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.

 

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. 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.
  3. 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.
  4. 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.
  5. 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.
  6. Dying in a Leadership Vacuum. N Engl J Med. 2020 Oct 8;383(15):1479-1480. doi: 10.1056/NEJMe2029812. PMID: 33027574.

 

Molecular Testing:

  1. Wang X, Yao H, Xu X, Zhang P, Zhang M, Shao J, Xiao Y, Wang H. Limits of Detection of Six Approved RT–PCR Kits for the Novel SARS-coronavirus-2 (SARS-CoV-2). Clinical Chemistry. 2020 Apr 13. PMID: 32282874
  2. Lippi G, Simundic AM, Plebani M. Potential preanalytical and analytical vulnerabilities in the laboratory diagnosis of coronavirus disease 2019 (COVID-19). Clinical Chemistry and Laboratory Medicine (CCLM). 2020 Mar 16;1(ahead-of-print). PMID: 32172228
  3. Sung H, Yoo CK, Han MG, Lee SW, Lee H, Chun S, Lee WG, Min WK. Preparedness and Rapid Implementation of External Quality Assessment Helped Quickly Increase COVID-19 Testing Capacity in the Republic of Korea. Clinical Chemistry. PMID: 32321159
  4. Ai T, Yang Z, Hou H, Zhan C, Chen C, Lv W, Tao Q, Sun Z, Xia L. Correlation of chest CT and RT-PCR testing in coronavirus disease 2019 (COVID-19) in China: a report of 1014 cases. Radiology. 2020 Feb 26:200642. PMID: 32101510
  5. Lassaunière R, Frische A, Harboe ZB, Nielsen AC, Fomsgaard A, Krogfelt KA, Jørgensen CS. Evaluation of nine commercial SARS-CoV-2 immunoassays. 2020 Jan 1
  6. Hanley B, Lucas SB, Youd E, Swift B, Osborn M. Autopsy in suspected COVID-19 cases. Journal of Clinical Pathology. 2020 May 1;73(5):239-42. PMID: 32198191
  7. Zhen W, Manji R, Smith E, Berry GJ. Comparison of Four Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2 in Nasopharyngeal Specimens. Journal of Clinical Microbiology. 2020 Apr 27. PMID: 32341143
  8. Lin C, Xiang J, Yan M, Li H, Huang S, Shen C. Comparison of throat swabs and sputum specimens for viral nucleic acid detection in 52 cases of novel coronavirus (SARS-Cov-2)-infected pneumonia (COVID-19). Clinical Chemistry and Laboratory Medicine (CCLM). 2020 Apr 16;1(ahead-of-print). PMID: 32301745
  9. Pan Y, Long L, Zhang D, Yan T, Cui S, Yang P, Wang Q, Ren S. Potential false-negative nucleic acid testing results for Severe Acute Respiratory Syndrome Coronavirus 2 from thermal inactivation of samples with low viral loads. Clinical Chemistry. 2020 Apr 4. PMID: 32246822
  10. Behrmann O, Bachmann I, Spiegel M, et al. Rapid detection of SARS-CoV-2 by low volume real-time single tube reverse transcription recombinase polymerase amplification using an exo probe with an internally linked quencher (exo-IQ). Clinical Chemistry. 2020 May 8. PMID: 32384153
  11. Peddu V, Shean RC, Xie H, et al. Metagenomic analysis reveals clinical SARS-CoV-2 infection and bacterial or viral superinfection and colonization. Clinical Chemistry. 2020 May 7. PMID: 32379863
  12. Dietzen DJ. Unleashing the Power of Laboratory Developed Tests: Closing gaps in COVID diagnosis and beyond. The Journal of Applied Laboratory Medicine. 2020 Apr 29.
  13. Basu A, Zinger T, Inglima K, Woo KM, Atie O, Yurasits L, See B, Aguero-Rosenfeld ME. Performance of the rapid Nucleic Acid Amplification by Abbott ID NOW COVID-19 in nasopharyngeal swabs transported in viral media and dry nasal swabs, in a New York City academic institution. bioRxiv. 2020 Jan 1. Preprint non-peer reviewed
  14. Ramdas K, Darzi A, Jain S. ‘Test, re-test, re-test’: using inaccurate tests to greatly increase the accuracy of COVID-19 testing. Nature Medicine. 2020 May 12:1-2. PMID: 32398878
  15. Wacharapluesadee S, Kaewpom T, Ampoot W, et al. Evaluating the efficiency of specimen pooling for PCR-based detection of COVID-19. J Med Virol. 2020 May 13;10.1002/jmv.26005. PMID: 32401343
  16. Basu A, Zinger T, Inglima K, Woo KM, Atie O, Yurasits L, See B, Aguero-Rosenfeld ME. Performance of Abbott ID NOW COVID-19 rapid nucleic acid amplification test in nasopharyngeal swabs transported in viral media and dry nasal swabs, in a New York City academic institution. J Clin Microbiol. 2020 May 29:JCM.01136-20. doi: 10.1128/JCM.01136-20. Epub ahead of print. PMID: 32471894.
  17. Traugott M, Aberle SW, Aberle JH, Griebler H, Karolyi M, Pawelka E, Puchhammer-Stöckl E, Zoufaly A, Weseslindtner L. Performance of SARS-CoV-2 antibody assays in different stages of the infection: Comparison of commercial ELISA and rapid tests. J Infect Dis. 2020 May 30:jiaa305. doi: 10.1093/infdis/jiaa305. Epub ahead of print. PMID: 32473021.
  18. Binnicker MJ. Emergence of a Novel Coronavirus Disease (COVID-19) and the Importance of Diagnostic Testing: Why Partnership between Clinical Laboratories, Public Health Agencies, and Industry Is Essential to Control the Outbreak. Clin Chem. 2020;66(5):664‐ doi:10.1093/clinchem/hvaa071. PMID: 32077933
  19. Shi J, Han D, Zhang R, Li J, Zhang R. Molecular and serological assays for SARS-CoV-2: insights from genome and clinical characteristics. Clin Chem. 2020 May 21:hvaa122. doi: 10.1093/clinchem/hvaa122. Epub ahead of print. PMID: 32437513.
  20. Kucirka LM, Lauer SA, Laeyendecker O, Boon D, Lessler J. Variation in False-Negative Rate of Reverse Transcriptase Polymerase Chain Reaction–Based SARS-CoV-2 Tests by Time Since Exposure. Annals of Internal Medicine. 2020 May 23. PMID: 32422057
  21. Jehi L, Ji X, Milinovich A, Erzurum S, Rubin B, Gordon S, Young J, Kattan MW. Individualizing risk prediction for positive COVID-19 testing: results from 11,672 patients. Chest. 2020 Jun 10. doi: 10.1016/j.chest.2020.05.580. Epub ahead of print. PMCID: PMC7286244.
  22. Pilcher CD, Westreich D, Hudgens MG. Group Testing for Sars-Cov-2 to Enable Rapid Scale-Up of Testing and Real-Time Surveillance of Incidence [published online ahead of print, 2020 Jun 27]. J Infect Dis. 2020;jiaa378. doi:10.1093/infdis/jiaa378
  23. Vogels CBF, Brito AF, Wyllie AL, et al. Analytical sensitivity and efficiency comparisons of SARS-CoV-2 RT-qPCR primer-probe sets [published online ahead of print, 2020 Jul 10]. Nat Microbiol. 2020;10.1038/s41564-020-0761-6. doi:10.1038/s41564-020-0761-6
  24. Fung B, Gopez A, Servellita V, et al. Direct Comparison of SARS-CoV-2 Analytical Limits of Detection across Seven Molecular Assays [published online ahead of print, 2020 Jul 10]. J Clin Microbiol. 2020;JCM.01535-20. doi:10.1128/JCM.01535-20
  25. Mallett S, Allen J, Graziadio S, Taylor SA, Sakai NS, Green K, Suklan J, Hyde C, Shinkins B, Zhelev Z, Peters J. At what times during infection is SARS-CoV-2 detectable and no longer detectable using RT-PCR based tests?: A systematic review of individual participant data. 2020 Jan 1.
  26. Mattiuzzi C, Henry BM, Sanchis-Gomar F, Lippi G. SARS-CoV-2 recurrent RNA positivity after recovering from coronavirus disease 2019 (COVID-19): a meta-analysis. Acta BioMed. 2020;91(3): Epub ahead of print. Doi: 10.23750/abm.v91i3.10303
  27. Artesi M, Bontems S, Göbbels P, Franckh M, Maes P, Boreux R, Meex C, Melin P, Hayette MP, Bours V, Durkin K. A recurrent mutation at position 26,340 of SARS-CoV-2 is associated with failure of the E-gene qRT-PCR utilized in a commercial dual-target diagnostic assay. Journal of Clinical Microbiology. 2020 Jul 20.
