Taiwan's iXensor Co., Ltd., the pioneer of mobile health, announced that its PixoTest^® POCT COVID-19 Antigen Test has received the CE-IVD mark. The PixoTest^® POCT COVID-19 Antigen Test provides the end-to-end fully digitalized rapid screening solution to prevent further outbreaks.

iXensor's PixoTest^® solution comprises a palm-sized analyzer that reads test results accurately, a digital health pass App, an Admin App, and a HIPAA-grade health management web portal. The fully digitized testing and reporting design shortens the test-to-report time to 15 minutes. In addition to overcoming the lab testing limitations, the solution allows for scaling in large screening settings, thereby enabling business continuity and reopening. 

With the PixoTest^® POCT Analyzer reading test results objectively, healthcare organizations and corporations can minimize the risks of having false-negative cases compared to rapid tests interpreted by human eyes.

The analyzer transmits test results simultaneously to the PixoHealth Pass App users via an encrypted QR code. The digital health pass also records App users' vaccination certificates, helping free movement in the upcoming summer holiday season.

The PixoHealth Pass Admin App is designed for organizations to verify the authenticity of PixoTest^® test results with one simple scan. The admin app protects organizations' safety amidst the pandemic by validating the cheat-proof, encrypted results shown on PixoHealth Pass App.

In the prospective clinical study completed in Brazil, the PixoTest^® showed 95% sensitivity and 98% specificity of nasopharyngeal specimens for the ranges of 0 to 7 days since symptom onset (DSO). Another study in the USA examined the clinical performance of anterior nasal specimens among symptomatic patients, which reported 92.8% sensitivity and 100% specificity, respectively.