Diagnostic accuracy of antigen-detection rapid diagnostic tests for diagnosis of COVID-19 in low-and middle-income countries: A systematic review and meta-analysis

Abstract

Antigen detection rapid diagnostic tests (Ag-RDTs) used for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleocapsid protein are inexpensive, faster and easy to use alternative of Nucleic Acid Amplification Test (NAAT) for diagnosis of Coronavirus disease 2019 (COVID-19). In this systematic review and meta-analysis, we assessed the diagnostic accuracy of Ag-RDTs in low and middle-income countries (LMICs). We included studies that evaluated the diagnostic accuracy of Ag-RDTs (sensitivity and specificity) against reverse transcription-polymerase chain reaction (RT-PCR) as a reference standard. The study population comprised of people living in LMICs irrespective of age and gender, who had undergone testing for COVID-19. We included peer reviewed prospective or retrospective cohort studies, cross-sectional studies, case control studies, randomized clinical trials (RCTs) as well as non-randomized experimental studies which addressed the review question. A systematic search was conducted in PubMed, CINAHL, Embase, Scopus, and Google Scholar to identify studies published between 1 January, 2020 and 15 August, 2021. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 tool was used to assess the methodological quality of studies. The analysis was done using Review Manager 5.4 and R software 4.0.2. From the total of 12 diagnostic accuracy studies with 4,817 study participants, pooled sensitivity and specificity were 78.2% and 99.5% respectively. Sensitivity was marginally higher in subgroup analysis based on studies with low risk of bias and applicability concerns (78.9%) and studies using SD Biosensor Ag-RDT (79.4%). However, an inverse relation between cycle threshold (Ct) and sensitivity of Ag-RDT was not seen. The review demonstrated pooled sensitivity value approaching the minimum performance requirement for diagnosis of COVID-19 by WHO with specificity value meeting the specified requirement. Ag-RDTs, therefore have the potential to be used as a screening tool for SARS-CoV-2 detection in low resource settings where RT-PCR might not be readily accessible. However, false negative results need to be interpreted with caution.

Factors Associated with COVID-19 Death in a High-Altitude Peruvian Setting during the First 14 Months of the Pandemic: A Retrospective Multicenter Cohort Study in Hospitalized Patients

“…Later, RT-PCR was largely replaced by serology tests. RT-PCR and antigen tests have comparable diagnostic utility, whereas the diagnostic use of serology has been widely discussed in acute disease [ 62 , 63 , 64 ]. Furthermore, the use of CT scans in the diagnosis of COVID-19 is not perfect, and the identification of infiltrate could vary between observers [ 65 , 66 , 67 ].…”

Comparative Analysis of COVID-19 Serological testing methods to Polymerase Chain Reaction: A systematic review and meta-analysis

“…The systematic review protocol was registered on PROSPERO (CRD42023445695) and was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines 8 .…”

“…The included studies were analysed on variations or inconsistencies in findings using random-effects meta-analysis. Heterogeneity was assessed using summary receiver operating characteristic (ROC) curves with 95% prediction regions estimated using bivariate meta-analysis with test-level random effect, and forest plots 8 .…”

Graphene-Based Electrochemical Nano-Biosensors for Detection of SARS-CoV-2

“…Consequently, researchers are increasingly interested in developing saliva-based test kits for SARS-CoV-2 [132,133]. Despite the numerous benefits of rapid antigen tests, commercially available COVID-19 test kits are associated with several drawbacks, including false negative results, limited accuracy, variability in test quality, and, most importantly, lack of standardization [134][135][136][137][138][139]. Although COVID-19 test kits have been instrumental in controlling the spread of the virus, their use is limited by these drawbacks and limitations [140].…”