  28. Matheeussen V, Corman VM, Mantke OD, McCulloch E, Lammens C, Goossens H, Niemeyer D, Wallace PS, Klapper P, Niesters HG, Drosten C. International external quality assessment for SARS-CoV-2 molecular detection and survey on clinical laboratory preparedness during the COVID-19 pandemic, April/May 2020. Eurosurveillance. 2020 Jul 9;25(27):2001223.
  29. Bossuyt PM. Testing COVID-19 tests faces methodological challenges. Journal of Clinical Epidemiology. 2020 Jul 3.
  30. Zhang Y, Wang C, Han M, et al. Discrimination of False Negative Results in RT-PCR Detection of SARS-CoV-2 RNAs in Clinical Specimens by Using an Internal Reference [published online ahead of print, 2020 Aug 4]. Virol Sin. 2020;1-10. doi:10.1007/s12250-020-00273-8
  31. Sriwijitalai W, Wiwanitkit V. Cost-Utility Analysis for Chest CT versus RT-PCR for COVID-19 Detection. Int J Prev Med. 2020;11:67. Published 2020 Jun 5. doi:10.4103/ijpvm.IJPVM_83_20
  32. Koyama T, Platt D, Parida L. Variant analysis of SARS-CoV-2 genomes. Bull World Health Organ. 2020;98(7):495-504. doi:10.2471/BLT.20.253591
  33. Pourbagheri-Sigaroodi A, Bashash D, Fateh F, Abolghasemi H. Laboratory Findings in COVID-19 Diagnosis and Prognosis [published online ahead of print, 2020 Aug 13]. Clin Chim Acta. 2020;S0009-8981(20)30412-5. doi:10.1016/j.cca.2020.08.019
  34. Kumari P, Singh A, Rinchui Ngasainao M, et al. Potential diagnostics and therapeutic approaches in COVID-19 [published online ahead of print, 2020 Aug 11]. Clin Chim Acta. 2020;S0009-8981(20)30395-8. doi:10.1016/j.cca.2020.08.013
  35. Wang B, Hu M, Ren Y, et al. Evaluation of seven commercial SARS-CoV-2 RNA detection kits based on real-time polymerase chain reaction (PCR) in China [published online ahead of print, 2020 Jul 13]. Clin Chem Lab Med. 2020;/j/cclm.ahead-of-print/cclm-2020-0271/cclm-2020-0271.xml. doi:10.1515/cclm-2020-0271
  36. Rödel J, Egerer R, Suleyman A, et al. Use of the variplex™ SARS-CoV-2 RT-LAMP as a rapid molecular assay to complement RT-PCR for COVID-19 diagnosis [published online ahead of print, 2020 Aug 31]. J Clin Virol. 2020;132:104616. doi:10.1016/j.jcv.2020.104616
  37. Michel D, Danzer KM, Groß R, et al. Rapid, convenient and efficient kit-independent detection of SARS-CoV-2 RNA [published online ahead of print, 2020 Sep 3]. J Virol Methods. 2020;113965. doi:10.1016/j.jviromet.2020.113965
  38. Mascuch SJ, Fakhretaha-Aval S, Bowman JC, et al. A blueprint for academic labs to produce SARS-CoV-2 RT-qPCR test kits [published online ahead of print, 2020 Sep 3]. J Biol Chem. 2020;jbc.RA120.015434. doi:10.1074/jbc.RA120.015434
  39. Sapkota D, Søland TM, Galtung HK, et al. COVID-19 salivary signature: diagnostic and research opportunities [published online ahead of print, 2020 Aug 7]. J Clin Pathol. 2020;jclinpath-2020-206834. doi:10.1136/jclinpath-2020-206834
  40. Campbell JR, Uppal A, Oxlade O, et al. Active testing of groups at increased risk of acquiring SARS-CoV-2 in Canada: costs and human resource needs [published online ahead of print, 2020 Sep 9]. CMAJ. 2020;cmaj.201128. doi:10.1503/cmaj.201128
  41. Yokota I, Shane PY, Okada K, Unoki Y, Yang Y, Inao T, Sakamaki K, Iwasaki S, Hayasaka K, Sugita J, Nishida M, Fujisawa S, Teshima T. Mass screening of asymptomatic persons for SARS-CoV-2 using saliva. Clin Infect Dis. 2020 Sep 25:ciaa1388. doi: 10.1093/cid/ciaa1388. Epub ahead of print. PMID: 32976596.
  42. Li L, Lowe CF, Ritchie G, Stefanovic A, Champagne S, Romney MG, Leung V, Matic N. SARS-CoV-2 molecular testing for the diagnosis of COVID-19: One test does not fit all. J Med Virol. 2020 Sep 19. doi: 10.1002/jmv.26532. Epub ahead of print. PMID: 32949164.
  43. Fernandes LL, Pacheco VB, Borges L, Athwal HK, de Paula Eduardo F, Bezinelli L, Correa L, Jimenez M, Dame-Teixeira N, Lombaert IMA, Heller D. Saliva in the Diagnosis of COVID-19: A Review and New Research Directions. J Dent Res. 2020 Sep 16:22034520960070. doi: 10.1177/0022034520960070. Epub ahead of print. PMID: 32936047.
  44. Fogarty A, Joseph A, Shaw D. Pooled saliva samples for COVID-19 surveillance programme. Lancet Respir Med. 2020 Sep 22:S2213-2600(20)30444-6. doi: 10.1016/S2213-2600(20)30444-6. Epub ahead of print. PMID: 32976755.
  45. Wyllie AL, Fournier J, Casanovas-Massana A, Campbell M, Tokuyama M, Vijayakumar P, Warren JL, Geng B, Muenker MC, Moore AJ, Vogels CBF, Petrone ME, Ott IM, Lu P, Venkataraman A, Lu-Culligan A, Klein J, Earnest R, Simonov M, Datta R, Handoko R, Naushad N, Sewanan LR, Valdez J, White EB, Lapidus S, Kalinich CC, Jiang X, Kim DJ, Kudo E, Linehan M, Mao T, Moriyama M, Oh JE, Park A, Silva J, Song E, Takahashi T, Taura M, Weizman OE, Wong P, Yang Y, Bermejo S, Odio CD, Omer SB, Dela Cruz CS, Farhadian S, Martinello RA, Iwasaki A, Grubaugh ND, Ko AI. Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2. N Engl J Med. 2020 Sep 24;383(13):1283-1286. doi: 10.1056/NEJMc2016359. Epub 2020 Aug 28. PMID: 32857487.
  46. Liu M, Li Q, Zhou J, Ai W, Zheng X, Zeng J, Liu Y, Xiang X, Guo R, Li X, Wu X, Xu H, Jiang L, Zhang H, Chen J, Tian L, Luo J, Luo C. Value of swab types and collection time on SARS-COV-2 detection using RT-PCR assay. J Virol Methods. 2020 Sep 16;286:113974. doi: 10.1016/j.jviromet.2020.113974. Epub ahead of print. PMID: 32949663.
  47. Larson D, Brodniak SL, Voegtly LJ, Cer RZ, Glang LA, Malagon FJ, Long KA, Potocki R, Smith DR, Lanteri C, Burgess T, Bishop-Lilly KA. A Case of Early Re-infection with SARS-CoV-2. Clin Infect Dis. 2020 Sep 19:ciaa1436. doi: 10.1093/cid/ciaa1436. Epub ahead of print. PMID: 32949240.
  48. Yang Z, Wu J, Ye F, Zhu B, Guan W, Huang J, Songyang Z, Liu Y, Chen Y, Du Q, Chen J, Zhang Y, Ke C, Lin Y, Sun B, Zeng J, Chen L, Ren J, Jiang X, Yu M, Di B, Zhong N, Zheng L. Expert consensus-based laboratory testing of SARS-CoV-2. J Thorac Dis. 2020 Aug;12(8):4378-4390. doi: 10.21037/jtd-20-1928. PMID: 32944351; PMCID: PMC7475603.
  49. Lee A, Thornley S, Morris AJ, Sundborn G. Should countries aim for elimination in the covid-19 pandemic? BMJ. 2020 Sep 9;370:m3410. doi: 10.1136/bmj.m3410. PMID: 32909958.
  50. Bordi L, Sberna G, Lalle E, Piselli P, Colavita F, Nicastri E, Antinori A, Boumis E, Petrosillo N, Marchioni L, Minnucci G, D'Agostini E, Castilletti C, Locatelli F, Zumla A, Ippolito G, Capobianchi MR, On Behalf Of Inmi ReCOVeRI Study Group. Frequency and Duration of SARS-CoV-2 Shedding in Oral Fluid Samples Assessed by a Modified Commercial Rapid Molecular Assay. Viruses. 2020 Oct 20;12(10):E1184. doi: 10.3390/v12101184. PMID: 33092065.
