The European Organisation of External Quality Assurance Providers in Laboratory Medicine (EQALM) Statement: guidelines for publishing about interlaboratory comparison studies (PubILC)

References

• European Committee for Standardization (CEN). EN 14136:2004. Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures. Brussels (Belgium): EQUATOR (Enhancing the quality and transparency of health research) Network; 2004.
   Google Scholar
• EQUATOR Network Website. [cited 2024 Mar 11]. Available from: https://www.equator-network.org/
   Google Scholar
• von Elm E, Altman DG, Egger M, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. PLoS Med. 2007;4(10):e296. doi:10.1371/journal.pmed.0040296.
   PubMed Web of Science ®Google Scholar
• Bossuyt PM, Reitsma JB, Bruns DE, et al. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015;351:h5527. doi:10.1136/bmj.h5527.
   PubMed Web of Science ®Google Scholar
• Loh TP, Cooke BR, Tran TCM, et al. The LEAP checklist for laboratory evaluation and analytical performance characteristics reporting of clinical measurement procedures. Biochem Med (Zagreb). 2023;33(3). doi:10.11613/BM.2023.030505.
   Google Scholar
• Nielsen S, Bzorek M, Vyberg M, et al. Lessons learned, challenges taken, and actions made for “precision” immunohistochemistry. Analysis and perspectives from the NordiQC Proficiency Testing Program. Appl Immunohistochem Mol Morphol. 2023;31(7):452–458. doi:10.1097/PAI.0000000000001071.
   PubMedGoogle Scholar
• Zhang C, Yan Y, Zeng J, et al. Evaluation of blood lead measurements by the 6-year external quality assessment program in China. Clin Chim Acta. 2023;544:117331. doi:10.1016/j.cca.2023.117331.
   PubMed Web of Science ®Google Scholar
• Verderio P, Ciniselli CM, Gaignaux A, et al. External Quality Assurance programs for processing methods provide evidence on impact of preanalytical variables. New Biotechnol. 2022;72:29–37. doi:10.1016/j.nbt.2022.08.006.
   PubMed Web of Science ®Google Scholar
• Donoso Mantke O, Corman VM, Taddei F, et al. Importance of external quality assessment for SARS-CoV-2 antigen detection during the COVID-19 pandemic. J Clin Virol. 2022;154:105222. doi:10.1016/j.jcv.2022.105222.
   PubMed Web of Science ®Google Scholar
• Kittel M, Eichner R, Aida S, et al. Results of a European-Wide External Quality Assessment (EQA) scheme for serological detection of anti-SARS-CoV-2 (CoVimm)-pitfalls of routine application. Viruses. 2022;14(8):1662. doi:10.3390/v14081662.
   PubMed Web of Science ®Google Scholar
• Pan J, Yan H, Li Z, et al. An external quality assessment for the molecular testing of the SARS-CoV-2 virus ­genome in Zhejiang Province, China. Diagn Microbiol Infect Dis. 2022;104(3):115766. doi:10.1016/j.diagmicrobio.2022.115766.
   PubMed Web of Science ®Google Scholar
• Zhang C, Zhang C. Analysis of current status of quantitative detection of biomarkers for liver fibrosis in clinical labs in China. J Clin Lab Anal. 2022;36(7):e24490.
   PubMed Web of Science ®Google Scholar
• Asai S, Seki A, Akai Y, et al. Nationwide external quality assessment of SARS-CoV-2 nucleic acid amplification tests in Japan. Int J Infect Dis. 2022;115:86–92. doi:10.1016/j.ijid.2021.11.022.
   PubMed Web of Science ®Google Scholar
• Zhou W, Deng Y, Zhang C, et al. Current status of therapeutic drug monitoring for methotrexate, imatinib, paclitaxel in China. Clin Biochem. 2022;104:44–50. doi:10.1016/j.clinbiochem.2022.03.005.
   PubMed Web of Science ®Google Scholar
• Kang F, Li W, Lou Y, et al. Application of biological variation and sigma metrics to evaluate the performance of HbA(1c) in external quality assessment. Scand J Clin Lab Invest. 2022;82(5):398–403. doi:10.1080/00365513.2022.2100822.
   PubMed Web of Science ®Google Scholar
• Mordue KE, Hector Y, Thomas DW, et al. UK NEQAS Haematology pilot scheme: reticulocyte haemoglobin content quantitation. Int J Lab Hematol. 2022;44(6):1088–1093. doi:10.1111/ijlh.13957.
   PubMed Web of Science ®Google Scholar
• Gómez Rioja R, Ventura M, Llopis MA, et al. External quality assessment of serum indices: Spanish SEQC-ML program. Clin Chem Lab Med. 2022;60(1):66–73. doi:10.1515/cclm-2021-0786.
