ABSTRACT
OBJECTIVES: Diagnosis of SARS-CoV-2 infection is a major public health issue. In a context of limited diagnostic capacity with the reference technique (real-time RT-PCR), many manufacturers have developed rapid diagnostic tests (RDTs). Although very promising in theory, these tests have raised many questions. This article is a rapid review that synthesizes data regarding different types of available RDTs, their performance, their limits and their potential indications in Tunisia as proposed by a multidisciplinary group of experts. METHODS: A literature review was carried out on the websites of international organizations, governmental bodies and on INAHTA database, completed by a search of relevant scientific articles up to 1 June 2020. The synthesis of the data was submitted to a panel of experts to propose recommendations for the Tunisian context. RESULTS: RDTs based on the detection of antigens and antibodies have sensitivity and specificity related issues. Few validation reports are published in the scientific literature. Pending more evidence on their performance and validity, several international organizations recommend their use only for research purposes. TDRs based on antibody detection are not appropriate for the early diagnosis of COVID-19. However, validated and specific tests could provide complementary diagnostic information to reference tests. CONCLUSION: Pending further evidence, the panel recommends the use of RDTs mainly for research purposes at the community level.
Subject(s)
COVID-19 Testing/methods , COVID-19/diagnosis , Humans , Time Factors , TunisiaABSTRACT
SARS-CoV-2 infection has to be confirmed by virological diagnosis. Multiple diagnostic tests are available without enough perspective on their reliability. Therefore, it is important to choose the most suitable test according to its sensitivity and specificity but also to the stage of the disease. Currently, the RT-PCR detection of the viral genome in respiratory samples is the most reliable test to confirm the diagnosis of an acute SARS-CoV-2 infection. It has to be done in Class II biological safety laboratory. However, it may lack sensitivity, particularly in the advanced phase of infection, and depends closely on the samples' quality. Rapid PCR by cartridge system reduces response times but is not suitable for laboratories with high throughput of requests. Detection of virus antigens on respiratory samples is a quick and easy to use technique; however it has not good specificity and sensitivity and cannot be used for diagnosis and patient management. The detection of specific antibodies against SARS-CoV-2 is better used for epidemiological analyses. Research should be encouraged to overcome the limits of the currently available diagnostic tests.