IFCC Information Guide on COVID-19 - Monday 14 September updates
Published: Sunday, August 23, 2020
IFCC Information Guide on COVID-19
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Coronavirus disease 2019, abbreviated to COVID-19, is an emerging global pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). As the number of individuals infected with COVID-19 continues to rise globally and healthcare systems become increasingly stressed, it is clear that the clinical laboratory will play an essential role in this crisis, contributing to patient screening, diagnosis, monitoring/treatment, as well as epidemiologic recovery/surveillance. This guide aims to organize relevant available information on laboratory screening, testing protocols, diagnosis, and other general information on COVID-19 for laboratory professionals, including links to helpful resources and interim guidelines. It will be continually updated as new guidelines and literature become available.
Please find below links to helpful websites and guidelines that have been put together by laboratory and clinical specialists from all over the world:
Scientific Journal Resources:
Global Practice Guidelines/Handbooks:
- A patient with acute respiratory illness (fever and at least one sign/symptom of respiratory disease, e.g., cough, shortness of breath), AND a history of travel to or residence in a location reporting community transmission of COVID-19 disease during the 14 days prior to symptom onset; OR
- A patient with any acute respiratory illness AND having been in contact with a confirmed or probable COVID-19 case (see definition of contact) in the last 14 days prior to symptom onset; OR
- A patient with severe acute respiratory illness (fever and at least one sign/symptom of respiratory disease, e.g., cough, shortness of breath; AND requiring hospitalization) AND in the absence of an alternative diagnosis that fully explains the clinical presentation.
A probable case is defined as:
- A suspect case for whom testing for the COVID-19 virus is inconclusive; OR
- A suspect case for whom testing could not be performed for any reason.
A confirmed case is defined as:
A person with laboratory confirmation of COVID-19 infection, irrespective of clinical signs and symptoms. See laboratory guidance for details.
3. Diagnostic Testing: Analytical and Clinical Aspects
Upon confirmation of a suspected case, specimens should be rapidly collected and tested. The Centers for Disease Control and Prevention (CDC) Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (updated April 8th) recommends collecting an upper respiratory specimen for initial diagnostic testing. The following specimens can be collected for swab-based testing: Nasopharyngeal specimen (preferred), Oropharyngeal specimen, Nasal mid-turbinate specimen and Anterior nares specimen. Lower respiratory tract specimen testing is also recommended by the CDC, if the specimens are available.
Nucleic Acid Amplification Tests (NAAT)
Real-time reverse transcription polymerase chain reaction (rRT-PCR) is the current gold standard for diagnosing suspected cases of COVID-19. rRT-PCR is a nucleic acid amplification test (NAAT) that detects unique sequences of the virus that causes COVID-19 (SARS-CoV-2) in respiratory tract specimens. The N, E, S, and RdRP are the viral genes currently targeted (WHO, Laboratory testing for coronavirus disease (COVID-19) in suspected human cases). A validated diagnostic workflow for detecting SARS-CoV-2 has been recently published by Corman and colleagues (PMID: 31992387), as follows: (a) First line screening: E gene, (b) Confirmatory screening: RdRP gene, and (c) Additional confirmatory screening: N gene.
The following table presents criteria for a case to be considered as laboratory-confirmed by validated NAAT assays according to the WHO:
In some cases, a negative result may be returned for a suspected case with a high likelihood of COVID-19 infection. If the negative result was concluded based on only an upper respiratory tract specimen, a lower respiratory tract specimen should be subsequently tested. Additional specimens eligible for testing include blood and stool (WHO, Laboratory testing for coronavirus disease (COVID-19) in suspected human cases).
Antigen assays belong to an additional class of pathogen detecting assays. They detect SATS-CoV-2 antigen in virtually the same sample types as molecular test. These types of assays have already used in the past for other respiratory diseases like influenza and are usually POC tests. There are known to have a good specificity, but a limited sensitivity compared to NAAT. Advantages are an almost instant result and lower cost compared to NAAT. They allow an early rule-in of patients. Negative results, however, still require follow-up NAAT testing. One antigen assay recently got an FDA EUA authorization the Quidel Sofia® 2 SARS Antigen FIA.
Currently Available Diagnostic Assays
Several in-house and commercial assays are currently being developed and optimized. Links to currently available in-house protocols can be accessed here via the World Health Organization. Countries who have no testing capacity or national COVID-19 laboratories with limited experience on COVID-19 testing are encouraged to send the first five positives and the first ten negative COVID-19 samples to WHO reference laboratories providing confirmatory testing for COVID-19. Additionally, the WHO also released a Laboratory Assessment Tool (LAT) which is designed to assess the capacity of existing laboratories which aim to implement COVID-19 testing: Access the tool!
Pre-analytical and Analytical Testing Issues
There are various pre-analytical and analytical issues that can affect diagnostic testing for COVID-19 infection. Some pre-analytical issues include improper collection, handling, transport and usage of swabs, as well as collection of inappropriate or inadequate material, interfering substances, and sample contamination. A common analytical issue is testing outside of the diagnostic window, in addition to active viral recombination and inadequately validated assays (PMID: 31992387).
In order to increase testing capacity and provide more flexible options for SARS-CoV-2 RNA screening, the prospect of patient self-collection of samples has been recently discussed. Indeed, the FDA recently authorized the first home test kit for COVID-19 (April 20 2020). While expanding consumer access to COVID-19 is important, various preanalytical considerations need to be considered, affecting sample quality and impacting result accuracy. These concerns are summarized in a recent letter from the AACC and supported by a recent publication by Sullivan and colleagues (PMID: 32310815).
There has been much debate regarding the current value of serological testing in COVID-19 diagnosis and monitoring. There is general concern regarding their use in the acute phase of infection as they detect infection too late in the course of illness (usually more than 7-10 days), they also may cross-react with serologic responses to seasonal coronaviruses and the rate and kinetics of serological response has not been clearly defined so far. However, there is anticipated value in using improved serological testing in the future for public and occupational health monitoring and assessment. Key publications are listed below.
Key Publications on Diagnostic and Serology Testing:
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
- 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
- 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
- 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
- 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.
- 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.
- 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
- 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.
- 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
- 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.
- 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
- 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
- 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
- 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.
- 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
- 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.
- 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.
