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Corona virus test kits

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Corona virus test kits

 

    COVID-19 IgG/IgM Rapid Test Device;  

     

    • Manufacturer: Assure Tech (Hangzhou) Co., Ltd., Building 4, No. 1418-50, Moganshan Road, Gongshu District, Hangzhou, Zhejiang 310011, China.

    • Distributor C3MD, Inc, 11870 W. SR 84, Davie, FL 33325 tached): • FDA Registered Establishment Number: 3009585529

    • FDA Owner Operator Number: 10040710

    • FDA EUA Application: Pending

    • EN ISO 13485:2016 • Brazil RDC ANVISA n. 16/2013,RDC  ANVISA n. 23/2012, RDC ANVISA n. 67/2009

    • Canada Medical Devices Regulations – Part 1 – SOR 98/282

    • United States 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 – Subparts A to D

    • Chinese Certificate for exportation of medical products: 20200145

     

    Product Information:


    • Type: In Vitro Diagnostic Medical Device

    • Product Name: COVID-19 IgG/IgM Rapid Test Device

    • Product Specs:

               o This test is an in vitro immunoassay for the direct and qualitative detection of anti-SARS- CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma.

              o The test is for professional use only.

              o Pending FDA EUA

    • Validation study: Completed in the U.S. 5/2020: Sensitivity 90%, Specificity 100% (n=66).

     

    Production Schedule:

     

    • Quantity Available: 50,000 units per shipment

     

    Payment Terms:

     

    • 50% EFT or ACH in advance, 50% EFT or ACH prior to shipment from PVG.

     

    Payment Method: • EFT or ACH

    Coronavirus covid-19 test-kits
    Will be available soon

 COVID-19 IgG/IgM Rapid Test Device
(Whole Blood / Serum / Plasma)

COVID-19 testing are now available for the rapid determination of disease using a single drop of blood. The test is a serologic test and looks for IgM (acute) and IgG (convalescent) antibodies to the virus.

What are the known results:
FaSTEP
(by Assure Tech)

Assure Tech. (Hangzhou) Co., Ltd., the manufacturer of FaSTEP performed clinical trials at two sites in China from February 2020 to March 2020. These clinical trials were aimed to evaluate the performance of the COVID-19 IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) against known patient PCR results:

IgM Testing

74/79 PCR+ patients who were also symptomatic also had a positive rapid test for IgM (93.7% sensitivity)

225/227 PCR (-) patients had a negative rapid test (Specificity 99.1%)

IgG Testing

82/83 patients who had recovered from the disease were positive for IgG

(Sensitivity 98.8%)

224/227 PCR (-) patients had a negative rapid test (Specificity 98.7%)

What are the upsides:

Testing is straightforward and results are immediate (see below for instructions).
  o
15 minutes to run the test.

The test uses 10 microliters of blood
  o
A nasopharyngeal swab is NOT required to administer this test.
  o
All contents required are found in the individually packaged kit.

It can help HCPs make decisions on who to get back to work and who may need to get further confirmatory testing.

Multiple tests can be done days apart to help improve accuracy.

 

 


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