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

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Lumigenex (Suzhou) Co. Ltd

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

Country/Region china
City & Province suzhou
Categories Dyestuff Intermediates
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Product Details

Infectious Disease Test Kit - IgG / IgM / Monkeypox ISO Certificate CE Registered Rapid Test In 15 Minutes

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

 

Intended Use

PocRoc® Monkeypox Virus IgM/IgG Antibody Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of monkeypox virus antigen in human whole blood, serum, plasma, or rash exudate.

 

For in vitro diagnostic use only.

 

 

Test Principle

The PocRoc® Monkeypox Virus IgM/IgG Antibody 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 NoPackageCassetteSample BufferPipetteLancetIFU
C3107-0011 test / box11111
C3107-0055 tests / box55551
C3107-01010 tests / box101010101
C3107-02525 tests / box252525251
C3107-05050 tests / box505050501

 

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 re-use in any circumstances.
6. Follow the clinical and/or laboratory safety guidelines in the collection, handling, storage, and disposal of patient samples and all items exposed to patient samples.
7. The best test 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) prior to testing.
9. Follow the storage recommendations listed on the product labels. Improper storage may adversely affect the product.
10. It is not recommended to run the test on blood samples with visible hemolysis. 
 

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