Point-of-Care Testing for Autoimmune Rheumatic Diseases: Benefits and Barriers

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Abstract

Point-of-care testing (POCT) is a near-patient detection technique that could provide results within minutes. Compared to
conventional laboratory testing, POCT is more beneficial particularly in emergency and urgent care settings. Detection of antinuclear antibodies and autoantibodies against extractable nuclear antigens are critical for the diagnosis and management of autoimmune rheumatic diseases (AIRD). At present, these autoantibodies are detected using conventional methods that take hours or days in centralized laboratories. POCT for AIRD is hardly practiced as they are chronic illnesses which are seen as clinical emergencies occasionally. Since POCT provides instant results, it may be life-saving in critically ill and confusing cases, particularly those admitted to intensive care units with multisystem organ failure. POCT is also very useful in rural and remote health-care centers, addressing the needs of emergent disease detection. This review aims to provide an overview of the potential use of POCT in AIRD as well as discuss the types, benefits, and shortcomings of POCT devices, and the hurdles that prevent their widespread clinical use.

Keywords

Point-of-care testing

Autoimmune rheumatic disorders

Antinuclear antibodies

Autoantibodies

References

[1]

Broten, L.; Aviña-Zubieta, J.A.; Lacaille, D.; Joseph, L.; Hanly, J.G.; Lix. L.; O’Donnell, S.; Barnabe, C.; Fortin, P.R.; Hudson, M.; Jean, S.; Peschken, C.; Edworthy, S.M.; Svenson, L.; Pineau, C.A.; Clarke, A.E.; Smith, M.; Bélisle, P.; Badley, E.M.; Bergeron, L.; Bernatsky, S. Systemic Autoimmune Rheumatic Disease Prevalence in Canada: Updated Analyses Across 7 Provinces. J. Rheumatol., 2014, 41(4), 673–9.

[2]

Minz, R.W.; Kumar, Y.; Anand, S.; Singh, S.; Bamberi, P.; Verma, S.; Shegal, S. Antinuclear Antibody-positive Autoimmune Disorders in North India: An Appraisal. Rheumatol. Int., 2012, 32(9), 2883–8.

[3]

Alamanos, Y.; Voulgari, P.V.; Drosos, A.A. Incidence and Prevalence of Rheumatoid Arthritis, Based on the 1987 American College of Rheumatology Criteria: A Systematic Review. Semin. Arthritis. Rheum., 2006, 36, 182–8.

[4]

Goldblatt, F.; O’Neill, S.G. Clinical Aspects of Autoimmune Rheumatic Diseases. Lancet, 2013, 382(9894), 797–808.

[5]

Bodolay, E.; Csiki, Z.; Szekanecz, Z.; Ben, T.; Kiss, E.; Zeher, M.; Szücs, G.; Dankó, K.; Szegedi, G. Five-year Follow-up of 665 Hungarian Patients with Undifferentiated Connective Tissue Disease (UCTD). Clin. Exp. Rheumatol., 2003, 21, 313–20.

[6]

Marder, W.; Vinet, E.; Somers, E.C. Rheumatic Autoimmune Diseases in Women and Midlife Health. Women’s Midlife Health, 2015, 1, 11.

[7]

Fritzler, M.J. The Opportunity and Imperative for Point-of-care Diagnostics in Systemic Lupus Erythematosus. Arthritis Res. Ther., 2014, 16(S1), A31.

[8]

Gilkar, A.; Fink, R.; Eardley, P.; Barron, C. The Effect of “On-Line” POCT on Patient waiting times in an Accident and Emergency Department. BMJ. Qual. Improv. Rep., 2013, 2(1), w685.

[9]

Olsen, N.J.; Choi, M.Y.; Fritzler, M.J. Emerging Technologies in Autoantibody Testing for Rheumatic Diseases. Arthritis Res. Ther., 2017, 19(1), 172.