  51. Mutesa L, Ndishimye P, Butera Y, Souopgui J, Uwineza A, Rutayisire R, Ndoricimpaye EL, Musoni E, Rujeni N, Nyatanyi T, Ntagwabira E, Semakula M, Musanabaganwa C, Nyamwasa D, Ndashimye M, Ujeneza E, Mwikarago IE, Muvunyi CM, Mazarati JB, Nsanzimana S, Turok N, Ndifon W. A pooled testing strategy for identifying SARS-CoV-2 at low prevalence. Nature. 2020 Oct 21. doi: 10.1038/s41586-020-2885-5. Epub ahead of print. PMID: 33086375.
  52. Jayamohan H, Lambert CJ, Sant HJ, Jafek A, Patel D, Feng H, Beeman M, Mahmood T, Nze U, Gale BK. SARS-CoV-2 pandemic: a review of molecular diagnostic tools including sample collection and commercial response with associated advantages and limitations. Anal Bioanal Chem. 2020 Oct 18:1–23. doi: 10.1007/s00216-020-02958-1. Epub ahead of print. PMID: 33073312; PMCID: PMC7568947.
  53. Eberly AR, Challener DW, Shweta FNU, Fida M, Boerger AC, Assi M, O'Horo JC, Binnicker MJ. Initial SARS-CoV-2 PCR crossing point does not predict hospitalization and duration of PCR positivity. J Microbiol Immunol Infect. 2020 Oct 10:S1684-1182(20)30244-9. doi: 10.1016/j.jmii.2020.08.020. Epub ahead of print. PMID: 33069621; PMCID: PMC7546960.
  54. Barreto HG, de Pádua Milagres FA, de Araújo GC, Daúde MM, Benedito VA. Diagnosing the novel SARS-CoV-2 by quantitative RT-PCR: variations and opportunities. J Mol Med (Berl). 2020 Oct 17:1–10. doi: 10.1007/s00109-020-01992-x. Epub ahead of print. PMID: 33067676; PMCID: PMC7567654.
  55. Volpato F, Lima-Morales D, Wink PL, Willig J, de-Paris F, Ashton-Prolla P, Barth AL. Pooling of samples to optimize SARS-CoV-2 diagnosis by RT-qPCR: comparative analysis of two protocols. Eur J Clin Microbiol Infect Dis. 2020 Oct 16:1–4. doi: 10.1007/s10096-020-04071-8. Epub ahead of print. PMID: 33063233; PMCID: PMC7561432.
  56. Dos Santos CC, Zehnbauer BA, Trahtemberg U, Marshall J. Molecular Diagnosis of Coronavirus Disease 2019. Crit Care Explor. 2020 Sep 17;2(9):e0184. doi: 10.1097/CCE.0000000000000184. PMID: 33063040; PMCID: PMC7515613.
  57. Barra GB, Santa Rita TH, Mesquita PG, Jácomo RH, Nery LFA. Analytical Sensitivity and Specificity of Two RT-qPCR Protocols for SARS-CoV-2 Detection Performed in an Automated Workflow. Genes (Basel). 2020 Oct 12;11(10):E1183. doi: 10.3390/genes11101183. PMID: 33053675.
  58. Senok A, Alsuwaidi H, Atrah Y, Al Ayedi O, Al Zahid J, Han A, Al Marzooqi A, Al Heialy S, Altrabulsi B, AbdelWareth L, Idaghdour Y, Ali R, Loney T, Alsheikh-Ali A. Saliva as an Alternative Specimen for Molecular COVID-19 Testing in Community Settings and Population-Based Screening. Infect Drug Resist. 2020 Oct 1;13:3393-3399. doi: 10.2147/IDR.S275152. PMID: 33061486; PMCID: PMC7534854.
  59. Aita A, Basso D, Cattelan AM, Fioretto P, Navaglia F, Barbaro F, Stoppa A, Coccorullo E, Farella A, Socal A, Vettor R, Plebani M. SARS-CoV-2 identification and IgA antibodies in saliva: One sample two tests approach for diagnosis. Clin Chim Acta. 2020 Nov;510:717-722. doi: 10.1016/j.cca.2020.09.018. Epub 2020 Sep 16. PMID: 32946791; PMCID: PMC7492139.
  60. Rattan A, Ahmad H. Can quantitative RT-PCR for SARS-CoV-2 help in better management of patients and control of coronavirus disease 2019 pandemic. Indian J Med Microbiol. 2020 Jul-Dec;38(3 & 4):284-287. doi: 10.4103/ijmm.IJMM_20_380. PMID: 33154236.
  61. Skalina KA, Goldstein DY, Sulail J, Hahm E, Narlieva M, Szymczak W, Fox AS. Extended storage of SARS-CoV-2 nasopharyngeal swabs does not negatively impact results of molecular-based testing across three clinical platforms. J Clin Pathol. 2020 Nov 3:jclinpath-2020-206738. doi: 10.1136/jclinpath-2020-206738. Epub ahead of print. PMID: 33144357.
  62. Schermer B, Fabretti F, Damagnez M, Di Cristanziano V, Heger E, Arjune S, Tanner NA, Imhof T, Koch M, Ladha A, Joung J, Gootenberg JS, Abudayyeh OO, Burst V, Zhang F, Klein F, Benzing T, Müller RU. Rapid SARS-CoV-2 testing in primary material based on a novel multiplex RT-LAMP assay. PLoS One. 2020 Nov 2;15(11):e0238612. doi: 10.1371/journal.pone.0238612. PMID: 33137122; PMCID: PMC7605681.
  63. Falasca F, Sciandra I, Di Carlo D, Gentile M, Deales A, Antonelli G, Turriziani O. Detection of SARS-COV N2 Gene: Very low amounts of viral RNA or false positive? J Clin Virol. 2020 Oct 14;133:104660. doi: 10.1016/j.jcv.2020.104660. Epub ahead of print. PMID: 33126109; PMCID: PMC7553900.
  64. Strasser EF, Steininger PA, Korn K, Achenbach S, Tenbusch M, Cunningham S, Zimmermann R, Überla K, Hackstein H. Validation of a SARS-CoV-2 RNA RT-PCR assay for high-throughput testing in blood of COVID-19 convalescent plasma donors and patients. Transfusion. 2020 Oct 30. doi: 10.1111/trf.16178. Epub ahead of print. PMID: 33125162.
  65. Mutesa L, Ndishimye P, Butera Y, Souopgui J, Uwineza A, Rutayisire R, Ndoricimpaye EL, Musoni E, Rujeni N, Nyatanyi T, Ntagwabira E, Semakula M, Musanabaganwa C, Nyamwasa D, Ndashimye M, Ujeneza E, Mwikarago IE, Muvunyi CM, Mazarati JB, Nsanzimana S, Turok N, Ndifon W. A pooled testing strategy for identifying SARS-CoV-2 at low prevalence. Nature. 2020 Oct 21. doi: 10.1038/s41586-020-2885-5. Epub ahead of print. PMID: 33086375.
  66. Österdahl MF, Lee KA, Lochlainn MN, Wilson S, Douthwaite S, Horsfall R, Sheedy A, Goldenberg SD, Stanley CJ, Spector TD, Steves CJ. Detecting SARS-CoV-2 at point of care: preliminary data comparing loop-mediated isothermal amplification (LAMP) to polymerase chain reaction (PCR). BMC Infect Dis. 2020 Oct 20;20(1):783. doi: 10.1186/s12879-020-05484-8. PMID: 33081710; PMCID: PMC7574392.
  67. Mancini F, Barbanti F, Scaturro M, Fontana S, Di Martino A, Marsili G, Puzelli S, Calzoletti L, Facchini M, Di Mario G, Fabiani C, Dstat AB, Riccardo F, Dstat PP, Stefanelli P, Rezza G, Ciervo A. Multiplex rt-Real Time PCR assays for diagnostic testing of SARS-CoV-2 and seasonal influenza viruses. A challenge of the phase 3 pandemic setting. J Infect Dis. 2020 Oct 20:jiaa658. doi: 10.1093/infdis/jiaa658. Epub ahead of print. PMID: 33080031.
  68. Kociolek LK, Muller WJ, Yee R, Dien Bard J, Brown CA, Revell P, Wardell H, Savage TJ, Jung S, Dominguez S, Parikh BA, Jerris RC, Kehl SC, Campigotto A, Bender JM, Zheng X, Muscat E, Linam M, Abuogi L, Smith C, Graff K, Hernandez-Leyva A, Williams D, Pollock NR. Comparison of upper respiratory viral load distributions in asymptomatic and symptomatic children diagnosed with SARS-CoV-2 infection in pediatric hospital testing programs. J Clin Microbiol. 2020 Oct 22:JCM.02593-20. doi: 10.1128/JCM.02593-20. Epub ahead of print. PMID: 33093026.
  69. Alcoba-Florez J, Gil-Campesino H, García-Martínez de Artola D, Díez-Gil O, Valenzuela-Fernández A, González-Montelongo R, Ciuffreda L, Flores C. Increasing SARS-CoV-2 RT-qPCR testing capacity by sample pooling. Int J Infect Dis. 2020 Nov 18:S1201-9712(20)32468-1. doi: 10.1016/j.ijid.2020.11.155. Epub ahead of print. PMID: 33220439.