- Bossuyt PM. Testing COVID-19 tests faces methodological challenges. Journal of Clinical Epidemiology. 2020 Jul 3.
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
- 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
- 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
- Iwasaki A, Yang Y. The potential danger of suboptimal antibody responses in COVID-19. Nature Reviews Immunology. 2020 Apr 21:1-3. PMID: 32317716
- 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
- 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
- Kran AM. Evaluation of eleven rapid tests for detection of antibodies against SARS-CoV-2. 2020 Apr 24
- 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
- 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
- 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
- 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
- Farnsworth CW, Anderson NW. SARS-CoV-2 Serology: Much Hype, Little Data. Clinical Chemistry. 2020 Apr 28. PMID: 32343775
- 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
- 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
- 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
- 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.
- 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
- 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
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- Lustig Y, Keler S, Kolodny R, et al. Potential antigenic cross-reactivity between SARS-CoV-2 and Dengue viruses [published online ahead of print, 2020 Aug 14]. Clin Infect Dis. 2020;ciaa1207. doi:10.1093/cid/ciaa1207
- McAndrews KM, Dowlatshahi DP, Dai J, et al. Heterogeneous antibodies against SARS-CoV-2 spike receptor binding domain and nucleocapsid with implications on COVID-19 immunity [published online ahead of print, 2020 Aug 14]. JCI Insight. 2020;142386. doi:10.1172/jci.insight.142386
- Flower B, Brown JC, Simmons B, et al. Clinical and laboratory evaluation of SARS-CoV-2 lateral flow assays for use in a national COVID-19 seroprevalence survey [published online ahead of print, 2020 Aug 12]. Thorax. 2020;thoraxjnl-2020-215732. doi:10.1136/thoraxjnl-2020-215732
- Muruato AE, Fontes-Garfias CR, Ren P, et al. A high-throughput neutralizing antibody assay for COVID-19 diagnosis and vaccine evaluation. Nat Commun. 2020;11(1):4059. Published 2020 Aug 13. doi:10.1038/s41467-020-17892-0
- Infantino M, Manfredi M, Grossi V, et al. Closing the Serological Gap in the Diagnostic Testing for COVID-19: The Value of Anti-SARS-CoV-2 IgA Antibodies [published online ahead of print, 2020 Aug 13]. J Med Virol. 2020;10.1002/jmv.26422. doi:10.1002/jmv.26422
- Qiu X, Xiang Y, Sun J, et al. Dynamic changes of throat swabs RNA and serum antibodies for SARS-CoV-2 and their diagnostic performances in patients with COVID-19 [published online ahead of print, 2020 Aug 12]. Emerg Microbes Infect. 2020;1-33. doi:10.1080/22221751.2020.1810133
- Traugott MT, Hoepler W, Seitz T, et al. Diagnosis of COVID-19 using multiple antibody assays in two cases with negative PCR results from nasopharyngeal swabs [published online ahead of print, 2020 Aug 12]. Infection. 2020;10.1007/s15010-020-01497-2. doi:10.1007/s15010-020-01497-2
- Atchison C, Pristerà P, Cooper E, et al. Usability and acceptability of home-based self-testing for SARS-CoV-2 antibodies for population surveillance [published online ahead of print, 2020 Aug 12]. Clin Infect Dis. 2020;ciaa1178. doi:10.1093/cid/ciaa1178
- Zheng Y, Yan M, Wang L, et al. Analysis of the application value of serum antibody detection for staging of COVID-19 infection [published online ahead of print, 2020 Jul 23]. J Med Virol. 2020;10.1002/jmv.26330. doi:10.1002/jmv.26330
- Johnson M, Wagstaffe HR, Gilmour KC, et al. Evaluation of a novel multiplexed assay for determining IgG levels and functional activity to SARS-CoV-2 [published online ahead of print, 2020 Aug 2]. J Clin Virol. 2020;130:104572. doi:10.1016/j.jcv.2020.104572
- Brochot E, Demey B, Handala L, François C, Duverlie G, Castelain S. Comparison of different serological assays for SARS-CoV-2 in real life [published online ahead of print, 2020 Aug 2]. J Clin Virol. 2020;130:104569. doi:10.1016/j.jcv.2020.104569
- den Hartog G, Schepp RM, Kuijer M, et al. SARS-CoV-2-specific antibody detection for sero-epidemiology: a multiplex analysis approach accounting for accurate seroprevalence [published online ahead of print, 2020 Aug 8]. J Infect Dis. 2020;jiaa479. doi:10.1093/infdis/jiaa479
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- Dora AV, Winnett A, Fulcher JA, et al. Using Serologic Testing to Assess the Effectiveness of Outbreak Control Efforts, Serial PCR Testing, and Cohorting of Positive SARS-CoV-2 Patients in a Skilled Nursing Facility [published online ahead of print, 2020 Aug 28].Clin Infect Dis. 2020;ciaa1286. doi:10.1093/cid/ciaa1286
- Whitman JD, Hiatt J, Mowery CT, et al. Evaluation of SARS-CoV-2 serology assays reveals a range of test performance [published online ahead of print, 2020 Aug 27].Nat Biotechnol. 2020;10.1038/s41587-020-0659-0. doi:10.1038/s41587-020-0659-0
- He L, Zeng Y, Zeng C, et al. Positive Rate of Serology and RT-PCR for COVID-19 among Healthcare Workers during Different Periods in Wuhan, China [published online ahead of print, 2020 Aug 24].J Infect. 2020;S0163-4453(20)30561-2. doi:1016/j.jinf.2020.08.027
- Loeffelholz MJ. Evaluation of High Throughput Serological Tests for SARS-CoV-2 [published online ahead of print, 2020 Aug 25].J Clin Microbiol. 2020;JCM.02179-20. doi:1128/JCM.02179-20
- Peterhoff D, Glück V, Vogel M, et al. A highly specific and sensitive serological assay detects SARS-CoV-2 antibody levels in COVID-19 patients that correlate with neutralization [published online ahead of print, 2020 Aug 21].Infection. 2020;1-8. doi:1007/s15010-020-01503-7
- van Tol S, Mögling R, Li W, et al. Accurate Serology for SARS-CoV-2 and common Human Coronaviruses using a Multiplex Approach [published online ahead of print, 2020 Aug 20].Emerg Microbes Infect. 2020;1-24. doi:1080/22221751.2020.1813636
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Additional Resources Related to Testing:
4. Biosafety Guidelines for the Clinical Laboratory
It is of the utmost importance that proper biosafety guidelines are followed by clinical laboratories when handling samples from suspected COVID-19 patients. The IFCC TF on COVID-19 recently published recommendations for biosafety measures for preventing infection from COVID-19 in clinical laboratories accessible at the following link. Key summary recommendations are listed below:
How can biosafety measures be implemented in clinical chemistry laboratories during the COVID-19 pandemic?
