Clinical Laboratory Validation Study of a High Sensitivity Troponin I Assay on a POCT (Point of Care Testing) Device
Background: In Acute Coronary Syndrome without ST-segment elevation, the use of high-sensitivity troponins in rapid protocols is considered the gold standard for diagnostic exclusion/confirmation, in conjunction with clinical stratification. The biggest concern regarding the techniques for troponin...
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Ubiquity Press
2024-12-01
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| Series: | Global Heart |
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| Online Access: | https://account.globalheartjournal.com/index.php/up-j-gh/article/view/1377 |
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| author | Fabio Grunspun Pitta Adriana Caschera Leme Simone Rodrigues Gomes Tarsila Perez Mota Fernanda Vieira Paladino José Leão de Souza Júnior Rosemeire de Paula Braz Thais Cristine Rodrigues Leonel Lamounier Jéssica Buzin Gomes Ferreira Carlos Eduardo dos Santos Ferreira |
| author_facet | Fabio Grunspun Pitta Adriana Caschera Leme Simone Rodrigues Gomes Tarsila Perez Mota Fernanda Vieira Paladino José Leão de Souza Júnior Rosemeire de Paula Braz Thais Cristine Rodrigues Leonel Lamounier Jéssica Buzin Gomes Ferreira Carlos Eduardo dos Santos Ferreira |
| author_sort | Fabio Grunspun Pitta |
| collection | DOAJ |
| description | Background: In Acute Coronary Syndrome without ST-segment elevation, the use of high-sensitivity troponins in rapid protocols is considered the gold standard for diagnostic exclusion/confirmation, in conjunction with clinical stratification. The biggest concern regarding the techniques for troponin evaluation is the time required between collection and delivery of the result. Objective: The objective of the present study is the clinical/laboratory validation of a POCT device for TnI. Methods: In the first phase of the study, samples from 108 patients with known troponin values High Sensitivity Automated Troponin T (TnT) assay from Roche Diagnostics were analyzed for analytical comparability between hs-cTnI of the Analyzer Atellica® vTLi and hs-cTnT Cobas®. The second phase of the study was performed with samples from 51 patients who reported to the emergency department with chest pain for a clinical prospective evaluation and correlation between the hs-cTnI assays of the Analyzer Atellica® vTLi, hs-cTnT Cobas® and Atellica IM 1300. Results: There was a correlation between the POCT Atellica® vTLi and hs-cTnT Cobas® in the serum samples of the control group (r = 0.660, p < 0.0001). Besides, there was a correlation between the Atellica® vTLi, serum hs-cTnT Cobas®, plasma hs-cTnT Cobas®, serum Atellica IM and plasma Atellica IM 1300 platforms in the second phase (p < 0.0001 in all cases). Conclusion: In the present study, the Siemens POCT Atellica® vTLi device showed excellent performance in laboratory validation and correlation with the high-sensitivity TnT assay in different troponin concentration ranges. Given these results, the device can be used in institutions that intend to use a POCT device for 0- and 1-hour chest pain protocols. |
| format | Article |
| id | doaj-art-1b5869bcee594ca58d1b02de19741170 |
| institution | Kabale University |
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| language | English |
| publishDate | 2024-12-01 |
| publisher | Ubiquity Press |
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| series | Global Heart |
| spelling | doaj-art-1b5869bcee594ca58d1b02de197411702025-01-08T07:57:06ZengUbiquity PressGlobal Heart2211-81792024-12-01191969610.5334/gh.13771358Clinical Laboratory Validation Study of a High Sensitivity Troponin I Assay on a POCT (Point of Care Testing) DeviceFabio Grunspun Pitta0https://orcid.org/0000-0001-7574-757XAdriana Caschera Leme1Simone Rodrigues Gomes2https://orcid.org/0009-0001-2519-5882Tarsila Perez Mota3https://orcid.org/0000-0001-7179-7350Fernanda Vieira Paladino4https://orcid.org/0000-0003-0785-970XJosé Leão de Souza Júnior5https://orcid.org/0009-0002-6393-3046Rosemeire de Paula Braz6https://orcid.org/0009-0005-4731-7982Thais Cristine Rodrigues Leonel