ABSTRACT
Background: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has become a global public health problem. The real-time reverse transcription-polymerase chain reaction (RT-PCR) is the gold standard test for the detection of SARS-CoV-2. However, the assay requires hours to get the final results. Therefore, antigen-based rapid assays are being used extensively to reduce the time. We have evaluated the performance of the antigen-based rapid test for the detection of SARS-CoV-2 virus in comparison with RT-PCR. Materials and methods: Nasopharyngeal and throat swabs were collected from 366 suspected patients of COVID-19 visiting our institute and subjected to qualitative RT-PCR and antigen-based rapid assays to detect the presence of SARS-CoV-2 virus. The sensitivity and specificity of the antigen-based assay were calculated in comparison with RT-PCR. Results: Compared with RT-PCR, sensitivity and specificity of the antigen-based rapid assay were observed to be 70.5% and 98.6%, respectively, in comparison with RT-PCR. However, the sensitivity of antigen-based rapid assay varied significantly with decreasing viral load. The sensitivity of the rapid antigen assay was equivalent to RT-PCR (23/23, 100%) at a higher viral load (Ct value 15�). In contrast, the antigen assay could only detect 3/21 (14.28%) samples with Ct value >30. Conclusion: The antigen-based assay could assist in the rapid screening of a large population. However, the rapid antigen assay might not detect early stages of infection represented by low viral load. Therefore, the antigen-based assay could not replace RT-PCR testing. The study reiterates that all antigen-based negative tests should be confirmed by RT-PCR.
ABSTRACT
The equivalence margin is the largest difference that is clinically acceptable between the test (or experimental) drug and the active control (or reference) drug. This paper discusses the scientific principles, along with the regulatory issues, that need to be addressed when determining the equivalence margin for the biosimilar product. The concept of assay sensitivity is introduced, and the ways to ensure assay sensitivity in the equivalence trial are emphasized. A hypothetical example is presented to show how an equivalence margin is determined. The regulatory agency should carefully assess if the equivalence margin of the biosimilar product was determined using a scientifically valid and clinically relevant approach, not subject to selection bias. This is important because the consumer risk of erroneously declaring equivalence when in fact it is not must be controlled conservatively low in the approval of any biosimilar products.