Analytical performances of Hemoclot Protein C Reagent on ACL TOP analyzer
Our study aimed to evaluate and validate according to standard NF EN ISO 15189 the original protocol ajustement of Hemoclot Protein C (PC) (Hyphen BioMed), clotting-based assay of PC on ACL TOP analyzer (Werfen/Instrumentation Laboratory). We evaluated the performance in terms of imprecision and we validate additional parameters in range B required by the SH GTA 04 (COFRAC): repeatability, reproducibility, detection and quantification limits, limits of linearity, stability, inter-samples and inter-reagents contamination, inaccuracy, evaluation of interferences (hemolysis, bilirubinemia and chyles). A comparison with Hemoclot PC on STA Compact analyzer (Stago) was performed. Coefficients of variation were lower than 5 %. Detection and quantification limits were respectively 8.3 % and 9.3 %. Superior limit of linearity was 140 %. The test didn't diplay any inter-samples and inter-reagents contamination. Reagent after reconstitution was stable 6 hours on ACL TOP. No interferences were observed for hemoglobin lower than 500 mg/dL, for bilirubin lower than and for chyles lower than 300 mg/dL. Comparison with Hemoclot PC on STA analyzer (Stago) was satisfactory. Hemoclot PC adjusted on ACL TOP analyzer showed satisfactory analytical performances with criteria chosen in our study. These data allow a better knowledge of the performances of this test and were useful to make a validation file in range B as recommended by SH GTA 04.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2016 |
|---|---|
| Erschienen: |
2016 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:74 |
|---|---|
| Enthalten in: |
Annales de biologie clinique - 74(2016), 6 vom: 01. Dez., Seite 735-746 |
| Sprache: |
Englisch |
|---|
| Weiterer Titel: |
Analyse des performances analytiques du réactif Hemoclot Protein C Hyphen BioMed sur automate ACL TOP : évaluation en portée B |
|---|
| Beteiligte Personen: |
Calmette, Leyla [VerfasserIn] |
|---|
| Themen: |
ACL TOP |
|---|
| Anmerkungen: |
Date Completed 10.02.2017 Date Revised 10.12.2019 published: Print Citation Status MEDLINE |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM266231853 |
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| 245 | 1 | 0 | |a Analytical performances of Hemoclot Protein C Reagent on ACL TOP analyzer |
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| 520 | |a Our study aimed to evaluate and validate according to standard NF EN ISO 15189 the original protocol ajustement of Hemoclot Protein C (PC) (Hyphen BioMed), clotting-based assay of PC on ACL TOP analyzer (Werfen/Instrumentation Laboratory). We evaluated the performance in terms of imprecision and we validate additional parameters in range B required by the SH GTA 04 (COFRAC): repeatability, reproducibility, detection and quantification limits, limits of linearity, stability, inter-samples and inter-reagents contamination, inaccuracy, evaluation of interferences (hemolysis, bilirubinemia and chyles). A comparison with Hemoclot PC on STA Compact analyzer (Stago) was performed. Coefficients of variation were lower than 5 %. Detection and quantification limits were respectively 8.3 % and 9.3 %. Superior limit of linearity was 140 %. The test didn't diplay any inter-samples and inter-reagents contamination. Reagent after reconstitution was stable 6 hours on ACL TOP. No interferences were observed for hemoglobin lower than 500 mg/dL, for bilirubin lower than and for chyles lower than 300 mg/dL. Comparison with Hemoclot PC on STA analyzer (Stago) was satisfactory. Hemoclot PC adjusted on ACL TOP analyzer showed satisfactory analytical performances with criteria chosen in our study. These data allow a better knowledge of the performances of this test and were useful to make a validation file in range B as recommended by SH GTA 04 | ||
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
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| 700 | 1 | |a Dunois, Claire |e verfasserin |4 aut | |
| 700 | 1 | |a Amiral, Jean |e verfasserin |4 aut | |
| 700 | 1 | |a Tetegan, Marcelle |e verfasserin |4 aut | |
| 700 | 1 | |a Sep Hieng, Sonnthida |e verfasserin |4 aut | |
| 700 | 1 | |a Peltier, Jean-Yves |e verfasserin |4 aut | |
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