   PubMed Web of Science ®Google Scholar
• Buchta C, Coucke W, Huf W, et al. External quality assessment providers’ services appear to more impact the immunohaematology performance of laboratories than national regulatory and economic conditions. Clin Chem Lab Med. 2022;60(3):361–369. doi:10.1515/cclm-2021-1219.
   PubMed Web of Science ®Google Scholar
• Rollborn N, Jakobsson J, Campbell A, et al. Accuracy of determination of free light chains (Kappa and Lambda) in plasma and serum by Swedish laboratories as monitored by external quality assessment. Clin Biochem. 2023;111:47–53. doi:10.1016/j.clinbiochem.2022.10.003.
   PubMed Web of Science ®Google Scholar
• Becking EC, Linthorst J, Patton S, et al. Variability in fetal fraction estimation: comparing fetal fractions reported by noninvasive prenatal testing providers globally. Clin Chem. 2023;69(2):160–167. doi:10.1093/clinchem/hvac207.
   PubMed Web of Science ®Google Scholar
• Zhou W, Luo W, Yu S, et al. Performance of HDL-C measurements assessed by a 4-year trueness-based EQA/PT program in China. Clin Chem Lab Med. 2022;60(10):1586–1597. doi:10.1515/cclm-2020-0658.
   PubMed Web of Science ®Google Scholar
• Zhao F, Pan G, Hong M, et al. Evaluation of analytical performance of homocysteine LC-MS/MS assay and design of internal quality control strategy. Clin Chem Lab Med. 2023;61(6):1069–1074. doi:10.1515/cclm-2022-0805.
   PubMed Web of Science ®Google Scholar
• Zahr N, Duce H, Duffy J, et al. Interlaboratory comparison study of immunosuppressant analysis using a fully automated LC-MS/MS system. Clin Chem Lab Med. 2022;60(11):1753–1762. doi:10.1515/cclm-2021-1340.
   PubMed Web of Science ®Google Scholar
• Larsen JB, Hoffmann-Lucke E, Aaslo PH, et al. Automated interlaboratory comparison of therapeutic drug monitoring data and its use for evaluation of published therapeutic reference ranges. Pharmaceutics. 2023;15(2):673. doi:10.3390/pharmaceutics15020673.
   PubMed Web of Science ®Google Scholar
• Buchta C, Camp JV, Jovanovic J, et al. Inadequate design of mutation detection panels prevents interpretation of variants of concern: results of an external quality assessment for SARS-CoV-2 variant detection. Clin Chem Lab Med. 2022;60(2):291–298.
   PubMed Web of Science ®Google Scholar
• Buchta C, Springer D, Jovanovic J, et al. Three rounds of a national external quality assessment reveal a link between disharmonic anti-SARS-CoV-2 antibody quantifications and the infection stage. Clin Chem Lab Med. 2023;61(7):1349–1358. doi:10.1515/cclm-2022-1161.
   PubMed Web of Science ®Google Scholar
• Buchta C, Camp JV, Jovanovic J, et al. Results of a SARS-CoV-2 virus genome detection external quality assessment round focusing on sensitivity of assays and pooling of samples. Clin Chem Lab Med. 2022;60(8):1308–1312. doi:10.1515/cclm-2022-0263.
   PubMed Web of Science ®Google Scholar
• Stavelin A, Rønneseth 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
• Zeng J, Zhang L, Zhang J, et al. Imprecision remains to be improved in the measurement of serum cystatin C with heterogeneous systems. Clin Chem Lab Med. 2023;61(8):1455–1462. doi:10.1515/cclm-2022-1299.
   PubMed Web of Science ®Google Scholar
• Coucke W, Charlier C, Croes K, et al. Analytical performance of eight enzymatic assays for ethanol in serum evaluated by data from the Belgian external quality assessment scheme. Clin Chem Lab Med. 2022;60(8):1211–1217. doi:10.1515/cclm-2022-0285.
   PubMed Web of Science ®Google Scholar
• Keppens C, Dequeker EMC, Patton SJ, et al. International pilot external quality assessment scheme for analysis and reporting of circulating tumour DNA. BMC Cancer. 2018;18(1):804. doi:10.1186/s12885-018-4694-x.
   PubMedGoogle Scholar
• Moerman A, Vernelen K, China B, et al. Importance of anti-SARS-CoV-2 assay antigenic composition as revealed by the results of the Belgian external quality assessment (EQA) scheme. Diagn Microbiol Infect Dis. 2022;102(2):115561. doi:10.1016/j.diagmicrobio.2021.115561.
   PubMed Web of Science ®Google Scholar
• Balcaen M, Ventura M, Gil C, et al. Challenges in drug surveillance: strengthening the analysis of new psychoactive substances by harmonizing drug checking services in proficiency testing. Int J Environ Res Public Health. 2023;20(5). doi:10.3390/ijerph20054628.
