Analytical performance specifications and quality assurance of point-of-care testing in primary healthcare

References

• Ngo A, Gandhi P, Miller WG. Frequency that laboratory tests influence medical decisions. J Appl Lab Med. 2017; 11(4):410–414. doi: 10.1373/jalm.2016.021634.
   PubMedGoogle Scholar
• Rohr UP, Binder C, Dieterle T, et al. The value of in vitro diagnostic testing in medical practice: a status report. PLoS One. 2016;11(3):e0149856. doi: 10.1371/journal.pone.0149856.
   PubMed Web of Science ®Google Scholar
• ISO22870. Point-of-care testing (POCT) - Requirements for quality and competence. International Organization for Standardization, Geneva, Switzerland. 2016;Final Draft.
   Google Scholar
• Orth M, Vollebregt E, Trenti T, et al. Direct-to-consumer laboratory testing (DTCT): challenges and implications for specialists in laboratory medicine. Clin Chem Lab Med. 2023;61(4):696–702. doi: 10.1515/cclm-2022-1227.
   PubMed Web of Science ®Google Scholar
• Stavelin A, Sandberg S. Essential aspects of external quality assurance for point-of-care testing. Biochem Med (Zagreb). 2017;27(1):81–85. doi: 10.11613/BM.2017.010.
   PubMed Web of Science ®Google Scholar
• Nichols JH, Alter D, Chen Y, et al. AACC guidance document on management of point-of-Care testing. J Appl Lab Med. 2020;5(4):762–787. doi: 10.1093/jalm/jfaa059.
   PubMedGoogle Scholar
• Khan AI, Pratumvinit B, Jacobs E, et al. Point-of-care testing performed by healthcare professionals outside the hospital setting: consensus based recommendations from the IFCC committee on point-of-Care testing (IFCC C-POCT). Clin Chem Lab Med. 2023;61(9):1572–1579. doi: 10.1515/cclm-2023-0502.
   PubMed Web of Science ®Google Scholar
• Wang P, O’Kane M. Point-of-Care testing. In: Rifai N, Chiu R, Young I, et al., editors. Tietz textbook of laboratory medicine., 7th edition. St. Louise, Missouri, USA: elsevier; 2023. p. 325–347.
   Google Scholar
• Venner AA, Beach LA, Shea JL, et al. Quality assurance practices for point of care testing programs: recommendations by the Canadian society of clinical chemists point of care testing interest group. Clin Biochem. 2021;88:11–17. doi: 10.1016/j.clinbiochem.2020.11.008.
   PubMed Web of Science ®Google Scholar
• CLSI. User verification of precision and estimation of bias; approved Guideline - Third edition. Clinical and Laboratory Standards Institute, Wayne, Pennsylvania, USA, CLSI document EP15-A3. 2014.
   Google Scholar
• SKUP. The Scandinavian evaluation of laboratory equipment for point of care testing [cited 2023 1st February]. Available from: https://skup.org/.
   Google Scholar
• Sandberg S, Nordin G, Martensson A, et al. Laboratory equipment for primary health care should be tested by independent authorities. Scandinavian SKUP is a good alternative]. Lakartidningen. 2008;105(46):3334–3339.
   PubMedGoogle Scholar
• Bukve T, Stavelin A, Sandberg S. Effect of participating in a quality improvement system over time for point-of-Care C-Reactive protein, glucose, and hemoglobin testing. Clin Chem. 2016;62(11):1474–1481. doi: 10.1373/clinchem.2016.259093.
   PubMed Web of Science ®Google Scholar
• Aarsand AK, Sandberg S. How to achieve harmonisation of laboratory testing -The complete picture. Clin Chim Acta. 2014;432:8–14. doi: 10.1016/j.cca.2013.12.005.
   PubMed Web of Science ®Google Scholar
• Stavelin A, Sandberg S. Harmonization activities of noklus - a quality improvement organization for point-of-care laboratory examinations. Clin Chem Lab Med. 2018;57(1):106–114. doi: 10.1515/cclm-2018-0061.
