The Basque SME located in Zamudio reinforces its commitment to the product line to fight the current pandemic, ranging from the detection of the infection to the evaluation of immunity.
This is an own product, from development to manufacture, with the production capacities for industrial scale-up, and which has been very well received in its first weeks in the market.
BIOLAN HEALTH has developed and validated a new antigen rapid test to detect the SARS-CoV-2 virus. It is a rapid and easy-to-use test that detects part of the structure of the virus from a nasal sample and makes it possible to identify people who are infected by the virus that causes COVID-19 and who may be contagious.
The fact that only a nasal swab is required, obtained by a less invasive and less uncomfortable way for the patient than nasopharyngeal swabbing, makes the test a clear advantage for the user.
The BIOLAN HEALTH COVID-19 antigen rapid test guarantees a reliable and accurate result in 15-20 minutes, with validated values of 96.5% sensitivity and 98.3% specificity, which meet the criteria defined by the OMS.
The BIOLAN HEALTH test performs excellently within the first 7 days of symptom onset, making it a very useful tool for early identification and isolation of potentially infectious COVID-19 positive cases, thus controlling the spread of the virus.
This new test has the corresponding CE marking certification, and BIOLAN HEALTH already has the manufacturing and export license from the Spanish Agency of Medicines and Health Products (AEMPS), as well as the ISO 13485 certification that guarantees all quality standards.
This product accompanies the BIOLAN HEALTH test for the detection of antibodies against COVID-19, which has been on the market since the beginning of 2021 and has become a very useful tool to assess the immunity of citizens naturally or derived from vaccination.
BIOLAN HEALTH’s rapid serological test allows the detection of neutralising antibodies, directed against a specific region of the S protein, which are the ones that generate vaccines, allowing the efficacy of vaccines to be evaluated efficiently and reliably, something that not all rapid tests provide because they are not designed for this purpose.
BIOLAN HEALTH, which also has the necessary capabilities to carry out the industrial-scale manufacturing of both products, thus reinforces its commitment to the fight against COVID-19, applying its knowledge and dedicating significant resources to provide society with tools that enable better management of the current pandemic situation.