Advancing excellence in laboratory medicine for better healthcare worldwide

Key Publications on Diagnostic and Serology Testing:

Disclaimer: This collection of resources on this webpage reflects a rapidly changing situation and due to the need for quick answers during the COVID-19 pandemic, we acknowledge that most fast-tracked publications are based on observations, often on a small number of cases, which would be considered as preliminary evidence. The IFCC Task Force has not critically appraised all resources cited here for scientific validity but tried to present information that is believed to help laboratory professionals in formulating their local policies in a more informed manner. The interim advice or conclusions presented here may change as more information is gathered.

 

 

Click on the title to visit the relevant section: Opinion - Molecular Testing - Antigen TestingSerology Testing

 

Opinion:

  1. Arturo EC, Saphire EO. Lifted Up from Lockdown. Cell. 2020 Oct 1;183(1):1-3. doi: 10.1016/j.cell.2020.09.027. PMID: 33007260; PMCID: PMC7528821.
  2. Lippi G, Henry BM, Sanchis-Gomar F. Potential drawbacks of frequent asymptomatic coronavirus disease 2019 (COVID-19) testing. Infect Control Hosp Epidemiol. 2020 Oct 29:1-2. doi: 10.1017/ice.2020.1305. Epub ahead of print. PMID: 33115549.
  3. Gill M, Gray M. Mass testing for covid-19 in the UK. BMJ. 2020 Nov 16;371:m4436. doi: 10.1136/bmj.m4436. PMID: 33199289.
  4. Shaman J, Galanti M. Will SARS-CoV-2 become endemic? Science. 2020 Oct 14:eabe5960. doi: 10.1126/science.abe5960. Epub ahead of print. PMID: 33055131.
  5. Dying in a Leadership Vacuum. N Engl J Med. 2020 Oct 8;383(15):1479-1480. doi: 10.1056/NEJMe2029812. PMID: 33027574.
  6. Mina MJ, Parker R, Larremore DB. Rethinking Covid-19 Test Sensitivity - A Strategy for Containment. N Engl J Med. 2020 Sep 30. doi: 10.1056/NEJMp2025631. Epub ahead of print. PMID: 32997903.

 

Molecular Testing:

  1. Manning BJ, Khan WA, Peña JM, Fiore ES, Boisvert H, Tudino MC, Barney RE, Wilson MK, Singh S, Mowatt JA, Thompson HJ, Tsongalis GJ, Blake WJ. High-Throughput CRISPR-Cas13 SARS-CoV-2 Test. Clin Chem. 2021 Oct 26:hvab238. doi: 10.1093/clinchem/hvab238. Epub ahead of print. PMID: 34718481.
  2. Berenger BM, Stokes W, Turnbull L, Pabbaraju K, Zelyas N, Venner AA, Tipples GA. Save the COVID-19 point of care nucleic acid test swab after testing to identify variants of concern. Clin Chem. 2021 Oct 23:hvab243. doi: 10.1093/clinchem/hvab243. Epub ahead of print. PMID: 34687302; PMCID: PMC8574308.
  3. Evans D, Cowen S, Kammel M, O'Sullivan DM, Stewart G, Grunert HP, Moran-Gilad J, Verwilt J, In J, Vandesompele J, Harris K, Hong KH, Storey N, Hingley-Wilson S, Dühring U, Bae YK, Foy C, Braybrook J, Zeichhardt H, Huggett JF. The dangers of using Cq to quantify nucleic acid in biological samples; a lesson from COVID-19. Clin Chem. 2021 Oct 11:hvab219. doi: 10.1093/clinchem/hvab219. Epub ahead of print. PMID: 34633030.
  4. Poon LLM. A Push for Real Normal: Mass Screening for COVID-19. Clin Chem. 2021 Oct 7:hvab190. doi: 10.1093/clinchem/hvab190. Epub ahead of print. PMID: 34617102; PMCID: PMC8500115.
  5. Buchta C, Camp JV, Jovanovic J, Radler U, Puchhammer-Stöckl E, Benka B, Huf W, Müller MM, Griesmacher A, Aberle SW, Görzer I. A look at the precision, sensitivity and specificity of SARS-CoV-2 RT-PCR assays through a dedicated external quality assessment round. Clin Chem Lab Med. 2021 Oct 20. doi: 10.1515/cclm-2021-1004. Epub ahead of print. PMID: 34668361.
  6. Berg MG, Zhen W, Lucic D, Degli-Angeli EJ, Anderson M, Forberg K, Olivo A, Sheikh F, Toolsie D, Greninger AL, Cloherty GA, Coombs RW, Berry GJ. Development of the RealTime SARS-CoV-2 quantitative Laboratory Developed Test and correlation with viral culture as a measure of infectivity. J Clin Virol. 2021 Oct;143:104945. doi: 10.1016/j.jcv.2021.104945. Epub 2021 Aug 17. PMID: 34450558; PMCID: PMC8367731.
  7. Caza M, Hogan CA, Jassem A, Prystajecky N, Hadzic A, Wilmer A. Evaluation of the clinical and analytical performance of the Seegene allplex™ SARS-CoV-2 variants I assay for the detection of variants of concern (VOC) and variants of interests (VOI). J Clin Virol. 2021 Nov;144:104996. doi: 10.1016/j.jcv.2021.104996. Epub 2021 Oct 2. PMID: 34628158; PMCID: PMC8487322.
  8. Wack M, Péré H, Demory-Guinet N, Kassis-Chikhani N, Janot L, Vedie B, Izquierdo L, Bélec L, Veyer D. No SARS-CoV-2 reinfection among staff health-care workers: Prospective hospital-wide screening during the first and second waves in Paris. J Clin Virol. 2021 Oct 19;145:104999. doi: 10.1016/j.jcv.2021.104999. Epub ahead of print. PMID: 34695725; PMCID: PMC8525071.