   PubMed Web of Science ®Google Scholar
• Price CP, St John A, Kricka L. Point-of-Care testing: needs, opportunity, and innovation. Washington DC, USA: AACC Press; 2010.
   Google Scholar
• Lewandrowski K, Gregory K, Macmillan D. Assuring quality in point-of-care testing: evolution of technologies, informatics, and program management. Arch Pathol Lab Med. 2011;135(11):1405–1414. doi: 10.5858/arpa.2011-0157-RA.
   PubMed Web of Science ®Google Scholar
• Meier FA, Jones BA. Point-of-care testing error: sources and amplifiers, taxonomy, prevention strategies, and detection monitors. Arch Pathol Lab Med. 2005; 129(10):1262–1267. doi: 10.5858/2005-129-1262-PTESAA.
   PubMed Web of Science ®Google Scholar
• Holt H, Freedman DB. Internal quality control in point-of-care testing: where’s the evidence? Ann Clin Biochem. 2016;53(Pt 2):233–239. doi: 10.1177/0004563215615148.
   PubMed Web of Science ®Google Scholar
• Shephard MD, Gill JP. Results of an innovative education, training and quality assurance program for point-of-care HbA1c testing using the bayer DCA 2000 in Australian aboriginal community controlled health services. Clin Biochem Rev. 2003;24(4):123–130.
   PubMedGoogle Scholar
• Liikanen E, Lehto L. Training of nurses in point-of-care testing: a systematic review of the literature. J Clin Nurs. 2013;22(15-16):2244–2252. doi: 10.1111/jocn.12235.
   PubMed Web of Science ®Google Scholar
• Shephard MD, Gill JP. The analytical quality of point-of-care testing in the ‘QAAMS’ model for diabetes management in Australian aboriginal medical services. Clin Biochem Rev. 2006;27(4):185–190.
   PubMedGoogle Scholar
• Van Hoof V, Barglazan D, Blairon L, et al. Organisation and quality monitoring for point-of-care testing (POCT) in Belgium: proposal for an expansion of the legal framework for POCT into primary health care. Acta Clin Belg. 2022;77(2):329–336. doi: 10.1080/17843286.2020.1868906.
   PubMed Web of Science ®Google Scholar
• Sandberg S, Roraas T, Aarsand AK, et al. Biological variation and analytical performance specifications (internet). In: rifai N, Chiu R, Young Ieditors. Tietz textbook of laboratory medicine., 7th edition. St. Louise, Missouri, USA: elsevier; 2023. p. 335–356.
   Google Scholar
• Sandberg S, Fraser CG, Horvath AR, et al. Defining analytical performance specifications: consensus statement from the 1st strategic conference of the european federation of clinical chemistry and laboratory medicine. Clin Chem Lab Med. 2015;53(6):833–835. doi: 10.1515/cclm-2015-0067.
   PubMed Web of Science ®Google Scholar
• Horvath AR, Bossuyt PM, Sandberg S, et al. Setting analytical performance specifications based on outcome studies - is it possible? Clin Chem Lab Med. 2015;53(6):841–848.
   PubMed Web of Science ®Google Scholar
• Skeie S, Perich C, Ricos C, et al. Postanalytical external quality assessment of blood glucose and hemoglobin A1c: an international survey. Clin Chem. 2005;51(7):1145–1153. doi: 10.1373/clinchem.2005.048488.
   PubMed Web of Science ®Google Scholar
• van Lint CL, van der Boog PJ, Romijn FP, et al. Application of a point of care creatinine device for trend monitoring in kidney transplant patients: fit for purpose? Clin Chem Lab Med. 2015;53(10):1547–1556.
   PubMed Web of Science ®Google Scholar
• Jani IV, Peter TF. How point-of-care testing could drive innovation in global health. N Engl J Med. 2013;368(24):2319–2324. doi: 10.1056/NEJMsb1214197.
   PubMed Web of Science ®Google Scholar
• TGA. Clinical performance requirements and risk mitation strategies for HIV tests, version 1.0. Australian Government Department of Health, Therapeutic Goods Administration (TGA). March 2015.