   PubMedGoogle Scholar
• Bille T, Coble MD, Kalafut T, et al. Study of CTS DNA proficiency tests with regard to DNA mixture interpretation: a NIST scientific foundation review. Genes (Basel). 2022;13(11):2171. doi:10.3390/genes13112171.
   PubMed Web of Science ®Google Scholar
• Karafin MS, DeSimone RA, Dvorak J, et al. Antibody titers in transfusion medicine: a critical reevaluation of testing accuracy, reliability, and clinical use. Arch Pathol Lab Med. 2023;147(12):1351–1359. doi:10.5858/arpa.2022-0248-CP.
   PubMedGoogle Scholar
• Kouassi KC, Dorkenoo AM, Gbada K, et al. The Togo national proficiency test pilot programme for basic clinical chemistry tests. Afr J Lab Med. 2022;11(1):1565. doi:10.4102/ajlm.v11i1.1565.
   PubMed Web of Science ®Google Scholar
• Kweekel DM, McCune JS, Punt AM, et al. Busulfan interlaboratory proficiency testing program revealed worldwide errors in drug quantitation and dose recommendations. Ther Drug Monit. 2023;45(6):760–765. doi:10.1097/FTD.0000000000001107.
   PubMed Web of Science ®Google Scholar
• Hart ED, Bynum ND, Evans A, et al. A pilot PT scheme for external assessment of laboratory performance in testing synthetic opioid compounds in urine, plasma, and whole blood. Forensic Sci Int. 2023;347:111679. doi:10.1016/j.forsciint.2023.111679.
   PubMed Web of Science ®Google Scholar
• Lin G, Zhang K, Li J. A national proficiency scheme for human leucocyte antigen typing by next-generation sequencing. Clin Chim Acta. 2022;533:85–88. doi:10.1016/j.cca.2022.06.015.
   PubMed Web of Science ®Google Scholar
• Mentula S, Paakkanen J, Hyyryläinen H-L. External quality assessment by European mycobacterial laboratories: results of AFB microscopy and identification rounds. Diagn Microbiol Infect Dis. 2022;104(2):115757. doi:10.1016/j.diagmicrobio.2022.115757.
   PubMed Web of Science ®Google Scholar
• Wegner F, Roloff T, Huber M, et al. External Quality Assessment of SARS-CoV-2 sequencing: an ESGMD-SSM pilot trial across 15 European laboratories. J Clin Microbiol. 2022;60(1):e0169821. doi:10.1128/JCM.01698-21.
   PubMed Web of Science ®Google Scholar
• Mogling R, Colavita F, Reimerink J, et al. External quality assessment of SARS-CoV-2 serology in European expert laboratories, April 2021. Euro Surveill. 2022;27(42). doi:10.2807/1560-7917.ES.2022.27.42.2101057.
   PubMedGoogle Scholar
• Deans ZC, Biricik A, De Rycke M, et al. Twelve years of assessing the quality of preimplantation genetic testing for monogenic disorders. Prenat Diagn. 2023;43(4):506–515. doi:10.1002/pd.6263.
   PubMed Web of Science ®Google Scholar
• Li RH, Wang QY. A localized small-scale external quality assessment (EQA) for PCR testing of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the molecular laboratories. J Virol Methods. 2022;301:114441. doi:10.1016/j.jviromet.2021.114441.
   PubMed Web of Science ®Google Scholar
• Ziemba YC, Abdulrehman J, Hollestelle MJ, et al. Diagnostic testing for von Willebrand disease: trends and insights from North American laboratories over the last decade. Semin Thromb Hemost. 2022;48(6):700–710. doi:10.1055/s-0042-1754332.
   PubMedGoogle Scholar
• Wu H, Zhou L, Zhou X, et al. Challenges in next generation sequencing of homology recombination repair genomic variants in prostate cancer: a nationwide survey and calibration project in China. Prostate Int. 2022;10(4):181–187. doi:10.1016/j.prnil.2022.07.002.
   PubMed Web of Science ®Google Scholar
• Anthony RM, Tagliani E, Nikolayevskyy V, et al. Experiences from 4 years of organization of an external quality assessment for Mycobacterium tuberculosis whole-genome sequencing in the European Union/European Economic Area. Microbiol Spectr. 2023;11(1):e0224422. doi:10.1128/spectrum.02244-22.
   PubMed Web of Science ®Google Scholar
• Litt D, Slack MPE, Nakamura T, et al. Evaluation of the World Health Organization Global Invasive Bacterial Vaccine-Preventable Disease (IB-VPD) Surveillance Network’s Laboratory External Quality Assessment Programme, 2014-2019. J Med Microbiol. 2023;72(1). doi:10.1099/jmm.0.001644.