1a. Laboratories should adopt social distancing measures within the workplace as much as possible and feasible.
1b. The potential exposure and health status of the laboratory personnel is monitored daily.
What personal hygiene and personal protective equipment (PPE) should be used in clinical chemistry laboratories during the COVID-19 pandemic?
2a. Laboratory professionals must adhere rigorously to universally recommended standard precautions (i.e. frequent hand washing for at least 40 s with soap and water, or hand sanitizer when there is no access to handwashing, and to avoid touching the face) to minimize the risk of exposure to the virus.
2b. Laboratory professionals must wear standard laboratory PPE (i.e. masks and gloves, laboratory coat or gown, and eye protection) at all times.
2c. Laboratory professionals should wear preferably an N95 mask while engaged in aerosol-generating procedures on all non-centrifuged samples potentially containing vital SARS-CoV-2 particles.
How should laboratory staff handle routine patient specimens during the COVID-19 pandemic?
3a. For routine testing of blood, urine and body fluids, laboratories should use automated instruments and analyzers with closed preanalytical robotics, where possible.
3b. When manually handling non-respiratory specimens, aerosol-generating non-centrifuged sample processing steps should be carried out in a BSL2 cabinet, wearing the recommended PPE.
3c. The specimens should be sealed immediately after testing. High-risk specimens should be promptly disinfected or autoclaved.
3d. If there are no accidents, wait for more than 10 min for further processing after centrifugation stops. When the specimen suspected of COVID-19 is centrifuged, the operator must not leave the centrifuge. If an accident is suspected, or in some way the centrifugation is abnormal, stop the centrifugation. After replacing the biosafety level 3 protection equipment, stop centrifugation for more than 30 min, carefully open the lid, and spray and sterilize with 75% ethanol or other disinfectants. Take out the centrifuge rotor with blood collection tubes and then put them in the biosafety cabinet to treat.
How should staff decontaminate laboratory equipment and surfaces during the COVID-19 pandemic?
4a. Laboratory staff should decontaminate working surfaces with standard disinfectants approved for SARS-CoV-2 infections. The frequency shall be decided on local basis according to the volume of work, but shall not be basically less frequent than every 3 h.
4b. If a sample positive for SARS-CoV-2 is suspected of being leaked or contaminates the biosafety cabinet and bench and causes limited pollution: use a disinfectant with an effective chlorine content of 5500 mg/L for disinfection for more than 30 min; the disinfectant must be prepared immediately and used within 24 h. If positive specimens cause laboratory contamination: keep the laboratory space closed to prevent access by unauthorized personnel and to prevent the spread of pollutants. Cover the contaminated area with a towel containing 5500 mg/L of effective chlorine disinfectant and disinfect for more than 30 min. Peracetic acid (2 g/m3) or other disinfectants (3% H2O2, 100 mg/L chlorine dioxide, etc.) can be used to fumigate the laboratory overnight or disinfectant aerosol can be sprayed for 1–2 h.
In addition, interim guidelines from the World Health Organization on laboratory biosafety guidance related to coronavirus disease were updated on March 19th, 2020.
Click here for a full list of WHO suggested decontaminants and here for a full list of EPA suggested decontaminants.
Efficacy of Masking: The efficacy and necessity of surgical grade or N95 masks in the clinical laboratory and the general public has not been well defined. In a recent paper in Nature Medicine by Leung and colleagues, surgical face masks were shown to significantly reduce the detection of influenza virus RNA in respiratory droplets and coronavirus RNA in aerosols, with a trend toward reduced detection of coronavirus RNA in respiratory droplets. In light of increasing evidence towards the efficacy of masking, the WHO has reversed its initial recommendation and now supports government initiatives that require or encourage the public wearing of masks, marking a major shift. The CDC has also encouraged general masking, highlighting the importance of masking for all healthcare workers whether patient-facing or not.
COVID-19 Detection in Different Clinical Specimens: An important consideration in biosafety is the detectability of COVID-19 in clinical specimens. A recent JAMA article investigated biodistribution among different clinical specimens of inpatients with COVID-19. Study findings are summarized below:
COVID-19 Detection in Domestic Animals: A recent publication in Science investigated the susceptibility of domestic animals, including dogs, cats, chickens, pigs, and ducks. Their findings demonstrated that cats are susceptible to airborne infection while COVID-19 replicates poorly in dogs, pigs, chickens, and dogs. Healthcare workers should keep this in mind when interacting with domestic pets.
Additional biosafety resources/publications from other associations include:
Key Publications on Biosafety:
- Lippi G, Adeli K, Ferrari M, Horvath AR, Koch D, Sethi S, Wang CB. Biosafety measures for preventing infection from COVID-19 in clinical laboratories: IFCC Taskforce Recommendations. Clinical Chemistry and Laboratory Medicine (CCLM). 2020 May 12;1(ahead-of-print). PMID: 32396137
- Chang D, Xu H, Rebaza A, Sharma L, Cruz CS. Protecting health-care workers from subclinical coronavirus infection. The Lancet Respiratory Medicine. 2020 Mar 1;8(3):e13. PMID: 32061333
- Yeo C, Kaushal S, Yeo D. Enteric involvement of coronaviruses: is faecal–oral transmission of SARS-CoV-2 possible?. The Lancet Gastroenterology & Hepatology. 2020 Apr 1;5(4):335-7. PMID: 32087098
- Chin A, Chu J, Perera M, Hui K, Yen HL, Chan M, Peiris M, Poon L. Stability of SARS-CoV-2 in different environmental conditions. 2020 Jan 1.
