The Infectious Diseases Society of America Guidelines on the Diagnosis of Coronavirus Disease 2019 (COVID-19): Antigen Testing

被引:69
作者
Hanson, Kimberly E. [1 ]
Altayar, Osama [2 ]
Caliendo, Angela M. [3 ]
Arias, Cesar A. [4 ,5 ]
Englund, Janet A. [6 ]
Hayden, Mary K. [7 ,8 ]
Lee, Mark J. [9 ,10 ]
Loeb, Mark [11 ]
Patel, Robin [12 ]
El Alayli, Abdallah [13 ]
Sultan, Shahnaz [14 ]
Falck-Ytter, Yngve [15 ]
Lavergne, Valery [16 ]
Mansour, Razan [13 ]
Morgan, Rebecca L. [17 ]
Murad, M. Hassan [18 ]
Patel, Payal [19 ]
Bhimraj, Adarsh [20 ]
Mustafa, Reem A. [21 ]
机构
[1] Univ Utah, Div Infect Dis, Salt Lake City, UT 84132 USA
[2] Washington Univ, Sch Med, Dept Med, St Louis, MO 63110 USA
[3] Brown Univ, Dept Med, Warren Alpert Med Sch, Providence, RI 02912 USA
[4] Univ Texas Hlth Sci Ctr Houston, McGovern Med Sch, Ctr Antimicrobial Resistance & Microbial Genom, Div Infect Dis, Houston, TX 77030 USA
[5] Sch Publ Hlth, Ctr Infect Dis, Houston, TX 77030 USA
[6] Univ Washington, Dept Pediat, Seattle Childrens Res Inst, Seattle, WA 98195 USA
[7] Rush Univ, Dept Med, Div Infect Dis, Med Ctr, Chicago, IL 60612 USA
[8] Rush Univ, Dept Pathol, Med Ctr, Chicago, IL 60612 USA
[9] Duke Univ, Sch Med, Dept Pathol, Durham, NC 27706 USA
[10] Duke Univ, Clin Microbiol Lab, Sch Med, Durham, NC USA
[11] McMaster Univ, Div Pathol & Mol Med, Hamilton, ON, Canada
[12] Mayo Clin, Div Clin Microbiol, Rochester, MN USA
[13] Univ Kansas, Med Ctr, Dept Internal Med, Outcomes & Implementat Res Unit, Kansas City, KS 66103 USA
[14] Univ Minnesota, Div Gastroenterol & Lepatol & Nutr, Minneapolis VA Healthcare Syst, Minneapolis, MN USA
[15] Case Western Reserve Univ, Sch Med, VA Northeast Ohio Healthcare Syst, Cleveland, OH USA
[16] Vancouver Gen Hosp, Dept Pathol & Lab Med, Vancouver, BC, Canada
[17] McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada
[18] Mayo Clin, Div Prevent Med, Rochester, MN USA
[19] Emory Univ, Dept Pulm Allergy Crit Care & Sleep Med, Dept Med, Atlanta, GA 30322 USA
[20] Cleveland Clin, Dept Infect Dis, Cleveland, OH 44106 USA
[21] Univ Kansas, Med Ctr, Dept Internal Med, Div Nephrol & Hypertens, Kansas City, KS 66103 USA
关键词
SARS CoV-2; diagnostic testing; rapid antigen tests; systematic review; diagnostic test performance; PERFORMANCE; WISCONSIN; CERTAINTY; BIAS;
D O I
10.1093/cid/ciab557
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Immunoassays designed to detect SARS-CoV-2 protein antigens are now commercially available. The most widely used tests are rapid lateral flow assays that generate results in similar to 15 minutes for diagnosis at the point-of-care. Higher throughput, laboratory-based SARS-CoV-2 antigen (Ag) assays have also been developed. The overall accuracy of SARS-CoV-2 Ag tests, however, is not well defined. The Infectious Diseases Society of America (IDSA) convened an expert panel to perform a systematic review of the literature and develop best-practice guidance related to SARS-CoV-2 Ag testing. This guideline is the third in a series of rapid, frequently updated COVID-19 diagnostic guidelines developed by IDSA. IDSA's goal was to develop evidence-based recommendations or suggestions that assist clinicians, clinical laboratories, patients, public health authorities, administrators, and policymakers in decisions related to the optimal use of SARS-CoV-2 Ag tests in both medical and nonmedical settings. A multidisciplinary panel of infectious diseases clinicians, clinical microbiologists, and experts in systematic literature review identified and prioritized clinical questions related to the use of SARS-CoV-2 Ag tests. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make testing recommendations. The panel agreed on 5 diagnostic recommendations. These recommendations address Ag testing in symptomatic and asymptomatic individuals as well as assess single versus repeat testing strategies. Data on the clinical performance of US Food and Drug Administration SARS-CoV-2 Ag tests with Emergency Use Authorization are mostly limited to single, one-time testing versus standard nucleic acid amplification testing (NAAT) as the reference standard. Rapid Ag tests have high specificity and low to modest sensitivity compared with reference NAAT methods. Antigen test sensitivity is heavily dependent on viral load, with differences observed between symptomatic compared with asymptomatic individuals and the time of testing post-onset of symptoms. Based on these observations, rapid reverse transcriptase-polymerase chain reaction (RT-PCR) or laboratory-based NAAT remain the diagnostic methods of choice for diagnosing SARS-CoV-2 infection. However, when molecular testing is not readily available or is logistically infeasible, Ag testing can help identify some individuals with SARS-CoV-2 infection. The overall quality of available evidence supporting use of Ag testing was graded as very low to moderate.