Lamounier7https://orcid.org/0009-0005-1304-260XJéssica Buzin Gomes Ferreira8https://orcid.org/0009-0006-8137-3491Carlos Eduardo dos Santos Ferreira9https://orcid.org/0000-0001-9149-1252Hospital Israelita Albert Einstein, Laboratório Clínico, São Paulo – SPHospital Israelita Albert Einstein, Laboratório Clínico. São Paulo – SPHospital Israelita Albert Einstein, Laboratório Clínico, São Paulo – SPHospital Israelita Albert Einstein, Laboratório Clínico, São Paulo – SPHospital Israelita Albert Einstein, Laboratório Clínico, São Paulo – SPHospital Israelita Albert Einstein, Laboratório Clínico, São Paulo – SPSiemens Healthcare Diagnósticos S.A, São Paulo – SPSiemens Healthcare Diagnósticos S.A, São Paulo – SPSiemens Healthcare Diagnósticos S.A, São Paulo – SPHospital Israelita Albert Einstein, Laboratório Clínico, São Paulo – SPBackground: In Acute Coronary Syndrome without ST-segment elevation, the use of high-sensitivity troponins in rapid protocols is considered the gold standard for diagnostic exclusion/confirmation, in conjunction with clinical stratification. The biggest concern regarding the techniques for troponin evaluation is the time required between collection and delivery of the result. Objective: The objective of the present study is the clinical/laboratory validation of a POCT device for TnI. Methods: In the first phase of the study, samples from 108 patients with known troponin values High Sensitivity Automated Troponin T (TnT) assay from Roche Diagnostics were analyzed for analytical comparability between hs-cTnI of the Analyzer Atellica® vTLi and hs-cTnT Cobas®. The second phase of the study was performed with samples from 51 patients who reported to the emergency department with chest pain for a clinical prospective evaluation and correlation between the hs-cTnI assays of the Analyzer Atellica® vTLi, hs-cTnT Cobas® and Atellica IM 1300. Results: There was a correlation between the POCT Atellica® vTLi and hs-cTnT Cobas® in the serum samples of the control group (r = 0.660, p < 0.0001). Besides, there was a correlation between the Atellica® vTLi, serum hs-cTnT Cobas®, plasma hs-cTnT Cobas®, serum Atellica IM and plasma Atellica IM 1300 platforms in the second phase (p < 0.0001 in all cases). Conclusion: In the present study, the Siemens POCT Atellica® vTLi device showed excellent performance in laboratory validation and correlation with the high-sensitivity TnT assay in different troponin concentration ranges. Given these results, the device can be used in institutions that intend to use a POCT device for 0- and 1-hour chest pain protocols.https://account.globalheartjournal.com/index.php/up-j-gh/article/view/1377point-of-caretroponinchest painacute coronary syndrome |
| spellingShingle | Fabio Grunspun Pitta Adriana Caschera Leme Simone Rodrigues Gomes Tarsila Perez Mota Fernanda Vieira Paladino José Leão de Souza Júnior Rosemeire de Paula Braz Thais Cristine Rodrigues Leonel Lamounier Jéssica Buzin Gomes Ferreira Carlos Eduardo dos Santos Ferreira Clinical Laboratory Validation Study of a High Sensitivity Troponin I Assay on a POCT (Point of Care Testing) Device Global Heart point-of-care troponin chest pain acute coronary syndrome |
| title | Clinical Laboratory Validation Study of a High Sensitivity Troponin I Assay on a POCT (Point of Care Testing) Device |
| title_full | Clinical Laboratory Validation Study of a High Sensitivity Troponin I Assay on a POCT (Point of Care Testing) Device |
| title_fullStr | Clinical Laboratory Validation Study of a High Sensitivity Troponin I Assay on a POCT (Point of Care Testing) Device |
| title_full_unstemmed | Clinical Laboratory Validation Study of a High Sensitivity Troponin I Assay on a POCT (Point of Care Testing) Device |
| title_short | Clinical Laboratory Validation Study of a High Sensitivity Troponin I Assay on a POCT (Point of Care Testing) Device |
| title_sort | clinical laboratory validation study of a high sensitivity troponin i assay on a poct point of care testing device |
| topic | point-of-care troponin chest pain acute coronary syndrome |
| url | https://account.globalheartjournal.com/index.php/up-j-gh/article/view/1377 |
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