[10]

Konstantinov, K.N.; Tzamaloukas, A.; Rubin, R.L. Detection of Autoantibodies in a Point-of-care Rheumatology Setting. Autoimmun. Highlights, 2013, 4(2), 55–61.

[11]

Chan, E.K.L.; Damoiseaux, J.; Carballo, O.G.; Conrad, K.; Cruvinel, W.D.M.; Francescantonio, P.L.C.; Fritzler, M.J.; La Torre,I.G.D.; Herold, M.; Mimori, T.; Satoh, M.; von Mühlen,C.A.; Andrade, L.E.C. Report of the First International Consensus on Standardized Nomenclature of Antinuclear Antibody HEp-2 Cell Patterns 2014-2015. Front. Immunol., 2015, 6, 412.

[12]

Steiner, G.; Smolen, J. Autoantibodies in Rheumatoid Arthritis and their Clinical Significance. Arthritis Res., 2002, 4(S2), S1–5.

[13]

Didier, K.; Bolko, L.; Giusti, D.; Toquet, S.; Robbins, A.; Antonicelli, F.; Servettaz, A. Autoantibodies Associated With Connective Tissue Diseases: What Meaning for Clinicians? Front. Immunol., 2018, 9, 541.

[14]

Bizzaro, N.; Tozzoli, R.; Shoenfeld, Y. Are we at a Stage to Predict Autoimmune Rheumatic Diseases? Arthritis Rheum., 2007, 56(6), 1736–44.

[15]

Cossio, M.; Menon, Y.; Wilson, W.; deBoisblanc, B.P. Lifethreatening Complications of Systemic Sclerosis. Crit. Care Clin.,2002, 18, 819–39.

[16]

Berman, S.; Bucher, J.; Koyfman, A.; Long, B.J. Emergent Complications of Rheumatoid Arthritis. J. Emerg. Med., 2018, 55(5), 647–58.

[17]

Vymetal, J.; Skacelova, M.; Smrzova, A.; Klicova, A.; Schubertova, M; Horak, P.; Zadrazil, J. Emergency situations in rheumatology with a focus on systemic autoimmune diseases. Biomed. Pap. Med. Fac. Univ. Palacky. Olomouc. Czech. Repub., 2016, 160(1), 20–99.

[18]

Srinivasan, B.; Tung, S. Development and Applications of Portable Biosensors. J. Lab. Autom., 2015, 20(4), 365–89.

[19]

Yanga, J.; Wanga, K.; Xub, H.; Yana, W.; Jinc, Q.; Cui, D. Detection Platforms for Point-of-care Testing Based on Colorimetric, Luminescent and Magnetic Assays: A Review. Talanta, 2019, 202, 96–110.

[20]

Liao, J.; Ip, W.S.; Cheung, K.Y.; Wan, W.M.; Cautherley, G.W.; Cai, X.; Lin, X.; Renneberg, R.; Chan, C.P.Y. Diagnostic Utility of an Anti-CCP Point-of-care Immunotest in Chinese Patients with Rheumatoid Arthritis. Clin. Chim. Acta, 2011, 412(9–10), 778–81.

[21]

Miyara, M.; Charuel, J.L.; Mudumba, S.; Wu, A.; GhillaniDalbin, P.; Amoura, Z.;Burlingame, R.W.; Musset, L. Detection in Whole Blood of Autoantibodies for the Diagnosis of Connective Tissue Diseases in Near-patient Testing Condition. PLoS One, 2018, 13(8), e0202736.

[22]

Ricci, F.; Adornetto, G.; Moscone, D.; Plaxco, K.W.; Palleschi, G. Quantitative, Reagentless, Single-step Electrochemical Detection of Anti-DNA Antibodies Directly in Blood Serum. Chem. Commun. (Camb.). 2010, 46(10), 1742–44.

[23]

Rubin, R.L.; Wall, D.; Konstantinov, K.N. Electrochemical Biosensor for Quantitation of anti-DNA Autoantibodies in Human Serum. Biosens. Bioelectron., 2014, 51, 177–83.

