EQAnord Hemolyseprosjekt November 2014 NKK møte 2015, Gro Gidske
143 deltakere (97%) 32 Danmark 25 Finland 4 Island 53 Norge 29 Sverige Økonomisk støtte fra Nordfond, NFKK
EQAnord Hemolysis project 2014
Prøvene (4 stk) 397 ml totalt 2,8 ml Hemolysat 5,7 ml Hemolysat 11,3 ml Hemolysat % hemolysat av totalvolum: 0% 0,7% 1,4% 2,8% 0 mg/dl 100 mg/dl 200 mg/dl 400 mg/dl
Hemolysat Masteroppgave: Sammenliknet tre metoder: - Vaskede erytrocytter - Frosset Litiumheparin blod -80 o C 2 timer - Presse gjennom tynn nål Analysert: Ålesund (Vitros) og Haukeland (Modular) Lippi, G. (2012). Interference Studies: Focus on Blood Cell Lysates Preparation and Testing. Clin. Lab., 58(3-4), 351-355.
Tidsplan Fredag: Serum tappet/separert i blodbank, 8 donorer Søndag: Tilsatt hemolysat, fra de samme 8 donorene Torsdag: Analysedag
15 Komponenter - ALP - B12 - Bil - Ca - CK - Cl - Fol - FT4 - Glu - GT - K - LD - Na - TSH - UA
Resultat: Hb konsentrasjon Pr Instrument n Sample 1 0 mg/dl added Sample 2 100 mg/dl Hb added Sample 3 200 mg/dl Hb added Sample 4 400 mg/dl Hb added Gruppe A Instrument n verdi verdi verdi verdi Gruppe B Instrument n verdi verdi verdi verdi Gruppe C osv Vektet gjennomsnitt, kvantitative resultat 96 2 114 218 441
Linjediagram (Pål):
Linjediagram: Minimum performance Bias (2002) < 0,375 * (cvb 2 + CV w2 ). Eks. Bil: ± 13% Desirable performance (2014) < 0,25 * (cvb 2 + CVw 2 ). Eks. Bil: ± 9% b=between-subject, w = within subject variation Fraser, C. G. (1999). General strategies to set quality specifications for reliability performance characteristics. Scand J Clin Lab Invest, 59(7), 487-490. Ricos, C., Alvarez, V., Cava, F., Garcia-Lario, J. V., Hernandez, A., Jimenez, C. V.,... Simon, M. (1999). Current databases on biological variation: pros, cons and progress. Scand J Clin Lab Invest, 59(7), 491-500.
ALP Sample 2 (Hb 100 mg/dl) 6 % 3 % 3 % 4 % Reject the result Reject the result with a comment Report the result ALP Sample 3 (Hb 200 mg/dl) 12 % 4 % 8 % 27 % Reject the result Reject the result with a comment Report the result 84 % Report the result with a comment No answer 49 % Report the result with a comment No answer ALP (n) Reject Sample 2 (Hb 100 mg/dl) Reject with comment Report Report with comment No answer Total (n) Reject Sample 3 (Hb 200 mg/dl) Reject with comment Report Report with comment No answer Abbott 22 1 23 1 2 19 1 23 Beckman AU 5 5 5 5 Beckman Access/Unicel 4 4 3 1 4 Kone 4 1 5 1 4 5 Perkin Elmer 1 1 1 1 Roche Cobas 2 49 1 52 5 23 12 11 1 52 Roche Integra 2 1 3 2 1 3 Roche Modular 8 8 2 6 8 Siemens Advia 1 13 3 17 1 3 11 1 1 17 Siemens Dimension 1 9 10 1 9 10 Vitros 3 3 4 3 2 15 4 4 1 4 2 15 Total 4 6 120 8 5 143 11 39 70 17 6 143 Total (n)
Spørsmål om hemolyserte prøver i laboratoriet
Denmark Finland Iceland Norway Diagramtittel Sweden 57% Automated detection of hemoglobin concentration (all samples) Manual inspection (all samples) Manual inspection, followed by automated detection of hemoglobin concentration if hemolysis is suspected Samples with unexpected analytical results are investigated for interference by hemolysis Other procedures Country (n) Total Den Fin Ice Nor Swe Total (%) Automated detection of hemoglobin concentration (all samples) 28 11 1 30 20 90 64 Manual inspection (all samples) 10 1 10 1 22 16 Manual inspection, followed by automated detection of hemoglobin concentration if hemolysis is 1 1 8 3 13 9 suspected Samples with unexpected analytical results are investigated for interference by hemolysis 1 1 1 Other procedures 3 4 5 2 14 10 Total 32 25 4 53 29 140 100
Country Den Fin Ice Nor Swe Total Median (10 and 90 10 (3-50) 10 (3-50) 10 20 (5-50) 20 (8-42) 13 (3-50) percentile) N 29 16 2 37 17 101
Yes No Other Den Fin Ice Nor Swe 80% Country (n) Total Den Fin Ice Nor Swe Total (%) Yes 32 22 1 43 27 125 88 No 2 2 8 12 8 Other 1 1 2 1 5 4 Total 32 25 4 53 28 142 100
Hvis du opprinnelig avviste noen resultat. Ville du rapportert ytterligere resultat om legen ringte? Prøve Nei Ja Totalt Prøve 2: 100 mg/dl, 2 år gml. gutt onkologisk avdeling Prøve 3: 200 mg/dl, 60 år gml. mann med brystsmerter... 50 (50 %) 50 (50 %) 100 76 (67%) 36 (32%) 112
Konklusjon: De største instrumentgruppene påvirkes stort sett likt av hemolyse og måler stort sett samme Hb-konsentrasjon (Roche Modular P/D litt høyere enn gj.snittet). 64% benytter automated detection of hemoglobin concentration (all samples). (57% Norge) 88 % har written procedures/guidelines for handling of hemolysed samples. (80% Norge) Med 1-2 % av prøvene blir det tatt «some kind of action» grunnet hemolyse. (2% Norge) Stort sett enighet ang. rapportere / avvise prøver, noen unntak. Ca 30-50% ville rapportert flere resultat dersom legen ringer, avhengig av hemolysegrad og sykehistorie.
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