Time scale performance of rapid antigen testing for SARS‐CoV‐2: Evaluation of 10 rapid antigen assays

Abstract

There is a great demand for more rapid tests for SARS‐CoV‐2 detection to reduce waiting time, boost public health strategies for combating disease, decrease costs, and prevent overwhelming laboratory capacities. This study was conducted to assess the performance of 10 lateral flow device viral antigen immunoassays for the detection of SARS‐CoV‐2 in nasopharyngeal swab specimens. We analyzed 231 nasopharyngeal samples collected from October 2020 to December 2020, from suspected COVID‐19 cases and contacts of positive cases at Biotechnology Research Center laboratories, Tripoli, Libya. The performance of 10 COVID‐19 Antigen (Ag) rapid test devices for the detection of SARS‐CoV‐2 antigen was compared to a quantitative reverse transcription‐polymerase chain reaction (RT‐qPCR). In this study, 161 cases had symptoms consistent with COVID‐19. The mean duration from symptom onset was 6.6 ± 4.3 days. The median cycle threshold ( C t ) of positive samples was 25. Among the 108 positive samples detected by RT‐qPCR, the COVID‐19 antigen (Ag) tests detected 83 cases correctly. All rapid Ag test devices used in this study showed 100% specificity. While tests from six manufacturers had an overall sensitivity range from 75% to 100%, the remaining four tests had a sensitivity of 50%–71.43%. Sensitivity during the first 6 days of symptoms and in samples with high viral loads ( C t < 25), was 100% in all but two of the test platforms. False‐negative samples had a median C t of 34 and an average duration of onset of symptoms of 11.3 days (range = 5–20 days). Antigen test diagnosis has high sensitivity and specificity in early disease when patients present less than 7 days of symptom onset. Patients are encouraged to test as soon as they get COVID‐19‐related symptoms within 1 week and to seek medical advice within 24 h if they develop disturbed smell/taste. The use of rapid antigen tests is important for controlling the COVID‐19 pandemic and reducing the burden on molecular diagnostic laboratories.

Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection

“…Next, overall sensitivity was 63.2% [CI: 53.1–73.4%] for QAT and 58.6% [CI: 48.3–69.0%] for RAT ( Table 1 ). These results are comparable to previous reported data [ 4 , 8 , 11 , 12 , 13 , 14 ]. QAT and RAT in our study did not meet the WHO acceptance criterion for sensitivity.…”

A systematic review and meta-analysis comparing the diagnostic accuracy tests of COVID-19

“…Regarding the NGS, MA, ELISA for IgG-IgM-IgA, ELISA for IgG-IgM / IgG-IgA, CLIA for IgG-IgM-IgA, CLIA for N protein, LFIA for S protein and ECLIA diagnostic techniques, one [89], zero, four [74,81,136,137], two [77,108], one [137], four [135,138–140], one [126], and three [105,107,111] studies were selected, respectively. According to the established criteria, at least five studies were needed for the analysis with a value of p < 0.05.…”

“…Sensitivity and specificity are reported as a mean (95% confidence limits). The forest plot represents the estimated sensitivity and specificity (black squares) and their 95% confidence limits (horizontal black line)[119][120][121][122][123][124][125][126][127][128][129][130][131][132].Figure 19. Data analysis and paired forest plot of the sensitivity and specificity of the chemiluminescent microparticle immunoassay (CMIA) in the diagnosis of COVID-19.Sensitivity and specificity are reported as a mean (95% confidence limits).…”

Enzyme-Linked Immunosorbent Assay: An Adaptable Methodology to Study SARS-CoV-2 Humoral and Cellular Immune Responses

“…In fact, testing nasopharyngeal samples in an N-chemiluminescence enzymatic immunoassay provided satisfactory concordance with gold-standard RT-qPCR [ 27 ]. To achieve high sensitivity and specificity, antigen-detection tests should be conducted up to seven days after infection [ 28 ]. However, a fluorescent ELISA to detect the Nucleocapsid antigen in serum was developed, as well as an ELISA to capture the Spike protein [ 7 , 29 ].…”