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Congratulations! ALLTEST Biotech's COVID-19 Antigen Products have passed the German BfArM Certification

July 6, 2021

GOOD NEWS! The COVID-19 (SARS-CoV-2) Antigen Rapid Test (Swab) independently developed by HANGZHOU ALLTEST BIOTECH CO.,LTD. has successfully passed the approval of the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) to enter the white list means that the quality of ALLTEST BIOTECH SARS-CoV-2 antigen rapid test kit is highly recognized and trusted by BfArM. Since then, ALLTEST BIOTECH has obtained CE certification and local qualification certification of relevant importing countries in more than 40 countries, and has assisted global epidemic prevention and control with a wealth of COVID-19 products and testing solutions.

 

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ALLTEST COVID-19 Antigen Rapid Test Offers:

Easy Nasal Swab specimen collection

Fast results in 15 minutes assay time

Easy visually interpretation

Simple operation, no equipment required

High accuracy

 

The test has been evaluated and approved by a reputable laboratory from Germany:

Clinical Study Results (>100 positive samples; >100 negative samples):

1. Analytical Results with correlation to Ct-values of the positive samples:

 

Ct Value No. of Samples No. of true positive Rapid Test Samples No. of false negative Rapid Test Samples Sensitivity of SARS-CoV-2 Antigen Rapid Test (CI)
≤30 82 81 1 98.8% (93-100)
≤32 106 101 5 95.3% (89-98)

 

2. Analytical Results with correlation to Ct-values of the negative samples:

 

No. of Samples No. of true negative Rapid Test Samples No. of false positive Rapid Test Samples Sensitivity of SARS-CoV-2 Antigen Rapid Test (CI)
100 100 0 100% (96-100), Wilson 95% CI: 96-100%

 

The product has been obtaining whitelisted by other European countries before, and the acquisition of the German whitelisting qualification marks that the product has once again been recognized. As the current epidemic situation at home and abroad is still very severe, ALLTEST BIOTECH will continue to help rapid test of the new coronavirus virus and contribute to the fight against the COVID-19 epidemic.