[24]

Fakhrullin, R.F.; Vinter, V.G.; Zamaleeva, A.I.; Matveeva, M.V.; Kourbanov, R.A.; Temesgen, B.K.; Ishmuchametova, D.G.; Abramova, Z.I.; Konovalova, O.A.; Salakhov, M.K. Quartz Crystal Microbalance Immunosensor for the Detection of Antibodies to Double-stranded DNA. Anal. Bioanal. Chem., 2007, 388(2), 367–75.

[25]

Buhl, A.; Metzger, J.H.; Heegaard, N.H.; von Landenberg, P.; Fleck, M.; Luppa, P.B. Novel Biosensor-based Analytic Device for the Detection of Anti-Double-stranded DNA Antibodies. Clin. Chem., 2007, 53(2), 334–41.

[26]

Konstantinov, K.N.; Sitdikov, R.A.; Lopez, G.P.; Atanassov, P.; Rubin, R.L., Rapid Detection of Anti-chromatin Autoantibodies in Human Serum Using a Portable Electrochemical Biosensor. Biosens. Bioelectron., 2009, 24(7), 1949–54.

[27]

Burbelo, P.D.; Gunti, S.; Keller, J.M.; Morse, C.G.; Deeks, S.G.; Lionakis, M.S.; Kapoor, A.; Li, Q.; Cohen, J.I.; Notkins, A.L.; Alevizos, I. Ultra-rapid Measurement of Diagnostic Antibodies by Magnetic Capture of Immune Complexes. Sci. Rep., 2017, 7(1), 3818.

[28]

Burbelo, P.D.; Ching, K.H.; Issa, A.T.; Loftus, C.M.; Li, Y.; Satoh, M.; Reeves, W,H.; Iadarola, M.J. Rapid Serological Detection of Autoantibodies Associated with Sjögren’s Syndrome. J. Transl. Med., 2009, 7, 83.

[29]

Rojanasantikul, P.; Pattrapornpisut, P.; Anuruckparadorn, K.; Katchamart, W., The Performance of a Point of Care Test for Detection of Anti-mutated Citrullinated Vimentin and Rheumatoid Factor in Early Rheumatoid. Clin. Rheumatol., 2014, 33(7), 919–23.

[30]

Metzger, J.; von Landenberg, P.; Kehrel, M.; Buhl, A.; Lackner, K.J.; Luppa, P. B. Biosensor Analysis of beta2-Glycoprotein I-Reactive Autoantibodies: Evidence for Isotype-specific Binding and Differentiation of Pathogenic from Infection-induced Antibodies. Clin. Chem., 2007, 53(6), 1137–43.

[31]

Offermann, N.; Conrad, K.; Fritzler, M.J.; Achterrath, M.F. Development, and Validation of a Lateral Flow Assay (LFA) for the Determination of IgG-antibodies to Pr3 (cANCA) and MPO (pANCA). J. Immunol. Methods, 2014, 403(1-2), 1–6.

[32]

Prabowo, B.A.; Purwidyantri, A.; Liu, K.C. Surface Plasmon Resonance Optical Sensor: A Review on Light Source Technology. Biosensors (Basel), 2018, 8(3), 80.

[33]

Kozel, T.R.; Burnham-Marusich, A.R. Point-of-care Testing for Infectious Diseases: Past, Present, and Future. J. Clin. Microbiol., 2017, 55, 2313–20.

[34]

Luppa, P.B.; Junker, R. (Eds.), Point-of-Care Testing. Germany: Springer-Verlag GmbH Germany, Springer Nature, 2018.

[35]

Luppa, P.B.; Müller, C.; Schlichtiger, A. Point-of-care Testing (POCT): Current Techniques and Future Perspectives. TrAC Trends Anal. Chem., 2011, 30(6), 887–98.

[36]

Liedberg, B.; Nylander, C.; Lundstrom, I. Biosensing with Surface Plasmon Resonance how it all Started. Biosens. Bioelectron., 1995, 10, 1–9.

