Successful PEI Evaluation of Accu-Tell® SARS-CoV-2 Ag Rapid Test for nasopharyngeal sample

Good News: Our Accu-Tell^® SARS-CoV-2 Ag Rapid Test for nasopharyngeal sample has successfully passed PEI evaluation by BfARM in Germany. Please check the attached screen shot: ja means yes for successful evaluation.

In our clinical study, ACCU-TELL® SARS-CoV-2 Ag Cassette (Nasopharyngeal Swab) has been evaluated with specimens obtained from the patients. RT-PCR is used as the reference method. Specimens were considered positive if PCR indicated a positive result. The performance characteristics are as following:

Relative Sensitivity: 95.7% (95%CI*:90.3%-98.6%)*

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

Relative accuracy: 98.3% (95%CI*:96.7%-99.3%)*

* Confidence Intervals

The Estimated LOD is 1000 TCID₅₀/mL.

Till now, our following rapid tests relevant to COVID-19 infection diagnosis have got CE registration in EU:
-       Accu-Tell^® COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma);
-       Accu-Tell_® SARS-CoV-2 Ag Rapid Test Cassette (Nasopharyngeal Swab);
-       Accu-Tell^® SARS-CoV-2 + Flu A&B Antigen Combo Cassette (Nasopharyngeal Swab);
-       Accu-Tell^® SARS-CoV-2 Neutralizing Antibody Cassette (Whole Blood/Serum/Plasma);
-       Accu-Tell^® COVID-19 Antigen Cassette (Saliva)；

-       Accu-Tell^® COVID-19 Antigen Cassette (Nasal Swab)；

-       Accu-Tell^® SARS-CoV-2 Neutralizing Antibody Cassette (RBD) (Whole Blood/Serum/Plasma)

If you need any of the above COVID-19 Testing products, please feel free to contact us. We will provide the samples for your evaluation.