- Klompas M, Morris CA, Sinclair J, Pearson M, Shenoy ES. Universal Masking in Hospitals in the Covid-19 Era. New England Journal of Medicine. 2020 Apr 1. PMID: 32237672
- van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, Tamin A, Harcourt JL, Thornburg NJ, Gerber SI, Lloyd-Smith JO. Aerosol and surface stability of SARS-CoV-2 as compared with SARS-CoV-1. New England Journal of Medicine. 2020 Mar 17. PMID: 32182409
- Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, Yu J, Kang M, Song Y, Xia J, Guo Q. SARS-CoV-2 viral load in upper respiratory specimens of infected patients. New England Journal of Medicine. 2020 Mar 19;382(12):1177-9. PMID: 32074444
- Leung NH, Chu DK, Shiu EY, Chan KH, McDevitt JJ, Hau BJ, Yen HL, Li Y, Ip DK, Peiris JM, Seto WH. Respiratory virus shedding in exhaled breath and efficacy of face masks. Nature Medicine. 2020 Apr 3:1-5.
- Wölfel R, Corman VM, Guggemos W, Seilmaier M, Zange S, Müller MA, Niemeyer D, Jones TC, Vollmar P, Rothe C, Hoelscher M. Virological assessment of hospitalized patients with COVID-2019. Nature. 2020 Apr 1:1-0. PMID: 32235945
- Wang W, Xu Y, Gao R, Lu R, Han K, Wu G, Tan W. Detection of SARS-CoV-2 in different types of clinical specimens. Jama. 2020 Mar 11. PMID: 32159775
- Shi J, Wen Z, Zhong G, Yang H, Wang C, Huang B, Liu R, He X, Shuai L, Sun Z, Zhao Y. Susceptibility of ferrets, cats, dogs, and other domesticated animals to SARS–coronavirus 2. Science. 2020 Apr 8. PMID: 32269068
- Zheng S, Fan J, Yu F, Feng B, Lou B, Zou Q, Xie G, Lin S, Wang R, Yang X, Chen W. Viral load dynamics and disease severity in patients infected with SARS-CoV-2 in Zhejiang province, China, January-March 2020: retrospective cohort study. bmj. 2020 Apr 21;369. PMID: 32317267
- Sunjaya AP, Jenkins C. Rationale for universal face masks in public against COVID-19. Respirology.2020 Apr 30;10.1111. PMID: 32353901
- Somsen GA, van Rijn C, Kooij S, Bem RA, Bonn D. Small droplet aerosols in poorly ventilated spaces and SARS-CoV-2 transmission. Lancet Respir Med. 2020 May 27:S2213-2600(20)30245-9. doi: 10.1016/S2213-2600(20)30245-9. Epub ahead of print. PMID: 32473123.
- Bain W, Lee JS, Watson AM, Stitt-Fischer MS. Practical Guidelines for Collection, Manipulation and Inactivation of SARS-CoV-2 and COVID-19 Clinical Specimens. Curr Protoc Cytom. 2020 Jun;93(1):e77. doi: 10.1002/cpcy.77. PMID: 32502333.
- IGI Testing Consortium. Blueprint for a pop-up SARS-CoV-2 testing lab. Nat Biotechnol. 2020 Jun 18. doi: 10.1038/s41587-020-0583-3. Epub ahead of print. PMID: 32555529.
5. Biochemical Monitoring of COVID-19 Patients:
The essential role of clinical laboratories in this pandemic extends beyond etiological diagnosis of COVID-19. Biochemical monitoring of COVID-19 patients through in vitro diagnostic testing is critical for assessing disease severity and progression as well as monitoring therapeutic intervention. Several common in vitro diagnostic tests have been implicated in unfavorable COVID-19 progression, potentially providing important prognostic information. A recommended test list based on current literature is included below along with the major laboratory abnormalities associated with adult COVID-19 patients and their potential clinical indication. In addition to more common laboratory tests, new evidence suggests that patients with severe COVID-19 could be at risk for cytokine storm syndrome. Cytokine tests, particularly IL-6, should be used where possible to assess severe patients suspected of hyperinflammation.
Special considerations for pediatrics: Importantly, unlike adults, the laboratory profile in severe COVID-19 pediatric patients is not clear and does not appear to be consistent with SARS. A recent publication recommends clinicians monitor lymphocyte count, c-reactive protein, and procalcitonin to assess severe infection. IL-6 should also be investigated as a potential pediatric prognostic indicator (2). A preliminary description of pediatric U.S. COVID-19 cases was published by the CDC on April 10th, 2020. In line with data from China, the CDC reports that pediatric COVID-19 cases might be less severe when compared to adults and that children may experience different symptoms. Specifically, positive pediatric patients were reported to not always be associated with fever or cough as reported signs and symptoms. Additionally, although most cases reported among children to date have not been severe, the CDC recommends clinicians maintain a high index of suspicion for COVID-19 infection in children and monitor for progression of illness, particularly among infants and children with underlying conditions. Importantly, interpretation of pediatric laboratory tests based on known adult trends is not recommended due to lack of pediatric information and characteristics. Recent data also suggests a new phenomenon affecting previously asymptomatic children with SARS-CoV-2 infection manifesting as a hyperinflammatory syndrome with multiorgan involvement similar to Kawasaki disease shock syndrome. Further research into the pediatric manifestations of COVID-19 is essential.
