well, any monkeypox virus present binds to the antibody-gold conjugate, forming an antigen-antibody complex.
This complex migrates along the membrane by capillary action. Upon reaching the test line (T), the complex binds to the immobilized monkeypox virus antibody, forming a visible burgundy band—indicating a positive (reactive) result. If no band appears at the test line, the result is negative (non-reactive).
The control line (C) serves as an internal procedural control. A burgundy band should always appear at the control line to validate the test, confirming that the sample has flowed correctly through the strip. If the control line does not appear, the result is invalid, and the test must be repeated with a new device.

Monkeypox virus IgG/IgM Test Kit
Application
The Monkeypox Virus IgG/IgM Test Kit (Immunochromatography) is a solid-phase immunochromatographic assay designed for the rapid and qualitative detection of IgG and IgM antibodies to the monkeypox virus in human blood samples. This test serves as a preliminary screening tool. Any reactive result must be confirmed with additional testing methods and interpreted alongside clinical findings.

Principle
The Monkeypox Virus IgG/IgM Test Kit (Immunochromatography) is based on the principle of immunochromatography. The test strip contains anti-human IgM (test line IgM), anti-human IgG (test line IgG), and goat anti-mouse IgG (control line C) immobilized on a nitrocellulose membrane. The conjugate pad is loaded with microspheres conjugated to recombinant monkeypox virus antigens and mouse IgG.
When a specimen is added to the sample well, followed by assay buffer, any IgM and/or IgG antibodies present in the sample will bind to the antigen-microsphere conjugates, forming antigen-antibody complexes. These complexes migrate along the membrane by capillary action. When they reach the respective test lines (IgM and/or IgG), they are captured by the immobilized antibodies, forming visible bands that indicate a reactive result.
A colored band at the control line (C) confirms proper sample flow and test validity. Absence of the control line indicates an invalid test, and the sample should be retested with a new device.

The production process of in vitro diagnostics

Interpoint Membrane
Class 100,000 Cleanroom

Carry out Sheet Scribing
For Colloidal Gold and Fluorescent Products

Gold Spray
Class 100,000 Cleanroom

Carry out Gold Label Spraying
For Colloidal Gold and Fluorescent Products

Inner Packing
Automatic Inner Packaging Machine

Strips Cutting
Precision Program Control

Pressure Plate
CCD Electronic Eye Detection

Bagging and Sealing
CCD Electronic Eye Detection

Outer Packing
Automatic Outer Packaging Machine

Folding Boxes and Packaging
Precise Packaging of Products
How to cooperate with us?
Submit Inquiry
You can send us inquiries via email or other available channels by providing your requirements and relevant details. Our professional team will respond promptly with comprehensive product information and a detailed quotation.
Assignment of Sales Personnel
Depending on your country of origin and target import market, we will assign dedicated sales representatives to provide personalized service tailored to your specific requirements.
Confirm Purchase Quantity and Price, Sign Contract
After you confirm the products and pricing, we will formalize our agreement by signing a contract that specifies purchase quantities, prices, and other key terms to protect the interests of both parties.
Customized Production
Based on your order requirements, we provide customization services to ensure the products fully meet your specifications. We will manufacture the goods accordingly and ensure timely delivery.
Brand Collaboration for Promotion
If you have branding and promotional needs, we offer collaborative services to help build your brand image and enhance product sales in the market.
After-Sales Service
We are committed to delivering high-quality after-sales service, supporting you in resolving any issues that may occur during product use. Your satisfaction is our highest priority.
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