Less recent publications on Molecular Testing:

  1. Chen H, Li Z, Feng S, et al. Femtomolar SARS-CoV-2 Antigen Detection Using the Microbubbling Digital Assay with Smartphone Readout Enables Antigen Burden Quantitation and Tracking [published online ahead of print, 2021 Aug 12]. Clin Chem. 2021;hvab158. doi:10.1093/clinchem/hvab158
  2. Stokes W, Kanji J, Hu J, Zelyas N, Berenger BM. Wide Variation in Cycle Threshold Values Cloud the Interpretation of COVID-19 Infectiousness [published online ahead of print, 2021 Jul 29]. Clin Chem. 2021;hvab145. doi:10.1093/clinchem/hvab145
  3. Srivatsan S, Heidl S, Pfau B, et al. SwabExpress: An end-to-end protocol for extraction-free COVID-19 testing. Preprint. bioRxiv. 2021;2020.04.22.056283. Published 2021 Apr 29. doi:10.1101/2020.04.22.056283
  4. Karon BS, Donato L, Bridgeman AR, et al. Analytical sensitivity and specificity of four point of care rapid antigen diagnostic tests for SARS-CoV-2 using real-time quantitative PCR, quantitative droplet digital PCR, and a mass spectrometric antigen assay as comparator methods [published online ahead of print, 2021 Jul 8]. Clin Chem. 2021;hvab138. doi:10.1093/clinchem/hvab138
  5. Potter RF, Ransom EM, Wallace MA, et al. Multiplatform assessment of saliva for SARS-CoV-2 molecular detection in symptomatic healthcare personnel and patients presenting to the emergency department [published online ahead of print, 2021 Sep 7]. J Appl Lab Med. 2021;jfab115. doi:10.1093/jalm/jfab115
  6. Hardy NL, Luethy PM. Evaluation of Inappropriate COVID-19 RT-PCR Test Utilization at an academic medical center [published online ahead of print, 2021 Jun 30]. J Appl Lab Med. 2021;jfab081. doi:10.1093/jalm/jfab081
  7. Lee SS, Park JH, Bae YK. Comparison of two digital PCR methods for EGFR DNA and SARS-CoV-2 RNA quantification. Clin Chim Acta. 2021;521:9-18. doi:10.1016/j.cca.2021.06.016
  8. Stelzl E, Kessler HH, Mustafa HG, et al. Alternative detection of SARS-CoV-2 RNA by a new assay based on mass spectrometry [published online ahead of print, 2021 Aug 12]. Clin Chem Lab Med. 2021;10.1515/cclm-2021-0483. doi:10.1515/cclm-2021-0483
  9. Buchta C, Camp JV, Jovanovic J, et al. The versatility of external quality assessment for the surveillance of laboratory and in vitrodiagnostic performance: SARS-CoV-2 viral genome detection in Austria. Clin Chem Lab Med. 2021;59(10):1735-1744. Published 2021 Jun 30. doi:10.1515/cclm-2021-0604
  10. Martin A, Storto A, Le Hingrat Q, et al. High-sensitivity SARS-CoV-2 group testing by digital PCR among symptomatic patients in hospital settings. J Clin Virol. 2021;141:104895. doi:10.1016/j.jcv.2021.104895
  11. Ong DSY, Koeleman JGM, Vaessen N, Breijer S, Paltansing S, de Man P. Rapid screening method for the detection of SARS-CoV-2 variants of concern. J Clin Virol. 2021;141:104903. doi:10.1016/j.jcv.2021.104903
  12. Nörz D, Grunwald M, Olearo F, et al. Evaluation of a fully automated high-throughput SARS-CoV-2 multiplex qPCR assay with built-in screening functionality for del-HV69/70- and N501Y variants such as B.1.1.7. J Clin Virol. 2021;141:104894. doi:10.1016/j.jcv.2021.104894
  13. Burnes LE, Clark ST, Sheldrake E, et al. One swab, two tests: Validation of dual SARS-CoV-2 testing on the Abbott ID NOW™. J Clin Virol. 2021;141:104896. doi:10.1016/j.jcv.2021.104896
  14. Singh AK, Stellrecht KA, Arunachalam T, et al. Lack of active SARS-CoV-2 virus in a subset of PCR-positive COVID-19 congregate care patients. J Clin Virol. 2021;141:104879. doi:10.1016/j.jcv.2021.104879
  15. Camp JV, Buchta C, Jovanovic J, et al. RT-PCR based SARS-CoV-2 variant screening assays require careful quality control. J Clin Virol. 2021;141:104905. doi:10.1016/j.jcv.2021.104905
  16. Lind A, Barlinn R, Landaas ET, et al. Rapid SARS-CoV-2 variant monitoring using PCR confirmed by whole genome sequencing in a high-volume diagnostic laboratory. J Clin Virol. 2021;141:104906. doi:10.1016/j.jcv.2021.104906
  17. Berg MG, Zhen W, Lucic D, et al. Development of the RealTime SARS-CoV-2 quantitative Laboratory Developed Test and correlation with viral culture as a measure of infectivity. J Clin Virol. 2021;143:104945. doi:10.1016/j.jcv.2021.104945
  18. Paradis S, Lockamy E, Cooper CK, Young S. Clinical evaluation of the molecular-based BD SARS-CoV-2/Flu for the BD MAX™ system. J Clin Virol. 2021;143:104946. doi:10.1016/j.jcv.2021.104946
  19. Andreani J, Lupo J, Germi R, et al. Evaluation of six commercial SARS-CoV-2 rapid antigen tests in nasopharyngeal swabs: Better knowledge for better patient management?. J Clin Virol. 2021;143:104947. doi:10.1016/j.jcv.2021.104947
  20. Bongiovanni M, Liuzzi G, Schiavon L, Gianturco L, Giuliani G. Evaluation of the immune response to COVID-19 vaccine mRNA BNT162b2 and correlation with previous COVID-19 infection. J Clin Virol. 2021;143:104962. doi:10.1016/j.jcv.2021.104962
  21. Migueres M, Lhomme S, Trémeaux P, et al. Evaluation of two RT-PCR screening assays for identifying SARS-CoV-2 variants. J Clin Virol. 2021;143:104969. doi:10.1016/j.jcv.2021.104969
  22. Fernandes PADC, Ferreira FADC, Morais OM, et al. Performance of saliva as a specimen to detect SARS-CoV-2. J Clin Virol. 2021;142:104913. doi:10.1016/j.jcv.2021.104913
  23. Uchida S, Uwamino Y, Uno S, et al. Universal Polymerase Chain Reaction Screening for Severe Acute Respiratory Syndrome Coronavirus 2 in Asymptomatic Patients Before Hospital Admission in Tokyo, Japan. J Clin Virol. 2021;142:104915. doi:10.1016/j.jcv.2021.104915

