Abstract
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.
Keywords: Antigen; Covid-19; Diagnosis; Madagascar; Rapid diagnostic test; SARS-CoV-2.
【저자키워드】 COVID-19, SARS-CoV-2, Diagnosis, Antigen, Rapid diagnostic test, madagascar, 【초록키워드】 SARS-CoV-2, pandemic, COVID-19 pandemic, Prospective Study, diagnostic test, Transcription, Test, diagnostic, RT-PCR, Laboratory, Antigen, early diagnosis, reverse transcription polymerase chain reaction, polymerase chain reaction, sensitivity, Diagnostic accuracy, Sensitivity and specificity, RDT, Rapid diagnostic test, Viral load, male, Patient, Rapid, gold, Rural area, age, SARS-CoV-2 RT-PCR, SARS-CoV-2 antigen, molecular, immunofluorescence, resource, immunochromatographic, Diagnostic method, Standard, Chain Reaction, human resource, gold standard, positive, SD Biosensor, immunochromatographic test, polymerase chain, disease categories, lack, evaluate, examined, evaluated, was determined, significantly higher, 【제목키워드】 SARS CoV-2, country,