International Journal of Microbiology

Research Article

Clinical Accuracy of Instrument-Read SARS-CoV-2 Antigen Rapid Diagnostic Tests (Ag-IRRDTs)

Table 1

Clinical sensitivity and specificity data for instrument-read rapid antigen tests (Ag-IRRDTs) against COVID-19.
Ref NoFirst Author NameLab. CountryMfrSample typeFresh sampleIFUCDSensitivitySensitivity CISpecificitySpecificity CI
[18]PekoszUSA1NPYN2510,964000,823–0,9940,987000,961–0,995
[19]SchuitHolland1NPYN26780,639000,576–0,6980,996000,992–0,998
[20]CaruanaSwiss1NPYN5320,412000,326–0,5040,998000,987–1,000
[21]KilicUSA1ANYY13840,664000,574–0,7430,988000,981–0,993
[22]VanderMoerenHolland1MT-OPNN3510,941000,730–0,9900,994000,978–0,998
[23]Karon BSUSA1NPNN3470,665000,596–0,7271,000000,975–1,000
[24]FINDaSwiss2NPYY2320,732000,581–0,8431,000000,980–1,000
[25]KweonOJKorea2NPNN3220,383000,313–0,4591,000000,976–1,000
[26]FernandezMSpain3NPYY460,875000,690–0,9571,000000,851–1,000
[27]DierksGermany3NPYY4440,455000,213–0,7200,995000,983–0,999
[28]CaramelioItaly3ANYY1490,866000,784–0,9200,885000,770–0,946
[29]KohmerGermany3NPYN1000,500000,389–0,6111,000000,871–1,000
[30]BiancoItaly3ANYN9070,903000,864–0,9310,921000,897–0,940
[31]KrügerGermany3NMTYY7610,822000,752–0,8750,993000,983–0,997
[32]DeninaMItaly3NPNN1910,941000,730–0,9900,919000,869–0,951
[33]LeliCItaly3NPNN7920,687000,613–0,7520,952000,932–0,966
[23]Karon BS2USA3NPNN3470,832000,774–0,8781,000000,975–1,000
[34]CentoVItaly3NPYY9600,856000,815–0,8890,972000,956–0,983
[35]OrsiItaly4NPYY1100,933000,841–0,9741,000000,929–1,000
[20]Caruana2Swiss5NPYN5320,483000,393–0,5730,995000,983–0,999
[36]BeckUSA6ANYY3460,770000,651–0,8580,996000,980–0,999
[37]FordLUSA6NMTYY10510,685000,553–0,7930,985000,975–0,991
[1]HarmonUSA6ANYY234620,229000,152–0,3300,998700,998–0,999
[38]HarrisUSA6ANYY24360,793000,746–0,8340,993000,988–0,996
[39]PrayUSA6ANYY10980,684200,553–0,7860,984600,975–0,991
[40]MackUSA6NPNN109820,511500,438–0,5850,996300,995–0,997
[41]SmithRDUSA6NPYY28870,766000,708–0,8160,997400,995–0,999
[42]BrihnAUSA6NPYY20390,658000,578–0,7280,993800,989–0,996
[43]BornemannGermany6NPYY13910,571000,469–0,6680,993000,987–0,996
[44]JaaskelainenFinland6NPNN1880,804000,733–0,8601,000000,912–1,000
[45]PorteLChile6NP-OPNN640,938000,799–0,9830,969000,843–0,994
[46]FINDbBrazil7NPYY4530,775000,692–0,8410,979000,957–0,990
[46]FINDcGermany7NPYY6760,692000,536–0,8140,969000,952–0,980
[47]KiroVIndia7NPYY3540,382000,305–0,4660,990000,967–0,997
[35]OrsiItaly7NPYY1100,867000,758–0,9311,000000,929–1,000
[48]ColavitaItaly7NPYY730700,543310,493–0,5930,994550,994–0,995
[49]BaccaniItaly7NPNN930,357000,207–0,5421,000000,944–1,000
[50]LiottiItaly7NPNN3590,470000,378–0,5660,984000,960–0,994
[51]OstermanGermany7NP-OPNN7410,454000,405–0,5040,978000,957–0,989
[52]KahnMGermany7NP-OPNN31100,593750,494–0,6870,989700,985–0,993
[45]PorteL2Chile7NPNN640,906000,758–0,9680,969000,843–0,994
[53]Parada-ricartSpain8NPYY1720,731000,539–0,8630,856000,790–0,904
[54]PorteL3Chile8NP-OPNN1270,939000,865–0,9741,000000,921–1,000
[55]WeitzelChile8NP-OPNN1110,850000,756–0,9121,000000,890–1,000
[56]PickeringUK9AN-OPNN2000,690000,594–0,7720,980000,930–0,994
[30]KaronBS1USA10NPNN3470,883000,831–0,9211,000000,975–1,000
[25]KweonOJ2Korea11NPNN3220,395000,324–0,4710,987000,954–0,996
[49]Baccani2Italy11NPNN810,375000,212–0,5731,000000,937–1,000
Total number of samples is 137,770, pooled sensitivity = 0.671 (95% CI: 0.659–0.683), pooled specificity = 0.994 (95%CI:0.994–0.994). D = Number of samples, Mfr = Manufacturer code: (1) Beckton, Dickinson and Co., Veritor USA; (2) Boditech Med., iChroma, COVID-19 Ag, Chuncheon-si, Gang-won-do, Korea; (3) Lumira Dx Limited, London, UK; (4) NanoEntek FREND, Guro-gu, Seoul, Korea; (5) Precision Biosensor Exdia, Daejeon, Korea; (6) Sofia FIA Quidel Corporation, San Diego, CA, USA; (7) Standard F, SD Biosensor, Suwon, Korea; (8)Shenzen Bioeasy Biotechnology, Shenzhen, Guangdong Province PRC; (9) Surescreen FIA, Derby DE1 3QB, UK; (10) FIAflex SARS-CoV-2 Antigen FIA ACON Biotech (Hangzhou) Co., Ltd. PRC; (11) Boditech Med., AFIAS COVID-19 Ag, Chuncheon-si, Gang-won-do, Korea.