Evaluation of antigen-based rapid detection test for the diagnosis of SARS CoV-2 in low-income countries

Background: In the context of the Covid-19 pandemic and following the increasing number of suspicious Covid-19 cases in Madagascar, Malagasy laboratories are overflowed mainly due to lack of human resource and available material restriction. The development and validation of rapid and easy-to-perform diagnostic methods are worth of interest and high priority. The aim of this prospective study was to evaluate the performances of a rapid immunochromatographic test for the detection of SARS-CoV-2 antigen, in comparison to Reverse transcription polymerase chain reaction (RT-PCR).

Methods: The fluorescence immunochromatographic SARS-CoV-2 antigen test StandardTM Q COVID-19 Ag Test (SD Biosensor Republic Korea) was evaluated in samples derived from patients who were examined for disease categories. Diagnostic accuracy was determined in comparison to SARS-CoV-2 RT-PCR considered as gold standard.

Results: A total of 200 samples were included; 94 were RT-PCR positive. Median patients' age was 38.36 years, 63.5 % were male. Overall sensitivity and specificity of the Standard TM Q COVID-19 Ag (SD Biosensor® Republic Korea) were 62.66 % and 100 %, the sensitivity was significantly higher (100 %) in samples with high viral loads (Ct<29).

Conclusions: This antigen-based immunofluorescence RDT could be the potential to become an important tool for the early diagnosis of SARS-CoV-2 particularly in situations with limited access to molecular methods particularly in rural area of Madagascar.