 

Antigen Testing:

  1. Puyskens A, Krause E, Michel J, Nübling CM, Scheiblauer H, Bourquain D, Grossegesse M, Valusenko R, Corman VM, Drosten C, Zwirglmaier K, Wölfel R, Lange C, Kramer J, Friesen J, Ignatius R, Müller M, Schmidt-Chanasit J, Emmerich P, Schaade L, Nitsche A. Establishment of a specimen panel for the decentralised technical evaluation of the sensitivity of 31 rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021. Euro Surveill. 2021 Nov;26(44). doi: 10.2807/1560-7917.ES.2021.26.44.2100442. PMID: 34738516.
  2. Scheiblauer H, Filomena A, Nitsche A, Puyskens A, Corman VM, Drosten C, Zwirglmaier K, Lange C, Emmerich P, Müller M, Knauer O, Nübling CM. Comparative sensitivity evaluation for 122 CE-marked rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021. Euro Surveill. 2021 Nov;26(44). doi: 10.2807/1560-7917.ES.2021.26.44.2100441. PMID: 34738515.
  3. Domínguez Fernández M, Peña Rodríguez MF, Lamelo Alfonsín F, Bou Arévalo G. Experience with Panbio™ rapid antigens test device for the detection of SARS-CoV-2 in nursing homes. Enferm Infecc Microbiol Clin (Engl Ed). 2021 Oct 25:S2529-993X(21)00211-2. doi: 10.1016/j.eimce.2021.10.002. Epub ahead of print. PMID: 34732341; PMCID: PMC8542453.
  4. Turcato G, Zaboli A, Pfeifer N, Sibilio S, Tezza G, Bonora A, Ciccariello L, Ausserhofer D. Rapid antigen test to identify COVID-19 infected patients with and without symptoms admitted to the Emergency Department. Am J Emerg Med. 2021 Oct 22;51:92-97. doi: 10.1016/j.ajem.2021.10.022. Epub ahead of print. PMID: 34717211; PMCID: PMC8530784