  70. Denny TN, Andrews L, Bonsignori M, Cavanaugh K, Datto MB, Deckard A, DeMarco CT, DeNaeyer N, Epling CA, Gurley T, Haase SB, Hallberg C, Harer J, Kneifel CL, Lee MJ, Louzao R, Moody MA, Moore Z, Polage CR, Puglin J, Spotts PH, Vaughn JA, Wolfe CR. Implementation of a Pooled Surveillance Testing Program for Asymptomatic SARS-CoV-2 Infections on a College Campus - Duke University, Durham, North Carolina, August 2-October 11, 2020. MMWR Morb Mortal Wkly Rep. 2020 Nov 20;69(46):1743-1747. doi: 10.15585/mmwr.mm6946e1. PMID: 33211678.
  71. Zhou Y, Pei F, Ji M, Wang L, Zhao H, Li H, Yang W, Wang Q, Zhao Q, Wang Y. Sensitivity evaluation of 2019 novel coronavirus (SARS-CoV-2) RT-PCR detection kits and strategy to reduce false negative. PLoS One. 2020 Nov 18;15(11):e0241469. doi: 10.1371/journal.pone.0241469. PMID: 33206690; PMCID: PMC7673793.
  72. Dollman NL, Griffin JH, Downard KM. Detection, Mapping, and Proteotyping of SARS-CoV-2 Coronavirus with High Resolution Mass Spectrometry. ACS Infect Dis. 2020 Nov 18. doi: 10.1021/acsinfecdis.0c00664. Epub ahead of print. PMID: 33205948.
  73. Zacharioudakis IM, Zervou FN, Prasad PJ, Shao Y, Basu A, Inglima K, Weisenberg SA, Aguero-Rosenfeld ME. Association of SARS-CoV-2 genomic load trends with clinical status in COVID-19: A retrospective analysis from an academic hospital center in New York City. PLoS One. 2020 Nov 17;15(11):e0242399. doi: 10.1371/journal.pone.0242399. PMID: 33201912; PMCID: PMC7671536.
  74. Lalli MA, Langmade SJ, Chen X, Fronick CC, Sawyer CS, Burcea LC, Wilkinson MN, Fulton RS, Heinz M, Buchser WJ, Head RD, Mitra RD, Milbrandt J. Rapid and extraction-free detection of SARS-CoV-2 from saliva by colorimetric reverse-transcription loop-mediated isothermal amplification. Clin Chem. 2020 Oct 24:hvaa267. doi: 10.1093/clinchem/hvaa267. Epub ahead of print. PMID: 33098427; PMCID: PMC7665435.
  75. Ravi N, Cortade DL, Ng E, Wang SX. Diagnostics for SARS-CoV-2 detection: A comprehensive review of the FDA-EUA COVID-19 testing landscape. Biosens Bioelectron. 2020 Oct 1;165:112454. doi: 10.1016/j.bios.2020.112454. Epub 2020 Jul 18. PMID: 32729549; PMCID: PMC7368663.
  76. Doshi P, Powers JH. Determining the infectious potential of individuals with positive RT-PCR SARS-CoV-2 tests. Clin Infect Dis. 2020 Dec 4:ciaa1819. doi: 10.1093/cid/ciaa1819. Epub ahead of print. PMID: 33277652.
  77. Bhadra S, Maranhao AC, Paik I, Ellington AD. One-Enzyme Reverse Transcription qPCR Using Taq DNA Polymerase. Biochemistry. 2020 Dec 4. doi: 10.1021/acs.biochem.0c00778. Epub ahead of print. PMID: 33275410.
  78. Cheong J, Yu H, Lee CY, Lee JU, Choi HJ, Lee JH, Lee H, Cheon J. Fast detection of SARS-CoV-2 RNA via the integration of plasmonic thermocycling and fluorescence detection in a portable device. Nat Biomed Eng. 2020 Dec 3. doi: 10.1038/s41551-020-00654-0. Epub ahead of print. PMID: 33273713.
  79. Fowler VL, Armson B, Gonzales JL, Wise EL, Howson ELA, Vincent-Mistiaen Z, Fouch S, Maltby CJ, Grippon S, Munro S, Jones L, Holmes T, Tillyer C, Elwell J, Sowood A, de Peyer O, Dixon S, Hatcher T, Patrick H, Laxman S, Walsh C, Andreou M, Morant N, Clark D, Moore N, Houghton R, Cortes N, Kidd SP. A highly effective reverse-transcription loop-mediated isothermal amplification (RT-LAMP) assay for the rapid detection of SARS-CoV-2 infection. J Infect. 2020 Nov 30:S0163-4453(20)30731-3. doi: 10.1016/j.jinf.2020.10.039. Epub ahead of print. PMID: 33271166; PMCID: PMC7703389.
  80. López-Martínez B, Guzmán-Ortiz AL, Nevárez-Ramírez AJ, Parra-Ortega I, Olivar-López VB, Ángeles-Floriano T, Vilchis-Ordoñez A, Quezada H. Saliva as a promising biofluid for SARS-CoV-2 detection during the early stages of infection. Bol Med Hosp Infant Mex. 2020;77(5):228-233. English. doi: 10.24875/BMHIM.20000204. PMID: 33064678.
  81. Dogan OA, Kose B, Agaoglu NB, Yildiz J, Alkurt G, Demirkol YK, Irvem A, Doganay GD, Doğanay L. Does sampling saliva increase detection of SARS-CoV-2 by RT-PCR? Comparing saliva with oro-nasopharyngeal swabs. J Virol Methods. 2020 Dec 30:114049. doi: 10.1016/j.jviromet.2020.114049. Epub ahead of print. PMID: 33387561.
  82. Dudley DM, Newman CM, Weiler AM, Ramuta MD, Shortreed CG, Heffron AS, Accola MA, Rehrauer WM, Friedrich TC, O'Connor DH. Optimizing direct RT-LAMP to detect transmissible SARS-CoV-2 from primary nasopharyngeal swab samples. PLoS One. 2020 Dec 31;15(12):e0244882. doi: 10.1371/journal.pone.0244882. PMID: 33382861.
  83. Mokhtar KM. Improved COVID-19 Testing by Extraction-Free SARS-CoV-2 RT-PCR. EJIFCC. 2020 Nov 20;31(4):362-368. PMID: 33376476; PMCID:
  84. Miscio L, Olivieri A, Labonia F, De Feo G, Chiodini P, Portella G, Atripaldi L, Parrella R, Conenna R, Buonaguro FM, Cavalcanti E, Ascierto P, Botti G, Bianchi A. Evaluation of the diagnostic accuracy of a new point-of-care rapid test for SARS-CoV-2 virus detection. J Transl Med. 2020 Dec 21;18(1):488. doi: 10.1186/s12967-020-02651-y. PMID: 33349261; PMCID: PMC7752099.
  85. Wikramaratna PS, Paton RS, Ghafari M, Lourenço J. Estimating the false-negative test probability of SARS-CoV-2 by RT-PCR. Euro Surveill. 2020 Dec;25(50). doi: 10.2807/1560-7917.ES.2020.25.50.2000568. PMID: 33334398.
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Antigen Testing:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. 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.
  16. 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.
  17. 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.
  18. 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.
  19. 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.
  20. 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.
  21. 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.
  22. 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.
  23. 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.
  24. 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.
  25. 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.
  26. 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.
  27. 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.
  28. 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.
  29. 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.
  30. 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.
  31. Corman VM, Haage VC, Bleicker T, Schmidt ML, Mühlemann B, Zuchowski M, Jo WK, Tscheak P, Möncke-Buchner E, Müller MA, Krumbholz A, Drexler JF, Drosten C. Comparison of seven commercial SARS-CoV-2 rapid point-of-care antigen tests: a single-centre laboratory evaluation study. Lancet Microbe. 2021 Apr 7. doi: 10.1016/S2666-5247(21)00056-2. Epub ahead of print. PMID: 33846704; PMCID: PMC8026170.
  32. Yin N, Debuysschere C, Decroly M, Bouazza FZ, Collot V, Martin C, Ponthieux F, Dahma H, Gilbert M, Wautier M, Duterme C, De Vos N, Delforge ML, Malinverni S, Cotton F, Bartiaux M, Hallin M. SARS-CoV-2 Diagnostic Tests: Algorithm and Field Evaluation From the Near Patient Testing to the Automated Diagnostic Platform. Front Med (Lausanne). 2021 Apr 6;8:650581. doi: 10.3389/fmed.2021.650581. PMID: 33889587; PMCID: PMC8055843.