   Web of Science ®Google Scholar
• Ishii Y, Aoki K, Oda M, et al. A study of quality assessment in SARS-CoV-2 pathogen nucleic acid amplification tests performance; from the results of external quality assessment survey of clinical laboratories in the Tokyo Metropolitan Government external quality assessment program in 2020. J Infect Chemother. 2022;28(2):242–247. doi:10.1016/j.jiac.2021.10.027.
   PubMed Web of Science ®Google Scholar
• Deshpande GR, Deshpande K, Kaur M, et al. External quality assurance of serological diagnosis of dengue, chikungunya and Japanese encephalitis virus infection. IJID Reg. 2023;6:113–119. doi:10.1016/j.ijregi.2022.11.014.
   PubMedGoogle Scholar
• Cuénod A, Aerni M, Bagutti C, et al. Quality of MALDI-TOF mass spectra in routine diagnostics: results from an international external quality assessment including 36 laboratories from 12 countries using 47 challenging bacterial strains. Clin Microbiol Infect. 2023;29(2):190–199. doi:10.1016/j.cmi.2022.05.017.
   PubMed Web of Science ®Google Scholar
• Waldock J, Weiss CD, Wang W, et al. An external quality assessment feasibility study; cross laboratory comparison of haemagglutination inhibition assay and microneutralization assay performance for seasonal influenza serology testing: a FLUCOP study. Front Immunol. 2023;14:1129765. doi:10.3389/fimmu.2023.1129765.
   PubMed Web of Science ®Google Scholar
• Buchta C, Zeichhardt H, Badrick T, et al. Classification of “Near-patient” and “Point-of-care” SARS-CoV-2 Nucleic Acid Amplification Test Systems and a first approach to evaluate their analytical independence of operator activities. J Clin Virol. 2023;165:105521. doi:10.1016/j.jcv.2023.105521.
   PubMed Web of Science ®Google Scholar
• Steenhuis M, Wouters E, Schrezenmeier H, et al. Quality assessment and harmonization of laboratories across Europe for multiple SARS-CoV-2 serology assays. Vox Sang. 2023;118(8):666–673. doi:10.1111/vox.13480.
   PubMed Web of Science ®Google Scholar
• Blasutig IM, Wheeler SE, Bais R, et al. External quality assessment practices in medical laboratories: an IFCC global survey of member societies. Clin Chem Lab Med. 2023;61(8):1404–1410. doi:10.1515/cclm-2023-0057.
   PubMed Web of Science ®Google Scholar
• International Organization for Standardization (ISO). ISO/IEC 17043:2023. Conformity assessment – general requirements for the competence of proficiency testing providers. 2nd ed. Geneva (Switzerland): ISO; 2023.
   Google Scholar
• World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. 2013 [cited 2024 Jan 18]. Available from: WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects – WMA – The World Medical Association.
   Google Scholar
• World Medical Association. WMA statement on animal use in biomedical research. 2022 [cited 2024 Jan 18]. Available from: WMA Statement on Animal Use in Biomedical Research – WMA – The World Medical Association.
   Google Scholar
• Hansen YBL. Recommendations on measurement units – why and how. EJIFCC. 2019;30(3):250–275.
   PubMedGoogle Scholar
• International Organization for Standardization (ISO). Guide 35:2017. Reference materials – guidance for characterization and assessment of homogeneity and stability. 4th ed. Geneva (Switzerland): ISO; 2017.
   Google Scholar
• International Organization for Standardization (ISO). ISO/FDIS 33405. Reference materials - approaches for characterization and assessment of homogeneity and stability. Geneva (Switzerland): ISO; (under development); Available from: https://www.iso.org/standard/84226.html [accessed 25 March, 2024].
   Google Scholar
• International Organization for Standardization (ISO). ISO 13528:2022. Statistical methods for use in proficiency testing by interlaboratory comparison. 3rd ed. Geneva (Switzerland): ISO; 2022.
   Google Scholar
• Sandberg S, Fauskanger P, Johansen JV, et al. Recommendations for setting a criterion and assessing commutability of sample materials used in external quality assessment/proficiency testing schemes. Clin Chem. 2023;69(11):1227–1237. doi:10.1093/clinchem/hvad135.
   PubMed Web of Science ®Google Scholar
• Grubbs F. Procedures for detecting outlying observations in samples. Technometrics. 1969;11(1):1–21. doi:10.1080/00401706.1969.10490657.
   Web of Science ®Google Scholar
• Simera I, Moher D, Hirst A, et al. Transparent and accurate reporting increases reliability, utility, and impact of your research: reporting guidelines and the EQUATOR Network. BMC Med. 2010;8(1):24. doi:10.1186/1741-7015-8-24.
   PubMedGoogle Scholar
• Ahmad N, Boutron I, Dechartres A, et al. Applicability and generalisability of the results of systematic reviews to public health practice and policy: a systematic review. Trials. 2010;11(1):20. doi:10.1186/1745-6215-11-20.
   PubMedGoogle Scholar