Less recent publications on Antigen Testing

  1. Brasen CL, Christensen H, Olsen DA, et al. Daily monitoring of viral load measured as SARS-CoV-2 antigen and RNA in blood, IL-6, CRP and complement C3d predicts outcome in patients hospitalized with COVID-19 [published online ahead of print, 2021 Aug 27]. Clin Chem Lab Med. 2021;10.1515/cclm-2021-0694. doi:10.1515/cclm-2021-0694
  2. Hartard C, Berger S, Josse T, Schvoerer E, Jeulin H. Performance evaluation of an automated SARS-CoV-2 Ag test for the diagnosis of COVID-19 infection on nasopharyngeal swabs [published online ahead of print, 2021 Jul 30]. Clin Chem Lab Med. 2021;10.1515/cclm-2021-0569. doi:10.1515/cclm-2021-0569
  3. Bourassa L, Perchetti GA, Phung Q, et al. A SARS-CoV-2 Nucleocapsid Variant that Affects Antigen Test Performance. J Clin Virol. 2021;141:104900. doi:10.1016/j.jcv.2021.104900
  4. Van der Moeren N, Zwart VF, Goderski G, et al. Performance of the Diasorin SARS-CoV-2 antigen detection assay on the LIAISON XL. J Clin Virol. 2021;141:104909. doi:10.1016/j.jcv.2021.104909
  5. Lee J, Song JU, Shim SR. Comparing the diagnostic accuracy of rapid antigen detection tests to real time polymerase chain reaction in the diagnosis of SARS-CoV-2 infection: A systematic review and meta-analysis [published online ahead of print, 2021 Sep 16]. J Clin Virol. 2021;144:104985. doi:10.1016/j.jcv.2021.104985
  6. Merino-Amador P, González-Donapetry P, Domínguez-Fernández M, et al. Clinitest rapid COVID-19 antigen test for the diagnosis of SARS-CoV-2 infection: A multicenter evaluation study. J Clin Virol. 2021;143:104961. doi:10.1016/j.jcv.2021.104961
  7. Gandolfo C dr, Morecchiato F dr, Pistello M prof, Rossolini GM prof, Cusi MG prof. Detection of SARS-CoV-2 N protein allelic variants by rapid high-throughput CLEIA antigen assay. J Clin Virol. 2021;142:104942. doi:10.1016/j.jcv.2021.104942
  8. Ngo Nsoga MT, et alI. Diagnostic accuracy of Panbio rapid antigen tests on oropharyngeal swabs for detection of SARS-CoV-2. PLoS One. 2021 Jun 24;16(6):e0253321. doi: 10.1371/journal.pone.0253321. PMID: 34166410.
  9. Smith RD, et al. Clinical Evaluation of Sofia Rapid Antigen Assay for Detection of Severe Acute Respiratory Syndrome Coronavirus 2 among Emergency Department to Hospital Admissions. Infect Control Hosp Epidemiol. 2021 Jun 24:1-22. doi: 10.1017/ice.2021.281. Epub ahead of print. PMID: 34162449.
  10. Hanson KE, et al. The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Antigen Testing. Clin Infect Dis. 2021 Jun 23:ciab557. doi: 10.1093/cid/ciab557. Epub ahead of print. PMID: 34160592.
  11. Eleftheriou I, et al Real-life evaluation of a COVID-19 rapid antigen detection test in hospitalized children. J Med Virol. 2021 Jun 22. doi: 10.1002/jmv.27149. Epub ahead of print. PMID: 34156112.
  12. Lindner AK, et al. Diagnostic accuracy and feasibility of patient self-testing with a SARS-CoV-2 antigen-detecting rapid test. J Clin Virol. 2021 May 29;141:104874. doi: 10.1016/j.jcv.2021.104874. Epub ahead of print. PMID: 34144452; PMCID: PMC8163726.
  13. Ferté T, et al. Accuracy of COVID-19 rapid antigenic tests compared to RT-PCR in a student population: The StudyCov study. J Clin Virol. 2021 Jun 5;141:104878. doi: 10.1016/j.jcv.2021.104878. Epub ahead of print. PMID: 34134035; PMCID: PMC8178956.
  14. Blairon L, Cupaiolo R, Thomas I, Piteüs S, Wilmet A, Beukinga I, Tré-Hardy M. Efficacy comparison of three rapid antigen tests for SARS-CoV-2 and how viral load impact their performance. J Med Virol. 2021 May 29. doi: 10.1002/jmv.27108. Epub ahead of print. PMID: 34050945.
  15. Koller G, Morrell AP, Galão RP, Pickering S, MacMahon E, Johnson J, Ignatyev K, Neil SJD, Elsharkawy S, Fleck R, Machado PMP, Addison O. More than the Eye Can See: Shedding New Light on SARS-CoV-2 Lateral Flow Device-Based Immunoassays. ACS Appl Mater Interfaces. 2021 May 28. doi: 10.1021/acsami.1c04283. Epub ahead of print. PMID: 34048220.
  16. Krüger LJ, Gaeddert M, Tobian F, Lainati F, Gottschalk C, Klein JAF, Schnitzler P, Kräusslich HG, Nikolai O, Lindner AK, Mockenhaupt FP, Seybold J, Corman VM, Drosten C, Pollock NR, Knorr B, Welker A, de Vos M, Sacks JA, Denkinger CM; study team. The Abbott PanBio WHO emergency use listed, rapid, antigen-detecting point-of-care diagnostic test for SARS-CoV-2-Evaluation of the accuracy and ease-of-use. PLoS One. 2021 May 27;16(5):e0247918. doi: 10.1371/journal.pone.0247918. PMID: 34043631.
  17. Shaikh N, Friedlander EJ, Tate PJ, Liu H, Chang CH, Wells A, Hoberman A. Performance of a Rapid SARS-CoV-2 Antigen Detection Assay in Symptomatic Children. Pediatrics. 2021 May 26:e2021050832. doi: 10.1542/peds.2021-050832. Epub ahead of print. PMID: 34039718.