  33. Jungnick S, Hobmaier B, Mautner L, Hoyos M, Haase M, Baiker A, Lahne H, Eberle U, Wimmer C, Hepner S, Sprenger A, Berger C, Dangel A, Wildner M, Liebl B, Ackermann N, Sing A, Fingerle V; Bavarian SARS-CoV-2-Public Health Laboratory Team; Bavarian SARS-CoV-Public Health Laboratory Team. Detection of the new SARS-CoV-2 variants of concern B.1.1.7 and B.1.351 in five SARS-CoV-2 rapid antigen tests (RATs), Germany, March 2021. Euro Surveill. 2021 Apr;26(16):2100413. doi: 10.2807/1560-7917.ES.2021.26.16.2100413. PMID: 33890568; PMCID: PMC8063588.

Less recent publications

  1. Selove W, Rao LV. Performance of rapid SOFIA Influenza A+ B test compared to Luminex x-TAG respiratory viral panel assay in the diagnosis of influenza A, B, and subtype H3. Journal of Investigative Medicine. 2016 Apr 1;64(4):905-7. PMID: 26911275
  2. Blairon L, Wilmet A, Beukinga I, Tré-Hardy M. Implementation of rapid SARS-CoV-2 antigenic testing in a laboratory without access to molecular methods: experiences of a general hospital. Journal of Clinical Virology. 2020 May 30:104472. PMID: 32504944
  3. Mak GC, Cheng PK, Lau SS, et al. Evaluation of rapid antigen test for detection of SARS-CoV-2 virus [published online ahead of print, 2020 Jun 8]. J Clin Virol. 2020;129:104500. doi:10.1016/j.jcv.2020.104500
  4. Dinnes J, Deeks JJ, Adriano A, et al. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection.Cochrane Database Syst Rev. 2020;8:CD013705. Published 2020 Aug 26. doi:10.1002/14651858.CD013705
  5. Kyosei Y, Namba M, Yamura S, et al. Proposal of De Novo Antigen Test for COVID-19: Ultrasensitive Detection of Spike Proteins of SARS-CoV-2.Diagnostics (Basel). 2020;10(8):E594. Published 2020 Aug 14. doi:10.3390/diagnostics10080594
  6. Nuovo G, Tili E, Suster D, Matys E, Hupp L, Magro C. Strong homology between SARS-CoV-2 envelope protein and a Mycobacterium sp. antigen allows rapid diagnosis of Mycobacterial infections and may provide specific anti-SARS-CoV-2 immunity via the BCG vaccine [published online ahead of print, 2020 Aug 13].Ann Diagn Pathol. 2020;48:151600. doi:10.1016/j.anndiagpath.2020.151600
  7. Scohy A, Anantharajah A, Bodéus M, Kabamba-Mukadi B, Verroken A, Rodriguez-Villalobos H. Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis.J Clin Virol. 2020;129:104455. doi:10.1016/j.jcv.2020.104455
  8. Ogata AF, Maley AM, Wu C, et al. Ultra-sensitive Serial Profiling of SARS-CoV-2 Antigens and Antibodies in Plasma to Understand Disease Progression in COVID-19 Patients with Severe Disease [published online ahead of print, 2020 Sep 8]. Clin Chem. 2020;hvaa213. doi:10.1093/clinchem/hvaa213
  9. Ogawa T, Fukumori T, Nishihara Y, et al. Another false-positive problem for a SARS-CoV-2 antigen test in Japan [published online ahead of print, 2020 Aug 25]. J Clin Virol. 2020;131:104612. doi:10.1016/j.jcv.2020.104612
  10. Candel FJ, Barreiro P, San Román J, Abanades JC, Barba R, Barberán J, Bibiano C, Canora J, Cantón R, Calvo C, Carretero M, Cava F, Delgado R, García-Rodríguez J, González Del Castillo J, González de Villaumbrosia C, Hernández M, Losa JE, Martínez-Peromingo FJ, Molero JM, Muñoz P, Onecha E, Onoda M, Rodríguez J, Sánchez-Celaya M, Serra JA, Zapatero A. Recommendations for use of antigenic tests in the diagnosis of acute SARS-CoV-2 infection in the second pandemic wave: attitude in different clinical settings. Rev Esp Quimioter. 2020 Oct 19:candelENG19oct2020. doi: 10.37201/req/120.2020. Epub ahead of print. PMID: 33070578.
  11. Cerutti F, Burdino E, Milia MG, Allice T, Gregori G, Bruzzone B, Ghisetti V. Urgent need of rapid tests for SARS CoV-2 antigen detection: Evaluation of the SD-Biosensor antigen test for SARS-CoV-2. J Clin Virol. 2020 Sep 29;132:104654. doi: 10.1016/j.jcv.2020.104654. Epub ahead of print. PMID: 33053494; PMCID: PMC7522649.
  12. Diao B, Wen K, Zhang J, Chen J, Han C, Chen Y, Wang S, Deng G, Zhou H, Wu Y. Accuracy of a nucleocapsid protein antigen rapid test in the diagnosis of SARS-CoV-2 infection. Clin Microbiol Infect. 2020 Oct 5:S1198-743X(20)30611-X. doi: 10.1016/j.cmi.2020.09.057. Epub ahead of print. PMID: 33031947; PMCID: PMC7534827.
  13. Young S, Taylor SN, Cammarata CL, Varnado KG, Roger-Dalbert C, Montano A, Griego-Fullbright C, Burgard C, Fernandez C, Eckert K, Andrews JC, Ren H, Allen J, Ackerman R, Cooper CK. Clinical evaluation of BD Veritor SARS-CoV-2 point-of-care test performance compared to PCR-based testing and versus the Sofia 2 SARS Antigen point-of-care test. J Clin Microbiol. 2020 Oct 6:JCM.02338-20. doi: 10.1128/JCM.02338-20. Epub ahead of print. PMID: 33023911.
  14. Guglielmi G. Fast coronavirus tests: what they can and can't do. Nature. 2020 Sep;585(7826):496-498. doi: 10.1038/d41586-020-02661-2. PMID: 32939084.
  15. Lee JH, Choi M, Jung Y, Lee SK, Lee CS, Kim J, Kim J, Kim NH, Kim BT, Kim HG. A novel rapid detection for SARS-CoV-2 spike 1 antigens using human angiotensin converting enzyme 2 (ACE2). Biosens Bioelectron. 2020 Oct 15;171:112715. doi: 10.1016/j.bios.2020.112715. Epub ahead of print. PMID: 33099241; PMCID: PMC7560266.
  16. Linares M, Pérez-Tanoira R, Carrero A, Romanyk J, Pérez-García F, Gómez-Herruz P, Arroyo T, Cuadros J. Panbio antigen rapid test is reliable to diagnose SARS-CoV-2 infection in the first 7 days after the onset of symptoms. J Clin Virol. 2020 Oct 16;133:104659. doi: 10.1016/j.jcv.2020.104659. Epub ahead of print. PMID: 33160179.
  17. Albert E, Torres I, Bueno F, Huntley D, Molla E, Fernández-Fuentes MÁ, Martínez M, Poujois S, Forqué L, Valdivia A, Solano de la Asunción C, Ferrer J, Colomina J, Navarro D. Field evaluation of a rapid antigen test (Panbio™ COVID-19 Ag Rapid Test Device) for COVID-19 diagnosis in primary healthcare centers. Clin Microbiol Infect. 2020 Nov 12:S1198-743X(20)30697-2. doi: 10.1016/j.cmi.2020.11.004. Epub ahead of print. PMID: 33189872; PMCID: PMC7662075.
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  83. Hirotsu, M. Maejima, M. Shibusawa, Y. Nagakubo, K. Hosaka, K. Amemiya, H. Sueki, M. Hayakawa, H. Mochizuki, T. Tsutsui, Y. Kakizaki, Y. Miyashita, S. Yagi, S. Kojima, M. Omata, Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients, Int. J. Infect. Dis. 99 (2020) 397–402. https://doi.org/10.1016/j.ijid.2020.08.029.
  84. Fenollar, A. Bouam, M. Ballouche, L. Fuster, E. Prudent, P. Colson, H. Tissot-Dupont, M. Million, M. Drancourt, D. Raoult, P.E. Fournier, Evaluation of the panbio COVID-19 rapid antigen detection test device for the screening of patients with COVID-19, J. Clin. Microbiol. 59 (2021). https://doi.org/10.1128/JCM.02589-20.
  85. Kashiwagi, Y. Ishii, K. Aoki, S. Yagi, T. Maeda, T. Miyazaki, S. Yoshizawa, K. Aoyagi, K. Tateda, Immunochromatographic test for the detection of SARS-CoV-2 in saliva, J. Infect. Chemother. 27 (2021) 384–386. https://doi.org/10.1016/j.jiac.2020.11.016.