   Google Scholar
• Solvik UO, Roraas T, Christensen NG, et al. Diagnosing diabetes mellitus: performance of hemoglobin A1c point-of-care instruments in general practice offices. Clin Chem. 2013;59(12):1790–1801. doi: 10.1373/clinchem.2013.210781.
   PubMed Web of Science ®Google Scholar
• Solvik UO, Risa M, Jacobsen CE, et al. Performance of 10 systems for self-monitoring of blood glucose by trained healthcare professionals and in the hands of the users. Clin Chem. 2015;61(5):772–774. doi: 10.1373/clinchem.2014.236760.
   PubMed Web of Science ®Google Scholar
• Sandberg S, Carobene A, Bartlett B, et al. Biological variation: recent development and future challenges. Clin Chem Lab Med. 2023;61(5):741–750. doi: 10.1515/cclm-2022-1255.
   PubMed Web of Science ®Google Scholar
• Cooper G, DeJonge N, Ehrmeyer S, et al. Collective opinion paper on findings of the 2010 convocation of experts on laboratory quality. Clin Chem Lab Med. 2011;49(5):793–802. doi: 10.1515/CCLM.2011.149.
   PubMed Web of Science ®Google Scholar
• Christensen TD, Larsen TB. Precision and accuracy of point-of-care testing coagulometers used for self-testing and self-management of oral anticoagulation therapy. J Thromb Haemost. 2012;10(2):251–260. doi: 10.1111/j.1538-7836.2011.04568.x.
   PubMed Web of Science ®Google Scholar
• Martin CL. Quality control issues in point of care testing. Clin Biochem Rev. 2008; 29(Suppl 1):S79–S82.
   PubMedGoogle Scholar
• Gidske G, Sandberg S, Fossum AL, et al. Point-of-care testing in primary healthcare: a scoring system to determine the frequency of performing internal quality control. Clin Chem Lab Med. 2022;60(5):740–747. doi: 10.1515/cclm-2021-1258.
   PubMed Web of Science ®Google Scholar
• Briggs C, Guthrie D, Hyde K, et al. Guidelines for point-of-care testing: haematology [practice guideline. ]Br J Haematol. 2008;142(6):904–915. doi: 10.1111/j.1365-2141.2008.07274.x.
   PubMed Web of Science ®Google Scholar
• Parvin CA, Gronowski AM. Effect of analytical run length on quality-control (QC) performance and the QC planning process. Clin Chem. 1997;43(11):2149–2154. doi: 10.1093/clinchem/43.11.2149.
   PubMed Web of Science ®Google Scholar
• Parvin CA. Assessing the impact of the frequency of quality control testing on the quality of reported patient results. Clin Chem. 2008;54(12):2049–2054. doi: 10.1373/clinchem.2008.113639.
   PubMed Web of Science ®Google Scholar
• Stavelin A, Petersen PH, Solvik U, et al. Internal quality control of prothrombin time in primary care: comparing the use of patient split samples with lyophilised control materials. Thromb Haemost. 2009;102(3):593–600. doi: 10.1160/TH09-02-0082.
   PubMed Web of Science ®Google Scholar
• Miller WG, Jones GR, Horowitz GL, et al. Proficiency testing/external quality assessment: current challenges and future directions [review. Clin Chem. 2011;57(12):1670–1680. doi: 10.1373/clinchem.2011.168641.
   PubMed Web of Science ®Google Scholar
• Stavelin A, Meijer P, Kitchen D, et al. External quality assessment of point-of-care international normalized ratio (INR) testing in Europe. Clin Chem Lab Med. 2012;50:81–88.
   Web of Science ®Google Scholar
• Stavelin A, Riksheim BO, Christensen NG, et al. The importance of reagent lot registration in external quality assurance/proficiency testing schemes. Clin Chem. 2016;62(5):708–715. doi: 10.1373/clinchem.2015.247585.
   PubMed Web of Science ®Google Scholar
• CLSI. Evaluation of commutability of processed samples; approved Guideline- Third edition. Clinical and Laboratory Standards Institute, Wayne, Pennsylvania, USA, CLSI document EP14–A3. 2014.