  18. Taher J, Randell EW, Arnoldo S, Bailey D, De Guire V, Kaur S, Knauer M, Petryayeva E, Poutanen SM, Shaw JLV, Uddayasankar U, White-Al Habeeb N, Konforte D. Canadian society of clinical chemists (CSCC) consensus guidance for testing, selection and quality management of SARS-CoV-2 point-of-care tests. Clin Biochem. 2021 May 25:S0009-9120(21)00151-X. doi: 10.1016/j.clinbiochem.2021.05.010. Epub ahead of print. PMID: 34048776.
  19. Klein JAF, Krüger LJ, Tobian F, Gaeddert M, Lainati F, Schnitzler P, Lindner AK, Nikolai O, Knorr B, Welker A, de Vos M, Sacks JA, Escadafal C, Denkinger CM; Study Team. Head-to-head performance comparison of self-collected nasal versus professional-collected nasopharyngeal swab for a WHO-listed SARS-CoV-2 antigen-detecting rapid diagnostic test. Med Microbiol Immunol. 2021 May 24:1–6. doi: 10.1007/s00430-021-00710-9. Epub ahead of print. PMID: 34028625; PMCID: PMC8142294.
  20. Koeleman JGM, Brand H, de Man SJ, Ong DSY. Clinical evaluation of rapid point-of-care antigen tests for diagnosis of SARS-CoV-2 infection. Eur J Clin Microbiol Infect Dis. 2021 May 22:1–7. doi: 10.1007/s10096-021-04274-7. Epub ahead of print. PMID: 34021840; PMCID: PMC8140309.
  21. Ulhaq ZS, Soraya GV. The diagnostic accuracy of seven commercial molecular in vitro SARS-CoV-2 detection tests: a rapid meta-analysis. Expert Rev Mol Diagn. 2021 May 20. doi: 10.1080/14737159.2021.1933449. Epub ahead of print. PMID: 34015984.
  22. Reza S, Corentin D, Te-Din H, Pierre B, Stéphanie E, Isaline W, Boutaina H, Pauline R, Olivier D. Rapid COVID-19 antigenic tests: Usefulness of a modified method for diagnosis. J Med Virol. 2021 May 19. doi: 10.1002/jmv.27094. Epub ahead of print. PMID: 34009649.
  23. Hayer J, Kasapic D, Zemmrich C. Real-world clinical performance of commercial SARS-CoV-2 rapid antigen tests in suspected COVID-19: A systematic meta-analysis of available data as per November 20, 2020. Int J Infect Dis. 2021 May 17:S1201-9712(21)00431-8. doi: 10.1016/j.ijid.2021.05.029. Epub ahead of print. PMID: 34015523; PMCID: PMC8127520.
  24. Pérez-García F, Romanyk J, Gutiérrez HM, Ballestero AL, Ranz IP, Arroyo JG, Ventosa VG, Pérez-Tanoira R, Cruz CD, Cuadros-González J. Comparative evaluation of Panbio and SD Biosensor antigen rapid diagnostic tests for COVID-19 diagnosis. J Med Virol. 2021 May 17. doi: 10.1002/jmv.27089. Epub ahead of print. PMID: 34002864.
  25. Brihn A, Chang J, OYong K, Balter S, Terashita D, Rubin Z, Yeganeh N. Diagnostic Performance of an Antigen Test with RT-PCR for the Detection of SARS-CoV-2 in a Hospital Setting - Los Angeles County, California, June-August 2020. MMWR Morb Mortal Wkly Rep. 2021 May 14;70(19):702-706. doi: 10.15585/mmwr.mm7019a3. PMID: 33983916; PMCID: PMC8118154.
  26. Abbasi J. A Next-Generation Rapid, Accurate SARS-CoV-2 Antibody Test. JAMA. 2021 May 11;325(18):1825. doi: 10.1001/jama.2021.6333. PMID: 33974035.
  27. Lee LYW, Rozmanowski S, Pang M, Charlett A, Anderson C, Hughes GJ, Barnard M, Peto L, Vipond R, Sienkiewicz A, Hopkins S, Bell J, Crook DW, Gent N, Walker AS, Peto TEA, Eyre DW. SARS-CoV-2 infectivity by viral load, S gene variants and demographic factors and the utility of lateral flow devices to prevent transmission. Clin Infect Dis. 2021 May 11:ciab421. doi: 10.1093/cid/ciab421. Epub ahead of print. PMID: 33972994; PMCID: PMC8136027.
  28. Bornemann L, Kaup O, Kleideiter J, Panning M, Ruprecht B, Wehmeier M. Real-life evaluation of the Sofia SARS-CoV-2 antigen assay in a large tertiary care hospital. J Clin Virol. 2021 May 10;140:104854. doi: 10.1016/j.jcv.2021.104854. Epub ahead of print. PMID: 34044330; PMCID: PMC8108474.
  29. Holzner C, Pabst D, Anastasiou OE, Dittmer U, Manegold RK, Risse J, Fistera D, Kill C, Falk M. SARS-CoV-2 rapid antigen test: Fast-safe or dangerous? An analysis in the emergency department of an university hospital. J Med Virol. 2021 May 9. doi: 10.1002/jmv.27033. Epub ahead of print. PMID: 33969499.
  30. Fouzas S. SARS-CoV-2 rapid antigen detection tests. Lancet Infect Dis. 2021 May 4:S1473-3099(21)00206-1. doi: 10.1016/S1473-3099(21)00206-1. Epub ahead of print. PMID: 33961800; PMCID: PMC8096322.
  31. Thakur P, Saxena S, Manchanda V, Rana N, Goel R, Arora R. Utility of Antigen-Based Rapid Diagnostic Test for Detection of SARS-CoV-2 Virus in Routine Hospital Settings. Lab Med. 2021 Apr 30:lmab033. doi: 10.1093/labmed/lmab033. Epub ahead of print. PMID: 33928384.
  32. Bruzzone B, De Pace V, Caligiuri P, Ricucci V, Guarona G, Pennati BM, Boccotti S, Orsi A, Domnich A, Da Rin G, Icardi G. Comparative diagnostic performance of different rapid antigen detection tests for COVID-19 in the real-world hospital setting. Int J Infect Dis. 2021 Apr 27:S1201-9712(21)00384-2. doi: 10.1016/j.ijid.2021.04.072. Epub ahead of print. PMID: 33930540; PMCID: PMC8078031.
  33. Bohn MK, Lippi G, Horvath AR, Erasmus R, Grimmler M, Gramegna M, Mancini N, Mueller R, Rawlinson WD, Menezes ME, Patru MM, Rota F, Sethi S, Singh K, Yuen KY, Wang CB, Adeli K; IFCC Taskforce on COVID-19. IFCC interim guidelines on rapid point-of-care antigen testing for SARS-CoV-2 detection in asymptomatic and symptomatic individuals. Clin Chem Lab Med. 2021 Apr 27. doi: 10.1515/cclm-2021-0455. Epub ahead of print. PMID: 33908222.