  86. Dinnes, J.J. Deeks, S. Berhane, M. Taylor, A. Adriano, C. Davenport, S. Dittrich, D. Emperador, Y. Takwoingi, J. Cunningham, S. Beese, J. Domen, J. Dretzke, L. Ferrante di Ruffano, I.M. Harris, M.J. Price, S. Taylor-Phillips, L. Hooft, M.M. Leeflang, M.D. McInnes, R. Spijker, A. Van den Bruel, Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection, Cochrane Database Syst. Rev. (2021). https://doi.org/10.1002/14651858.CD013705.pub2
  87. Ristić, N. Nikolić, V. Čabarkapa, V. Turkulov, V. Petrović, Validation of the STANDARD Q COVID-19 antigen test in Vojvodina, Serbia., PLoS One. 16 (2021) e0247606. https://doi.org/10.1371/journal.pone.0247606.
  88. Saeed, S.R. Uppal, Z.Z. Piracha, A. Rasheed, Z. Aftab, H. Zaheer, R. Uppal, Evaluation of SARS-CoV-2 antigen-based rapid diagnostic kits in Pakistan: formulation of COVID-19 national testing strategy, Virol. J. 18 (2021). https://doi.org/10.1186/s12985-021-01505-3.
  89. Lambert-Niclot, A. Cuffel, S. Le Pape, C. Vauloup-Fellous, L. Morand-Joubert, A.M. Roque-Afonso, J. Le Goff, C. Delaugerre, Evaluation of a rapid diagnostic assay for detection of sars-cov-2 antigen in nasopharyngeal swabs, J. Clin. Microbiol. 58 (2020). https://doi.org/10.1128/JCM.00977-20.
  90. Nagura-Ikeda, K. Imai, S. Tabata, K. Miyoshi, N. Murahara, T. Mizuno, M. Horiuchi, K. Kato, Y. Imoto, M. Iwata, S. Mimura, T. Ito, K. Tamura, Y. Kato, Clinical evaluation of self-collected saliva by quantitative reverse transcription-PCR (RT-qPCR), Direct RT-qPCR, reverse transcription-loop-mediated isothermal amplification, and a rapid antigen test to diagnose COVID-19, J. Clin. Microbiol. 58 (2020). https://doi.org/10.1128/JCM.01438-20.
  91. M. Moghadas, M.C. Fitzpatrick, P. Sah, A. Pandey, A. Shoukat, B.H. Singer, A.P. Galvani, The implications of silent transmission for the control of COVID-19 outbreaks, Proc. Natl. Acad. Sci. U. S. A. 117 (2020) 17513–17515. https://doi.org/10.1073/pnas.2008373117.
  92. 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
  93. Sood N, Shetgiri R, Rodriguez A, Jimenez D, Treminino S, Daflos A, Simon P. Evaluation of the Abbott BinaxNOW rapid antigen test for SARS-CoV-2 infection in children: Implications for screening in a school setting. PLoS One. 2021 Apr 5;16(4):e0249710. doi: 10.1371/journal.pone.024971

 

Serology Testing:

  1. Yokoyama APH, et al. COVID-19 convalescent plasma cohort study: evaluation of the association between both donor and recipient neutralizing antibody titers and patient outcomes. Transfusion. 2021 Jun 26. doi: 10.1111/trf.16573. Epub ahead of print. PMID: 34173248.
  2. Heggestad JT, et al. Multiplexed, quantitative serological profiling of COVID-19 from blood by a point-of-care test. Sci Adv. 2021 Jun 25;7(26):eabg4901. doi: 10.1126/sciadv.abg4901. PMID: 34172447.
  3. Zeng F, et al. Over one-year duration and age difference of SARS-CoV-2 antibody in convalescent COVID-19 patients. J Med Virol. 2021 Jun 25. doi: 10.1002/jmv.27152. Epub ahead of print. PMID: 34170519.
  4. Wang R, et al. Analysis of SARS-CoV-2 variant mutations reveals neutralization escape mechanisms and the ability to use ACE2 receptors from additional species. Immunity. 2021 Jun 8:S1074-7613(21)00247-8. doi: 10.1016/j.immuni.2021.06.003. Epub ahead of print. PMID: 34166623; PMCID: PMC8185182.
  5. Verderese JP, et al. Neutralizing Monoclonal Antibody Treatment Reduces Hospitalization for Mild and Moderate COVID-19: A Real-World Experience. Clin Infect Dis. 2021 Jun 24:ciab579. doi: 10.1093/cid/ciab579. Epub ahead of print. PMID: 34166513.
  6. Choe PG, et al. Persistence of Neutralizing Antibody Response up to One Year after Asymptomatic or Symptomatic SARS-CoV-2 infection. J Infect Dis. 2021 Jun 24:jiab339. doi: 10.1093/infdis/jiab339. Epub ahead of print. PMID: 34166506.
  7. Theel ES, et al. SARS-CoV-2 Serologic Assays Dependent on Dual-Antigen Binding Demonstrate Diverging Kinetics Relative to Other Antibody Detection Methods. J Clin Microbiol. 2021 Jun 24:JCM0123121. doi: 10.1128/JCM.01231-21. Epub ahead of print. PMID: 34166066.
  8. Bradley BT, et al. Anti-SARS-CoV-2 antibody levels measured by the Advise Dx SARS-CoV-2 assay are concordant with previously available serologic assays but are not fully predictive of sterilizing immunity. J Clin Microbiol. 2021 Jun 24:JCM0098921. doi: 10.1128/JCM.00989-21. Epub ahead of print. PMID: 34165323.
  9. Jamiruddin MR, et al. Longitudinal Antibody Dynamics Against Structural Proteins of SARS-CoV-2 in Three COVID-19 Patients Shows Concurrent Development of IgA, IgM, and IgG. J Inflamm Res. 2021 Jun 14;14:2497-2506. doi: 10.2147/JIR.S313188. PMID: 34163208; PMCID: PMC8214341.
  10. Kamaladasa A, et al. Comparison of two assays to detect IgG antibodies to the receptor binding domain of the SARS‑CoV‑2 as a surrogate marker for assessing neutralizing antibodies in COVID-19 patients. Int J Infect Dis. 2021 Jun 20:S1201-9712(21)00520-8. doi: 10.1016/j.ijid.2021.06.031. Epub ahead of print. PMID: 34161801; PMCID: PMC8214815.
  11. Sharwani K, et al. Detection of serum cross-reactive antibodies and memory response to SARS-CoV-2 in pre-pandemic and post-COVID-19 convalescent samples. J Infect Dis. 2021 Jun 23:jiab333. doi: 10.1093/infdis/jiab333. Epub ahead of print. PMID: 34161567.
  12. Bonfante F, et al. Mild SARS-CoV-2 Infections and Neutralizing Antibody Titers. Pediatrics. 2021 Jun 22:e2021052173. doi: 10.1542/peds.2021-052173. Epub ahead of print. PMID: 34158312.
  13. Wang H, et al Case-Control Study of Individuals with Discrepant Nucleocapsid and Spike Protein SARS-CoV-2 IgG Results. Clin Chem. 2021 Mar 15:hvab045. doi: 10.1093/clinchem/hvab045. Epub ahead of print. PMID: 33720347; PMCID: PMC7989591.
  14. Kyosei Y, et al. Improved detection sensitivity of an antigen test for SARS-CoV-2 nucleocapsid proteins with thio-NAD cycling. Biol Pharm Bull. 2021 Jun 19. doi: 10.1248/bpb.b21-00387. Epub ahead of print. PMID: 34148926.
  15. Vengesai A, Midzi H, Kasambala M, Mutandadzi H, Mduluza-Jokonya TL, Rusakaniko S, Mutapi F, Naicker T, Mduluza T. A systematic and meta-analysis review on the diagnostic accuracy of antibodies in the serological diagnosis of COVID-19. Syst Rev. 2021 May 26;10(1):155. doi: 10.1186/s13643-021-01689-3. PMID: 34039423; PMCID: PMC8152206.
  16. Le Vu S, Jones G, Anna F, Rose T, Richard JB, Bernard-Stoecklin S, Goyard S, Demeret C, Helynck O, Escriou N, Gransagne M, Petres S, Robin C, Monnet V, Perrin de Facci L, Ungeheuer MN, Léon L, Guillois Y, Filleul L, Charneau P, Lévy-Bruhl D, van der Werf S, Noel H. Prevalence of SARS-CoV-2 antibodies in France: results from nationwide serological surveillance. Nat Commun. 2021 May 21;12(1):3025. doi: 10.1038/s41467-021-23233-6. PMID: 34021152.
  17. Whitaker HJ, Elgohari S, Rowe C, Otter AD, Brooks T, Linley E, Hayden I, Ribeiro S, Hewson J, Lakhani A, Clarke E, Tsang C, Campbell CN, Ramsay M, Brown K, Amirthalingam G. Impact of COVID-19 vaccination program on seroprevalence in blood donors in England, 2021. J Infect. 2021 May 11:S0163-4453(21)00224-3. doi: 10.1016/j.jinf.2021.04.037. Epub ahead of print. PMID: 33989631; PMCID: PMC8110696.
