Thrombin generation measured on ST Genesia, a new platform in the coagulation routine lab: Assessment of analytical and between‐subject variation
Abstract Background The thrombin generation (TG) assay, which measures global coagulation, has mainly been used as a research tool to investigate thrombotic and bleeding disorders. Recently, Diagnostica Stago launched the ST Genesia, a fully automated system to perform “routine version” of this assa...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-01-01
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| Series: | Research and Practice in Thrombosis and Haemostasis |
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| Online Access: | https://doi.org/10.1002/rth2.12654 |
| _version_ | 1797757815340662784 |
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| author | Søren Risom Kristensen Jette Nybo Shona Pedersen |
| author_facet | Søren Risom Kristensen Jette Nybo Shona Pedersen |
| author_sort | Søren Risom Kristensen |
| collection | DOAJ |
| description | Abstract Background The thrombin generation (TG) assay, which measures global coagulation, has mainly been used as a research tool to investigate thrombotic and bleeding disorders. Recently, Diagnostica Stago launched the ST Genesia, a fully automated system to perform “routine version” of this assay. The objectives of this study were to evaluate the imprecision compared with the previous method, Thrombinoscope CAT, and to establish reference intervals. Methods Thrombin generation was measured in platelet‐poor citrated plasma from 20 normal controls (fresh and after freezing at −80°C up to 12–13 weeks) on CAT and ST Genesia in duplicate to estimate the total variation, and within and between variations. The reference intervals were estimated nonparametrically in 30 men, 30 women taking combined oral contraceptives (COCs), and 30 women not taking COCs. These were sampled in both Vacutainer and Monovette tubes (i.e., tubes with a high and minimal contact activation, respectively). Results Freezing had minimal effects. Imprecision was comparable between the ST Genesia and CAT, with a strong correlation between the two methods. TG was higher when sampled in Vacutainer than in Monovette. We observed a distinct difference between women taking and not taking COCs, whereas men and women not taking COC were quite similar. Conclusions Thrombin generation on ST Genesia showed an analytical variation similar to that of CAT. The results depended on the type of sample tubes; thus, reference intervals must be established for the collection tubes used in each laboratory. Furthermore, a considerable difference was observed between women using and not using COCs. |
| first_indexed | 2024-03-12T18:20:57Z |
| format | Article |
| id | doaj.art-38bef942d163486e97768ccab673f504 |
| institution | Directory Open Access Journal |
| issn | 2475-0379 |
| language | English |
| last_indexed | 2024-03-12T18:20:57Z |
| publishDate | 2022-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Research and Practice in Thrombosis and Haemostasis |
| spelling | doaj.art-38bef942d163486e97768ccab673f5042023-08-02T08:53:40ZengElsevierResearch and Practice in Thrombosis and Haemostasis2475-03792022-01-0161n/an/a10.1002/rth2.12654Thrombin generation measured on ST Genesia, a new platform in the coagulation routine lab: Assessment of analytical and between‐subject variationSøren Risom Kristensen0Jette Nybo1Shona Pedersen2Department of Clinical Biochemistry Aalborg University Hospital Aalborg DenmarkDepartment of Clinical Biochemistry Aalborg University Hospital Aalborg DenmarkDepartment of Basic Medical Sciences College of Medicine QU Health Qatar University Doha QatarAbstract Background The thrombin generation (TG) assay, which measures global coagulation, has mainly been used as a research tool to investigate thrombotic and bleeding disorders. Recently, Diagnostica Stago launched the ST Genesia, a fully automated system to perform “routine version” of this assay. The objectives of this study were to evaluate the imprecision compared with the previous method, Thrombinoscope CAT, and to establish reference intervals. Methods Thrombin generation was measured in platelet‐poor citrated plasma from 20 normal controls (fresh and after freezing at −80°C up to 12–13 weeks) on CAT and ST Genesia in duplicate to estimate the total variation, and within and between variations. The reference intervals were estimated nonparametrically in 30 men, 30 women taking combined oral contraceptives (COCs), and 30 women not taking COCs. These were sampled in both Vacutainer and Monovette tubes (i.e., tubes with a high and minimal contact activation, respectively). Results Freezing had minimal effects. Imprecision was comparable between the ST Genesia and CAT, with a strong correlation between the two methods. TG was higher when sampled in Vacutainer than in Monovette. We observed a distinct difference between women taking and not taking COCs, whereas men and women not taking COC were quite similar. Conclusions Thrombin generation on ST Genesia showed an analytical variation similar to that of CAT. The results depended on the type of sample tubes; thus, reference intervals must be established for the collection tubes used in each laboratory. Furthermore, a considerable difference was observed between women using and not using COCs.https://doi.org/10.1002/rth2.12654CATcontact activationimprecisionreference intervalsST genesiathrombin generation |
| spellingShingle | Søren Risom Kristensen Jette Nybo Shona Pedersen Thrombin generation measured on ST Genesia, a new platform in the coagulation routine lab: Assessment of analytical and between‐subject variation Research and Practice in Thrombosis and Haemostasis CAT contact activation imprecision reference intervals ST genesia thrombin generation |
| title | Thrombin generation measured on ST Genesia, a new platform in the coagulation routine lab: Assessment of analytical and between‐subject variation |
| title_full | Thrombin generation measured on ST Genesia, a new platform in the coagulation routine lab: Assessment of analytical and between‐subject variation |
| title_fullStr | Thrombin generation measured on ST Genesia, a new platform in the coagulation routine lab: Assessment of analytical and between‐subject variation |
| title_full_unstemmed | Thrombin generation measured on ST Genesia, a new platform in the coagulation routine lab: Assessment of analytical and between‐subject variation |
| title_short | Thrombin generation measured on ST Genesia, a new platform in the coagulation routine lab: Assessment of analytical and between‐subject variation |
| title_sort | thrombin generation measured on st genesia a new platform in the coagulation routine lab assessment of analytical and between subject variation |
| topic | CAT contact activation imprecision reference intervals ST genesia thrombin generation |
| url | https://doi.org/10.1002/rth2.12654 |
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