  34. Baro B, Rodo P, Ouchi D, Bordoy AE, Saya Amaro EN, Salsench SV, Molinos S, Alemany A, Ubals M, Corbacho-Monné M, Millat-Martinez P, Marks M, Clotet B, Prat N, Ara J, Vall-Mayans M, G-Beiras C, Bassat Q, Blanco I, Mitjà O. Performance characteristics of five antigen-detecting rapid diagnostic test (Ag-RDT) for SARS-CoV-2 asymptomatic infection: a head-to-head benchmark comparison. J Infect. 2021 Apr 18:S0163-4453(21)00191-2. doi: 10.1016/j.jinf.2021.04.009. Epub ahead of print. PMID: 33882299; PMCID: PMC8053403.
  35. Kenyeres B, Ánosi N, Bányai K, Mátyus M, Orosz L, Kiss A, Kele B, Burián K, Lengyel G. Comparison of four PCR and two point of care assays used in the laboratory detection of SARS-CoV-2. J Virol Methods. 2021 Apr 16;293:114165. doi: 10.1016/j.jviromet.2021.114165. Epub ahead of print. PMID: 33872650; PMCID: PMC8051013.
  36. Häuser F, Sprinzl MF, Dreis KJ, Renzaho A, Youhanen S, Kremer WM, Podlech J, Galle PR, Lackner KJ, Rossmann H, Lemmermann NA. Evaluation of a laboratory-based high-throughput SARS-CoV-2 antigen assay for non-COVID-19 patient screening at hospital admission. Med Microbiol Immunol. 2021 Apr 15:1–7. doi: 10.1007/s00430-021-00706-5. Epub ahead of print. PMID: 33856557; PMCID: PMC8047582.
  37. Ford L, Lee C, Pray IW, Cole D, Bigouette JP, Abedi GR, Bushman D, Delahoy MJ, Currie DW, Cherney B, Kirby M, Fajardo G, Caudill M, Langolf K, Kahrs J, Zochert T, Kelly P, Pitts C, Lim A, Aulik N, Tamin A, Harcourt JL, Queen K, Zhang J, Whitaker B, Browne H, Medrzycki M, Shewmaker P, Bonenfant G, Zhou B, Folster J, Bankamp B, Bowen MD, Thornburg NJ, Goffard K, Limbago B, Bateman A, Tate JE, Gieryn D, Kirking HL, Westergaard R, Killerby M; CDC COVID-19 Surge Laboratory Group. Epidemiologic characteristics associated with SARS-CoV-2 antigen-based test results, rRT-PCR cycle threshold values, subgenomic RNA, and viral culture results from university testing. Clin Infect Dis. 2021 Apr 13:ciab303. doi: 10.1093/cid/ciab303. Epub ahead of print. PMID: 33846714.
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  49. Olearo F, Nörz D, Heinrich F, Sutter JP, Roedl K, Schultze A, Wiesch JSZ, Braun P, Oestereich L, Kreuels B, Wichmann D, Aepfelbacher M, Pfefferle S, Lütgehetmann M. Handling and accuracy of four rapid antigen tests for the diagnosis of SARS-CoV-2 compared to RT-qPCR. J Clin Virol. 2021 Mar 3;137:104782. doi: 10.1016/j.jcv.2021.104782. Epub ahead of print. PMID: 33711691; PMCID: PMC7927591.
  50. Paltiel AD, Zheng A, Sax PE. Clinical and Economic Effects of Widespread Rapid Testing to Decrease SARS-CoV-2 Transmission. Ann Intern Med. 2021 Mar 9. doi: 10.7326/M21-0510. Epub ahead of print. PMID: 33683930.
  51. Strand R, Thelaus L, Fernström N, Sunnerhagen T, Lindroth Y, Linder A, Rasmussen M. Rapid diagnostic testing for SARS-CoV-2: Validation and comparison of three point-of-care antibody tests. J Med Virol. 2021 Mar 5. doi: 10.1002/jmv.26913. Epub ahead of print. PMID: 33666238.
  52. Kiang MV, Chin ET, Huynh BQ, Chapman LAC, Rodríguez-Barraquer I, Greenhouse B, Rutherford GW, Bibbins-Domingo K, Havlir D, Basu S, Lo NC. Routine asymptomatic testing strategies for airline travel during the COVID-19 pandemic: a simulation study. Lancet Infect Dis. 2021 Mar 22:S1473-3099(21)00134-1. doi: 10.1016/S1473-3099(21)00134-1
  53. Thommes L, Burkert FR, Öttl KW, Goldin D, Loacker L, Lanser L, Griesmacher A, Theurl I, Weiss G, Bellmann-Weiler R. Comparative evaluation of four SARS-CoV-2 antigen tests in hospitalized patients. Int J Infect Dis. 2021 Feb 17:S1201-9712(21)00138-7. doi: 10.1016/j.ijid.2021.02.052. Epub ahead of print. PMID: 33609774.
  54. Mina MJ, Peto TE, García-Fiñana M, Semple MG, Buchan IE. Clarifying the evidence on SARS-CoV-2 antigen rapid tests in public health responses to COVID-19. Lancet. 2021 Feb 17:S0140-6736(21)00425-6. doi: 10.1016/S0140-6736(21)00425-6. Epub ahead of print. PMID: 33609444.
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  58. Merino P, Guinea J, Muñoz-Gallego I, González-Donapetry P, Galán JC, Antona N, Cilla G, Hernáez-Crespo S, Díaz-de Tuesta JL, Torrella AG, González-Romo F, Escribano P, Sánchez-Castellano MÁ, Sota-Busselo M, Delgado-Iribarren A, García J, Cantón R, Muñoz P, Folgueira MD, Cuenca-Estrella M, Oteo-Iglesias J; Spanish Panbio™ COVID-19 validation group, Medrano S, Pérez A, Galar A, Martínez-Expósito O, Alejo-Cancho I, Martín-Higuera MC, Rolo M, Estévez MJ, Bravo T, Vicente D, Montes M. Multicenter evaluation of the Panbio™ COVID-19 rapid antigen-detection test for the diagnosis of SARS-CoV-2 infection. Clin Microbiol Infect. 2021 Feb 15:S1198-743X(21)00076-8. doi: 10.1016/j.cmi.2021.02.001. Epub ahead of print. PMID: 33601009; PMCID: PMC7884234.