Special considerations for pregnant women during COVID-19 pandemic: Researchers have reported potential vertical transmission of COVID-19 in China (19, 20). Thus, minimizing the risk transmission and viral exposure to pregnant women is incredibly important. Many labs have implemented modifications for the required Gestational Diabetes Mellitus screening, including:
Key Publications on Biochemical Monitoring:
- Henry BM, de Oliveira MH, Benoit S, Plebani M, Lippi G.Hematologic, biochemical and immune biomarker abnormalities associated with severe illness and mortality in coronavirus disease 2019 (COVID-19): a meta-analysis. Clinical Chemistry and Laboratory Medicine (CCLM). 2020 Apr 10;1(ahead-of-print). PMID:32286245
- Lippi G, Plebani M. Laboratory abnormalities in patients with COVID-2019 infection. Clinical Chemistry and Laboratory Medicine (CCLM). 2020 Mar 3. PMID:32119647
- Lippi G, Plebani M. The critical role of laboratory medicine during coronavirus disease 2019 (COVID-19) and other viral outbreaks. Clinical Chemistry and Laboratory Medicine (CCLM). 2020 Mar 19. PMID:32191623
- Gao Y, Li T, Han M, Li X, Wu D, Xu Y, Zhu Y, Liu Y, Wang X, Wang L. Diagnostic Utility of Clinical Laboratory Data Determinations for Patients with the Severe COVID‐ Journal of Medical Virology. 2020 Mar 17. PMID: 32181911
- Rodriguez-Morales AJ, Cardona-Ospina JA, Gutiérrez-Ocampo E, Villamizar-Peña R, Holguin-Rivera Y, Escalera-Antezana JP, Alvarado-Arnez LE, Bonilla-Aldana DK, Franco-Paredes C, Henao-Martinez AF, Paniz-Mondolfi A. Clinical, laboratory and imaging features of COVID-19: A systematic review and meta-analysis. Travel Medicine and Infectious Disease. 2020 Mar 13:101623. PMID: 32179124
- Ruan Q, Yang K, Wang W, Jiang L, Song J. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Medicine. 2020 Mar 3:1-3. PMID:32125452
- Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. The Lancet. 2020 Mar 11. PMID:32171076
- Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DS, Du B. Clinical characteristics of coronavirus disease 2019 in China. New England Journal of Medicine. 2020 Feb 28. PMID: 32109013
- Kavsak PA, de Wit K, Worster A. Clinical chemistry tests for patients with COVID-19–important caveats for interpretation. Clinical Chemistry and Laboratory Medicine (CCLM). 2020 Apr 16;1(ahead-of-print). PMID: 32301748
- Liu Y, Yang Y, Zhang C, Huang F, Wang F, Yuan J, Wang Z, Li J, Li J, Feng C, Zhang Z. Clinical and biochemical indexes from 2019-nCoV infected patients linked to viral loads and lung injury. Science China Life Sciences. 2020 Mar;63(3):364-74. PMID:32048163
- Sanders JM, Monogue ML, Jodlowski TZ, Cutrell JB.Pharmacologic Treatments for Coronavirus Disease 2019 (COVID-19): A Review. JAMA. 2020 Apr 13.PMID:32282022
- Ferrari D, Motta A, Strollo M, Banfi G, Locatelli M. Routine blood tests as a potential diagnostic tool for COVID-19. Clinical Chemistry and Laboratory Medicine (CCLM). 2020 Apr 16;1(ahead-of-print). PMID: 32301746
- Lippi G, South AM, Henry BM. ANNALS EXPRESS: Electrolyte Imbalances in Patients with Severe Coronavirus Disease 2019 (COVID-19. Ann Clin Biochem. 2020 Apr 8 (ahead-of-print). PMID: 32266828
- Nichols JH, Rauch CA. A Laboratory Risk Assessment during the Coronavirus (COVID-19) Pandemic. The Journal of Applied Laboratory Medicine. 2020 Apr 16. PMCID: PMC7184397
- Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW, Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 Apr 22. PMID: 32320003
- Kavsak PA, de Wit K, Worster A. Emerging key laboratory tests for patients with COVID-19. Clinical Biochemistry. 2020 Apr 30. PMID: 32360478
- Lu G, Wang J. Dynamic changes in routine blood parameters of a severe COVID-19 case. Clinica Chimica Acta. 2020 May 13. PMID: 32405079
- Zhu L, She ZG, Cheng X, Qin JJ, Zhang XJ, Cai J, Lei F, Wang H, Xie J, Wang W, Li H, Zhang P, Song X, Chen X, Xiang M, Zhang C, Bai L, Xiang D, Chen MM, Liu Y, Yan Y, Liu M, Mao W, Zou J, Liu L, Chen G, Luo P, Xiao B, Zhang C, Zhang Z, Lu Z, Wang J, Lu H, Xia X, Wang D, Liao X, Peng G, Ye P, Yang J, Yuan Y, Huang X, Guo J, Zhang BH, Li H. Association of Blood Glucose Control and Outcomes in Patients with COVID-19 and Pre-existing Type 2 Diabetes. Cell Metab. 2020 Jun 2;31(6):1068-1077.e3. doi: 10.1016/j.cmet.2020.04.021. Epub 2020 May 1. PMID: 32369736
- Wang M, Zhang J, Ye D, et al. Time-dependent changes in the clinical characteristics and prognosis of hospitalized COVID-19 patients in Wuhan, China: A retrospective study [published online ahead of print, 2020 Jul 6]. Clin Chim Acta. 2020;510:220-227. doi:10.1016/j.cca.2020.06.051
- Yang HS, Hou Y, Vasovic LV, et al. Routine laboratory blood tests predict SARS-CoV-2 infection using machine learning [published online ahead of print, 2020 Aug 21].Clin Chem. 2020;hvaa200. doi:10.1093/clinchem/hvaa200
- Panteghini M. Lactate dehydrogenase: an old enzyme reborn as a COVID-19 marker (and not only) [published online ahead of print, 2020 Aug 24].Clin Chem Lab Med. 2020;/j/cclm.ahead-of-print/cclm-2020-1062/cclm-2020-1062.xml. doi:10.1515/cclm-2020-1062
- Lippi G, Plebani M. Procalcitonin in patients with severe coronavirus disease 2019 (COVID-19): a meta-analysis. Clinica chimica acta; international journal of clinical chemistry. 2020 Mar 4. PMID:32145275
- Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ. COVID-19: consider cytokine storm syndromes and immunosuppression. The Lancet. 2020 Mar 16. PMID:32192578
- Monteleone G, Sarzi-Puttini PC, Ardizzone S. Preventing COVID-19-induced pneumonia with anticytokine therapy. The Lancet Rheumatology. 2020 Apr 6. PMID: TBD
- McGonagle D, Sharif K, O'Regan A, Bridgewood C. Interleukin-6 use in COVID-19 pneumonia related macrophage activation syndrome. Autoimmunity Reviews. 2020 Apr 3:102537. PMID: 32251717
- Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y.Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus–infected pneumonia in Wuhan, China. Jama. 2020 Mar 17;323(11):1061-9. PMID: 32031570
- Chen X, Zhao B, Qu Y, Chen Y, Xiong J, Feng Y, Men D, Huang Q, Liu Y, Yang B, Ding J. Detectable serum SARS-CoV-2 viral load (RNAaemia) is closely correlated with drastically elevated interleukin 6 (IL-6) level in critically ill COVID-19 patients. Clinical Infectious Diseases. 2020 Apr 17. PMID: 32301997
- Zhao Y, Qin L, Zhang P, Li K, Liang L, Sun J, Xu B, Dai Y, Li X, Zhang C, Peng Y. Longitudinal Profiling of Cytokines and Chemokines in COVID-19 Reveals Inhibitory Mediators IL-1Ra and IL-10 Are Associated with Disease Severity While Elevated RANTES Is an Early Predictor of Mild Disease. Non-peer reviewed preprint.
