Rapid Test Ag 2019-nCoV (PROGNOSIS, BIOTECH, Larissa, Greece); Performance Evaluation in Hospital Setting with Real Time RT-PCR

Abstract

Introduction: Rapid antigen tests (RATs) are convenient for SARS-CoV-2 detection because they are simpler and faster than nucleic acid amplification tests (NAATs). This study aimed to assess the accuracy of a locally manufactured test; Rapid Test Ag 2019-nCoV (PROGNOSIS, BIOTECH, Larissa, Greece) in a clinical setting and during mass screening. Methods: Nasopharyngeal samples from 624 individuals were analyzed. The results of the rapid test were compared to real-time reverse-transcription quantitative polymerase chain reaction (RT-qPCR). At the end of the test’s procedure, positive test strips were scanned in an S-Flow reader in order to roughly estimate the antigen concentration. Results: The lower limit of detection of the test was 468.75 genome copies/mL. The PROGNOSIS rapid test displayed a sensitivity of 85.5% (141/165) (95%CI: 79.1–90.5) and a specificity of 99.8% (458/459) (95%CI: 98.8%–100.0%). The general inter-rater agreement was 0.89 (95%CI: 85.1–93.3). The regression analysis between the S-flow reader measurements (viral antigen) and the viral load of the positive samples demonstrated a weak correlation (R2 = 0.288, p < 0.001). Conclusion: The Rapid Test Ag 2019-nCoV demonstrated sufficient sensitivity, excellent specificity and could be available to be used with low overall cost. Thus, it could be used as point of care test, but also for mass screening for rapid detection of infected persons (e.g., for travelers).

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

“…Fourteen studies were selected using LFIA as an N protein detection technique [119][120][121][122][123][124][125][126][127][128][129][130][131][132]. A total of 11,750 subjects were studied.…”

“…Positive Likelihood ratio, Negative likelihood ratio, and Diagnostic Odds ratio are reported with a mean (95% confidence limits). The Forest plot depicts the estimated sensitivity and specificity (black squares) and its 95% confidence limits (horizontal black line) [119][120][121][122][123][124][125][126][127][128][129][130][131][132]. Supplementary 16.…”

“…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).…”

Utilization of rapid antigen tests for screening SARS-CoV-2 prior to dental treatment

“…Another approach for SARS-CoV-2 detection is antigen testing. A rapid antigen test is proposed as a simple screening tool for identifying asymptomatic cases, as the agreement between the rapid antigen test and RT-PCR was high ( 13 ). It has been reported in several publications that the rapid antigen test was highly reliable ( 14 ).…”

Negative Predictive Value of the Rapid Test Ag 2019-nCoV During the Predominance of Omicron over the Delta Variant and Implications in the Emergency Department

“…We retrospectively reviewed 636 negative rapid test results (Rapid Test Ag 2019-nCoV, ProGnosis Biotech S.A., Larissa, Greece, manufactured to detect the SARS-CoV-2 nucleocapsid protein) of nasopharyngeal specimens collected in our emergency department between November 1, 2021, and January 21, 2022, that were tested also by RT-PCR on the same day using the NeuMoDx SARS-CoV-2 or the Abbott RealTime SARS-CoV-2 assay. The Rapid Test Ag 2019-nCoV has a sensitivity of 85.5% and a specificity of 99.8% [ 9 ]. From November 1 to mid-December 2021, Delta was the only variant present in our hospital.…”