  59. Gili A, Paggi R, Russo C, Cenci E, Pietrella D, Graziani A, Stracci F, Mencacci A. Evaluation of automated test Lumipulse® G SARS-CoV-2 antigen assay for detection of SARS-CoV-2 nucleocapsid protein (NP) in nasopharyngeal swabs for community and population screening. Int J Infect Dis. 2021 Feb 26:S1201-9712(21)00184-3. doi: 10.1016/j.ijid.2021.02.098. Epub ahead of print. PMID: 33647511; PMCID: PMC7908845.
  60. Pérez-García F, Romanyk J, Gómez-Herruz P, Arroyo T, Pérez-Tanoira R, Linares M, Pérez Ranz I, Labrador Ballestero A, Moya Gutiérrez H, Ruiz-Álvarez MJ, Cuadros-González J. Diagnostic performance of CerTest and Panbio antigen rapid diagnostic tests to diagnose SARS-CoV-2 infection. J Clin Virol. 2021 Feb 21;137:104781. doi: 10.1016/j.jcv.2021.104781. Epub ahead of print. PMID: 33639492; PMCID: PMC7897407.
  61. Drain PK, Ampajwala M, Chappel C, Gvozden AB, Hoppers M, Wang M, Rosen R, Young S, Zissman E, Montano M. A Rapid, High-Sensitivity SARS-CoV-2 Nucleocapsid Immunoassay to Aid Diagnosis of Acute COVID-19 at the Point of Care: A Clinical Performance Study. Infect Dis Ther. 2021 Feb 24:1–9. doi: 10.1007/s40121-021-00413-x. Epub ahead of print. PMID: 33629225; PMCID: PMC7904038.
  62. Pollock NR, Jacobs JR, Tran K, Cranston AE, Smith S, O'Kane CY, Roady TJ, Moran A, Scarry A, Carroll M, Volinsky L, Perez G, Patel P, Gabriel S, Lennon NJ, Madoff LC, Brown C, Smole SC. Performance and Implementation Evaluation of the Abbott BinaxNOW Rapid Antigen Test in a High-throughput Drive-through Community Testing Site in Massachusetts. J Clin Microbiol. 2021 Feb 23:JCM.00083-21. doi: 10.1128/JCM.00083-21. Epub ahead of print. PMID: 33622768.
  63. Courtellemont L, Guinard J, Guillaume C, Giaché S, Rzepecki V, Seve A, Gubavu C, Baud K, Le Helloco C, Cassuto GN, Pialoux G, Hocqueloux L, Prazuck T. High performance of a novel antigen detection test on nasopharyngeal specimens for diagnosing SARS-CoV-2 infection. J Med Virol. 2021 Feb 21. doi: 10.1002/jmv.26896. Epub ahead of print. PMID: 33615487.
  64. Thommes L, Burkert FR, Öttl KW, Goldin D, Loacker L, Lanser L, Griesmacher A, Theurl I, Weiss G, Bellmann-Weiler R. Comparative evaluation of four SARS-CoV-2 antigen tests in hospitalized patients. Int J Infect Dis. 2021 Feb 17;105:144–6. doi: 10.1016/j.ijid.2021.02.052. Epub ahead of print. PMID: 33609774; PMCID: PMC7888994.
  65. Singh NK, Ray P, Carlin AF, Magallanes C, Morgan SC, Laurent LC, Aronoff-Spencer ES, Hall DA. Hitting the diagnostic sweet spot: Point-of-care SARS-CoV-2 salivary antigen testing with an off-the-shelf glucometer. Biosens Bioelectron. 2021 Feb 26;180:113111. doi: 10.1016/j.bios.2021.113111. Epub ahead of print. PMID: 33743492.
  66. Masiá M, Fernández-González M, Sánchez M, Carvajal M, García JA, Gonzalo-Jiménez N, Ortiz de la Tabla V, Agulló V, Candela I, Guijarro J, Gutiérrez JA, de Gregorio C, Gutiérrez F. Nasopharyngeal Panbio COVID-19 Antigen Performed at Point-of-Care Has a High Sensitivity in Symptomatic and Asymptomatic Patients With Higher Risk for Transmission and Older Age. Open Forum Infect Dis. 2021 Feb 2;8(3):ofab059. doi: 10.1093/ofid/ofab059. PMID: 33723512; PMCID: PMC7928615.
  67. Paltiel AD, Zheng A, Sax PE. Clinical and Economic Effects of Widespread Rapid Testing to Decrease SARS-CoV-2 Transmission. Ann Intern Med. 2021 Mar 9. doi: 10.7326/M21-0510. Epub ahead of print. PMID: 33683930.
  68. Crozier A, Rajan S, Buchan I, McKee M. Put to the test: use of rapid testing technologies for covid-19. BMJ. 2021 Feb 3;372:n208. doi: 10.1136/bmj.n208. PMID: 33536228.
  69. Rottenstreich A, Zarbiv G, Kabiri D, Benenson S, Oster Y, Porat S, Sompolinsky Y, Reubinoff B. Rapid antigen detection testing for universal screening for SARS-CoV-2 in women admitted for delivery. Am J Obstet Gynecol. 2021 Jan 13:S0002-9378(21)00025-9. doi: 10.1016/j.ajog.2021.01.002. Epub ahead of print. PMID: 33453181.
  70. Favresse J, Gillot C, Oliveira M, Cadrobbi J, Elsen M, Eucher C, Laffineur K, Rosseels C, Van Eeckhoudt S, Nicolas JB, Morimont L, Dogné JM, Douxfils J. Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection. J Clin Med. 2021 Jan 13;10(2):E265. doi: 10.3390/jcm10020265. PMID: 33450853.
  71. Osterman A, Baldauf HM, Eletreby M, Wettengel JM, Afridi SQ, Fuchs T, Holzmann E, Maier A, Döring J, Grzimek-Koschewa N, Muenchhoff M, Protzer U, Kaderali L, Keppler OT. Evaluation of two rapid antigen tests to detect SARS-CoV-2 in a hospital setting. Med Microbiol Immunol. 2021 Jan 16. doi: 10.1007/s00430-020-00698-8. Epub ahead of print. PMID: 33452927.
  72. Komarov A, Kaznadzey A, Li Y, Kireeva M, Mazo I. Dual-Antigen System Allows Elimination of False Positive Results in COVID-19 Serological Testing. Diagnostics (Basel). 2021 Jan 11;11(1):E102. doi: 10.3390/diagnostics11010102. PMID: 33440690.
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Serology Testing:

  1. Rapp AR, Ogunbileje JO, Djouodo-Nemzou D, Okorodudu AO. Methods matter - Tailoring SARS-CoV-2 antibody targets to vaccination status. Clin Chim Acta. 2021 Aug;519:140-141. doi: 10.1016/j.cca.2021.04.009. Epub 2021 Apr 17. PMID: 33872607; PMCID: PMC8052504.
  2. Padoan A, Dall'Olmo L, Rocca FD, Barbaro F, Cosma C, Basso D, Cattelan A, Cianci V, Plebani M. Antibody response to first and second dose of BNT162b2 in a cohort of characterized healthcare workers. Clin Chim Acta. 2021 Aug;519:60-63. doi: 10.1016/j.cca.2021.04.006. Epub 2021 Apr 20. PMID: 33857476; PMCID: PMC8056941.
  3. Raposo F, Lippi G. Antibody response induced by the boost overdose during COVID-19 heterologous prime-boost vaccination strategy. Clin Chim Acta. 2021 Sep 29;523:201-204. doi: 10.1016/j.cca.2021.09.022. Epub ahead of print. PMID: 34599902; PMCID: PMC8480142.
  4. Ferrari D, Clementi N, Spanò SM, Albitar-Nehme S, Ranno S, Colombini A, Criscuolo E, Di Resta C, Tomaiuolo R, Viganó M, Mancini N, De Vecchi E, Locatelli M, Mangia A, Perno CF, Banfi G. Harmonization of six quantitative SARS-CoV-2 serological assays using sera of vaccinated subjects. Clin Chim Acta. 2021 Nov;522:144-151. doi: 10.1016/j.cca.2021.08.024. Epub 2021 Aug 20. PMID: 34425105; PMCID: PMC8378065.
  5. He Y, Tong Y. A theoretical simulation of SARS-CoV-2 pooled testing: Pooled sample collection outperforms pooled RNA extraction. Clin Chim Acta. 2021 Oct;521:155-157. doi: 10.1016/j.cca.2021.07.016. Epub 2021 Jul 16. PMID: 34274344; PMCID: PMC8282448.
  6. Nandakumar V, Profaizer T, Lozier BK, Elgort MG, Rychert J, Slev PR, Delgado JC. Evaluation of a Novel Multiplex Platform for Simultaneous Detection of IgG Antibodies against the Four Main SARS-CoV-2 Antigens. J Appl Lab Med. 2021 Nov 6:jfab161. doi: 10.1093/jalm/jfab161. Epub ahead of print. PMID: 34741514.
  7. Wu AHB, Nguyen ED, Ong CM, Yun C, Lynch KL. Rate of Serum SARS-CoV-2 Antibody Decline for two mRNA Vaccines. J Appl Lab Med. 2021 Oct 14:jfab137. doi: 10.1093/jalm/jfab137. Epub ahead of print. PMID: 34648027; PMCID: PMC8524641.
  8. Jung J, Rajapakshe D, Julien C, Devaraj S. Analytical and clinical performance of cPass neutralizing antibodies assay. Clin Biochem. 2021 Sep 21:S0009-9120(21)00249-6. doi: 10.1016/j.clinbiochem.2021.09.008. Epub ahead of print. PMID: 34560062; PMCID: PMC8453782.
  9. Cook N, Xu L, Hegazy S, Wheeler BJ, Anderson AR, Critelli N, Yost M, McElroy AK, Shurin MR, Wheeler SE. Multiplex assessment of SARS-CoV-2 antibodies improves assay sensitivity and correlation with neutralizing antibodies. Clin Biochem. 2021 Nov;97:54-61. doi: 10.1016/j.clinbiochem.2021.08.006. Epub 2021 Aug 26. PMID: 34453893; PMCID: PMC8387133.
  10. Poore B, Nerenz RD, Brodis D, Brown CI, Cervinski MA, Hubbard JA. A comparison of SARS-CoV-2 nucleocapsid and spike antibody detection using three commercially available automated immunoassays. Clin Biochem. 2021 Sep;95:77-80. doi: 10.1016/j.clinbiochem.2021.05.011. Epub 2021 Jun 9. PMID: 34118242; PMCID: PMC8188801.
  11. Poore B, Nerenz RD, Brodis D, Brown CI, Cervinski MA, Hubbard JA. A comparison of SARS-CoV-2 nucleocapsid and spike antibody detection using three commercially available automated immunoassays. Clin Biochem. 2021 Sep;95:77-80. doi: 10.1016/j.clinbiochem.2021.05.011. Epub 2021 Jun 9. PMID: 34118242; PMCID: PMC8188801.
  12. Heaney CD, Pisanic N, Randad PR, Kruczynski K, Howard T, Zhu X, Littlefield K, Patel EU, Shrestha R, Laeyendecker O, Shoham S, Sullivan D, Gebo K, Hanley D, Redd AD, Quinn TC, Casadevall A, Zenilman JM, Pekosz A, Bloch EM, Tobian AAR. Comparative performance of multiplex salivary and commercially available serologic assays to detect SARS-CoV-2 IgG and neutralization titers. J Clin Virol. 2021 Oct 9;145:104997. doi: 10.1016/j.jcv.2021.104997. Epub ahead of print. PMID: 34695724; PMCID: PMC8502080.

Less recent publications on Serology Testing

  1. Suhandynata RT, Bevins NJ, Tran JT, et al. SARS-CoV-2 Serology Status Detected by Commercialized Platforms Distinguishes Previous Infection and Vaccination Adaptive Immune Responses. J Appl Lab Med. 2021;6(5):1109-1122. doi:10.1093/jalm/jfab080
  2. Ou J, Tan M, He H, et al. SARS-CoV-2 Antibodies and Associated Factors at Different Hospitalization Time Points in 192 COVID-19 Cases. J Appl Lab Med. 2021;6(5):1133-1142. doi:10.1093/jalm/jfab003
  3. El-Khoury JM, Schulz WL, Durant TJS. Longitudinal Assessment of SARS-CoV-2 Antinucleocapsid and Antispike-1-RBD Antibody Testing Following PCR-Detected SARS-CoV-2 Infection. J Appl Lab Med. 2021;6(4):1005-1011. doi:10.1093/jalm/jfab030
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