- Liu F, Li L, Xu M, Wu J, Luo D, Zhu Y, Li B, Song X, Zhou X. Prognostic value of interleukin-6, C-reactive protein, and procalcitonin in patients with COVID-19. Journal of Clinical Virology. 2020 Apr 14:104370. PMID: 32344321
- Aziz M, Fatima R, Assaly R. Elevated Interleukin‐6 and Severe COVID‐19: A Meta‐ Journal of Medical Virology. 2020 Apr 28. PMID: 32343429
- Lapić I, Rogić D, Plebani M. Erythrocyte sedimentation rate is associated with severe coronavirus disease 2019 (COVID-19): a pooled analysis. Clinical chemistry and laboratory medicine. 2020 May 9. PMID: 32386190
- Del Valle et al. An inflammatory cytokine signature helps predict COVID-19 severity and death. https://doi.org/10.1101/2020.05.28.20115758
- Ognibene A, Lorubbio M, Magliocca P, Tripodo E, Vaggelli G, Iannelli G, Feri M, Scala R, Tartaglia AP, Galano A, Pancrazzi A. ELEVATED MONOCYTE DISTRIBUTION WIDTH IN COVID-19 PATIENTS: THE CONTRIBUTION OF THE NOVEL SEPSIS INDICATOR. Clinica Chimica Acta. 2020 Jun 3. PMID: 32504637
- Chi Y, Ge Y, Wu B, Zhang W, Wu T, Wen T, Liu J, Guo X, Huang C, Jiao Y, Zhu F, Zhu B, Cui L. Serum Cytokine and Chemokine profile in Relation to the Severity of Coronavirus disease 2019 (COVID-19) in China. J Infect Dis. 2020 Jun 21:jiaa363. doi: 10.1093/infdis/jiaa363. Epub ahead of print. PMID: 32563194.
- Spectrum of innate and adaptive immune response to SARS CoV 2 infection across asymptomatic, mild and severe cases; a longitudinal cohort study. https://doi.org/10.1101/2020.06.22.20137141
- Long QX, Tang XJ, Shi QL, Li Q, Deng HJ, Yuan J, Hu JL, Xu W, Zhang Y, Lv FJ, Su K. Clinical and immunological assessment of asymptomatic SARS-CoV-2 infections. Nature Medicine. 2020 Jun 18:1-5. https://doi.org/10.1038/s41591-020-0965-6
- Pfaar O, Torres MJ, Akdis CA. COVID-19: A series of important recent clinical and laboratory reports in immunology and pathogenesis of SARS-CoV-2 infection and care of allergy patients [published online ahead of print, 2020 Jun 26]. Allergy. 2020;10.1111/all.14472. doi:10.1111/all.14472
- Gupta A, Madhavan MV, Sehgal K, et al. Extrapulmonary manifestations of COVID-19 [published online ahead of print, 2020 Jul 10]. Nat Med. 2020;10.1038/s41591-020-0968-3. doi:10.1038/s41591-020-0968-3
- Rocio LG, Alberto UR, Paloma T, et al. Interleukin-6-based mortality risk model for hospitalised COVID-19 patients [published online ahead of print, 2020 Jul 22]. J Allergy Clin Immunol. 2020;S0091-6749(20)31027-7. doi:10.1016/j.jaci.2020.07.009
- Zhang D, Zhou X, Yan S, et al. Correlation between cytokines and coagulation-related parameters in patients with coronavirus disease 2019 admitted to ICU [published online ahead of print, 2020 Jul 6]. Clin Chim Acta. 2020;510:47-53. doi:10.1016/j.cca.2020.07.002
- Hu D, Li L, Shi W, Zhang L. Less expression of CD4+and CD8+ T cells might reflect the severity of infection and predict worse prognosis in patients with COVID-19: Evidence from a pooled analysis [published online ahead of print, 2020 Jun 27]. Clin Chim Acta. 2020;510:1-4. doi:10.1016/j.cca.2020.06.040
- Del Valle DM, Kim-Schulze S, Huang HH, et al. An inflammatory cytokine signature predicts COVID-19 severity and survival [published online ahead of print, 2020 Aug 24].Nat Med. 2020;10.1038/s41591-020-1051-9. doi:10.1038/s41591-020-1051-9
- Buszko M, Park JH, Verthelyi D, Sen R, Young HA, Rosenberg AS. The dynamic changes in cytokine responses in COVID-19: a snapshot of the current state of knowledge [published online ahead of print, 2020 Aug 27].Nat Immunol. 2020;10.1038/s41590-020-0779-1. doi:1038/s41590-020-0779-1
- Zeng Z, Yu H, Chen H, et al. Longitudinal changes of inflammatory parameters and their correlation with disease severity and outcomes in patients with COVID-19 from Wuhan, China.Crit Care. 2020;24(1):525. Published 2020 Aug 27. doi:1186/s13054-020-03255-0
- Lippi G, Lavie CJ, Sanchis-Gomar F. Cardiac troponin I in patients with coronavirus disease 2019 (COVID-19): Evidence from a meta-analysis. Progress in cardiovascular diseases. 2020 Mar 10. PMID:32169400
- Guo T, Fan Y, Chen M, Wu X, Zhang L, He T, Wang H, Wan J, Wang X, Lu Z. Cardiovascular implications of fatal outcomes of patients with coronavirus disease 2019 (COVID-19). JAMA cardiology. 2020 Mar 27. PMID: 32219356
- Zheng YY, Ma YT, Zhang JY, Xie X. COVID-19 and the cardiovascular system. Nature Reviews Cardiology. 2020 Mar 5:1-2. PMID:32139904
- American College of Cardiology. Troponin and BNP Use in COVID-19. 28 Mar 2020.
