iXensor, the pioneer of mobile health, is set to launch its end-to-end digital COVID-19 rapid antigen test solution that digitizes the entire user journey from screening, reporting to access control to combat outbreaks. The clinical performance evaluation has demonstrated superior accuracy of the PixoTest® POCT COVID-19 Antigen Test. The test is currently undergoing the CE self-declaration procedure, and is expected to become available under CE Mark soon using nasal swab or nasopharyngeal swab method.
The PixoTest® POCT COVID-19 Antigen Test is a smart rapid testing solution, which enables fast and cost-efficient screening at decentralized settings. It offers testees the PixoTest Pass app for free self-registration with privacy consent before testing. Then the PixoTest® POCT Analyzer analyzes specimens and transmits test results simultaneously to PixoHealth Pass app users via an encrypted QR code scan. The seamless digital connectivity shortens the wait time for the test report from days to minutes.
With the hand-held size analyzer reading test results objectively, semi-closed communities such as corporations, manufactures, schools and event organizers can minimize the risks of having false-negative cases and sustain a safe environment amidst ongoing pandemic.
A prospective clinical evaluation was conducted in Brazil with symptomatic subjects, the study reported promising accuracy of nasopharyngeal samples — 94% sensitivity and 100% specificity by comparing PixoTest® with RT-PCR assay for the ranges of 0 to 7 days since symptom onset (DSO).
Another two retrospective studies of clinical performance evaluation were completed in the USA, concluding that PixoTest® POCT COVID-19 Antigen Test’s accuracy meets EU standard of quality rapid antigen test. The sensitivity and specificity for nasal specimens are 92.8% and 100% respectively among symptomatic patients.
iXensor, the pioneer of mobile health, turns smartphones into lab-grade mobile medical diagnostics. In 2017, iXensor introduced the PixoTest® Blood Glucose Monitoring System as the world’s first US FDA-approved smartphone camera-based blood test. Based on the PixoTech® platform, iXensor has ventured into at-home self-testing and clinical diagnostics across infectious diseases, women’s health, and cardiovascular diseases.
Spokesperson: Patrick Liao
Company Website: www.ixensor.com
Phone: +886-2-8751-1335 ext.205