Evaluation of FAST COVID-19 SARS-CoV-2 Antigen Rapid Test Kit for Detection of SARS-CoV-2 in Respiratory Samples from Mildly Symptomatic or Asymptomatic Patients

Abstract

Molecular tests are the gold standard to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection but are associated with a diagnostic delay, while antigen detection tests can generate results within 20 min even outside a laboratory. In order to evaluate the accuracy and reliability of the FAST COVID-19 SARS-CoV-2 Antigen Rapid Test Kit (Ag-RDT), two respiratory swabs were collected simultaneously from 501 patients, with mild or no coronavirus disease 2019 (COVID-19)-related symptoms, and analyzed with both the Reverse Transcriptase-quantitative Polymerase Chain Reaction (RT-qPCR) and the FAST COVID-19 SARS-CoV-2 Antigen Rapid Test. Results were then compared to determine clinical performance in a screening setting. We measured a precision of 97.41% (95% CI 92.42–99.15%) and a recall of 98.26% (95% CI 93.88–99.25%), with a specificity of 99.22% (95% CI 97.74–99.74%), a negative predictive value of 99.48% (95% CI 97.98–99.87%), and an overall accuracy of 99.00% (95% CI 97.69–99.68%). Concordance was described by a Kappa coefficient of 0.971 (95% CI 0.947–0.996). Considering short lead times, low cost, and opportunities for decentralized testing, the Ag-RDT test can enhance the efforts to control SARS-CoV-2 spread in several settings.

Nasal swab is a good alternative sample for detecting SARS-CoV-2 with rapid antigen test: A meta-analysis

“…To determine if nasal samples have an equivalent detection ability to nasopharyngeal samples with RAT, we also included 115 papers that employ nasopharyngeal swabs ( Table S2 ). Among the 49 studies on nasal swabs containing 79,073 samples [ [2] , [3] , [4] , 6 , [10] , [11] , [12] , [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] , [28] , [29] , [30] , [31] , [32] , [33] , [34] , [35] , [36] , [37] , [38] , [39] , [40] , [41] , [42] , [43] , [44] , [45] , [46] , [47] , [48] , [49] , [50] , [51] , [52] , [53] , [54] ], all of them were published between 2021 and 2022, and twenty-one studies were conducted in the USA [ 12 , 14 , 15 , 18 , 21 , 22 , [25] , [26] , [27] , [32] , [33] , [34] , [35] ...…”

“…5 D) depicted two outlier studies. The overall results were only minimally changed after the two studies were removed [ 24 , 34 ]. (Sensitivity: 0.81 versus 0.81; Specificity: 1.00 versus 1.00; AUC: 0.97 versus 0.96), indicating that our results were not driven by these outlying points.…”

SARS-CoV-2 Surveillance in Indoor Air Using Electrochemical Sensor for Continuous Monitoring and Real-Time Alerts

“…It should be noted that the three steps of the sensing process took less than 24 s. Ideally, when everything is synchronized, the result can be given in 2 s after sample collection, which provides ultra-fast sensing faster than most of its counterparts such as the fast antigen (<20 min) [ 27 ] and RT-PCR (<90 min) test [ 28 ].…”

The Deceptive COVID-19: Lessons from Common Molecular Diagnostics and a Novel Plan for the Prevention of the Next Pandemic

“…As a result, several issues should be taken into consideration and reassessed appropriately. First and foremost, it must be highlighted, that, according to the molecular biology principles, «molecular tests», include all nucleic acid amplification tests (NAATs) such as the widely performed polymerase chain reaction (PCR) assay for the genetic identification of SARS-CoV-2 and all serological tests, either for antigen or antibody detection, such as the lateral flow immunoassays (LFIAs) that society regarded as ‘rapid tests’, as well as the laboratory antigen and antibody detection tests, such as the widely preferred enzyme-linked immunosorbent assay (ELISA) [ 21 , 22 , 23 , 24 , 25 ]. All these testing platforms and several others have already been applied for managing the molecular diagnosis of infectious diseases, while common and new ones were applied for the identification of SARS-CoV-2 [ 26 ].…”