Abnova COVID-19 Antigen Rapid Test Nasal Cavity Sampling Advantage Speeds Up Home Use IRB Submission and Clinical Study

Neihu, Taiwan (June 17, 2021)

Abnova announced today that one of the biggest advantages of its TFDA EUA approved COVID-19 antigen rapid test is the nasal cavity sampling. In contrast, all of the current competitors and their rapid tests use nasopharyngeal sampling for the professional use market in Taiwan. Nasopharyngeal sampling can be done by professionals such as physicians, nurses, and medical technicians. However, it cannot be performed easily and safely by average users in the home market. This competitive advantage has speed up Abnova’s antigen rapid test home use IRB submission and clinical study this week.

Under the TFDA requirement, since Abnova’s approved COVID-19 antigen rapid test already uses nasal cavity sampling, a simple comparative test between a regular user (self-testing) versus a professional testing is all that is required for IRB submission and approval for clinical study. No PCR comparator is needed which obviates the PCR nasopharyngeal sampling. This speeds up the clinical study involving a total of 150 patients with 30 confirmed positives. Abnova is currently working efficiently with the local hospitals and their nearby clinical sampling stations to achieve this goal.

Taiwan TFDA recently has approved two types of rapid tests for home testing, Roche SARS-CoV-2 Antigen Self Test Nasal and Lucira CHECK-IT COVID-19 Test Kit. Both rapid tests use nasal cavity (not nasopharyngeal) sampling for ease of testing among home users. Since Taiwan COVID-19 outbreak in the middle May, antigen rapid test has become an indispensable tool in the prevention and transmission of disease. The use of the antigen rapid test has evolved from the community to corporate to home testing. As a result, the frequency of transmission and death have gained better controlled.