it is vital that laboratories are adhering to and meeting the ISO 15189:2012 requirement to ensure accurate and reliable test results for COVID-19 adverse outcomes for swift and effective treatment plan implementation. In turn, this will ensure increasing confidence that performance mirrors that of the patient sample, producing accurate and reliable results, enabling effective treatment plan intervention.
Importance of external quality assessment External quality assessment (EQA) is a critical aspect of the laboratory quality management system, and is a method that enables a laboratory to compare its testing with another laboratory. The ISO/IEC Guide 43-1: 1997 states: “Proficiency testing schemes (PTS) are interlaboratory comparisons that are organised regularly to assess the performance of analytical laboratories and the competence of the analytical personnel.” Participation in EQA is essential for laboratories that are accredited, or plan to seek accreditation.19 ISO 15189:2012 addresses EQA
requirements for laboratories, highlighting the necessity for a department to participate in interlaboratory comparisons.19
Selecting an EQA provider
who is accredited to ISO/IEC 17043:2010 is ideal as it guarantees high-quality programmes that are fit for purpose and assist laboratories in achieving their own accreditation.20
During the SARS-CoV-2 pandemic, it is vital that laboratories participate in an EQA scheme that adheres to the ISO/IEC guide and ISO/IEC 17043:2010 to ensure optimum performance of the analytical service, including instrumentation, and the competence of the analytical personnel.
While diagnostics has always played an essential role, we are now in an era where diagnostics is vitally important to aid in reducing the mortality rate from SARS- CoV-2 and COVID-19. As such, accurate and reliable controls and reagents are even more vital to clinical laboratory results. In addition, superior assay methodologies can aid in the early identification of adverse outcomes, enabling timely and effective treatment plan implementation. In doing so, quality control, both internally and externally, is vital to ensure optimum performance of assays, instrumentation, laboratories and personnel.
References 1 WebMD. Complications coronavirus can
a pooled analysis. Liver Int 2020; 40 (7): 1787–8. doi: 10.1111/liv.14477.
13 Dhungana N, Morris C, Krasowski MD. Operational impact of using a vanadate oxidase method for direct bilirubin measurements at an academic medical center clinical laboratory. Pract Lab Med 2017; 8: 77–85. doi: 10.1016/ j.pl
14 Moriarty PM, Gorby LK, Stroes ES, Kastelein JP, Davidson M, Tsimikas S. Lipoprotein(a) and its potential association with thrombosis and inflammation in COVID-19: a testable hypothesis. Curr Atheroscler Rep 2020; 22 (9): 48. doi: 10.1007/s11883-020-00867-3.
Quality control samples should be commutable, meaning the controls react to the test system in the same manner as the patient sample.
2 George A. Cytokine storm: an overreaction of the body’s immune system (www.newscientist.co
3 Sinha P, Matthey MA, Calfee CS. Is a “cytokine storm” relevant to COVID-19? JAMA Intern Med 2020; 180 (9): 1152–4. doi: 10.1001/jamainternmed.2020.3313.
4 Qin C, Zhou L, Hu Z et al. Dysregulation of immune response in patients with coronavirus 2019 (COVID-19) in Wuhan, China. Clin Infect Dis 2020; 71 (15): 762–8. doi: 10.1093/cid/ciaa248.
5 Del Valle DM, Kim-Schulze S, Huang HH et al. An inflammatory cytokine signature helps predict COVID-19 severity and death. medRxiv 2020; 2020.05.28.20115758. doi: 10.1101/2020.05.28.20115758. Preprint.
6 Tighe PJ, Ryder RR, Todd I, Faircloght LC. ELISA in the multiplex era: potentials and pitfalls. Proteomics Clin Appl 2015; 9 (3–4): 406–22. doi: 10.1002/prca.201400130.
7 Schmidt RL, Straseski JA, Raphael KL, Adams AH, Lehman CM. A risk assessment of the Jaffe vs enzymatic method for creatinine measurement in an outpatient population. PLoS One 2015; 10 (11): e0143205. doi: 10.1371/ journal.pone.0143205.
8 Swedko PJ, Clark HD, Paramsothy K, Akbari A. Serum creatinine is an inadequate screening test for renal failure in elderly patients. Arch Intern Med 2003; 163 (3): 356–60. doi: 10.1001/archinte.163.3.356.
9 Gounden V, Jialal I. Renal function tests. Treasure Island: StatPearls Publishing, 2020 (www.ncbi.nlm.nih.gov/books/NBK507821/
10 Siordia JA. Epidemiology and clinical features of COVID-19: a review of current literature. J Clin Virol 2020; 127: 104357. doi: 10.1016/j.jcv.2020.104357.
11 Cai Q, Huang D, Yu H et al. COVID-19: Abnormal liver function tests. J Hepatol 2020; 73 (3): 566–74. doi: 10.1016/ j.jhep.2020.04.006.
12 Paliogiannis P, Zinellu A. Bilirubin levels in patients with mild and severe Covid-19:
15 Cegla J, Dermot R, Neely G et al.; HEART UK Medical, Scientific and Research Committee. HEART UK consensus statement on lipoprotein(a): a call to action. Atherosclerosis 2019; 291: 62–70. doi: 10.1016/j.at
herosclerosis.2019.10.011. Corrigendum in Atherosclerosis 2020; 296: 48. doi: 10.1016/ j.at
16 Pai S, Frater JL. Quality management and accreditation in laboratory hematology: perspectives from India. Int J Lab Hematol 2019; 41 (Suppl 1): 177–83. doi: 10.1111/ijlh.13017.
17 Eden PR. Quality control in clinical laboratory samples. Medical Laboratory Observer 2020 (www.mlo-online.co
m/home/ article/13007888/quality-control-in-clinical- laboratory-samples#:~:text=Quality% 20control%20(QC)%20is%20one,accuracy% 20of%20patient%20sample%20results.&text =When%20quality%20control%20works% 20effectively,incorrect%20patient%20results %20are%20released).
18 International Organization for Standardization. Medical laboratories – requirements for quality and competence (ISO 15189:2012). Geneva: ISO, 2020 (www.erndim.org/store/docs/
19 World Health Organization. Assessment – external quality assessment. Geneva: WHO, 2020 (https://extranet.who.in
t/lqsi/sites/ default/files/attachedfiles/LQMS%2010.%20 Assessment%20-%20EQA.pdf).
20 International Organization for Standardization. ISO/IEC 17043:2010 Conformity assessment – General requirements for proficiency testing. Geneva: ISO, 2020 (www.iso.org/standard/ 29366.ht
For further details, please contact: Randox Laboratories 55 Diamond Road Crumlin, Co. Antrim, UK BT29 4QY Tel: +44 (0)28 9442 2413 Email: firstname.lastname@example.org
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