   Google Scholar
• Miller WG, Schimmel H, Rej R, et al. IFCC working group recommendations for assessing commutability part 1: general experimental design. Clin Chem. 2018;64(3):447–454. doi: 10.1373/clinchem.2017.277525.
   PubMed Web of Science ®Google Scholar
• Nilsson G, Budd JR, Greenberg N, et al. IFCC working group recommendations for assessing commutability part 2: using the difference in bias between a reference material and clinical samples. Clin Chem. 2018;64(3):455–464. doi: 10.1373/clinchem.2017.277541.
   PubMed Web of Science ®Google Scholar
• Sandberg S, Fauskanger P, Johansen JV, et al. Recommendations for setting a criterion for assessing commutability of sample materials used in external quality assessment/proficiency testing schemes. Clin Chem. 2023. Epub ahead of print. doi: 10.1093/clinchem/hvad135.
   Web of Science ®Google Scholar
• Bukve T, Sandberg S, Vie WS, et al. Commutability of a Whole-Blood external quality assessment material for point-of-Care C-Reactive protein, glucose, and hemoglobin testing. Clin Chem. 2019;65(6):791–797. doi: 10.1373/clinchem.2018.300202.
   PubMed Web of Science ®Google Scholar
• Wang Y, Plebani M, Sciacovelli L, et al. Commutability of external quality assessment materials for point-of-care glucose testing using the clinical and laboratory standards institute and international federation of clinical chemistry approaches. J Clin Lab Anal. 2020;34(8):e23327.
   PubMed Web of Science ®Google Scholar
• Stavelin A, Petersen PH, Solvik UO, et al. External quality assessment of point-of-care methods: model for combined assessment of method bias and single-participant performance by the use of native patient samples and noncommutable control materials. Clin Chem. 2013;59(2):363–371. doi: 10.1373/clinchem.2012.191957.
   PubMed Web of Science ®Google Scholar
• Stavelin A, Ronneseth E, Gidske G, et al. Using three external quality assurance schemes to achieve equivalent international normalized ratio results in primary and secondary healthcare. Clin Chem Lab Med. 2023;61(3):419–426. doi: 10.1515/cclm-2022-1080.
   PubMed Web of Science ®Google Scholar
• Stavelin A, Albe X, Meijer P, et al. An overview of the european organization for external quality assurance providers in laboratory medicine (EQALM). Biochem Med (Zagreb). 2017;27(1):30–36. doi: 10.11613/BM.2017.005.
   PubMed Web of Science ®Google Scholar
• Thomas A. External quality assessment in laboratory medicine: is there a rationale to determine frequency of surveys? Accred Qual Assur. 2009;14(8-9):439–444. doi: 10.1007/s00769-009-0563-2.
   Web of Science ®Google Scholar
• Tollanes MC, Jenum AK, Berg TJ, et al. Availability and analytical quality of hemoglobin A1c point-of-care testing in general practitioners’ offices are associated with better glycemic control in type 2 diabetes. Clin Chem Lab Med. 2020;58(8):1349–1356. doi: 10.1515/cclm-2020-0026.
   PubMed Web of Science ®Google Scholar
• Bukve T, Roraas T, Riksheim BO, et al. Point-of-care urine albumin in general practice offices: effect of participation in an external quality assurance scheme. Clin Chem Lab Med. 2015;53(1):45–51.
   PubMed Web of Science ®Google Scholar
• Price CP, Smith I, Van den Bruel A. Improving the quality of point-of-care testing. Fam Pract. 2018;35(4):358–364. doi: 10.1093/fampra/cmx120.
   PubMed Web of Science ®Google Scholar
• Bietenbeck A, Geilenkeuser WJ, Klawonn F, et al. External quality assessment schemes for glucose measurements in Germany: factors for successful participation, analytical performance and medical impact. Clin Chem Lab Med. 2018;56(8):1238–1250. doi: 10.1515/cclm-2017-1142.
   PubMed Web of Science ®Google Scholar