[37]

St John, A. Benchtop Instruments for Point-of-care Testing. In: Price, C.P.; St John, A.; Hicks, J.M (Eds.), Point-of-care Testing. 2nd ed. Washington, DC: AACC Press, 2004, p. 31–46.

[38]

Corstjens, A.M.; Ligtenberg, J.J.; van der Horst, I.C.; Spanjersberg, R.; Lind, J.S.; Tulleken, J.E.; Meertens, J.H.J.; Zijlstra, J.G. Accuracy and feasibility ofpoint-of-care and continuous blood glucose analysis in critically ill ICU patients. Crit. Care, 2006, 10, R135.

[39]

Wolters, F.; Bovenkamp, J.V.; Bosch, B.V.; Brink, S.V.; Broeders, M.; Chung, N.H.; Favié, B.; Goderski, G.; Kuijpers.; Overdevest, I.; Rahamat-Langedoen, J.; Wijsman, L.; Melchers, W.J.; Meijer, A. Multi-center Evaluation of Cepheid xpert® xpress SARS-CoV-2 Point-of-care Test during the SARSCoV-2Pandemic. J. Clin. Virol., 2020, 128, 104426.

[40]

Green, K.; Graziadio, S.; Turner, P.; Fanshawe, T.; Allen, J. Molecular and Antibody Point-of-care Tests to Support the Screening, Diagnosis, and Monitoring of COVID-19. Available from: https://www.cebm.net/covid-19/molecular-and-antibodypoint-of-care-tests-to-support-the-screening-diagnosis-andmonitoring-of-covid-19/. [Last accessed on 2020 Jun 05].

[41]

St John, A.; Price, C.P. Existing and Emerging Technologies for Point-of-Care Testing. Clin. Biochem. Rev., 2014, 35(3), 155–67.

[42]

Päkkilä, H.; Soukka, S. Simple, and Inexpensive ImmunoassayBased Diagnostic Tests. Bioanal. Rev., 2011, 3, 27–40.

[43]

Tenda, K.; van Gerven, B.; Arts, R.; Hiruta, Y.; Merkx, M.; Citterio, D. Paper-Based Antibody Detection Devices Using Bioluminescent BRET-Switching Sensor Proteins. Angew. Chem. Int. Ed. Engl., 2018, 57(47), 15369–73.

[44]

Fritzle, M.J. Perspectives on the Imperatives, Opportunities, and Challenges for Point-of-care Diagnostics in Systemic Lupus Erythematosus. Int. J. Clin. Rheumatol., 2014, 9(5), 449–56.

[45]

Pruijn, G.J.; Wiik, A.; van Venrooij, W.J. The Use of Citrullinated Peptides and Proteins for the Diagnosis of Rheumatoid Arthritis. Arthritis Res. Ther., 2010, 12(1), 203.

[46]

Uddin, M.N.; Paul, S.; Sattar, M.A.; Faruk, G.; Kibria, A.; Alamgir, M.M.; Biswas, R.S.; Karim, M.R.; Lohani, K.H.; Nath, R.K.; Rahman, M. Evaluation of anti-CCP for Early Diagnosis and Assessment of Disease Severity in Rheumatoid Arthritis Patients. Int. J. Curr. Res., 2017, 9(8), 55762–6.

[47]

Mabey, D.; Peeling, R.W.; Ustianowski, A.; Perkins, M.D. Diagnostics for the Developing World. Nat. Rev., 2004, 2, 231–40.

[48]

Drain, P.K.; Hyle, E.P.; Noubary, F.; Freedberg, K.A.; Wilson, D.; Bishai, W.R.; Rodriguez, W.; Bassett, I.V. Diagnostic Point-ofcare Tests in Resource-limited Settings. Lancet Infect. Dis., 2014, 14(3), 239–49.

[49]

Rooney, K.D.; Schilling, U.M. Point-of-Care Testing in the Overcrowded Emergency Department can it Make a Difference? Crit. Care, 2014, 18, 692.

