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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.
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.