  18. Soffer S, Glicksberg BS, Zimlichman E, Efros O, Levin MA, Freeman R, Reich DL, Klang E. The Association Between Obesity and Peak Antibody Titer Response in COVID-19 Infection. Obesity (Silver Spring). 2021 May 4. doi: 10.1002/oby.23208. Epub ahead of print. PMID: 33945220.
  19. Bubonja-Šonje M, Batičić L, Abram M, Cekinović Grbeša Đ. Diagnostic accuracy of three SARS-CoV2 antibody detection assays, neutralizing effect and longevity of serum antibodies. J Virol Methods. 2021 Jul;293:114173. doi: 10.1016/j.jviromet.2021.114173. Epub 2021 Apr 27. PMID: 33930473; PMCID: PMC8078047.
  20. Tollånes MC, Jenum PA, Kierkegaard H, Abildsnes E, Bævre-Jensen RM, Breivik AC, Sandberg S. Evaluation of 32 rapid tests for detection of antibodies against SARS-CoV-2. Clin Chim Acta. 2021 Apr 27;519:133-139. doi: 10.1016/j.cca.2021.04.016. Epub ahead of print. PMID: 33930425; PMCID: PMC8078036.
  21. Werner M, Pervan P, Glück V, Zeman F, Koller M, Burkhardt R, Glück T, Wenzel JJ, Schmidt B, Gessner A, Peterhoff D. Evaluation of a Broad Panel of SARS-CoV-2 Serological Tests for Diagnostic Use. J Clin Med. 2021 Apr 8;10(8):1580. doi: 10.3390/jcm10081580. PMID: 33918081; PMCID: PMC8070215.
  22. Florin L, Maelegheer K, Vandewal W, Bernard D, Robbrecht J. Performance Evaluation of the Siemens SARS-CoV-2 Total Antibody and IgG Antibody Test. Lab Med. 2021 Apr 30:lmab027. doi: 10.1093/labmed/lmab027. Epub ahead of print. PMID: 33928377.
  23. Jin DK, Nesbitt DJ, Yang J, Chen H, Horowitz J, Jones M, Vandergaast R, Carey T, Reiter S, Russell SJ, Kyratsous C, Hooper A, Hamilton J, Ferreira M, Deng S, Straus D, Baras A, Hillyer CD, Luchsinger LL. Seroprevalence of anti-SARS-CoV-2 antibodies in a cohort of New York City metro blood donors using multiple SARS-CoV-2 serological assays: Implications for controlling the epidemic and "Reopening". PLoS One. 2021 Apr 28;16(4):e0250319. doi: 10.1371/journal.pone.0250319. PMID: 33909646.
  24. Jalkanen P, Pasternack A, Maljanen S, Melén K, Kolehmainen P, Huttunen M, Lundberg R, Tripathi L, Khan H, Ritvos MA, Naves R, Haveri A, Österlund P, Kuivanen S, Jääskeläinen AJ, Kurkela S, Lappalainen M, Rantasärkkä K, Vuorinen T, Hytönen J, Waris M, Tauriainen S, Ritvos O, Kakkola L, Julkunen I. A combination of N and S antigens with IgA and IgG measurement strengthens the accuracy of SARS-CoV-2 serodiagnostics. J Infect Dis. 2021 Apr 27:jiab222. doi: 10.1093/infdis/jiab222. Epub ahead of print. PMID: 33905505.
  25. Zhou X, Ma F, Xie J, Yuan M, Li Y, Shaabani N, Zhao F, Huang D, Wu NC, Lee CD, Liu H, Li J, Chen Z, Hong Y, Liu WH, Xiao N, Burton DR, Tu H, Li H, Chen X, Teijaro JR, Wilson IA, Xiao C, Huang Z. Diverse immunoglobulin gene usage and convergent epitope targeting in neutralizing antibody responses to SARS-CoV-2. Cell Rep. 2021 Apr 24:109109. doi: 10.1016/j.celrep.2021.109109. Epub ahead of print. PMID: 33932326.
  26. Padoan A, Bonfante F, Cosma C, Di Chiara C, Sciacovelli L, Pagliari M, Bortolami A, Costenaro P, Musso G, Basso D, Giaquinto C, Plebani M. Analytical and clinical performances of a SARS-CoV-2 S-RBD IgG assay: comparison with neutralization titers. Clin Chem Lab Med. 2021 Apr 13. doi: 10.1515/cclm-2021-0313. Epub ahead of print. PMID: 33855843.
  27. Matusali G, Colavita F, Lapa D, Meschi S, Bordi L, Piselli P, Gagliardini R, Corpolongo A, Nicastri E, Antinori A, Ippolito G, Capobianchi MR, Castilletti C, Inmi Covid-Laboratory Team. SARS-CoV-2 Serum Neutralization Assay: A Traditional Tool for a Brand-New Virus. Viruses. 2021 Apr 10;13(4):655. doi: 10.3390/v13040655. PMID: 33920222; PMCID: PMC8069482.
  28. Andrey DO, Yerly S, Meyer B, Arm-Vernez I, Roux-Lombard P, Togni G, Guessous I, Spechbach H, Stringhini S, Agoritsas T, Stirnemann J, Reny JL, Siegrist CA, Eckerle I, Kaiser L, Vuilleumier N. Head-to-Head Evaluation of Five Automated SARS-CoV-2 Serology Immunoassays in Various Prevalence Settings. J Clin Med. 2021 Apr 10;10(8):1605. doi: 10.3390/jcm10081605. PMID: 33920076; PMCID: PMC8069412.
  29. Sibai M, Solis D, Röltgen K, Stevens BA, Mfuh KO, Sahoo MK, Shi RZ, Zehnder J, Boyd SD, Pinsky BA. Evaluation of SARS-CoV-2 total antibody detection via a lateral flow nanoparticle fluorescence immunoassay. J Clin Virol. 2021 Apr 1;139:104818. doi: 10.1016/j.jcv.2021.104818. Epub ahead of print. PMID: 33932848.
  30. Nagura-Ikeda M, Imai K, Kubota K, Noguchi S, Kitagawa Y, Matsuoka M, Tabata S, Miyoshi K, Ito T, Tamura K, Maeda T. Clinical characteristics and antibody response to SARS-CoV-2 spike 1 protein using VITROS Anti-SARS-CoV-2 antibody tests in COVID-19 patients in Japan. J Med Microbiol. 2021 Apr;70(4). doi: 10.1099/jmm.0.001291. PMID: 33861191.

Less recent publications

  1. Ju B, Zhang Q, Ge X, Wang R, Yu J, Shan S, Zhou B, Song S, Tang X, Yu J, Ge J. Potent human neutralizing antibodies elicited by SARS-CoV-2 infection. bioRxiv. 2020 Jan 1.
  2. Castro R, Luz PM, Wakimoto MD, Veloso VG, Grinsztejn B, Perazzo H. COVID-19: a meta-analysis of diagnostic test accuracy of commercial assays registered in Brazil. The Brazilian Journal of Infectious Diseases. 2020 Apr 18. PMID: 32330437
  3. Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, Wang X, Yuan J, Li T, Li J, Qian S. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clinical Infectious Diseases. 2020 Jan 1. PMID: 32221519
  4. Iwasaki A, Yang Y. The potential danger of suboptimal antibody responses in COVID-19. Nature Reviews Immunology. 2020 Apr 21:1-3. PMID: 32317716
  5. Wu F, Wang A, Liu M, Wang Q, Chen J, Xia S, Ling Y, Zhang Y, Xun J, Lu L, Jiang S. Neutralizing antibody responses to SARS-CoV-2 in a COVID-19 recovered patient cohort and their implications. Preprint at medrxiv
  6. Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proceedings of the National Academy of Sciences. 2020 Apr 6. PMID: 32253318
  7. Kran AM. Evaluation of eleven rapid tests for detection of antibodies against SARS-CoV-2. 2020 Apr 24
  8. Padoan A, Cosma C, Sciacovelli L, Faggian D, Plebani M. Analytical performances of a chemiluminescence immunoassay for SARS-CoV-2 IgM/IgG and antibody kinetics. Clinical Chemistry and Laboratory Medicine (CCLM). 2020 Apr 16;1(ahead-of-print). PMID: 32301749
  9. Azzi L, Carcano G, Gianfagna F, Grossi P, Dalla Gasperina D, Genoni A, Fasano M, Sessa F, Tettamanti L, Carinci F, Maurino V. SALIVA IS A RELIABLE TOOL TO DETECT SARS-CoV-2. Journal of Infection. 2020 Apr 14. PMID: 32298676
  10. Perera RA, Mok CK, Tsang OT, Lv H, Ko RL, Wu NC, Yuan M, Leung WS, Chan JM, Chik TS, Choi CY. Serological assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), March 2020. Eurosurveillance. 2020 Apr 23;25(16):2000421. PMID: 32347204
  11. Zeng QL, Yu ZJ, Gou JJ, Li GM, Ma SH, Zhang GF, Xu JH, Lin WB, Cui GL, Zhang MM, Li C. Effect of Convalescent Plasma Therapy on Viral Shedding and Survival in COVID-19 Patients. The Journal of Infectious Diseases. 2020 Apr 29. PMID: 32348485
  12. Farnsworth CW, Anderson NW. SARS-CoV-2 Serology: Much Hype, Little Data. Clinical Chemistry. 2020 Apr 28. PMID: 32343775
  13. Bryan A, Pepper G, Wener MH, et al. Performance Characteristics of the Abbott Architect SARS-CoV-2 IgG Assay and Seroprevalence in Boise, Idaho. J Clin Microbiol. 2020 May 7. PMID: 32381641
  14. Adams ER, Anand R, Andersson MI, Auckland K, Baillie JK, Barnes E, Bell J, Berry T, Bibi S, Carroll M, Chinnakannan S. Evaluation of antibody testing for SARS-Cov-2 using ELISA and lateral flow immunoassays. 2020 Jan 1 - non-peer reviewed
  15. Qu J, Wu C, Li X, Zhang G, Jiang Z, Li X, Liu L. Profile of IgG and IgM antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Clinical Infectious Diseases. 2020 Apr 27. PMID: 32337590
  16. Anderson DE, Tan CW, Chia WN, Young BE, Linster M, Low JH, Tan YJ, Chen MI, Smith GJD, Leo YS, Lye DC, Wang LF. Lack of cross-neutralization by SARS patient sera towards SARS-CoV-2. Emerg Microbes Infect. 2020 Dec;9(1):900-902. PMID: 32380903.