[50]

Shaw, J.L.V. Practical Challenges Related to Point of Care Testing. Pract. Lab. Med., 2016, 4, 22–9.

[51]

Cantero, M.; Redondo, M.; Martin, E.; Callejon, G.; Hortas, M.L. Use of Quality Indicators to Compare Point-of-care Testing Errors in a Neonatal Unit and Errors in a STAT Central Laboratory. Clin. Chem. Lab. Med., 2015, 3, 239–47.

[52]

Larsson, A.; Greig-Pylypczuk, R.; Huisman, A. The State of PointOf-Care Testing: A European Perspective. Ups J. Med. Sci., 2015, 120, 1–10.

[53]

St-Louis, P. Status of Point-of-Care Testing: Promise, Realities, and Possibilities. Clin. Biochem., 2000, 33(6), 427–40.

[54]

Clouse, K.; Page-Shipp, L.; Dansey, H.; Moatlhodi, B.; Scott, L.; Bassett, J.; Stevens, W.; Sanne, I.; Van Rie, A. Implementation of Xpert MTB/RIF for Routine Point-of-care Diagnosis of Tuberculosis at the Primary Care Level. S. Afr. Med. J., 2012, 102(10), 805–7.

[55]

Engel, N.; Ganesh, G.; Patil, M.; Yellappa, V.; Pai, N.P.; Vadnais, C. Barriers to Point-of-Care Testing in India: Results from Qualitative Research across Different Settings, Users and Major Diseases. PLoS One, 2015, 10(8), e0135112.

[56]

John, S.A.; Price, C.P. Economic Evidence, and Point-of-Care Testing. Clin. Biochem. Rev., 2013, 34(2), 61–74.

[57]

Laurence, C.O.; Moss, J.R.; Briggs, N.E.; Beilby, J.J.; PoCT Trial Management Group. The Cost-effectiveness of Point of Care Testing in a General Practice Setting: Results from a Randomized Controlled Trial. BMC Health Serv. Res., 2010, 10, 165.

[58]

Spaeth, B.A.; Kaambwa, B.; Shephard, M.D.; Omond, R. Economic Evaluation of Point-of-care Testing in the Remote Primary Health Care Setting of Australia’s Northern Territory. Clinicoecon. Outcomes Res., 2018, 10, 269–77.

[59]

El-Osta, A.; Woringer, M.; Pizzo, E.; Verhoef, T.; Dickie, C.; Ni, M.Z.; Huddy, J.R.; Soljak, M.; Hanna, G.B.; Majeed, A. Does Use of Point-of-care Testing Improve the Cost-effectiveness of the NHS Health Check Program in the Primary Care Setting? A Costminimization Analysis. BMJ. Open, 2017, 7(8), e015494.

[60]

Price, C.P.; John, S.A. The Value Proposition for Point-ofcare Testing in Healthcare: HbA1c for Monitoring in Diabetes Management as an Exemplar. Scand. J. Clin. Lab. Invest., 2019, 79(5), 298–304.

[61]

Junker, R.; Petersmann, A.; Luppa, P.B. The Relevance of POCT in Healthcare. In: Luppa, P.B.; Junker, R (Eds.), Point-of-Care Testing. Berlin, Heidelberg: Springer, 2018.

[62]

Wool, G.D. Benefits and Pitfalls of Point-of-Care Coagulation Testing for Anticoagulation Management: An ACLPS Critical Review. Am. J. Clin. Pathol., 2019, 151(1), 1–17.

[63]

Wiencek, J.; Nichols, J. Issues in the Practical Implementation of POCT: Overcoming Challenges. Exp. Rev. Mol. Diagn., 2016, 16(4), 415–22.

[64]

Poe, S.S.; Nichols, J.H. Quality Assurance, Practical Management, and Outcomes of Point-of-care Testing: Laboratory Perspectives, Part II. JCLMA, 2000, 14, 12–8.

