Performance of 22 Rapid Lateral Flow Tests for SARS-CoV-2 Antigen Detection and Influence of “Variants of Concern”: Implications for Clinical Use
Aurélie Gourgeon, Alexandre Soulier, Étienne Audureau, Souraya Khouider, Arnaud Galbin, Camille Langlois, Magali Bouvier‐Alias, Christophe Rodriguez, Stéphane Chevaliez, Jean–Michel Pawlotsky, Slim Fourati
Abstract
The use of lateral-flow tests (LFTs) to detect SARS-CoV-2 has expanded worldwide. LFTs detect SARS-CoV-2 viral antigen and are less sensitive than nucleic acid amplification testing (NAAT). Their performance must be evaluated independently of the manufacturers. Our study assessed the performance of 22 SARS-CoV-2 antigen LFTs in large panels of well-characterized samples. The majority of LFTs tested exhibited satisfactory sensitivity and specificity, while some assays yielded unacceptable proportions of false-positive results, and others lacked sensitivity for samples containing large amounts of virus. The sensitivity of the best-performing assays did not vary according to the VOC, including the alpha, beta, delta, and omicron variants.