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Accu-Tell<sup>®</sup> SARS-CoV-2 Ag Rapid Test Cassette with CE Registration Available Now

Nov. 17, 2020
مشاركة:

STATEMENT:

1. Accu-Tell® SARS-CoV-2 Ag Cassette is for professional use. It is NOT for self-testing or home use;

2. Any distributor shall notify to your local authority about the product and get the appropriate approval before you import and place the product in your local market;

3. We are not marketing, selling, or distributing Accu-Tell® SARS-CoV-2 Ag Cassette without FDA clearance in USA.

 

Following the successful launch of Accu-Tell® COVID-19 IgG/IgM Rapid Test, Accu-Tell® SARS-CoV-2 Ag Rapid Test Cassette is available now. We also got CE registration in EU for our Accu-Tell® SARS-CoV-2 Ag Rapid Test Cassette.

 

ACCU-TELL® SARS-CoV-2 Ag Cassette (Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigen in Nasopharyngeal swab. The identification is based on the monoclonal antibodies specific for the Nucleocapsid(N)protein of SARS-CoV-2. It is intended to aid in the rapid differential diagnosis of COVID-19 infections. It is for professional in vitro diagnostic use only.

 

After continuous clinical trials and technical improvements, ACCU-TELL® SARS-CoV-2 Ag Cassette (Nasopharyngeal Swab) demonstrates the reliable performance characteristics as below:

Relative Sensitivity: 95.0% (95%CI*:83.1%-99.4%)*

Relative Specificity: 99.2% (95%CI*:97.6%-99.8%)*

Relative accuracy: 98.8% (95%CI*:97.1%-99.6%)*

* Confidence Intervals

 

The LOD for ACCU-TELL® SARS-CoV-2 Ag Cassette (Nasopharyngeal Swab) was established using limiting dilutions of a viral sample inactivated. The material (ZeptoMetrix, 0810587CFHI) was supplied at a concentration of 1.15x107 TCID50/mL. The Estimated LOD is 1000 TCID50/mL.

 

Now, we are ready to produce and deliver ACCU-TELL® SARS-CoV-2 Ag Cassette as well as Accu-Tell® COVID-19 IgG/IgM Rapid Test to our distributors worldwide. All our distributors, end users at hospitals and clinical labs and relevant research institutions are welcome to inquire about our products.

 

Accu-Tell® SARS-CoV-2 Ag Cassette

Accu-Tell® COVID-19 IgG/IgM Rapid Test