Comparative evaluation of Panbio and SD Biosensor antigen rapid diagnostic tests for COVID‐19 diagnosis

• Published in: Journal of medical virology Vol. 93; no. 9; pp. 5650 - 5654
• Main Authors: Pérez‐García, Felipe, Romanyk, Juan, Moya Gutiérrez, Helena, Labrador Ballestero, Andrea, Pérez Ranz, Inés, González Arroyo, Javier, González Ventosa, Victoria, Pérez‐Tanoira, Ramón, Domingo Cruz, Concepción, Cuadros‐González, Juan
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01-09-2021; John Wiley and Sons Inc
• Subjects: Agreements; antigen rapid diagnostic test; Antigens; Biosensors; Coronaviruses; COVID-19; Diagnostic systems; Diagnostic tests; Infections; lateral flow immunoassay; Panbio COVID‐19 Ag; Performance evaluation; Polymerase chain reaction; Respiratory diseases; SARS‐CoV‐2; SD biosensor COVID‐19 Ag FIA; Sensitivity analysis; Severe acute respiratory syndrome; Severe acute respiratory syndrome coronavirus 2; Short Communication; Viral diseases; Virology; COVID-19; SD Biosensor COVID-19 Ag FIA; SARS-CoV-2; Panbio COVID-19 Ag; antigen rapid diagnostic test; lateral flow immunoassay
• ISSN: 0146-6615; 1096-9071
• DOI: 10.1002/jmv.27089

The aim of our study was to evaluate the diagnostic performance of two antigen rapid diagnostic tests (Ag‐RDTs) to diagnose severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) infection. We evaluated Panbio and SD‐Biosensor Ag‐RDTs. We employed 186 polymerase chain reaction (PCR) negative samples to evaluate the specificity and 170 PCR positive samples to assess the sensitivity. We evaluated their sensitivity according to Cycle threshold (C
t) values and days post onset of symptoms (d.p.o.). Tests were compared using the McNemar's test. Agreement was evaluated using the kappa score. Specificity was 100% for Panbio and 97.3% for SD‐Biosensor. Sensitivity for samples with C
t ≤ 20 was 100% for both assays and for samples with C
t = 20–25 was 93.0% (Panbio) and 95.3% (SD‐Biosensor) (p =  1.000). Sensitivity decreased for samples wit C
t = 25–30 (Panbio: 41.3%, SD‐Biosensor: 52.2%, p = 0.125) and samples with C
t ≥ 30 (Panbio: 5.0%, SD‐Biosensor: 17.5%, p = 0.063). Sensitivity within seven d.p.o. was 87.7% for Panbio and 90.4% for SD‐Biosensor and notably decreased after seven d.p.o. Agreement with PCR was excellent for high viral load samples (C
t ≤ 25): Panbio, 98.9%, kappa = 0.974; SD‐Biosensor, 97.4%, kappa = 0.940. Agreement between Ag‐RDTs was excellent (94.9%, kappa = 0.882). Panbio and SD‐Biosensor Ag‐RDTs showed excellent agreement and diagnostic performance results for samples with high viral loads (C
t ≤ 25) or samples within seven d.p.o.
Highlights
Panbio and SD‐Biosensor Ag‐RDTs are reliable to diagnose SARS‐CoV‐2 infection.
They showed high specificity: 100% (Panbio) and 97.3% (SD‐Biosensor).
Sensitivity for samples with Ct ≤ 20 was 100% and for samples with Ct ≤ 25 was over 93%.
Their sensitivity was over 87% within 7 days after symptoms onset. Agreement between them was excellent (agreement = 94.9%, kappa = 0.882).