Improved potassium reliability in whole blood through hemolysis detection on the novel GEM Premier 7000 blood gas analyzer
Background: Hemolysis is the most frequent preanalytical error in clinical laboratories, but its detection in point-of-care (POC) settings remains challenging due to the lack of sample separation. This study was planned to validate the hemolysis index (HI) threshold of GEM Premier 7000 blood gas ana...
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Society of Medical Biochemists of Serbia, Belgrade
2025-01-01
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| Series: | Journal of Medical Biochemistry |
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| Online Access: | https://scindeks-clanci.ceon.rs/data/pdf/1452-8258/2025/1452-82582504915P.pdf |
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| author | Pighi Laura Salvagno Gian Luca Marcazzan Filippo Rizza Mariateresa Lippi Giuseppe |
| author_facet | Pighi Laura Salvagno Gian Luca Marcazzan Filippo Rizza Mariateresa Lippi Giuseppe |
| author_sort | Pighi Laura |
| collection | DOAJ |
| description | Background: Hemolysis is the most frequent preanalytical error in clinical laboratories, but its detection in point-of-care (POC) settings remains challenging due to the lack of sample separation. This study was planned to validate the hemolysis index (HI) threshold of GEM Premier 7000 blood gas analyzer for detecting hemolysis levels that may generate clinically significant interference in potassium measurement. Methods: Heparinized whole blood samples were collected from healthy volunteers and divided into six aliquots; one was used as non-hemolyzed control, while hemolysis was mechanically induced in the remaining five aliquots by repeated aspirations through a fine-gauge needle. HI and potassium were measured on GEM Premier 7000. Results: The final study population consisted of 18 volunteers. Both HI and potassium levels increased progressively and significantly with the number of fine-needle aspirations (p<0.001 for both). A strong positive correlation was observed between HI values and percentage increases in potassium concentration in hemolyzed aliquots (r=0.985, p<0.001). Receiver operating characteristic (ROC) curve analysis confirmed excellent diagnostic accuracy of HI in detecting potassium increases above the minimum total 7.4% allowable error threshold, with an area under the curve (AUC) of 1.00 and optimal cutoff of 102 mg/dL (0.94 sensitivity and 1.00 specificity). At the manufacturer-recommended 116 mg/dL threshold, the AUC was 0.95, with 0.89 sensitivity and 1.00 specificity. Conclusions: These results confirm that the novel GEM Premier 7000 blood gas analyzer provides accurate detection of hemolysis thresholds in whole blood that may impair potassium test reliability. |
| format | Article |
| id | doaj-art-2bfe3e809d4e4d03ae349292ab9ea86d |
| institution | Kabale University |
| issn | 1452-8258 1452-8266 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Society of Medical Biochemists of Serbia, Belgrade |
| record_format | Article |
| series | Journal of Medical Biochemistry |
| spelling | doaj-art-2bfe3e809d4e4d03ae349292ab9ea86d2025-08-20T03:28:51ZengSociety of Medical Biochemists of Serbia, BelgradeJournal of Medical Biochemistry1452-82581452-82662025-01-0144491591810.5937/jomb0-586041452-82582504915PImproved potassium reliability in whole blood through hemolysis detection on the novel GEM Premier 7000 blood gas analyzerPighi Laura0Salvagno Gian Luca1https://orcid.org/0000-0003-0487-9051Marcazzan Filippo2Rizza Mariateresa3Lippi Giuseppe4Section of Clinical Biochemistry, University of Verona, Verona, ItalySection of Clinical Biochemistry, University of Verona, Verona, ItalySection of Clinical Biochemistry, University of Verona, Verona, ItalySection of Clinical Biochemistry, University of Verona, Verona, ItalySection of Clinical Biochemistry, University of Verona, Verona, ItalyBackground: Hemolysis is the most frequent preanalytical error in clinical laboratories, but its detection in point-of-care (POC) settings remains challenging due to the lack of sample separation. This study was planned to validate the hemolysis index (HI) threshold of GEM Premier 7000 blood gas analyzer for detecting hemolysis levels that may generate clinically significant interference in potassium measurement. Methods: Heparinized whole blood samples were collected from healthy volunteers and divided into six aliquots; one was used as non-hemolyzed control, while hemolysis was mechanically induced in the remaining five aliquots by repeated aspirations through a fine-gauge needle. HI and potassium were measured on GEM Premier 7000. Results: The final study population consisted of 18 volunteers. Both HI and potassium levels increased progressively and significantly with the number of fine-needle aspirations (p<0.001 for both). A strong positive correlation was observed between HI values and percentage increases in potassium concentration in hemolyzed aliquots (r=0.985, p<0.001). Receiver operating characteristic (ROC) curve analysis confirmed excellent diagnostic accuracy of HI in detecting potassium increases above the minimum total 7.4% allowable error threshold, with an area under the curve (AUC) of 1.00 and optimal cutoff of 102 mg/dL (0.94 sensitivity and 1.00 specificity). At the manufacturer-recommended 116 mg/dL threshold, the AUC was 0.95, with 0.89 sensitivity and 1.00 specificity. Conclusions: These results confirm that the novel GEM Premier 7000 blood gas analyzer provides accurate detection of hemolysis thresholds in whole blood that may impair potassium test reliability.https://scindeks-clanci.ceon.rs/data/pdf/1452-8258/2025/1452-82582504915P.pdfhemolysisblood gas analysispoint of care testingpreanalytical variability |
| spellingShingle | Pighi Laura Salvagno Gian Luca Marcazzan Filippo Rizza Mariateresa Lippi Giuseppe Improved potassium reliability in whole blood through hemolysis detection on the novel GEM Premier 7000 blood gas analyzer Journal of Medical Biochemistry hemolysis blood gas analysis point of care testing preanalytical variability |
| title | Improved potassium reliability in whole blood through hemolysis detection on the novel GEM Premier 7000 blood gas analyzer |
| title_full | Improved potassium reliability in whole blood through hemolysis detection on the novel GEM Premier 7000 blood gas analyzer |
| title_fullStr | Improved potassium reliability in whole blood through hemolysis detection on the novel GEM Premier 7000 blood gas analyzer |
| title_full_unstemmed | Improved potassium reliability in whole blood through hemolysis detection on the novel GEM Premier 7000 blood gas analyzer |
| title_short | Improved potassium reliability in whole blood through hemolysis detection on the novel GEM Premier 7000 blood gas analyzer |
| title_sort | improved potassium reliability in whole blood through hemolysis detection on the novel gem premier 7000 blood gas analyzer |
| topic | hemolysis blood gas analysis point of care testing preanalytical variability |
| url | https://scindeks-clanci.ceon.rs/data/pdf/1452-8258/2025/1452-82582504915P.pdf |
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