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Infectious Disease IgG IgM Monkeypox ISO Certificate Rapid In 15 Minutes

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China Lumigenex (Suzhou) Co. Ltd certification
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Infectious Disease IgG IgM Monkeypox ISO Certificate Rapid In 15 Minutes

Infectious Disease IgG IgM Monkeypox ISO Certificate Rapid In 15 Minutes
Infectious Disease IgG IgM Monkeypox ISO Certificate Rapid In 15 Minutes Infectious Disease IgG IgM Monkeypox ISO Certificate Rapid In 15 Minutes Infectious Disease IgG IgM Monkeypox ISO Certificate Rapid In 15 Minutes Infectious Disease IgG IgM Monkeypox ISO Certificate Rapid In 15 Minutes Infectious Disease IgG IgM Monkeypox ISO Certificate Rapid In 15 Minutes

Large Image :  Infectious Disease IgG IgM Monkeypox ISO Certificate Rapid In 15 Minutes

Product Details:
Place of Origin: China
Brand Name: Lumigenex
Certification: ISO13485, CE
Model Number: C3107-001, C3107-005, C3107-010, C3107-025, C3107-050.
Payment & Shipping Terms:
Minimum Order Quantity: 1000
Price: USD1.5/test
Packaging Details: Normally 20Tests/Box,1200Tests/Carton;Individually/5/10/50 Tests/Box Negotiable
Delivery Time: Depends On Order Quantity,Negotiable
Payment Terms: T/T, Western Union, Alipay
Supply Ability: 500,000-600,000 Pcs/Day

Infectious Disease IgG IgM Monkeypox ISO Certificate Rapid In 15 Minutes

Description
Product Name: PocRoc® Monkeypox Virus IgM/IgG Antibody Rapid Test Kit (Colloidal Gold) Function: Detection Of Monkeypox Virus IgM/IgG Antibody
Application: IVD Professional Test In Hospital Clinic Laboratory Format: Cassette
Specimen: Whole Blood /Serum/Plasma Storing Temperature: 4℃-30℃
Shelf Life: 24 Months Sensitivity: 93.33%
Specificity: 99.16%
High Light:

Monkeypox Infectious Disease Detection Kit

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ISO Certificate Monkeypox Test Kit

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Monkeypox Test Kit 15 Minutes

Infectious Disease Detection Kit IgG IgM Monkeypox ISO Certificate Rapid In 15 Minutes

PocRoc® Monkeypox Virus IgM/IgG Antibody Rapid Test Kit (Colloidal Gold)
 

 

Intended Use

The PocRoc® Monkeypox Virus IgM/IgG Antibody Rapid Test Kit (Colloidal Gold) is intended for in vitro qualitative detection and differentiation of anti-Monkeypox Virus IgM and IgG antibodies in human serum/plasma/whole blood samples (including venous blood and fingertip blood) from patients suspected of Monkeypox Virus infection.

 

For in vitro diagnostic use only.

 

Infectious Disease IgG IgM Monkeypox ISO Certificate Rapid In 15 Minutes 0

 

Test Principle

The Rapid Test Kit (Colloidal Gold) is based on a one-step capture method. The test strip contains two separated test lines which are pre-coated respectively with two mouse-anti-human IgM and anti-human IgG antibodies in the nitrocellulose membrane. Monkeypox virus recombinant envelope protein antigen which can specifically bind to human anti-monkeypox virus antibodies (IgM and IgG) and goat anti-chicken IgY antibodies are bound to colloidal gold particles and sprayed on conjugation pads. When the sample is applied to the sample well, the human anti-monkeypox virus IgM and/or IgG antibodies and the labeled monkeypox virus recombinant envelope protein antigens complexes are formed and travel up the test strip. The complexes are captured respectively by the mouse anti-human IgM and anti-human IgG antibodies in the two test lines, then the labeled colloidal gold colorimetric particles form a visible red line respectively in the two test lines. The control (C) line is pre-coated with Chicken IgY. The control (C) line appears in the result window when the sample has flowed through the strip. The control line is used as procedural control. The control line should always appear if the test procedure is performed properly and the reagents are working as intended.

 

Package

 

REF No Package Cassette Sample Buffer Pipette Lancet IFU
C3107-001 1 test / box 1 1 1 1 1
C3107-005 5 tests / box 5 5 5 5 1
C3107-010 10 tests / box 10 10 10 10 1
C3107-025 25 tests / box 25 25 25 25 1
C3107-050 50 tests / box 50 50 50 50 1

 

IgM IgG Antibody Rapid Test Kits Features & Advantages:

  • Rapid & Swift: The test can be finished in about 15 minutes. simple operation, and accuracy of 99.16%.
  • Convenient: Simple to use, with visible results explanation.
  • High Specific: Very few false negative test results, and a positive detection rate of about 95%.
  • Economical: Low cost
  • Certificates: ISO13485 and CE
Warnings and Precautions

1. Only for in vitro diagnostic and medical professional usage.
2. Carefully read the packaging booklet and follow all directions. 
3. Do not use the test kit beyond the expiry date on the packaging.
4. Sample buffers and test strips from different batches cannot be combined.
5. The test is only for single use. Don't reuse it in any circumstances.
6. Follow the safety guidelines of the clinic or lab in the procedure of collection, handling, storage, and disposal of patient samples and all items exposed to patient samples.
7. Suitable temperature is 20°C ~ 30°C and humidity RH is 40% ~ 60%.
8. Allow the test kit and specimen to equilibrate to room temperature (15-30°C) before testing.
9. Follow the storage recommendations listed on the packing labels. Improper storage may adversely affect the product.
10. It is not recommended to run the test on blood samples with visible hemolysis. 
 

Contact Details
Lumigenex (Suzhou) Co. Ltd

Contact Person: Bonnie

Tel: 86-13814877381

Send your inquiry directly to us (0 / 3000)