引用
收藏
页码:e208 / e229
页数:22
相关论文
共 47 条
[1]   Postoperative mortality among surgical patients with COVID-19: a systematic review and meta-analysis [J].
Abate, Semagn Mekonnen ;
Mantefardo, Bahiru ;
Basu, Bivash .
PATIENT SAFETY IN SURGERY, 2020, 14 (01)
[2]   World Health Organization recommendations are often strong based on low confidence in effect estimates [J].
Alexander, Paul E. ;
Bero, Lisa ;
Montori, Victor M. ;
Brito, Juan Pablo ;
Stoltzfus, Rebecca ;
Djulbegovic, Benjamin ;
Neumann, Ignacio ;
Rave, Supriya ;
Guyatt, Gordon .
JOURNAL OF CLINICAL EPIDEMIOLOGY, 2014, 67 (06) :629-634
[3]   How to perform a meta-analysis with R: a practical tutorial [J].
Balduzzi, Sara ;
Ruecker, Gerta ;
Schwarzer, Guido .
EVIDENCE-BASED MENTAL HEALTH, 2019, 22 (04) :153-160
[4]   Comparison of the Quidel Sofia SARS FIA Test to the Hologic Aptima SARS-CoV-2 TMA Test for Diagnosis of COVID-19 in Symptomatic Outpatients [J].
Beck, Eric T. ;
Paar, Wendy ;
Fojut, Lara ;
Serwe, Jordan ;
Jahnke, Renee R. .
JOURNAL OF CLINICAL MICROBIOLOGY, 2021, 59 (02)
[5]   Comparison of a laboratory-developed test targeting the envelope gene with three nucleic acid amplification tests for detection of SARS-CoV-2 [J].
Bulterys, Philip L. ;
Garamani, Natasha ;
Stevens, Bryan ;
Sahoo, Malaya K. ;
Huang, ChunHong ;
Hogan, Catherine A. ;
Zehnder, James ;
Pinsky, Benjamin A. .
JOURNAL OF CLINICAL VIROLOGY, 2020, 129
[6]  
Caruana, 2021, MICROORGANISMS
[7]  
Centers for Disease Control and Prevention, RECOMMENDATIONS ISOL
[8]   SARS-CoV-2, SARS-CoV, and MERS-CoV viral load dynamics, duration of viral shedding, and infectiousness: a systematic review and meta-analysis [J].
Cevik, Muge ;
Tate, Matthew ;
Lloyd, Ollie ;
Maraolo, Alberto Enrico ;
Schafers, Jenna ;
Ho, Antonia .
LANCET MICROBE, 2021, 2 (01) :E13-E22
[9]   Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study [J].
Bhangu A. ;
Nepogodiev D. ;
Glasbey J.C. ;
Li E. ;
Omar O.M. ;
Gujjuri R.R. ;
Morton D.G. ;
Tsoulfas G. ;
Keller D.S. ;
Smart N.J. ;
Siaw-Acheampong K. ;
Chaudhry D. ;
Dawson B.E. ;
Evans J.P. ;
Heritage E. ;
Jones C.S. ;
Kamarajah S.K. ;
Khatri C. ;
Keatley J.M. ;
Mckay S.C. ;
Pellino G. ;
Tiwari A. ;
Trout I.M. ;
Wilkin R.J.W. ;
Adamina M. ;
Ademuyiwa A.O. ;
Agarwal A. ;
Alameer E. ;
Alderson D. ;
Alakaloko F. ;
Alser O. ;
Arnaud A.P. ;
Augestad K.M. ;
Bankhead-Kendall B.K. ;
Barlow E. ;
Benson R.A. ;
Blanco-Colino R. ;
Brar A. ;
Minaya-Bravo A. ;
Breen K.A. ;
Buarque I.L. ;
Caruana E.J. ;
Chakrabortee S. ;
Cox D. ;
Cunha M.F. ;
Davidson G.H. ;
Desai A. ;
Saverio S.D. ;
Drake T.D. ;
Edwards J.G. .
LANCET, 2020, 396 (10243) :27-38
[10]   Effectiveness of Sample Pooling Strategies for SARS-CoV-2 Mass Screening by RT-PCR: A Scoping Review [J].
Deka, Sangeeta ;
Kalita, Deepjyoti .
JOURNAL OF LABORATORY PHYSICIANS, 2020, 12 (03) :212-218