- Shi S, Qin M, Shen B, Cai Y, Liu T, Yang F, Gong W, Liu X, Liang J, Zhao Q, Huang H. Association of cardiac injury with mortality in hospitalized patients with COVID-19 in Wuhan, China. JAMA cardiology. 2020 Mar 25. PMID: 32211816
- Chapman AR, Bularga A, Mills NL. High-Sensitivity Cardiac Troponin Can Be An Ally in the Fight Against COVID-19. Circulation. 2020 Apr 6. PMID: 32251612
- Shi S, Qin M, Cai Y, Liu T, Shen B, Yang F, Cao S, Liu X, Xiang Y, Zhao Q, Huang H. Characteristics and clinical significance of myocardial injury in patients with severe coronavirus disease 2019. European Heart Journal. 2020 May 11. PMID: 32391877
- Connors JM, Levy JH. COVID-19 and its implications for thrombosis and anticoagulation. Blood, The Journal of the American Society of Hematology. 2020 Jun 4;135(23):2033-40. PMID: 32339221
- Harmouch F, Shah K, Hippen J, Kumar A, Goel H. Is it all in the heart? Myocardial injury as major predictor of mortality among hospitalized COVID-19 patients [published online ahead of print, 2020 Jul 25]. J Med Virol. 2020;10.1002/jmv.26347. doi:10.1002/jmv.26347
- Deng P, Ke Z, Ying B, Qiao B, Yuan L. The diagnostic and prognostic role of myocardial injury biomarkers in hospitalized patients with COVID-19 [published online ahead of print, 2020 Jul 16]. Clin Chim Acta. 2020;510:186-190. doi:10.1016/j.cca.2020.07.018
- Qin JJ, Cheng X, Zhou F, et al. Redefining cardiac biomarkers in predicting mortality of inpatients with COVID-19 [published online ahead of print, 2020 Jul 14]. Hypertension. 2020;10.1161/HYPERTENSIONAHA.120.15528. doi:10.1161/HYPERTENSIONAHA.120.15528
- Hafiane A. SARS-CoV-2 and the cardiovascular system [published online ahead of print, 2020 Jul 16]. Clin Chim Acta. 2020;510:311-316. doi:10.1016/j.cca.2020.07.019
- Deng P, Ke Z, Ying B, Qiao B, Yuan L. The diagnostic and prognostic role of myocardial injury biomarkers in hospitalized patients with COVID-19 [published online ahead of print, 2020 Jul 16]. Clin Chim Acta. 2020;510:186-190. doi:10.1016/j.cca.2020.07.018
- Sawalha K, Abozenah M, Kadado AJ, et al. Systematic review of COVID-19 related myocarditis: Insights on management and outcome [published online ahead of print, 2020 Aug 18].Cardiovasc Revasc Med. 2020;S1553-8389(20)30497-8. doi:10.1016/j.carrev.2020.08.028
- Lombardi CM, Carubelli V, Iorio A, et al. Association of Troponin Levels With Mortality in Italian Patients Hospitalized With Coronavirus Disease 2019: Results of a Multicenter Study [published online ahead of print, 2020 Aug 26].JAMA Cardiol. 2020;10.1001/jamacardio.2020.3538. doi:10.1001/jamacardio.2020.3538
- Liu D, Yang Q, Chen W, et al. Troponin I, a risk factor indicating more severe pneumonia among patients with novel coronavirus infected pneumonia.Clin Infect Pract. 2020;7:100037. doi:10.1016/j.clinpr.2020.100037
- Raad M, Dabbagh M, Gorgis S, et al. Cardiac Injury Patterns and Inpatient Outcomes Among Patients Admitted With COVID-19 [published online ahead of print, 2020 Jul 24].Am J Cardiol. 2020;S0002-9149(20)30774-8. doi:10.1016/j.amjcard.2020.07.040
- Stefanini GG, Chiarito M, Ferrante G, et al. Early detection of elevated cardiac biomarkers to optimise risk stratification in patients with COVID-19 [published online ahead of print, 2020 Aug 14].Heart. 2020;heartjnl-2020-317322. doi:10.1136/heartjnl-2020-317322
- Shah P, Doshi R, Chenna A, et al. Prognostic Value of Elevated Cardiac Troponin I in Hospitalized Covid-19 Patients [published online ahead of print, 2020 Aug 27]. Am J Cardiol. 2020;S0002-9149(20)30898-5. doi:10.1016/j.amjcard.2020.08.041
- Aladağ N, Atabey RD. The role of concomitant cardiovascular diseases and cardiac biomarkers for predicting mortality in critical COVID-19 patients [published online ahead of print, 2020 Sep 4]. Acta Cardiol. 2020;1-8. doi:10.1080/00015385.2020.1810914
- Fan BE, Chong VC, Chan SS, Lim GH, Lim KG, Tan GB, Mucheli SS, Kuperan P, Ong KH. Hematologic parameters in patients with COVID-19 infection. American journal of hematology. 2020 Mar 4. PMID:32129508
- Lippi G, Plebani M, Henry BM. Thrombocytopenia is associated with severe coronavirus disease 2019 (COVID-19) infections: A meta-analysis. Clinica Chimica Acta. 2020 Mar 13. PMID:32178975
- Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. Journal of Thrombosis and Haemostasis. 2020 Jan 1. PMID:32073213
- Han H, Yang L, Liu R, Liu F, Wu KL, Li J, Liu XH, Zhu CL. Prominent changes in blood coagulation of patients with SARS-CoV-2 infection. Clinical Chemistry and Laboratory Medicine (CCLM). 2020 Mar 16;1(ahead-of-print). PMID: 32172226
- Zhang Y, Xiao M, Zhang S, Xia P, Cao W, Jiang W, Chen H, Ding X, Zhao H, Zhang H, Wang C. Coagulopathy and antiphospholipid antibodies in patients with Covid-19. New England Journal of Medicine. 2020 Apr 8. PMID: 32268022
- Salamanna F, Maglio M, Landini MP, Fini M. Platelet functions and activities as potential hematologic parameters related to Coronavirus Disease 2019 (Covid-19). Platelets. 2020 May 12:1-6. PMID: 32397915
- Levi M, Thachil J, Iba T, Levy JH. Coagulation abnormalities and thrombosis in patients with COVID-19. The Lancet Haematology. 2020 May 11. PMID: 32407672
- Al-Samkari H, Karp Leaf RS, Dzik WH, Carlson JC, Fogerty AE, Waheed A, Goodarzi K, Bendapudi P, Bornikova L, Gupta S, Leaf D, Kuter DJ, Rosovsky RP. COVID and Coagulation: Bleeding and Thrombotic Manifestations of SARS-CoV2 Infection. Blood. 2020 Jun 3:blood.2020006520. doi: 10.1182/blood.2020006520. Epub ahead of print. PMID: 32492712.