  17. Diamandis P, Prassas I, Diamandis EP. Antibody tests for COVID-19: drawing attention to the importance of analytical specificity. Clinical chemistry and laboratory medicine. 2020 May 9. PMID: 32386187
  18. Tang MS, Hock KG, Logsdon NM, et al. Clinical Performance of Two SARS-CoV-2 Serologic Assays. Clin Chem. May 13 2020;hvaa120. PMID: 32402061
  19. Montesinos I, Gruson D, Kabamba B, Dahma H, Van den Wijngaert S, Reza S, Carbone V, Vandenberg O, Gulbis B, Wolff F, Rodriguez-Villalobos H. Evaluation of two automated and three rapid lateral flow immunoassays for the detection of anti-SARS-CoV-2 antibodies. J Clin Virol. 2020 May 5;128:104413. PMID: 32403010
  20. Riccò M, Ferraro P, Gualerzi G, Ranzieri S, Henry BM, Said YB, Pyatigorskaya NV, Nevolina E, Wu J, Bragazzi NL, Signorelli C. Point-of-Care Diagnostic Tests for Detecting SARS-CoV-2 Antibodies: A Systematic Review and Meta-Analysis of Real-World Data. Journal of Clinical Medicine. 2020 May;9(5):1515. PMID: 32443459
  21. Kontou PI, Braliou GG, Dimou NL, Nikolopoulos G, Bagos PG. Antibody Tests in Detecting SARS-CoV-2 Infection: A Meta-Analysis. Diagnostics (Basel). 2020 May 19;10(5):E319. PMID: 32438677
  22. Kofler N, Baylis F. Ten reasons why immunity passports are a bad idea. Nature. 2020 May;581(7809):379-381 (opinion). PMID: 32439992
  23. Dinges et al. Seroprevalence of SARS-CoV-2 among children visiting a hospital during the initial Seattle outbreak (non-peer reviewed). https://doi.org/10.1101/2020.05.26.20114124
  24. Nuccetelli M, Pieri M, Grelli S, Ciotti M, Miano R, Andreoni M, Bernardini S. SARS-CoV-2 infection serology: a useful tool to overcome lockdown?. Cell Death Discovery. 2020 May 26;6(1):1-9.
  25. Ong DS, Stijn J, Lindeboom FA, Koeleman JG. Comparison of diagnostic accuracies of rapid serological tests and ELISA to molecular diagnostics in patients with suspected COVID-19 presenting to the hospital. Clinical Microbiology and Infection. 2020 Jun 2. PMID: 32502646
  26. Tang MS, Hock KG, Logsdon NM, Hayes JE, Gronowski AM, Anderson NW, Farnsworth CW. Clinical Performance of the Roche SARS-CoV-2 Serologic Assay. Clin Chem. 2020 Jun 2:hvaa132. doi: 10.1093/clinchem/hvaa132. Epub ahead of print. PMID: 32484860.
  27. Bermingham WH, Wilding T, Beck S, Huissoon A. SARS-CoV-2 serology: Test, test, test, but interpret with caution! Clin Med (Lond). 2020 Jun 2:clinmed.2020-0170. doi: 10.7861/clinmed.2020-0170. Epub ahead of print. PMID: 32487681.
  28. Beavis KG, Matushek SM, Abeleda APF, Bethel C, Hunt C, Gillen S, Moran A, Tesic V. Evaluation of the EUROIMMUN Anti-SARS-CoV-2 ELISA Assay for detection of IgA and IgG antibodies. J Clin Virol. 2020 May 23;129:104468. doi: 10.1016/j.jcv.2020.104468. Epub ahead of print. PMID: 32485620; PMCID: PMC7255182.
  29. Plebani M, Padoan A, Negrini D, Carpinteri B, Sciacovelli L. Diagnostic performances and thresholds: the key to harmonization in serological SARS-CoV-2 assays? [published online ahead of print, 2020 May 30]. Clin Chim Acta. 2020;S0009-8981(20)30263-1. doi:10.1016/j.cca.2020.05.050. PMID: 32485157
  30. Egger M, Bundschuh C, Wiesinger K, Gabriel C, Clodi M, Mueller T, Dieplinger B. Comparison of the Elecsys® Anti-SARS-CoV-2 immunoassay with the EDITMenzyme linked immunosorbent assays for the detection of SARS-CoV-2 antibodies in human plasma. Clin Chim Acta. 2020 May 30:S0009-8981(20)30261-8. doi: 10.1016/j.cca.2020.05.049. Epub ahead of print. PMID: 32485155; PMCID: PMC7261064.
  31. Bélec L, Péré H, Bouassa RM, Veyer D, Jenabian MA. Potential pitfalls of routine SARS-CoV-2 serology for mass screening. J Med Virol. 2020 Jun 2. doi: 10.1002/jmv.26034. Epub ahead of print. PMID: 32484942.
  32. Eroshenko N, Gill T, Keaveney MK, Church GM, Trevejo JM, Rajaniemi H. Implications of antibody-dependent enhancement of infection for SARS-CoV-2 countermeasures. Nat Biotechnol. 2020 Jun 5. doi: 10.1038/s41587-020-0577-1. Epub ahead of print. PMID: 32504046.
  33. To KK, Cheng VC, Cai JP, Chan KH, Chen LL, Wong LH, Choi CY, Fong CH, Ng AC, Lu L, Luo CT. Seroprevalence of SARS-CoV-2 in Hong Kong and in residents evacuated from Hubei province, China: a multicohort study. The Lancet Microbe. 2020 Jun 3. DOI:https://doi.org/10.1016/S2666-5247(20)30053-7
  34. Luchsinger LL, Ransegnola B, Jin D, Muecksch F, Weisblum Y, Bao W, George PJ, Rodriguez M, Tricoche N, Schmidt F, Gao C. Serological Analysis of New York City COVID19 Convalescent Plasma Donors. medRxiv. 2020 Jan 1. https://doi.org/10.1101/2020.06.08.20124792
  35. Behrens GMN, Cossmann A, Stankov MV, Witte T, Ernst D, Happle C, Jablonka A. Perceived versus proven SARS-CoV-2-specific immune responses in health-care professionals. Infection. 2020 Jun 10:1–4. doi: 10.1007/s15010-020-01461-0. Epub ahead of print. PMID: 32524515; PMCID: PMC7286418.
  36. Chew KL, Tan SS, Saw S, Pajarillaga A, Zaine S, Khoo C, Wang W, Tambyah P, Jureen R, Sethi SK. Clinical evaluation of serological IgG antibody response on the Abbott Architect for established SARS-CoV-2 infection. Clinical Microbiology and Infection. 2020 Jun 9. PMID: 32531475
  37. Premkumar L, Segovia-Chumbez B, Jadi R, et al. The receptor binding domain of the viral spike protein is an immunodominant and highly specific target of antibodies in SARS-CoV-2 patients. Sci Immunol. 2020;5(48):eabc8413. doi:10.1126/sciimmunol.abc8413
  38. Theel ES, Harring J, Hilgart H, Granger D. Performance Characteristics of Four High-Throughput Immunoassays for Detection of IgG Antibodies against SARS-CoV-2 [published online ahead of print, 2020 Jun 8]. J Clin Microbiol. 2020;JCM.01243-20. doi:10.1128/JCM.01243-20
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