Approval for Self-Testing in Malaysia Granted for BHM® COVID-19 Antigen Rapid Test After 100% Accuracy in WHO Collaborating Lab Testing

AsiaIn Vitro Diagnostic Testing
Written By Guest User

Birmingham Biotech’s BHM® COVID-19 Antigen Rapid Test achieved positive validation results at the WHO Collaborating Centre for Arbovirus Reference & Research in the University of Malaya.

The evaluation study was performed to determine the performance of the self-test kit, BHM® COVID-19 Antigen Rapid Test in detecting SARS-CoV-2 antigen from nasal swab samples. The positive samples consisted of samples displaying Ct values between 13.70-29.37. Results showed that using the BHM® COVID-19 Antigen Rapid Test, SARS-CoV-2 antigen could be detected in all of the tested positive samples (n=30) and no false positives were detected in the negative samples. The evaluation showed that the tested device was able to detect SARS-CoV-2 antigen in the tested nasal swab samples with 100% sensitivity and 100% specificity.

Subsequently, following the positive reccommendation from the testing centre, the Medical Devices Authority (MDA) in Malaysia granted its approval for import and distribution for self-testing.

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