- Dewaele K, Claeys R. Hemophagocytic lymphohistiocytosis in SARS-CoV-2 infection. Blood. 2020 Jun 18;135(25):2323. doi: 10.1182/blood.2020006505. PMID: 32556137.
- Mezalek ZT, Khibri H, Ammouri W, et al. COVID-19 Associated Coagulopathy and Thrombotic Complications. Clin Appl Thromb Hemost. 2020;26:1076029620948137. doi:10.1177/1076029620948137
- Hardy M, Douxfils J, Bareille M, et al. Studies on hemostasis in COVID-19 deserve careful reporting of the laboratory methods, their significance and their limitations [published online ahead of print, 2020 Aug 13]. J Thromb Haemost. 2020;10.1111/jth.15061. doi:10.1111/jth.15061
- Nicolai L, Leunig A, Brambs S, et al. Immunothrombotic Dysregulation in COVID-19 Pneumonia is Associated with Respiratory Failure and Coagulopathy [published online ahead of print, 2020 Jul 28]. Circulation. 2020;10.1161/CIRCULATIONAHA.120.048488. doi:10.1161/CIRCULATIONAHA.120.048488
- Elshazli RM, Toraih EA, Elgaml A, et al. Diagnostic and prognostic value of hematological and immunological markers in COVID-19 infection: A meta-analysis of 6320 patients.PLoS One. 2020;15(8):e0238160. Published 2020 Aug 21. doi:10.1371/journal.pone.0238160
- Zhang S, Liu Y, Wang X, et al. SARS-CoV-2 binds platelet ACE2 to enhance thrombosis in COVID-19. J Hematol Oncol. 2020;13(1):120. Published 2020 Sep 4. doi:10.1186/s13045-020-00954-7
- Christensen B, Favaloro EJ, Lippi G, Van Cott EM. Hematology Laboratory Abnormalities in Patients with Coronavirus Disease 2019 (COVID-19) [published online ahead of print, 2020 Sep 2]. Semin Thromb Hemost. 2020;10.1055/s-0040-1715458. doi:10.1055/s-0040-1715458
- Bangash MN, Patel J, Parekh D. COVID-19 and the liver: little cause for concern. The Lancet Gastroenterology & Hepatology. 2020 Mar 20. PMID: 32203680
- Cheng Y, Luo R, Wang K, Zhang M, Wang Z, Dong L, Li J, Yao Y, Ge S, Xu G. Kidney disease is associated with in-hospital death of patients with COVID-19. Kidney international. 2020 Mar 20. PMID: 32247631
- Fan Z, Chen L, Li J, Cheng X, Yang J, Tian C, Zhang Y, Huang S, Liu Z, Cheng J. Clinical features of COVID-19-related liver damage. Clinical Gastroenterology and Hepatology. 2020 Apr 10. PMID: 32283325
- Lax SF, Skok K, Zechner P, Kessler HH, Kaufmann N, Koelblinger C, Vander K, Bargfrieder U, Trauner M. Pulmonary arterial thrombosis in COVID-19 with fatal outcome: results from a prospective, single-center, clinicopathologic case series. Annals of Internal Medicine. 2020 May. PMID: 32422076
- Agarwal A, Chen A, Ravindran N, To C, Thuluvath PJ. Gastrointestinal and liver manifestations of COVID-19. Journal of Clinical and Experimental Hepatology. 2020 Apr 1. PMCID: PMC7212283
- Su H, Yang M, Wan C, Yi LX, Tang F, Zhu HY, Yi F, Yang HC, Fogo AB, Nie X, Zhang C. Renal histopathological analysis of 26 postmortem findings of patients with COVID-19 in China. Kidney international. 2020 Apr 9. PMID: 32327202
- Portincasa P, Krawczyk M, Smyk W, Lammert F, Di Ciaula A. COVID-19 and nonalcoholic fatty liver disease: two intersecting pandemics [published online ahead of print, 2020 Jun 26]. Eur J Clin Invest. 2020;e13338. doi:10.1111/eci.13338
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Free Course on COVID-19 from AACC Learning Lab: AACC developed this content with leading scientists as part of AACC Learning Lab on NEJM Knowledge+. The free course covers COVID-19 transmission, complications, diagnosis, and more.
Science Webinar: Monitoring the immune system to fight COVID-19: CD4 status, lymphopenia, and infectivity
Siemens Healthineers COVID-19 Testing Guide: A new COVID-19 Laboratory Testing Guide from Siemens Healthineers provides essential information for clinicians to help manage each stage of COVID-19 patient care: diagnosis, prognosis, therapy and follow-up.
CAP Webinar: Navigating Implementation of SARS-CoV-2 Testing in Your Laboratory
7. Big Data Tools in COVID-19
- COVID-19 Open Research Dataset (CORD-19): A freely available, downloadable and updated weekly collection of publications (many as full text) on COVID-19, SARS-CoV-2, and related coronaviruses
- World Health Organization: Global research on coronavirus disease (COVID-19) Registry
- LITCOVID: National Institutes of Health and the National Library of Medicine aggregation of COVID-19 general information and news.
- Centers for Disease Control and Prevention COVID-19 Research Articles Downloadable Database: The Stephen B. Thacker CDC Library is collecting COVID-19 research articles and compiling them into an easily accessible and downloadable database to help researchers find the latest COVID-19 research
- COVIDView: A Weekly Surveillance Summary of U.S. COVID-19 Activity provided by the Centers for Disease Control and Prevention.
- Mark Tech Post: COVID-19 resources for machine learning and data science research (lists 29 different datasets)
- Larson T, Culbreath K, Chavez D, Larson R, Crossey M, Grenache DG. Modeling SARS-CoV-2 positivity using laboratory data: timing is everything. Clinical Chemistry. 2020 Apr 30. PMID: 32353116
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.