[65]

Quinn, A.D.; Dixon, D.; Meenan, B.J. Barriers to Hospital-based Clinical Adoption of Point-of-care Testing (POCT): A Systematic Narrative Review. Crit. Rev. Clin. Lab. Sci., 2016, 53(1), 1–12.

[66]

Louie, R.F.; Ferguson, W.J.; Curtis, C.M.; Vy, J.H.; Kost, G.J. Vulnerability of Point-of-care Test Reagents and Instruments to Environmental Stresses: Implications for Health Professionals and Developers. Clin. Chem. Lab. Med., 2014, 52(3), 325–35.

[67]

Jena, G.B.; Chavan, S. Implementation of Good Laboratory Practices (GLP) in Basic Scientific Research: Translating the Concept beyond Regulatory Compliance. Regul. Toxicol. Pharmacol., 2017, 89, 20–5.

[68]

Martin, C.L. Quality Control Issues in Point of Care Testing. Clin. Biochemist. Rev., 2008, 29(S1), S79–82.

[69]

Bamberg, R.; Schulman, K.; MacKenzie, M.; Moore, J.; Olchesky, S. Effect of Adverse Storage Conditions on Performance of Glucometer Test Strips. Clin. Lab. Sci., 2005, 18(4), 203–9.

[70]

Taylor, B.M.; DeJear, L.; Teehee, M. The Role of Education and Point of Care use Inappropriate Surface Disinfection Compliance. Am. J. Infect. Control, 2013, 41(6), S130.

[71]

Nichols, J.H.; Rauch, C.A. Clinical Chemistry: Quality in Laboratory Diagnosis. New York: Demos Medical, 2014.

[72]

Culliney, K.; McCowan, L.M.E.; Okesene-Gafa, K.; Murphy, R.; Rowan, J.; Taylor, R.S.; Mckinlay, C.J.D.; HUMBA Study Group. Accuracy of Point-of-care HbA1c Testing in Pregnant Women. Aust. N. Z. J. Obstet. Gynaecol., 2018, 58(6), 643–7.

[73]

Gentile, N.L.; Louie, R.F.; Sifontes, J.; Mecozzi, D.; Hale, K.; Kost, G.J. Standardization, Harmonization, and Realization. Point Care, 2008, 7(3), 110–12.

[74]

Engel, N.; Wachter, K.; Pai, M.; Gallarda, J.; Boehme, C.; Celentano, I. Addressing the Challenges of Diagnostics Demand and Supply: Insights from an Online Global Health Discussion Platform. BMJ. Glob. Health, 2016, 1, e000132.

[75]

Embrey, M.A. Management Science for Health. MDS-3: Managing Access to Medicines and Health Technologies. Sterling, VA, USA: Kumarian Press, 2012.

[76]

Khan, A.H.; Shakeel, S.; Hooda, K.; Siddiqui, K.; Jafri, L. Best Practices in the Implementation of a Point of Care Testing Program: Experience From a Tertiary Care Hospital in a Developing country. EJIFCC, 2019, 30(3), 288–302.

[77]

Palamountain, K.M.; Baker, J.; Cowan, E.P.; Essajee, S.; Mazzola, L.T.; Metzler, M. Perspectives on Introduction and Implementation of New Point-of-care Diagnostic Tests. J. Infect.Dis., 2012, 205(S2), S181–90.

[78]

Briggs, C.; Guthrie, D.; Hyde, K.; Mackie, I.; Parker, N.; Popek, M.;Porter, N.; Stephens, C.; British Committee for Standards in Haematology General Haematology Task Force. British Committee for Standards in Haematology General Haematology Task Force. Guidelines for Point-of-care Testing: Hematology. Br. J. Haematol., 2008, 142(6), 904–15.

[79]

Louie, R.F.; Ferguson, W.J.; Curtis, C.M.; Vy, J.H.; Tang, C.S.; Kost, G.J. Effects of Environmental Conditions on Point-of-care Cardiac Biomarker Test Performance during a Simulated Rescue: Implications for Emergency and Disaster Response. Am. J. Disaster Med., 2013, 8(3), 205–12.

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